Pfizer

Within 5 minutes of the vaccine, patient had wheezing, shortness of breath and chest pain. patient given epi x 4, decadron, fluids with some improvement and then hospitalized. IN the hospital, patient continued to have chest pain and satting well but with protracted course and is still in the hospital.

Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold

Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."

Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.

Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021 MRN: 3274958   Subjective Patient is a 60 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.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, 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 abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020   PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.     ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm     APRN Electronically Signed 1/6/2021 12:45 PM    

Pfizer BioNTech COVID-19 Vaccine EUA Patient given vaccine and nurse used CDC screening check list. Patient's noted yes to allergies made nurse talk to lead nurse regarding allergies. Plan of care was to vaccinate but have patient stay at least 20 minutes. During the 20 minute wait, the observer was notified by patient she was having some throat tickling and tightening. Observer notified lead nurse. Lead nurse approached patient and had her move from waiting area back into her nurses room. Patient complained of throat tickling and tightening but stated she was fine. Nurses noted increasing coughing. Pulse ox and respirations checked. Patient continued to state she was fine and was not in physical distress. Nursing director was called and nurses advised to give epi and follow protocol. Epi given in left thigh. Patient vitals monitored and patient was able to tell throat started to loosen and coughing stopped. 911 called but patient refused transport after EMS assessed patient. Nursing Director discussed patient incident with Medical Director and nurses were advised to administer a IM dose of benadryl. Patient agreed and verbalized understanding her risks of not going to ER for monitoring. Patient signed refusal for treatment form and planned to call her doctor when she left. Patient vitals were stable and patient left clinic on her own accord around 11:00 am.

Progress Notes Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Patient is a 60 y.o. female who was seen at SVH COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience throat tightness. She denied rash, hives, welts, 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 she 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 with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   No previous hx of vaccine reactions.     ALLERGY REVIEW OF SYSTEMS: All other systems negative       Objective   Vitals Vitals:   01/06/21 1705 01/06/21 1720 01/06/21 1724 BP: 134/82 (!) 145/84 134/72 Pulse: 94 80 77 SpO2: 97% 99% 100%     Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal.       Assessment/Plan Treatment included: antihistamines and benadryl. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Diphenhydramine 25 mg given at 5:15   Pt dismissed at 5:25.

dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath

She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F

Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest

Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inhaler for 3-4 inhalations. Given Epinephrine, Benadryl, Solu-Medrol IM injections administered. 2L O2 via NC applied. Elevated BP and HR noted. Patient transported to ER. Duo-Neb nebulizer treatment provided. Bronchospasm and Wheezing subsided after approximately 45 minutes. Patient discharged hone with Prednisone and EPI pen prescriptions.

Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.

Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.

I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.

Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.

Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.

1 hour after vaccine -itchy injection site and small rash starting on top of left arm, took 50mg of Benadryl 1 hour after Benadryl- rash was spreading to the whole arm , neck and intermittent labored breathing started patient was taken to hospital and received 2 doses of epinephrine and nebulizer treatment

Pfizer BioNTech COVID-19 Vaccine EUA approximately 10 minutes after receiving her second dose, patient report throat tingling and tightness. Later started to have an intermittent cough

allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it. Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.

After my vaccine, started coughing so bad. I had a Covid test which was negative and they gave me antibiotics. They also gave me an inhaler for my wheezing. I also felt a tightness sensation in my chest and lungs from all the coughing.

Wheezing, shortness of breath, felt like someone was sitting on my chest. Was given a burst of 40mg of Prednisone for 3 days and Nebulizer treatments 4 x a day. The Prednisone and nebulizer treatments helped.

headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm

Developed Itching and feeling of tightness in back of nose/throat. Advised employee to go to ED. Was given 1L fluid, Solu-Medrol and Benadryl. No swelling of airways was observed and no respiratory distress noted. ED discharged patient to home.

minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.

Swelling of face & throat; rapid heart beat Hospital I received, a steroid shot & Hydroxyzine pill and Rex?s + contact regular doc 3 Rx-1) 40 mg Prednisone for 4 days 2) Hydroxyzine 25mg as needed 3) Epi pen RETURNED TO ER 2/5/21 same symptoms after taking prednisone; told to take Hydroxyzine even though I have no rash & rare itchiness. ON GOING SYMPTOMS; UNRESOLVED

Tightness in chest, throat swelling, tongue tingling. Lasted about 45 minutes. Did NOT use epipen. Went to ER on site, received saline IV, was thoroughly checked and monitored, stayed 2 hours.

shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.

The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection site, about the size of a 0.50 cent piece. Later that day I had a fever of 102.5 and chills. Day 3 the redness had spread and still had the lump. Day 4 or 5 the color changed to purple and the lump had decreased. It took about a week for the lump to go away. I still have a discoloration on my arm where the vaccine was given. It looks a bruise but no pain. The whole time the area blanched well. The first dose I had on my left arm and the next day I had a small welt with redness. I am on my second round of steroids to try and get my asthma under control and had to increase my Advair to the highest dose. My doctor put me on a antibiotic as well with the second round of steroids. My asthma is a little better but not at my baseline.

Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.

presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021

Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.

SHORTNESS OF BREATH 1.29.21 TO CURRENT AND HAS NOT STOPPED, EXTREMLY TIRED FOR 7 DAY, FAST HEART BEAT. DIZZINESS FOR APPROX 4 DAYS, HEADACHE FOR APPROX 4 DAYS

Being a diabetic, my blood sugar was in the 300's, and even after changing my insulin pump because I believed there may have been an issue with delivery, my blood sugar continued to rise. I did not eat anything until about 6 PM when my blood sugar began to lower. At that time, I tried to eat some chicken soup, but after a few mouthfuls, my throat began to constrict and my tongue and the inside of my mouth began to itch. This continued every time I began to try to eat something and I still could feel what felt like some constriction in the back of my throat the next day (Monday).

5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.

Felt like throat was closing, gave epinephrine and Benadryl, called EMS who transported patient from building to ER.

I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.

10 minutes after getting the shot I felt like I was going to pass out, I felt like my heart was beating slowly, I was breathing but felt like I couldn't get a good breath. It lasted about 5 minutes. I had the same reaction on methotrexate, which I quit taking.

On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.

Throat tight, tongue feels numb, chest pressure. Evaluated by EMS- Transported to Emergency room/department or urgent care.

Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma

This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.

within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.

I began experiencing shortness of breath the day after the vaccine. I went to my primary care physician and he referred me for a chest xray. There was a small area of linear opacity near the right lung base. This could be related to atelectasis or acute infection. The remainder of the lungs clear, no pleural effusions. Heart size not enlarged. Normal contour of the mediastinum. No acute osseous findings.

acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse voice, presyncope but epipen administered on site of vaccination location to avert syncope or cardiovascular collapse promptly. Symtoms occurred within 10 minutes of vaccine administration . Vaccine given 12:18 pm or 12:25 pm and symptoms within 10 minutes since in ER 12:30 pm but had received epipen en route before ER arrival since medical building was next to ER

1/11 vaccination 1/12 I just had body aches, chills. 2:13 PM i was on my couch, I could hear myself having trouble breathing while dreaming. I sat up, elevated, and went back to sleep. SOB that afternoon. I slept and woke up the next day and felt fine, went to work. 1/14 I worked all day. 3:10 I couldn't breath. Was with my neurologist. Pulsox was 79. I went to the ER. Hooked me up to IV, chest xray. Dr. said anxiety was up. After 4.5 hours I was able to go home. symptoms subsided.

Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

Lip swelling and shortness of breath that began about 10 hours after injection. Other common post vaccine symptoms were observed.

A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back area which persisted to a heaviness in my chest going into Thursday. Thursday night I woke up in the middle of the night to the feeling of not being able to breathe. I laid awake for a while but dosed back off and it happened again a little later. It felt as if someone was sitting on my chest which prompted me to go to the ER the next day. Various test were done and I was admitted in the hospital for further observation. After admission I developed a massive headache which lasted from that Friday afternoon until that Sunday. I was released on that Sat and the symptoms seemed to be getting better and by that Sunday evening all symptoms had subsided.

12 hours post vaccine, began to experience extreme chills, hyperventilation, breathing difficulties, and fever of 103. Couldn't talk due to chills without extreme stuttering. Ended up being transported to a local ER for care where I remained for approximately 7 hours. Was given IV fluids and Toporol to control fever. Fever persisted for 72 hours, loss of appetite and extreme fatigue. Now 7-days post 2nd shot and still experiencing fatigue.

As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.

I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird. The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs. Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad. My stomach feels better. Haven?t eaten anything, I am more concerned about under my breast hurt so much when I take a deep breathe or cough. I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting

COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

Fever (fluctuated between 99 and 102 degrees), chills, achy body, nausea, headache for approximately 12-15 hours did not feel well. The next morning (Sunday 3/21) woke up nauseous and had trouble breathing. Went outside for cold air and breathing was OK.

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

Shortness of breath, dizziness, chest pressure, started about 5 minutes after administration of vaccine.

Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk to the bathroom and made aware that we needed her to be stable before getting up again. Patient took a 5 minute rest and felt better. Patient guided to the bathroom but once she came out of the bathroom she became dizzy again. Patient was provided with a chair again but started to become frantic so we provided her with a cot and laid her down but patient started to become very short of breathe. Medics called and provided with hand off.

Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days

Began to feel bad one week after receiving injection and made appt with provider, xray showed infiltrate, pnuemonia, in right lower lobe, antibiotics prescribed and taken increased shortness of breath at time of visit.

Pruritis, shortness of breath Patient to the hospital via EMS. Vitals remained stable and lungs clear. Vitals upon discharge 164/99, HR 86, oxygen saturation 98%. Patient was observed until 12:15pm and was wheeled out to her transportation service.

As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.

Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**

Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hip, sore to touch, tired. Day 3 bone, muscle pain moved upper back, tired. Took aspirin. Day 4 bone, muscle pain more extreme, tired. Took aspirin. Day 5 extreme pain in hip and ribs, sore to touch hard to breath, fainted, tired. Took tylenol. Pain went away

100? Fever, total body aches, nausea, inflammation, some shortness of breath, chest tightening, fatigue, headache.

2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breathing and lip swelling at 7pm. Brought to ED, given epipen and methylprednisolone. Monitored closely overnight, symptoms resolved by AM.

Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021

Patient immediately reported onset of a throbbing headache, consistent with her first shot. A few minutes later she noted that she had some "tingling" sensation along the back of her throat with the sensation of tightness, though she denied any shortness of breath, chest pain, or any difficulty breathing. Pt examined intermittently without any progression of symptoms. At 4:50 pm, pt checked out,

Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.

tickle and cough. pt. has a hx of asthma. pt. self medicated herself with her inhaler in total 4 puffs; lungs all clear. no SOB. pt. states she feels better and wants to go home. HX- Asthma- food allergies. BP: 132/78; O2=98%; P=76

Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinephrine (patient thinks 2 doses) and Benadryl administered in the field. Patient brought to hospital by ambulance where she received IV SoluMedrol, Pepcid, Benadryl, and fluids scheduled throughout hospitalization. Patient improved and was discharged the following day (3/27/21).

Important to share: I had a strong case of Covid in March, 2020. No hospitalization and no need to go to hospital but I was very sick for three weeks. Oddly, after Covid I had odd heart pains and erratic high blood pressure. I saw a cardiologist and my heart was fine but it lasted on and off for months. I've been very well for months now. 1) The day after the shot, I felt tired and had a headache, which is expected and no big deal. The evening after the shot I experienced a lot of pain around my heart area. It was very similar to what I experienced post-Covid but more painful. It hurt enough that I went to the ER at Hospital in because of the chest pain. EKG, chest x-ray, and all blood tests were normal. 2) The next day, I fell asleep on a hammock in my backyard. I was wearing jeans and a sweater so the sun wasn't directly on me but I noticed later that the outside of my R leg and the inside of my L leg were covered in a red, lacey-looking rash. Oddly, my arms and torso had no rash. I called my Internist (Dr.) who asked me to email photos. She said it looked like an allergic reaction to the vaccine and advised me to submit info on this site and to take a benedryl. The rash was definitely where the warm sun hit me.

Patient is a 60-year-old female with a past medical history of of restrictive lung disease, Poland syndrome right side of the chest, 50% lung capacity at birth s/p multiple surgeries, left breast cancer in 2018 s/p lumpectomy/chemo/radiation, neuropathy presented to the ED with complaints of chest tightness and shortness of breath which started yesterday morning. She reports that she uses oxygen 3 L nasal cannula as needed at bedtime, her O2 sat was 93%, yesterday she was using the oxygen. She received her second dose of Covid vaccine yesterday, the symptoms worsened after that. She received DuoNeb, magnesium sulfate 2 g, Solu-Medrol 125 mg from ED. ED provider planned her discharge, patient states she has to come back after calling EMS since she is hard to breathe. Patient wants to currently she is resting in bed without any distress, O2 sat 96% on room air at the monitor. Her second EKG showed ventricular bigeminy. Troponin 0.012, 0.012. 2 D echo done on 4/29/2019 shows EF 58%, mild concentric LVH. Her BP was high while at ED, states usually normal.

Received 1st dose of Pfizer vaccine at 1:50 pm and verbalized no discomfort. At 2:10pm complained of slight tightening in her throat that was not there before the vaccine was given. Oxygen Saturation = 98% on room air. Vitals were: BP 110/76, HR 86. Given 2.0L oxygen via nasal cannula. Oxygen Saturation = 99%. Pt. denied any complaint of difficulty breathing or chest pain. NP assessed patient and ordered Diphenhydramine 25mg IM stat. Order given via right arm. Patient continuously monitored. At 2:20 pm vitals were: BP 107/67, HR 82. Patient verbalized relief of symptoms. At 2:45pm, vitals were: BP 104/67, HR 79 and 134/89, HR 92. Patient remained asymptomatic. Patient was discharged to home ambulatory alert and oriented x 3 and MD was informed of event.

Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.

Nausea - Not Diaphoretic Reports being "lightheaded" No Emesis No Syncope No rash Reports being cold Reports tightness in throat - EMS activated

Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.

Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shortness of breath, Blood pressure elevated and elevated Heart rate. Duration: 30+ minutes.

After about 30 minutes experienced a warm flushing feeling and shortness of breath. Lasted about 8-10 minutes and then started to subside. Pulse oximetry 99%, HR 72, BP 144/84, RR 20. States she has had anxiety reactions to vaccines in the past. Monitored for an extra 30 minutes. Refused Benedryl or Epinephrine. Refused a visit to emergency room. Advised when leaving if symptoms increase to search out medical care. States she feels back to her normal self upon leaving.

My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2

anaphylaxis with stridor and diffuse wheezes. No rash, GI symptoms. Received epinephrine, bronchodilators, IV steroids, histamine blockers, epinephrine drip. ICU admission

1358 60 y/o female received 1st Covid vaccine and was sitting in observation room for 30 minutes. At the 30 minute mark pt stated that she felt dizzy when she tried to stand up. Brought Pt to backroom for evaluation she stated that her tongue felt thick and her lips felt numb. Vitals BP 136/75 P 74 Temp 99.3 . Pt was evaluated by Dr and he determined that she needed to be observed. 1412 Asked pt how she was feeling "Right eye feels funny like pressure and her throat was tight. At this time Dr determined that pt needed Epi Pen. 1413 Epi Pen administered to right thigh EMS was called. Vitals BP 174/86 P 75 R 22. Denied difficulty breathing. Pt became very emotional and stated she was scared. Reassured pt she was going to be fine and provided additional blankets for her chills. 1419 EMS took over her care

Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.

tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious. Information on the lot/batch number has been requested.

Two weeks after 1st Pfizer shot I began to have very heavy breathing while on a daily walk that continued with any exertion. It continued for several days. I called PCP and was seen. Chest Xray & bloodwork was done. Was called to go to E.R. for CT scan of lungs. Pulmonary Embolisims were seen and a blood thinner was given. Heart monitored for previous Afib (ablation performed 5 yrs ago). CT scan w/dye was done of abdomen, Right leg ultrasound with compare L, MRI w/contrast done of abdomen/pelvis. No reason has been found for cause of several blood clots in both lungs - sub arteries. Am being followed up by Vascular Doctors in 2 weeks.

Very bad sometimes extreme pain in my left breast area that radiates into my chest area. Hurts to touch my left breast area and the pain is a shooting pain that is constant and feels like a stabbing pain. Hurts to move my left arm. I've been taking 3 Advil at a time and the pain subsides for a couple of hours but comes back. It doesn't matter if I'm sitting up or lying down the pain is always there. I sometimes feel like I've had the wind knocked out of me when the pain radiates to the front of my chest area. There is no longer any pain at the injection site.

Pt calling to report a vaccine reaction to the 1st dose of covid vaccine. Pt describes about an hr after the shot she experienced dizziness, flushed face, tightness in throat, feeling of obstruction in her throat.

Dizziness, diaphoretic Felt like throat was tight Chest clear, airway clear and was very anxious Benadryl 25mg given by mouth

Three days after receiving her first vaccine dose, patient developed a sore throat that felt like she had a foreign body in her throat. Throat began to swell, had trouble breathing. Patient was driven to urgent care where she received a steroid shot and antihistamine. Patient felt better the next day but woke with eyes swollen shut. She took Benadryl and made an emergency appointment with an ophthalmologist. Patient was prescribed prednisone drops.

I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated many, many times in past without any side effects. It was uneventful. The following AM, I felt exhausted, dizzy, had mild headache, thirsty, and had minimal nausea. And when I tried to do my daily walk of 3 miles, I was SOB on hills so I stopped. I had no F/C, cough, CP, palpitations or resp symptoms at rest. I pushed fluids and rested. I held my BP meds thinking I was a bit dehydrated and maybe my BP was low. After 4 days of no improvement, I went to see my internist. Exam, ECG and CBC, Chem 7 were all normal. BP was mildly elevated so I restarted my meds. These symptoms slowly resolved over next several days and now I feel back to normal. So I don't know if these were delayed side effects to COVID vaccine or due to the blood donation. I'm a bit worried about receiving the #2 vaccine.

Since this vaccine I now have frequent painful mouth ulcers and tiredness. I seem to lose my breath more easily than before. I am afraid to get the second dose. There is a study that COVID has these sores as a symptom - why are we not learning of this? Also, no one provided me with any information that would indicate the vaccine could create a problem if given while taking other medications. I have all of my paperwork from that first shot. Yet at this site there is a file full of possible adverse interactions.

Patient vaccinated and complained initially of tingling sensation in fingertips at 1025. Patient went to bathroom 10 minutes later. At 1045 patient began complaining of coughing, throat was "tight", face was visibly flushed. RN called Pharmacist requesting Benadryl. Patient declined the liquid Benadryl offered by the pharmacist. Patient had her own Benadryl 25 mg tablets in her car. She agreed to take one 25 mg Benadryl po at 1050. Patient normally takes 50 mg po every day and wanted to take another dose so she did at 1053. Pulse was 60 and regular. Patient did have relief of symptoms, decreased flushing, decreased throat tightness, and more calm after 30 minutes. Patient agreed to wait awhile longer. She was encouraged to follow up with her primary care doctor to discuss reactions and to determine how to proceed regarding getting a second dose of Pfizer vaccine. At 1215 patient felt fine to drive home. She was accompanied by her son. RN to call patient later to see how she is feeling.

SOB and wheezing much improved and nausea subsided. Pulse OX remained 96% or above. Team member allowed to leave and return to work. ,Team member had some brief nausea after vaccine given however it passed and she left the vaccine site after 15 minute, Team member rested on stretcher for 15 minutes Hr decreased to 90 SOB and wheezing much improved and nausea subsided. Pt had Shortness of Breath, Wheezing.

Patient called me Wednesday April 14,2021 at 12:44 pm explaining that she was having a hard time breathing that day. Due to her chronic lung health, I didn?t think much of it. She passed away in the early hours of Thursday April 15,2021 in her sleep.

4/4/ Patient returned to the ED with SOB, cough and home pulse ox readings in the 80's. She was started on O2 at 2L NC and was admitted on IV Remdesivir and Decadron. By 4/8, she was able to be weaned off O2 and completed 4 days of Remdesivir and Decadron therapy. She refused rx to complete 10 day course of Decadron due to concerns regarding hyperglycemia and her diabetes.

Following my first Covid 19 Pfizer vaccine 03/11/21: **Note, I went through 1 1/2 days dull ache in arm no concerns > days 2--5 went through a HYPER-WELL (no age aches, prior-hurt finger didn't ache, energy, ladies room habits back to what I reported to daughter "age 20!" for these four days, amazing, enjoyable, then > day 6 very early am woke up with swollen neck lymph nodes half-palm sized rocks on neck, breathing difficulties (lungs not neck), bad dull intrusive headache (different pain from Migraine, or low-hydration pain), cough dry and have called this my HYPER-CRASH because I could barely walk, backward C-shape abdomen hurt (dull ache big always + frequent stabbing pains from below bra bottom line to left abdomen down side then curving to my right across bottom abdomen at both leg-attaches-to-abdomen locations. Difficulty breathing, pain, extreme swelling over upper abdomen when I even drank water to swallow morning Hydrochlorothiazide pill and would stay swollen for 4-8 hours with continued surprise to me gulps of air throughout period, weak, nausea but not vomiting, dizzy, unable to walk more than a few steps at a time, fever taken and wavered from 95 to 99 degrees (my usual body registered 97.8 degrees) but never over 99 degrees, and only over 97.8 degrees perhaps three times very little above it and only for a few hours. >>I went to Urgent Care in person no better at all on 3/24/21/roughly day 12 after vaccine shot 3/11/21 (Urgent Care) which took blood and urine tests determining roaring infection and blood in tests and a CT CONTRAST scan should be ordered by my PCP asap at appt PCP already scheduled 3/26/21 but she couldn't order CONTRAST version the PCP would need to and she prescribed three antibiotics to take over next 2 weeks >> I went to PCP 3/26/21/day 14 after vaccine shot and he ordered CT Scan but insurance required pre-auth and they refused it at first so PCP referred me to GI SPECIALIST who again referred me for CT CONTRAST test, which I did have on Friday afternoon 4/16/21 (Clinic), and I await the results today 4/19/21. Today I continue to have pain abdomen, though softer and throbbing, same C-shaped region, HUGE issue even drinking water with Hydrochlorothiazide pill only for many hours as abdomen swells at bottom bra-line center in a palm size mound for hours, and back hurts badly, solid headache which may be only right side of head more than left but I am taking nothing for any symptoms afraid of GI issue. NOTING AGAIN: Yes I was diagnosed roughly 2015 with a single incidence of diverticulitis/osis by GI SPECIALIST in Town and went through series of Colonoscopies and tests, but tests only determined incidental few polyps removed over all tests and no incidents at all since that. Knowing what I know of my body and health, the trigger seemed to be the first shot of Covid 19 Pfizer vaccination which remarkably seemed to react first with a few days of better health than I have had for decades (eating, moving, energy etc. for my age), where after days of extreme great health and energy (where I went nowhere, and still did not push myself much) my body then crashed to unable to move much or even breath normally for many days after and with a multi-level infection in my gut that needed three antibiotics and after those I still hurt in the same locations. I cannot confidently rule out the Vaccine as the cause, and what I know of my body suggests in fact some "overdrive" function in my system was triggered and then caused the crash that resulted in infection and that continues to interfere with my walking, eating, moving, breathing, and even drinking a small glass of water today. Final note: PCP confirmed I should take the second Vaccine Pfizer shot, which I did on 4/1/21 - same site, Lot #EW0150, after which second vaccine shot I had the same two days of dull arm pain, and I continued to finish the antibiotics until finished (but pain though softer continues to today). I did not experience a #-Days HYPER-WELL episode then HYPER-CRASH after this second vaccine shot, only the arm ache, but throughout was still very unwell (breathing, pain, no activity, weak, unable to eat, swelling, headache, cough intermittent, back hurts, etc.) throughout, and same to this day 4/19/21 as I await CT CONTRAST results. I felt compelled to share I feel this was triggered by the first Vaccine shot, and would not have happened had I not had the Vaccine shot. Thank you.

2 days after shot I felt unable to get deep breaths, slight pressure in chest and feeling of shortness of breath. 3rd day cough developed, and continued for 6 days, now is improved but still slight cough and not quite normal

Redness to face/arms, Itching to body Shortness of breath, Feeling it move to my mouth, throat, nose, so far some symptoms have lasted 3 days

Received the shot about 1:30. Everything was fine. By evening, the arm was sore and left armpit hurt. Went to bed about 10. Woke up about 1:30/2:00 with left arm hurt a lot. Took Advil and went back to bed. Woke up at 4 am to get ready for work and felt awful. Noticed was out of breath on short horizontal walk from bedroom to bathroom, chest tight, acting like an asthma attack. Took a puff of albuterol inhaler and went back to sleep. Got up just before 7, still sore to breath. Grabbed oximeter (being asthmatic, I have one) and noticed )s level down to 94/95 when normally it reads 98/99 on this one. Called allergist to cancel allergy shot scheduled for that morning. Took another puff of albuterol. (Waiting to see if need nebulizer.) Breathing becoming easier and reading now about 97/98 with pulse lower, more normal. Lungs a bit touchy this time of year anyway. And I have had allergic reactions in the past take place as an asthma attack. (For instance, if I eat a small quantity of something with yellow dye 5 in it, I will notice that my breathing is more difficult.)

Have had rapid heartbeat, little shortness of breath, blood pressure has been elevated. More severe than normal heartburn, little burning in chest and gallbladder pain. not sleeping well because of it

Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.

3/19/21: patient is a 60yo female who presented with complains of facial droop. The sister reports the patient complained about headache in the left temporal area around 8-9pm, reports having the same pain throughout the week but today was stronger, and the sister noticed she had facial droop and was unable to open her left eye. The patient also reports abdominal discomfort the the epigastric region and LUQ that started today and was associated with nausea. She denies diarrhea or fever. Of note patient reports having Covid Pfeizer vaccine yesterday and 5 minutes later being were unable to speak with edema in her lips and tongue, associated with SOB. She was taken to a ER, was given epipen, albuterol, benadril, prednisone and was discharged home at night with improvement on her symptoms. Patient discharge note on 3/22/21: Admitted for facial paresthesias in setting of arnold-chiari malformation, HTN, HLD, after covid vaccine, neuro work up neg, discharged home on 3/22/21.

Fever; Fast heart rate; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 05Apr2021 17:00 (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included ongoing cholesterol high (States it doesn't require to take medication, it's under control. Diagnosed in 2016-2017). The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2, via an unspecified route of administration on unspecified date (Lot Number: EN6204) as single dose for covid-19 immunisation and the patient sprained her ankle and it is a little swollen, not so much. The patient experienced fast heart rate, shortness of breath on 06Apr2021; fever on 06Apr2021 10:00. Her symptoms started with a fast heart rate and a little shortness of breath. She went to the doctor and had an echocardiogram which was negative for any heart problems. She adds that she had the vaccine on Monday, on Tuesday she had fever. Her fever started in the morning at 10:00 and had it the whole day until 2200-2300 that same night. Her fever reached 100.6 degrees Fahrenheit. She did not treat the fever in any way. Her fast heart rate started on Tuesday, which come and goes. She did not treat her symptoms in any way after the second dose. The doctor had told her it would be better if she doesn't take anything. The events fast heart rate, shortness of breath required a visit to physician office. The outcome of the event Fast heart rate was recovered on 08Apr2021, fever was recovered on 06Apr2021 23:00, Shortness of breath was recovering. No follow-up attempts are needed. No further information is expected.

1 month of malaise, sore throat, dry cough, and shortness of breath. The patient initially attributed her symptoms to seasonal allergies and felt that they got worse after she received her pfizer covid vaccination on 3/20 and 4/11.

She had a slow infection in her chest; She was breathing fine, but she got out of breath every now and then; her immune system was not too good; no sleeping; She was so tired; she woke up on Thursday (08Apr2021) sick; She had a cold all year long, but normally doesn't have a color from her chest and nose (mucus). She said she now had a color to her chest and nose mucus; Has had a bad cold after the vaccine and an infection in her lungs; She had no energy, and couldn't work; This is a spontaneous report from a contactable consumer, the patient. This 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration in the left arm on 07Apr2021 around 12:15 (at the age of 60 years-old) for COVID-19 vaccination. Medical history included smoker since 1976 pack-a-day of cigarettes since 16, quit for 11 months, she went back to smoking, x-rays done in the 1990's and the patient was told that the lower part of her lungs were flat and was told she had chronic obstructive pulmonary disease (COPD) and emphysema at that time. She said her lungs were pretty bad. Family Medical History Relevant to adverse events were not provided. Concomitant medications included ascorbic acid, rosa canna fruit (VITAMIN C PLUS NATURAL ROSE HIPS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had a slow infection in her chest on an unspecified date (also reported as her doctor told her she had a little bit of an infection), a bad cold after the vaccine and an infection in her lungs on Apr2021, she woke up on Thursday 08Apr2021 sick, was so tired on 08Apr2021, had no energy and slept for 5 hours, couldn't work on Apr2021, had a cold all year long, but normally clear drainage from her chest and nose, she now had a color to her chest and nose mucus on Apr2021, she was breathing fine, but she got out of breath every now and then on an unspecified date and her immune system was not too good on an unspecified date. She reported that on 11Apr2021 to 13Ap2021 she has been fine, no sleeping. The patient had been told by her doctors that her immune system was not too good, and she should quit smoking. She said her sister was a licensed practical nurse (LPN), and her sister told her that she thought she (the reporter) may have had a cold when she got her first COVID-19 Vaccine. She said she had felt good since Sunday (12Apr2021). She said she felt stronger, but her cold was not better. She said she was breathing fine, but she got out of breath every now and then. The patient reported that she would get a lung infection if she had a bad cold. She said her doctor told her she took way too many antibiotics in the past, and now her body was used to the antibiotics It was also reported that she said she doesn't take antibiotics. She reported that her second COVID-19 Vaccine dose was scheduled for 05May2021, which was 4 weeks after the first COVID-19 Vaccine dose. There were no relevant laboratory tests done. There were no emergency room (ER) or physician office visits. Nature Made Vitamin C 1000mg yesterday (12Apr2021). She said she was taking 1 Nature Made Vitamin C (Lot Number: 2370401, Expiration Date: Feb2024) 1000mg a day. Adverse events following prior vaccinations were not applicable. The clinical outcome of no sleep, chest infection, no energy, couldn't work, out of breath, immune system was not too good was unknown, not recovered for cold, sick, color to her chest and nose mucus and recovering for tired. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish directly; feeling discomfort in my lungs; pain in my lung/chest area; pain in my lung/chest area/right-sided chest pain under the rib; difficult and extremely painful to breathe/significant shortness of breath/shortness of breath due to extreme pain; blood clots; This is a spontaneous report from a contactable consumer (patient) and physician. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 07Apr2021 17:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at time of vaccination. The patient's concomitant medications included cetirizine, diphenhydramine, and phenylephrine. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), right arm first dose on 10Mar2021 for COVID-19 Immunization. On 07Apr2021 21:30, the patient felt sluggish directly after receiving the second dose. The patient began feeling discomfort in my lungs about 5 hours after the dose. The pain in my lung/chest area grew worse throughout the night to the point where it was difficult and extremely painful to breathe. The patient went to urgent care in the morning, and they ran an EKG, urine analysis, and chest X-ray: all with unknown results. They were concerned it could be something worse along with potential pneumonia, so they sent me to the emergency room. In the emergency room, I received a CT scan where they found multiple pulmonary embolisms (1 large one in my right and multiple in my left lung). The patient stated that she had just had my yearly physical the previous week (Apr2021), with no signs of any health issues. With that, the doctors believed my condition to be related to my 2nd dose, so I was admitted to the hospital. I had to stayed for 2 nights. I am now on blood thinners, other meds (pain medications), and require oxygen during sleep (O2 levels drop too low). I have been referred to lung and hematology specialists. Also, reported that patient experiencing significant shortness of breath and right-sided chest pain under the rib. This persisted for some time until she presented to the emergency department found to have segmental and subsegmental pulmonary embolus. Additionally, the patient experienced blood clots, chest pain, and shortness of breath due to extreme pain. Hypercoagulable work-up pending. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. 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.

One hour post vaccine - severe SOB lasting maybe 30 min, followed by right leg/ankle/foot swelling - not painful, but would not resolve with furosemide 40 mg. Severe Swelling persisted for over 2 weeks before eventually resolving. My concern is I?m due to get #2 vaccine 5/2/21 and am worried about possible blood clot as I have a past history of a blood clot (left leg) 14 years ago.

VS: HR: 70s BP: 131/74 O2: 95% Symptoms: Felt mildly SOB. Did not feel anything like her MI, nor her allergic reaction to Dilaudid. No N/V/Diaphoresis. No itchiness, throat closing, tongue swelling sensations. Normal exam. Pt feeling better and wanted to just go home with her family member driving. Aware that if feels worse or any concerns to go to the nearest hospital. Will take antihistamine H1+H2 blocker as a precaution when gets home.

Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around March 8-12 per husband); in mid-April patient started reporting intermittent low intensity headaches. On April 23, patient had severe headache and vomiting, went to urgent care and was thought to have sinusitis and started on antibiotics and discharged home. On April 24th, patient became more drowsy with worsening headache and unresponsive. On April 25, she was taken to outside hospital and was noted to have abnormal brain MRI. She was transferred to our facility on April 26 after clinical worsening. Imaging revealed venous sinus thrombosis in deep cerebral veins and patient was intubated due to worsening mentation. Imaging also revealed a venous stroke with hemorrhage in her left thalamus and diffuse brain edema. Treatment includes extraventricular drain placement, anticoagulation (heparin), hypertonic saline to manage brain edema. We also did extensive workup but no history of hormone therapy, contraceptive pills, underlying cancers. Tumor markers are negative. Hypercoagulable panel and rheumatologic panel are negative. Body imaging did reveal multiple uterine fibroids but no other cancer. Patient remains in the ICU, on the ventilator, heavily sedated for management of refractory intracranial hypertension.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

my chest started hurting; I couldn't breathe; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 16:00 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included mild asthma. The patient is not pregnant. Concomitant medications included lisinopril; fexofenadine hydrochloride (ALLEGRA); and estradiol. The patient previously took morphine, tramadol, and nickel and all had known allergies. The patient experienced her chest started hurting and she couldn't breathe the next day (29Dec2020). She slept for 2 days. Symptoms progressed and got worse and she had been to the emergency room (ER) five times. She also had many Doctor (Dr) appointments and symptoms had not improved. The events assessed as serious with disability and hospitalization of one day. Treatment received for these events included dexamethasone, duo neb, lorazepam, and hydromorphone. No COVID prior to vaccination and COVID tested post vaccine (unspecified date): unknown results. No other vaccines received in four weeks. The outcome of the events was not recovered. Information on about lot /batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. 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.

Chest pain/dizziness/throat swelling/weakness. 0.3 autoinjector EpiPen and 50mg IM Benadryl given while patient was observed for acute life-threatening changes. EMS came and took the patient in a distressed but stable condition to the nearest ER.

Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.

4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Had continued symptoms. Test positive for SARS-CoV-2 4/15 Treated with mAB 4/17 Presented to ED w/nausea and decreased appetite. Vitals stable. No hypoxemia. +electrolyte imbalance K+ was 2.9. Given IFV and K repletion and discharged to home 4/19 Started on Zpack and Decadron as outpt 4/21 Returned to ED with increasing SOB and reported home pulse ox 75-82% w/ exertion. In ED, sats in low 90's. Tachypnea with RR24-28. CTA + for PNA and new PE Discharge summary : Pulmonary embolus Likely secondary to COVID-19 infection; HRT possibly contributing Chest CTA showed a small subsegmental pulmonary embolus in the left lower lobe. Flattening of the interventricular septum possibly indicating acute right heart strain Lovenox 1 mg/kg twice daily in the hospital and transitioned to Eliquis at discharge Patient currently on estrogen placement therapy-discontinued Covid-19 Virus Infection Date of onset of symptoms: 4/9/2021 Symptoms present on admission: Productive cough, dyspnea Date of covid positive test: 4/12/2021 Vaccination status: First dose given on 3/31/2021 Special isolation anticipated end date: 4/22/2021 if symptomatically improving Imaging: Chest CTA with interval worsening of diffuse interstitial infiltrates Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Continue oral Decadron 6 mg daily Consultants following: None Inflammatory markers: LDH 306, ferritin 507, CRP 54.3 and D-dimer 2.07 Disharged on codeine cough syrup and Tessalon for persistent cough

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: syncope-Mild, Additional Details: Patient reported throat tightness and difficulty breathing. immediately after patient lost consciousness. patient was repositioned and one injection of epinephrine was given. paramedics came within 10 minutes and carted her off to hospital.

Mild but noticeable shortness of breath occurred within an hour or two of receiving the vaccine. Not serious enough to seek medical attention. Subsided after about 4-5 hours. Arm soreness at the site for several days.

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.

Bronco spasm, cough, throat swelling, inability to speak-treated with solumedrol,epinephrine,Benadryl, Pepcid, resp neb(pulmocor and Duoneb),

Same-day reactions -within 5 minutes: hives in face and neck - a few more minutes later: swollen lips (had to take Benadryl and 20 mg of prednisone that I was carrying because the hospital only had the epipen) - within 24 hours: shortness of breath, palpitations - couple of days later: admitted to the ER with pneumonia and PVC arrhythmia

light headed/dizzy; shortness of breath; chest pain; headache; her arm bothered her for couple of days; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 60-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Lot Number: EW0172, Expiry date: Unknown) as single dose for COVID-19 immunisation. Medical history included stroke from an unknown date and unknown if ongoing, Cancer; Variant Cancer with Vitamin D from an unknown date and unknown if ongoing, thoracic aortic aneurysm from an unknown date and unknown if ongoing, heart Surgery from an unknown date and unknown if ongoing, seizures from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing, problem with my stomach from an unknown date and unknown if ongoing, lost my gall bladder from an unknown date and unknown if ongoing, reflux from an unknown date and unknown if ongoing, thyroid cancer from an unknown date and unknown if ongoing. The patient previously took cipro 1a pharma and experienced hypersensitivity before, it stopped her heart, demerol and experienced hypersensitivity, it made her throat close up and Pneumonia vaccine in the past, made her swell up all over her body. Patient had Gastric Bypass before heart surgery. Patient can only take Acetaminophen. Patient cannot take anything with Naproxen in it. So, patient do not know if that matters with this vaccine or not. So, just thought and will let you know. Patient cannot take pain killers because patient raise her grandson. Concomitant medication(s) included topiramate (TOPAMAX) 100 mg taken for seizure, start and stop date were not reported; atenolol (ATENOLOL) 100 mg taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D 3) taken for osteopenia, start and stop date were not reported; cyanocobalamin (B-12) taken for anaemia every 2 months, start and stop date were not reported; benzethonium chloride, ethanol (PENTAL COL) 20 mg 3 times a day for Problem with my stomach, start and stop date were not reported; pepsin (PEPSIN) 20 mg taken for an unspecified indication, start and stop date were not reported; fluorometholone (FLUROMET) do take 1 or 2 Over the Counter pills. I take Fluromet if that is needed when I have migraine, that's not everyday and 2 more over the counter taken for migraine, start and stop date were not reported; diphenhydramine hydrochloride, paracetamol (LEGATRIN PM) taken for restless legs, start and stop date were not reported; rivaroxaban (XARELTO) for Antithrombin 3 blood clotting disorder, start and stop date were not reported; pamabrom, paracetamol (BACKAID) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; hctz (HCTZ) 12.5 mg taken for heart, start and stop date were not reported; ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) 60 mg twice a day taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced lightheaded/dizzy, shortness of breath, chest pain, headache and her arm bothered her for couple of days. She states the paramedics made her stay for about 30 minutes to monitor her. Consumer stated, she was going to check with her Cardiologist and if he says that's okay patient was going to take the other shot. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Chest pain and couldn't hardly breathe and hard to get up off the bed; Chest pain and couldn't hardly breathe and hard to get up off the bed; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Body Aches where can't walk; Body Aches where can't walk; Fatigue; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Fever 102F; Weak and Can't Hardly Walk; Diarrhea; Blurred Vision in Both Eyes; Right Arm Pain; Headache; Lightheadedness; flu bug, virus in her body; This is a spontaneous report received from a contactable consumer (patient). A 60 years old female patient received the first dose of bnt162b2 (Pfizer COVID 19 vaccine) via unspecified route of administration in right arm on 09Apr2021 09:10 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect ad no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No family medical history. The patient experienced diarrhea on 18Apr2021, blurred vision in both eyes on 18Apr2021, sweats; hot and cold; chills on 19Apr2021, body aches where can't walk on 19Apr2021, really bad fatigue on 19Apr2021, nauseated and can't eat; vomiting dry heaves on 19Apr2021, dehydrated and dry mouth and mucous on 19Apr2021, fever on 19Apr2021, weak and can't hardly walk on 19Apr2021, chest pain and couldn't hardly breathe and hard to get up off the bed from 20Apr2021 to 20Apr2021, right arm pain from 09Apr2021 to 12Apr2021, headache from 09Apr2021, lightheadedness comes and goes from 09Apr2021. Right after the shot her headache started and the soreness in the arm. The patient stated she didn't know how to ride out her headaches, they were so severe like bricks in her brain. For diarrhea, the patient stated it is like water and she is going to the bathroom right now. For Nausea, the patient stated if she eats or drinks anything she is throwing up, further clarifies that nothing comes up but dry heaves. For fever, the patient stated her temperature was 102F 19Apr2021 night, 100F 20Apr2021 morning, and it is 101F at the reporting time. The patient stated she had a cold rag on her forehead. For weakness, she has to use a cane to get up and move around because of the weakness. The patient received none treatment. The events did not require a visit to Emergency Room or Physician Office. The PCP stated he is treating it like flu bug and said she just has to ride it out. The patient stated she was supposed to go back for her second shot 28Apr2021, but she is hesitant because she can't take care of her children because she is sick. The patient stated she didn't know if she was going to take the second vaccine and didn't know what to do for her side effects. The patient asked, with these symptoms, if recommended she get the second shot, because it is like a virus in her body. The outcome of the events sweats; hot and cold; chills was resolving. The outcome of the event chest pain and couldn't hardly breathe and hard to get up off the bed, right arm pain was resolved. The outcome of the other events was not recovered. Diarrhea, blurred vision in both eyes worsened. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Few problems at times of 1st dose, and no problems at time of 2nd injection, but went outside to do yard work 2 weeks later and found myself extremely short of breath with very little exertion. I had donated blood the day before, so that might be a contributing factor, but wanted to put this on the record just in case.

24 hours after second shot I had a sever migraine, nausea, pain in joints/bones, and fatigue. My lungs also had a minimal amount of pressure/discomfort

throat closed up and my tongue feels thick; throat closed up and my tongue feels thick; I couldn't swallow; severe itching in the shot area; severe itching in chest area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) via unspecified route on right shoulder (right arm) unknown single for COVID-19 immunization on 23Apr2021 at 60-year-old. Medical history and concomitant medication were not reported. 15 minutes after the patient took the shot (23Apr2021), patient throat closed up and tongue felt thick, the patient couldn't swallow but the patient was medical services at the bin where the patient had the shot. After about 30 or 40 after minutes (23Apr2021), maybe 30 minutes after the shot, the patient started doing lot of itching, severe itching in the shot area in the shoulder in chest area, severe itching was given some diphenhydramine hydrochloride (BENADRYL) and it did a help so but still had itching in chest area. Outcome of the event severe itching in chest area was not resolved, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

early morning after vaccine felt chest congestion and crackling sound in chest. felt congestion for the next 6 days. on tuesday 5/4 i could not breath. went to the emergency room in an ambulance. ER gave me oxygen and increased my lasix to double the dose. chest xray showed fluid build up in the lungs. that night breathing retuned to normal. spent two nights in the hospital with double doses of lasix each day. discharged on 5/6/2021

Patient complained of itchy throat, itchy ear and tight breathing approximately 25 min post-vaccination. Patient has history of allergies. Receives routine allergy shots. Reported these are her normal allergy symptoms. 25 PO Benadryl given. Approximately 1 hour, 15 min post-vaccination, patient reported symptoms had improved. On call MD aware. Patient discharged home.

My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.

She starts having headaches; Flu like symptoms; Fever; Chill/Chills; Pain in her lungs; oxygen drops when she walks she has to get back on oxygen; This is a spontaneous report from a Contactable Consume (patient) reported. A 60-year-old non-pregnant female received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN6201), via unspecified route on 13Feb2021 (patient was 60-year-old at the time of vaccination) at a first single dose for COVID-19 immunisation. The patient's medical history included patient She does had COPD which was ongoing She has had it for years she doesn't know how long. patient stated she had asthma and they said it turned into COPD. She had been off oxygen for 3 months, but her oxygen has been dropping whenever she gets up, it gets low and she doesn't like that part. She says if it gets too low, she starts having headaches, she says that happened with the headaches when she was in the hospital last July with double pneumonia, she confirms that was happening last July before the vaccine not right now. "Patient stated, she had double pneumonia related to Covid back in Jul2020 and was in the ICU for almost a month and had double pneumonia. The patient's concomitant medications were not reported. On an unspecified date, after the first dose of the Pfizer Covid-19 vaccine the patient experienced fever, chill, pain in lungs, and oxygen dropping when she walks. reporter wanted to know if that was associated with receiving the first Covid-19 vaccine on 13Feb2021. Patient was Referred to HCP for treatment of symptoms and to discuss receiving second dose of vaccine. She had the shot Saturday 13Feb then Sunday, yesterday at about 9:00 that morning, she said her shot was after 3 pm Saturday but about 9:00 Sunday she had flu like symptoms. This was her first dose not the second one complication anyone have to go through on the shot. She clarified with complications reported, have these been associated with the first dose. Her oxygen drops when she walks she had to get back on oxygen. She had COPD. She says she had asthma and they said the asthmas changed into COPD. She had the Pfizer COVID-19 vaccine. She had the shot Saturday 13Feb2021 then Sunday, yesterday at about 9:00 that morning, she says her shot was after 15:00 Saturday but about 9:00 Sunday she had flu like symptoms. She felt fever, chills, pain in her lungs. She does have COPD and she COVID 19 back in July last year and had double pneumonia. She says the shot has affected her lungs her oxygen drops when she walks, she had to get back on oxygen. She had been off oxygen for 3 months, but her oxygen has been dropping whenever she gets up, it gets low and she doesn't like that part. She said if it gets too low she starts having headaches, she said that happened with the headaches when she was in the hospital last July with double pneumonia, she confirms that was happening last July before the vaccine not right now. The patient also wants to know how long it will last, fever is done but she is still having the problems with her lungs and her oxygen and she would like to know how long that had supposed to last. She said she also wants to know how long will it last. Her fever is done but she is still having the problems with her lungs and her oxygen and she would like to know how long is that supposed to last. This is her first dose not the second one complication anyone have to go through on the shot. She clarifies she means had with complications reported, had these been associated with the first dose. The case classified as non-serious. The outcome of the events were unknown. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

Patient reported symptoms ~ 2mins after receiving vaccine per administering clinician. Patient noted to have coughing. Patient reported lip numbness and mild shortness of breath. Patient then continued to say that she was having difficulty swallowing. EMS was contacted. Patient awake, alert, oriented. Patient refused EPI administration at vaccine site. Patient taken by EMS to ED. Per medical record patient received IV antihistamines and steroids and was observed.

Anaphylaxis (lip swelling, generalized hives, shortness of breath) within 30-45 minutes of vaccine. Because patient has a history of anaphylaxis, she was able to treat it by giving herself epinephrine, oral antihistamines, and nebulizer treatment with levalbuterol every few hours for the next 3 days. She recovered and did not report this until 5/12/21.

she had a fever of 101F (her normal body temp is 96.8F); rash on her forehead; little pustules; headache; little trouble breathing; This is a spontaneous report received from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A 60-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown, Expiry date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 60 years) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included she had an anaphylactic reaction twice in her life, once to macadamia nuts, and once to "an allergy shot with dust stuff in it". She had a complicated allergy history. Also reported allergies to corn and Benadryl and allergic to an ingredient in benadryl, originally reported as "polypropylene glycol", but later corrected to "polyethylene glycol". The patient was allergic to corn and poly-something in BENADRYL so she couldn't take it anymore. Co-suspect medication included diphenhydramine hydrochloride (BENADRYL). She stated that after the first dose, she had fever of 101F (her normal body temp is 96.8F), a rash on her forehead, and a headache, and noted that on the second day she 'had a little trouble breathing' but said it might be from seasonal allergies. Pretty normal reactions- her normal body temperature was 96.8F had a fever of 101F that's one of the regular side effects and a little bit of a problem breathing- on the second day. Rash on forehead right away, headache too. kept a cold compress and kept switching it every couple of minutes b/c of the fever little pustules. When she put the cloth on regularly it soaked her skin. Rash went away after she had 2 anaphylactic rxn - macadamia nut & allergen shot that had dust stuff in it. She treated the fever and forehead rash with cool compresses and kept switching it every couple of minutes, putting the cloth on regularly it soaked in skin and noted that the rash had what appeared to be 'little pustules" and thought the rash may have been caused by the fever because they resolved at the same time. She had a side effect after the first dose of the vaccine. She asked whether she could receive the second dose and whether she should get the second dose. The nurse that gave her husband his shot said that the reactions to the second dose were more severe. She received the response stating that provided contraindications and discussed potential signs and symptoms of severe allergic reaction as listed in 'CONS-what are the risks of the vaccine (v5.0)' and when they would expect them to occur. Confirmed that fever was commonly reported and that common AEs were more frequently reported after dose 2 in clinical trials (Tables 1-4). Referred caller to her HCP or vaccination site for additional guidance and monitoring. Confirmed that polyethylene glycol is an ingredient in the Pfizer Covid19 vaccine. She should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knew her health situation and had access to information that can better help inform that decision. The caller was unsure if she should take 2nd dose of COVID vaccine. Bendadryl no longer Pfizer but unclear when she developed allergy to it. The outcome of events she had a fever of 101F (her normal body temp is 96.8F), rash and little pustules was recovered on an unknown date. The outcome of the events headache and little trouble breathing was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Follow-up (16Apr2021): New information received from a Pfizer-sponsored program via a contactable consumer (patient) reported for herself included: Added Benadryl as co-suspect medication.

Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfizer. Patient has known COVID19 exposure from her son and was COVID19 positive in April. The patient had a positive asymptomatic COVID-19 test. Patient was tested prior to planned colonoscopy. The patient completed 10 days of quarantine until April 22. Patient presented to hospital (sister hospital) on May 2nd after 1 week of fevers and productive cough. At MSQ patient received cefepime/vancomycin/doxycycline for CAP. She initially improved, but on 5/5 she had recurrent fever with rapid decline, her respiratory status requiring 2L of NC to HFNC to NRB. CXR with B/L opacifications. CTA chest was negative for PE, but patient with diffuse groundglass and consolidative opacities. Also had TTE that showed LVEF 71% and grade 1 diastolic dysfunction. She was evaluated by MSQ Infectious Diseases physician and was started on bactrim for PCP prophylaxis and resumed on broad spectrum antibiotics. She was also evaluated by rheum in sitting of her SLE and patient was started on prednisone 40 mg q8h methylprednisolone for potential SLE flare. Continued on cefepime and vancomycin. Patient was transferred to Hospital due to worsening respiratory status and tested positive for COVID-19 at MSH on 5/9. Admitted to the MICU, patient received a loading dose and one 100 mg dose of remdesivir - stopped due to elevated liver enzymes. On 5/16 extensive new ischemic/hemorrhagic strokes throughout intracranial vascular distribution, DIC d/t COVID vs AF and intubated for mental status changes. Patient's clinical picture worsening - requiring pressors. Chest x-ray with diffuse ground glass opacities, ARDs and pulmonary edema. Patient remains in critical condition in MICU as of 5/19.

Since having COVID in November 2020 still experiencing shortness of breath and ringing in ears. After the shot , Felt fine first day, next morning woke up nauseous and dizzy, achy in muscles , especially in legs, pain in knees. Worsen shortness of breath with even short distances . Ringing in ears louder and high pitched. Brain fog. Each day the symptoms got worse, more intense. By the 8th day, pain in muscles so bad , had to be helped to walk or use a cane. Breathing was gasp for breath within short distances.Stayed in bed for several days and muscle pain got better. Breathing got better.

Client c/o tightness in chest, dry mouth and shortness of breath 20 min. after vaccination. Care initiated by onsite EMS. Client placed on stretcher. O2 applied. EMS transported client to ambulance for transport to hospital. Client's son and niece declined transport. EMS monitored client in the ambulance for 10-15 min. Client stated that she felt "okay". Declined transport to hospital. Client signed papers provided by Fire Rescue. Client exited ambulance, ambulating with assist by son and niece. Stated that she was "okay". Encouraged client to follow up with Emergency Services and PCP as needed. Verbalized understanding. Driven off site by son.

I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; Severe allergic reaction; I had dizziness, I was so dizzy I thought I was going to pass out and that was like at the top of the steps when you getting to walk down the stairs; My body was red and I had blotches bumps all over me my back under my right breast; My body was red and I had blotches bumps all over me my back under my right breast; My entire body was inflamed; Started getting hives on my back, under my right breast, both arms and both legs and thighs and I started getting bump. I broke out in hives in sleep in middle of night; I woke up out of my sleep in the middle of the night like the wee hours of the morning itching; I had like difficulty breathing; I had severe headache and I had it like all week; severe headache; My pressure went up like 140 over 100; high blood pressure; This is spontaneous report from a contactable consumer (Patient herself). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unknown route route on 04May2021, as a single dose, for COVID-19 immunization. Patient's medical history included seasonal allergy (using an inhaler), Asthma and Diabetes. The patient's concomitant medications included insulin. On the same day of vaccination on 04May2021, at the first hour, the patient had a severe allergic reaction. The patient also experienced severe headache and I had it like all week and her pressure went up like 140 over 100 and then like the next day you know I had like difficulty breathing. On the third day, The patient also had a severe allergic reaction. The patient stated that her entire body was inflamed and then she started getting hives on her back, under the right breast, both arms and both legs and thighs. The patient also experienced bumps. The patient further stated that she had dizziness and was going to pass out when she had to walk down the stairs. The patient also stated that she broke out in to hives in her sleep in the middle of the night. The patient had itching at the wee hours in the morning. The patient stated that she went and looked in the mirror and her body was red and I had blotches bumps all over her back under my right breast. The patient wanted to know whether she can take the second shot. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The patient did not had any physician visit for the events. The patient used Benadryl as treatment medication for the events. The patient asked whether the vaccine was going to affect her and if so, she cannot take it. Patient was supposed to take the second shot on 26May2021. The outcome of the events was unknown. Information about batch/lot number was available. Further information was expected.

incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her breasts; concentration levels are off; but being that sick makes her so weary.; She goes to the bathroom 12 times a night to urinate; body aches; feet hurt/top of her feet hurt really super bad/legs hurt; pressing under her arm and she had pain really bad there; pain went around her back /whole back started hurting; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 27Apr2021 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, diabetes, high cholesterol and high blood pressure. Concomitant medication(s) included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported, noted as on of the 2 new heart medication; and another unspecified heart medication. No other vaccine within 4 weeks. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, then 2 days later on 29Apr2021 she developed side effects of body aches and couldn't get comfortable sitting, laying down, or standing, and her feet hurt, the top of her feet hurt really super bad and her legs hurt. She stated she was feeling "fair to partly cloudy" and "this is just beyond anything". She stated she literally didn't want to exist anymore the pain was that horrible, that when she was experiencing adverse effects she couldn't get comfortable in any way, nowhere to go, nothing to do, no warm bath, no hot warm or cool compresses, it was just her whole body. She said there was nothing that would help and she just didn't know if she could do that again. She only had relief through paracetamol (TYLENOL) and she took so much that she felt her liver was in jeopardy. She stated it was a really bad experience. The patient was also having incredible chest pressure and shortness of breath, onset date unspecified. She had a diagnosis of heart failure/a history of congestive heart failure, with the body aches she was having, she thought she was going into heart failure. She did call an ambulance twice (maybe 29Apr2021 then 01May2021; she didn't remember exactly which days) and the emergency medical technicians (EMT) took an EKG each time. The first time she called the ambulance the EMT's offered to take her to the hospital. Her EKG did look abnormal but it could have been attributed to her history of heart related issues or anxiety. The second time her chest started hurting it was hard to distinguish between pain and pressure. There was definitely pressure. There was also pain across her breasts (onset date unspecified) and underneath her arm (on 29Apr2021; initially she was pressing under her arm and she had pain really bad there), she was questioning her lymph nodes. Then the pain went around her back and then her whole back started hurting and her whole body was hurting, onset date 29Apr2021. She had never experienced anything like this before, as stated. She also reported that her concentration levels were off (onset date unspecified). She couldn't listen to music or do anything like that. She spoke with her doctor but being that sick made her so weary (onset date unspecified). The patient reported she didn't know if her symptoms were because of the COVID-19 vaccine or because of her new heart medication, but she said it's stupid to think her symptoms could be caused from her new pills. Her doctor wanted blood work on 27Apr2021 primarily because of all the medical diseases she had. She's guessing maybe blood work would give her an indication of why the vaccine made her feel the way it did. She went on 05May2021 to get bloodwork. She went to the bathroom 12 times a night to urinate (onset date unspecified) and she asked her doctor to put her on Lasix so she could just get the urine out. The doctor told her that her heart and her lungs sound good. The patient asked if she should still get the second dose of the vaccine as she was worried that the symptoms could be worse after the second dose. She was supposed to return for her second COVID-19 vaccine on 14May2021, but she was not going (though she knew she needed to get the second dose), she did not want to get it. The events body aches, feet hurting/legs hurting, pain underneath her arm, back pain, were ongoing but lessened in severity. As of the time of reporting, she had started to feel better, these events (body aches, feet hurting/legs hurting, pain underneath her arm, back pain) were resolving. The outcome of the other events was unknown.

no energy; Sore arm; spike of asthma; chills; tiredness; fever; body ache; headache; nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Lot /Batch Number: EN6205), Dose 2 via an unspecified route of administration on left arm on 04Mar2021 at 10:15 (at the age of 60 years) as a single dose for COVID-19 immunization. Medical history included heart attack, diabetes, obesity, asthma and Sulfa allergic. The patient's past medical history included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: EN6201) dose 1 on 13Feb2021 at 10:00 as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took Nasal swab test for COVID-19 and was tested negative at 04Feb2021. Concomitant medications include Meloxicam ER (Manufacturer Unknown), Metformin (Manufacturer Unknown), Spironolac (Manufacturer Unknown), Pantoprazole (Manufacturer Unknown), Metoprolol tartrate (MANUFACTURER UNKNOWN), Atorvastatin (Manufacturer Unknown), Clopidogrel (Manufacturer Unknown), Losartan (Manufacturer Unknown), Montelukast (Manufacturer Unknown). The patient experienced no other adverse event except for sore arm until 11Mar2021. On 11Mar2021 around 03:30am it started with chills but moved on and would cycle through between chills, fevers up to 102.4, headaches, body aches, tiredness, spikes in asthma, nausea, and just an overall feeling of feeling bad and 6 days later the patient feels ok, just no energy. Patient not taken any treatment for reported events. Therapeutic outcome of reported events was recovering at the time of report. No follow-up attempts are needed. No further information is expected.

chest pain, shortness of breath, fatigue, malaise, headache that occurred the evening after vaccine was given

Released from ER after receiving 2nd Pfizer vaccine. 1 mile down the road, I could no longer drive. I had to pull over on the highway. I had a tingling in my face, immediately followed by a combination of severe headache, hard to breath, rapid heartbeat and feeling like I was going to pass out. I wasn't able to even dial my phone. A construction worker on the side of the highway called for the ambulance and I was transported back to the ER.

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

aching all over; her arm hurt very bad where she got shot, right arm, "her arm was killing her; shooting from her arm up to her neck; chills; feeling really unwell; heart started beating a little bit fast; shortness of breath; tiredness; headache; muscle pain; joint pain really bad; really weak; Back Pain; Throat Hurting; injection site pain; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the right arm on 12May2021 08:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history included allergic to dye (last time she had black dye, her head was itching and burning like fire and her head is still red and her hair is falling out by handfuls), back injury ongoing since 2004, and ongoing diabetes mellitus that started 14.5 years ago. The patient was tested negative on the COVID Nasal swab on 08Nov2020. The patient was hospitalized for 7 days for COVID-19 from 07Feb2021 or 08Feb2021 when she had "diarrhea coming out both ends", and when she had come home, she had on/off head spinning for 2 weeks and in a month her head stopped spinning. She waited 90 days before getting the vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not enrolled in a clinical study or a program. Concomitant medications included naproxen (NAPROSYN E) taken as needed for back pain. On 12May2021, the patient experienced injection site pain. On 13May2021, she started experiencing aching all over for about 8 hours and has been hurting all morning from 08:00, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, couldn't hardly walk legs were hurting started today worse, headache, muscle pain, really bad joint pain, chills, feeling really unwell, really weak, heart started beating a little bit fast and shortness of breath. she has no swollen lymph nodes. She stated her back wasn't hurting yesterday and now today (13May2021) she has back pain so much so that she can't hardly get out of bed. She also stated throat hurting. She reported that the persistent/significant aching all over for about 8 hours & "her arm hurt very bad where she got shot, right arm" were serious due to disability/incapacity. If it keeps up like this, she doesn't know if she will take the second one. She is scheduled for her second one on 02Jun2021. Later, she stated, "I was aching about 8 hours. After that I think I had took a Tylenol" but she can't be sure. The clinical outcome of the event "aching all over" was resolved after 8 hours on 13May2021 around 16:00. The clinical outcomes of the events chills and heart started beating a little bit fast were resolving, the events injection site pain, "her arm hurt very bad where she got shot, right arm", "her arm was killing her; shooting from her arm up to her neck", tiredness, headache, muscle pain, joint pain really bad, really weak, throat hurting were not resolved, while the events feeling really unwell, shortness of breath and back pain were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected

2nd dose: Stinging a few minutes after shot, I felt really woozy, and then started shaking all over having a hard time processing and talking. Went home the next day (Wed) fever, chills, headache, 24 hours better, returned to work on Thursday, day (2). Day (3), Friday, I noticed a red rash at the site of the injection earlier in the day, but no symptoms, just a little tender. Friday evening I noticed a little SOB, a little burning sensation under my skin on both forearms, and a couple times felt a little dizzy, but I didn't think much about it. Day (4) Saturday morning, I went to spin class, I felt a little off, halfway through spin class I noticed I was struggling with some breathing, thought it was because I was wearing mask, but pushed through. Ran a couple of errands afterwards and then noticed the SOB was continuing, my skin started burning again under forearms and now my legs with tingling into my feet. At this point I decided I probably needed to go home. On my way home my chest started to hurt in the very center of my chest, and slowly felt like some pressure, with squeezing sensation. Then starting at the center of my chest I could almost feel what felt like a numbness creepy from my chest to my throat. I went to the ER. My legs felt really wobbly and had a difficult time walking, and was feeling dizzy. They ran a variety of blood work and tests. They noted my D-dimers were elevated and (4) lymph nodes enlarged. They ran an additional series of test and released me at 10pm with follow-up to cardiologist. I am still experiencing SOB, not as bad, and the burning sensations under my skin.

After 18 hours of 2nd dose. Symptoms: cold, temperature degrees from 37.8 C to 39.9 C. 6/8 around 12:00AM, I had headaches, muscle pain, shortness of breath, cough, muscle pain, weakness, dizzy. Sleeping until 1:00pm on 6/9. The body temperature was down to 37.8C?but still dizzy and no energy at all. I feel better today, and body temperature has down to 37.4, and the shortness of breath is getting better, but not as normal, and had cough sometimes, but not too bad.

throat swelling/numbness; throat swelling/numbness; lips feeling numb; Her face up to below her eyes was starting to feel numb; the rest of her left side of her head, and her ear was feeling numb; Her left arm was feeling a little bit less sensation than her other arm; a little tired; short of breath; Her esophagus going down the first few inches of her chest was feeling numb; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6200, Expiration date: Unknown) via intramuscularly administered, in left arm on 09Mar2021 at 07:10 am (At the age of 60-years-old) as 1 ST DOSE, SINGLE for Covid-19 immunization. The patient medical history included Asthma, gastrooesophageal reflux disease (GERD), Hypertension, Migraines, Anxiety, Hypothyroidism. The patient concomitant medications were not reported. The patient has seasonal allergies and often rashes and reactions to drugs. Patient makes the comment that patient was canary in a coal mine. It was reported that all medical history were long-term and patient has had them all for more than 20 years, and some conditions, she has had longer than 20 years. It was reported that there were no prior vaccinations within 4 weeks of vaccination. It was reported that the patient received the vaccine on 09Mar2021 at 7:10 am in the morning and she felt fine until the afternoon. By 1:00 pm, patient started feeling a little tired, may be a little short of breath, very slightly. At about 3:00 pm, patient started feeling like her throat was swelling, like it might swell shut. It was only on her left side. By that time, patient drove herself to the (emergency room) ER and when she got there, it was 3:45 pm. Patient's throat felt numb, and it felt like it was swelling. Her face up to below her eyes was starting to feel numb and lips were feeling numb. Patient clarifies the numbness was only on the left side and esophagus going down the first few inches of her chest was feeling numb. It was all on the left side. Then, the rest of her left side of her head, and her ear was feeling numb. Her left arm was feeling a little bit less sensation than her other arm. Patient was checked out and looked at the ER and was told, there was no swelling, no muscle weakness, no drooping or swelling of her face or mouth. Patient just had that feeling of numbness. She confirms all of the numbness was on the left side which is where patient received the vaccine. Patient confirms that she was not admitted into the hospital. She was only seen and discharged from the ER. They checked patient to make sure she did not have a stroke, or bells palsy. On 09Mar2021, the patient had blood test and EKG showed unknown. Patient was seen at the ER and treated with Benadryl, Pepcid, and sent home last night. About midnight, patient took a couple of Benadryl because it had worn off and patient was feeling numbness again. Patient took 20 mg of Pepcid AC which she takes for reflux anyway this morning. Patient was only experiencing a little bit of numbness, very slight. The outcome of all the events were recovering. Description of product complaint was as follows: When probed for any product information for the medication patient has taken in treatment of her symptoms, patient explains she doesn't know what they gave her in the hospital. Patient took Benadryl last night at home and clarifies its probably a generic that came from pharmacy . Patient clarifies its out of the package so she cannot provide a specific name for what she was taking. (Manufacturer: , Lot: P120251, Expiry date: May2023). Patient clarifies she took a pharmacy Generic of Pepcid AC, 20mg (Lot: 0CE2921A, Expiry date: Jan2022). No further details were provided or obtained. No follow up attempts were possible. No further information was expected.

patient received Pfizer covid vaccine on 5/12/21. pt called and spoke to rph about having chest pain and SOB. she was advised to seek medical help. pt went to urgent care according to pt she had an abnormal EKG and was referred to her pcp and cardiologist. In addition to the chest pain and SOB, she also reported having a blistering rash on her back She finally able to see her pcp and her cardiologist. Per pt, EKG is back to normal . She is only complaining about the blister scabs on her back

Patient developed life-challenging pericarditis approximately 7 days following vaccination #2 (given on May 1, 2021) causing fever, DOE and prompting emergent hospitalization followed by surgery for a pericardial window. The patient continued to have fever after the pericardial window and has been treated for possible flare of her arteritis with increased prednisone and increased CellCept. Prior to vaccination she had been in remission for at least 24 months on prednisone 1 mg per day and CellCept 500 mg twice per day.

Really bad headache; Nauseous; Diarrhea; Maybe she was hyperventilating; She's feeling a little sick; Having a problem breathing a little bit; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), via an intramuscular route on 08Jun2021 at 10:45 (at the age of 60-years) as single dose in the right arm for covid-19 immunisation. The patient's medical history included high cholesterol, temporal arteritis. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin (LIPITOR) with dose 20 mg, daily for high cholesterol, Fish Oil with dose 2000 mg, daily for unspecified indication, venlafaxine hydrochloride (EFFEXOR) with dose 150 mg, daily for depression. The patient previously took Prednisone for temporal arteritis since 24Dec2020 and she had been holding off on getting the COVID 19 vaccine until she was taking a lower dose of the Prednisone. She's taking 8mg of Prednisone. The Prednisone is in a pharmacy bottle. The Prednisone 5mg tablet is in a yellow pharmacy bottle. She took her Prednisone every day at 2:30PM. Her doctor told her on 07Jun2021, that she was ok to get the COVID 19 vaccine. She was taking 60mg of Prednisone but she's weaning off of the Prednisone. She has gained weight while taking the Prednisone. On unspecified date at 14:30 (4 hours after vaccination), the patient experienced really bad headache, nauseous, having a problem breathing a little bit, maybe she was hyperventilating and She's feeling a little sick. She had diarrhoea when she first got home after getting the COVID 19 vaccine. She's scared. She hadn't reached out to her doctor or gone to the emergency room. She doesn't wanted to got the COVID 19 virus. She was been quarantined for a year. Patient reported that she took Ibuprofen and her headache is going away. She thinks she's feeling better now. She's still a little nauseous. And her breathing, maybe she was hyperventilating because of the nausea. She is starting to feel better. The outcome of the events really bad headache, breathing, maybe she was hyperventilating was recovering and other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

61 y/o with past medical history of Diabetes who presents with shortness of breath, nervousness and possibly elevated glucose. Patient states that she did not take any of her prescribed medications this am or check her glucose. Patient states that she had Cuban coffee, café con leche and pastelitos (Cuban pastries) prior to arrival. Patient states that this is the first dose in the two-dose series (Pfizer). Patient states that she received the vaccination to the left arm. Patient denies previous reaction to vaccinations in the past. Patient denies sore throat, difficulty swallowing, chest pain or rash. NP and Paramedics at patient side. Patient vitals within normal limits (156/81, 127/85, 132/79, 146/82, 133/85 BP, O2 Sats 96-99% RA, 86-98 HR). Patient glucose markedly elevated (202). Patient placed on 2 L O2 by nasal cannula. Within 5 mins of observation patient states that she is feeling better. Patient states that prescribed medication is on her person. NP instructed patient to take prescribed Metformin. Patient states was nervous to get the vaccination and didn?t want to take medications. Patient states also didn?t want to check sugar in case it was high. Glucose rechecked 25 mins post medication administration. Patient glucose decreased to 194. Advise patient needs to seek further medical evaluation/Fire Rescue. Patient denies need for transport and states that she wants to go home. Patient signed Against Medical Advice form. Patient walked off site with husband at side.

lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was on fire; trouble breathing; face felt like it was on fire; headache; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19May2021 09:00 (age at vaccination: 60 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing multiple allergies. She has had allergies her whole life. Concomitant medication included rosuvastatin calcium (CRESTOR OD) taken for blood cholesterol increased which she has taken it for 15 or 20 years; fenofibrate (LIPOFEN) taken for blood cholesterol increased, which probably she has taken it for 15. On 19May2021, she experienced multiple symptoms 15 minutes after initial vaccination including, trouble breathing which started maybe an hour after she had the vaccine, face felt like it was on fire which lasted for 2 or 3 days, headache, felt really tired and her whole face and neck was really red and felt like it was on fire; on 21May2021, the patient lost sense of taste. Her sense of taste is back now. She thinks her tiredness has gone away. The adverse events did not require emergency room visit or a physician's office visit. The patient did not get other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient feels hesitant about getting her second dose of the vaccine tomorrow and would like some guidance, asking if she should get her second dose or not. The outcome of the event dyspnoea was reported as not recovered; burning sensation, erythema was unknown; headache was recovered on 24May2021, Ageusia was recovered on 23May2021 and tiredness was recovered on May2021. Information on Lot/Batch number was available. Additional information has been requested.

Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; Pain in the right side of her leg and in her stomach; Caller stated she has been vomiting mainly from the draining that is choking her.; Throat tightened up and glands swell; Barely able to breath, shortness of breath; Pain in right side, below her breast; Within 1 hour had tightness in her chest, wheezing and her throat started to tighten up; She was so sick; Caller stated she has been vomiting mainly from the draining that is choking her.; Headaches; Pain in the right side of her leg and in her stomach; Burning in her chest and throat/ pain was in the right side of the chest; Burning in her chest and throat/ throat has been like its on fire; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jun2021 (Batch/Lot Number: EW0177) as 1ST DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given: Between 12:00 and 1:00pm. Medical history included when she was a child, she had bronchial asthma. Has not had any problems in years. Prior Vaccinations (within 4 weeks): No, has been years. Has not even had the flu shot in 3 years. The patient's concomitant medications were not reported. Caller stated she had the first dose of the Pfizer covid 19 vaccine and stated she is having a reaction. Caller stated it feels like she has covid. Caller stated she got the vaccine 3 days ago and within 1 hour had tightness in her chest, wheezing and her throat started to tighten up. All she could do was wheeze. Her throat started tightening up and her glands started swelling. Caller stated she then had draining down the back of her throat. Caller reported burning in her chest and throat. Caller reported pain in the right side of her leg on 02Jun2021 and in her stomach. Caller stated she has been vomiting on 02Jun2021 mainly from the draining that is choking her. Caller stated she is still draining but not vomiting. Caller reported she is having headaches. Caller was concerned about what she should do, go to her doctor or go to the ER. Caller wanted to know how long the symptoms should last. Caller stated she is 52 hours out from the vaccine, Throat tightened up and glands swell, Barely able to breath, shortness of breath, pain on 02Jun2021. She was so sick. She was barely able to breathe within an hour and has been in pain. It is now a struggle, with shortness of breath. Her throat has been like its on fire, and lungs filled with a huge amount of drainage in the back of her throat. Is having right leg pain and pain in her stomach. It is not severe pain, but there is some pain there, is having a lot of burning sensation with the drainage. It now feels like she has Covid now. She read in the paperwork that this could not cause Covid. She was perfectly fine when she had the vaccine. She has no allergies. Does not know what to do. It has been 48 hours. She was perfectly fine until an hour later. She contacted the pharmacy and they didn't do anything. She then contacted this number to report this. Her biggest concern was the severe drainage. There were globs of drainage down the back of her throat. Her chest tightened prior to that and she was wheezing. She has not had bronchial asthma since she was a child. Has had no flus, or nothing. Had the pain after the burning in her chest, the pain was in the right side of the chest. Pain in right side of leg: Hasn't stopped completely. Still has pain in the right leg and in the chest. It is barely any better. It is probably because it is in one spot in the calf on her right leg. The pain in the right side, below her breast. The pain seems to be in the right side. Pain in stomach: Seems to be both sides. Has gotten better some, in the stomach. Vomiting: Was vomiting from all the drainage, it was choking her. It started within 2 hours. She is still experiencing the drainage, but not the vomiting. Has also been experiencing headaches. Shortness of breath: Was the same time as the tightness in the chest. It was within an hour after she left. They kept her there 15 minutes and she was fine when she left. Within the hour, she could barely breathe. She didn't know if she should go to the emergency room or if it would get better in a few days. The shortness of breath and wheezing is not worse, but is constant and really hard. Her breathing is really labored. She is not having pain, other than the tightness and wheezing, which she can hear. It is like she had asthma for years, or pneumonia. Outcome of events Wheezing, Chest burning, Throat burning sensation, headache, and Shortness of breath, pain of was not recovered, of Pain in leg, Stomach pain was recovering, of Vomiting was recovered in Jun2021, of others was unknown.

2 days after my second Pfizer vaccine I experienced lung pain when breathing, pleurisy, fever, dypsnea, shortness of breath, extreme fatigue.

Patient stated that her face swelled up about 2 hours post vaccine. Client notified me at her appointment of her second dose. Dose was not administered and she was referred to clinic for that dose due to our rural location and lack of emergency services. I called the client to find out how she did with the second dose, she stated they did not administer it. She informed me at that time that she thinks she also had shortness of breath following the first dose while she was driving to work 1 hour away. All symptoms resolved on their own with no treatment.

The dizziness was incapacitating; Had 100.6 temp and body aches; Had 100.6 temp and body aches; Sore arm; Temporary shortness of breath; This is a spontaneous report from a contactable other hcp. A 60-years-old female patient received BNT162B2 (COMIRNATY) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, (Lot Number: EL3248 expiry date was not reported) dose 1 via intramuscularly administered at Arm Right on 13Jan2021 11:30 as 1st Dose, Single for Covid-19 immunization.The patient's procedural history included tonsillectomy and adenoidectomy, total abdominal hysterectomy, salpingo-oopherectomy and cholesytectomy (01Jan2004). The patient's medical history included mononucleosis (from 01Jun2020 to 01Mar2021). The patient's concurrent conditions noted hypertension (from 01Jan2013) and hot flashes. The patient family history included hypertension for maternal grandmother.Concomitant medications included . The patient had reaction immediately after 1st vaccine and she felt short of breath that evening on 13Jan2021. The patient had a sore arm 14Jan2021 (the next day). On an unspecified date, the patient had dizziness which was incapacitating and could not drive and also had 100.6 temp and body aches. The patient unable to stand without passing out.The patient received Dramamine for dizziness and Nyquil for fever and body aches and temperature.The patient received Nyquil (doxylamine-DM-acetaminophen) and went to bed. The patient reported that she was okay. The outcome of all the events was resolved on an unspecified date in 2021. Causal relationship:Is there a reasonable possibility that the event is related to suspect product: Yes No follow-up attempts are possible. No further information is expected. Comments/narrative: Reaction immediately after 1st vaccine. Felt short of breath that evening, took Nyquil went to bed. Besides a sore arm the next day, I was okay. Approximately 12 hours after second vaccine, I was achy, dizzy and had temperature of 100.6. Did go to walk but by the afternoon, felt bad enough and went home. The next day, was still dizzy, achy and was vasovagal with standing.Stayed home from work. The 3rd day, I felt ok, went to work.

her voice feels a little weak; having problems breathing; lot of Phlegm; coughing a lot; fingers started tingling; waves of nausea; light headedness; She started to itch; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN8203 and expiration date 30Aug2021), via an unspecified route of administration in left arm on 01Mar2021 at 14:30 (age at vaccination 60-year-old) as single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus, hashimoto's disease, high cholesterol and high blood pressure. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. On 01Mar2021, with a few minutes just driving to the waiting spot she was having problems breathing. There was plenty of staff there in the hospital parking lot to help. They were monitoring her oxygen and her heart also on 01Mar20210, patient experienced lot of phlegm, coughing a lot, fingers started tingling, waves of nausea, light headedness and on 03Mar2021, patients voice felt a little weak. She was treated with Benadryl and an inhaler. The outcome of event having problems breathing, fingers started tingling, light headedness, waves of nausea was recovered on 01Mar2021. The outcome of event lot of Phlegm and coughing a lot was recovering at the time of reporting. The outcome of itching and her voice feels a little weak was unknown. No follow-up attempts are possible. No further information is expected.

Day of First shot: headache, sore arm, extreme exhaustion, feeling that some virus or illness was coming on, intermittent chills. 36 hours after first shot: sore arm, headache, stomach ache (upper and lower), cramping, swollen gland on front of neck (just one gland). Had all of these symptoms on my second shot too, but not as bad. I did not have a swollen throat/neck gland, BUT had shortness of breath/asthma reaction on my second shot, and chest & sinus congestion. The intermittent asthma/shortness of breath, (haven't had in a long time), was without wheezing. I used my albuterol rescue inhalor and it seems to help me get through these boughts. The asthma came on at about 29-36 hrs and has lasted 6 days so far.

Within 4 hours of receiving the vaccine, I developed chills and an fever of 101.5. I had muscle aches, pains, stomach upset, and nausea. At night I had difficulty breathing so I had to take extra medicine for my asthma. My temperature had went down to 100. I had severe body pains, abdominal pains, and vomiting. I was told to take Tylenol and stay hydrated by my doctor. He sent me to ER on March 11th. I went to ER and they ruled out a Covid or flu infection and any other infections. They said it was caused by the vaccine. They administered IV fluids, pain medicines, and vomiting medicines. 9 hours later after waiting, I decided to leave the ER and continued with taking pain and vomiting medicines. The symptoms lasted for 16 days. I met with my PCP and decided to get the 2nd shot three weeks later. I got similar symptoms as 1st shot with 2nd dose. Off and on I have been having adnominal discomfort. I have been having a hard time swallowing and chewing food. June 2nd I seen my PCP, and he said there was a problem with food processing into my stomach. He sent me to a gastroenterologist on June 22nd and they are scheduling a procedure to take a look into my esophagus and stomach to see the issue.

Woke up three days after the vaccination with sever fatigue, shortness of breath, and a severe headache. Fiance rushed me to the ER because I couldn't catch my breath. All tests came back negative/normal. CT scan didn't show any pulmonary embolism which they thought I had. They released me. The symptoms have continued and have gotten worse. I now have tightening around the heart and lungs along with headaches on a daily basis. When I get those "attacks" it can drop me to my knees. Am currently looking to follow up with a cardiologist.

On oxygen had major congestion for 3 weeks has subsided; Since the vaccine it will not go down under 250 stays there to 300 with same insulin requirements; This is a spontaneous report from a contactable consumer (patient reported for herself). A 60-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 10May2021 11:00 AM (At the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history included oxygen insulin COPD (chronic obstructive pulmonary disease). The patient had known allergies to Amoxicillan. Concomitant medications included Insulin, metformin, furosemide, lisinopril and atorvastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. On 11May2021 at 07:00 AM, the patient experienced on oxygen had major congestion and Insulin dependent sugars not going down under 250 stays there to 300. The clinical course of the events as follows: on oxygen had major congestion for 3 weeks has subsided. Insulin dependent sugars level was between 110 and 130. Since the vaccine it would not go down under 250 stayed there to 300 with same insulin requirements. The patient visited the physician office for the events. On 18May2021, COVID test post vaccination: Nasal Swab was Negative. The events were not resulted into the seriousness criteria of death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The outcome of the event on oxygen had major congestion was resolving and the outcome of other event was not resolved at the time of this report. Information about lot/batch number has been requested.

BPPV VERTIGO, NO TREATMENT, BUT MANEUVERS. IN GOOD HEALTH UNTIL I TOOK VACCINE. Last shot 4/24/2021 - BPPV VERTIGO - 5/11/2021

The patient received her first dose of the Pfizer Covid-19 vaccine in her home. About 15 seconds after administration the patient subjectively stated, "I can't breath", and "my throat and chest feel tight". I objectively evaluated the patient who appeared unchanged from baseline. The daughter and caretaker were present during the event, and the daughter stated that "she always say's that". However, the patient replied, "she is lying, I don't always say that, I can't breath!". Due to the patient's subjective complaint of shortness of breath EMS was called and arrived within 10 minutes. During that 10 minutes the patient remained stable. No hives, no wheezing, no eye tearing or nasal discharge. No facial, tongue, or throat swelling observed. Patient continued to speak in full sentences and did not have any labored breething. Epinephrine was not adminstered during this time due to the lack of objective signs of anphylaxis. EMS arrived and performed an evaluation; vital signs were stable; however, the patient continued to state that she "couldn't breath". No medications were administered by EMS on-scene at the patient's house. The patient was taken to the hospital for observation and possible treatment. Symptoms most likely due to a panic attack but anaphylaxis could not be ruled out and the patient was trasferrred to a higher level of care.

Congestive heart failure; shortness of breath; This is a spontaneous report received from a contactable consumer (patient sister). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was Unknown), via an unspecified route of administration, administered in Arm Right on 10Mar2021 11:00 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, heart disease. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced shortness of breath, time of onset: (24-hour clock) was unsure but possibly after the first dose. On an unspecified date congestive heart failure. Patient called regarding the Pfizer COVID 19 vaccine mentioned while providing family history, her sister had the COVID 19 vaccination and also had shortness of breath. Added her sister got her vaccination in Mar2021 but she doesn't have her card with her. She also had shortness of breath and was still having it. She do not put two and two and together until her sister had it. This was a clone report is created to document the sister's experience. Patient added the shortness of breath that started in Mar2021. States she had previously been off work for a year with AFib but she was doing really well; she had started walking around the block and everything. Then she had the first dose of the Pfizer COVID 19 vaccine on 10Mar2021 at 1100AM in the right arm; and the second dose 30Mar2021 she thought at 1100am in the right arm. Reports she is unsure of exactly when she noticed the shortness of breath. She went from the car to the store and she was short of breath so she went to the emergency room to get it checked but everything was good. Mentions she was also diagnosed with congestive heart failure about a month ago. After she went to the emergency room she just went back and forth to her doctors. The lung doctor said she was okay; and the heart doctor, too. She kept going to the doctor because it do not dawn on her that the shortness of breath might be related to the vaccination until her sister got her vaccination and had the shortness of breath. Now she believed she noticed the shortness of breath after the first dose. Mentions she has the emergency room records and her vaccination card at home to verify her information. Adds she was talking to a guy at the bus station and he had shortness of breath too. She could go get the test results when she gets the information and had blood, EKG, and chest x-ray; they said was it was good. Mentioned she was still pressing the issue about her breathing but they couldn't detect it. History of all previous immunization with the Pfizer vaccine considered as suspect. Additional vaccines administered on same date of the Pfizer suspect was none. No vaccine administered at Facility. The patient underwent lab tests and procedures which included blood test, chest x-ray, EKG: was good on an unspecified date. Events resulted in emergency room visit and physician office visit. The clinical outcome of events shortness of breath was not recovered and congestive heart failure was unknown. Information about batch/Lot number has been requested.

This is a spontaneous report from a contactable consumer (patient's sister) or other HCP. This is 1st of 2 reports.A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at Arm Right on 10Mar2021 at 11:00 (at the age of 60-years-old) as Dose 1, single for COVID-19 immunization. The patient's medical history included atrial fibrillation, cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other products were used.On an unspecified date the patient experienced congestive heart failure and shortness of breath on an unknown date in Mar2021. The patient underwent lab tests and procedures which included blood test: good on, chest x-ray: good on, electrocardiogram: good on. Outcome of the event was cardiac failure congestive was unknown, shortness of breath was not recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient fully vaccinated with Pfizer COVID vaccine. Patient experienced COVID symptoms including: headache, sore throat, chills, body aches, chest pain, shortness of breath, cough, nausea, congestion, runny nose, change in taste started on 7/11/21. Patient initially tested COVID negative via antigen test on 7/12/21. Patient then tested COVID positive via PCR swab on 7/18/21. Patient had to be seen at urgent care for chest pain, shortness of breath, cough, and severe headache on 7/18/21 prompting 2nd COVID test.

pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; diahrea; Weakness; nausea; fatigue; low tolerance to sound and light; low tolerance to sound and light; vertigo; feeling cold; headaches; muscle/joint pain in all extremities; muscle/joint pain in all extremities; diminished sense of taste; blurred vision; confusion; mood changes; increased sleep; physical agitation; difficulty breathing; Aggravation/exacerbation of underlying neurological/ pulmonary conditions; Pain in injection arm persists; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 60-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9261) via an unspecified route of administration in Arm Left on 29Jan2021 07:00 (age at vaccination 60 years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing None in past 5-6 years, arthritis from an unknown date and unknown if ongoing, affective disorder from an unknown date and unknown if ongoing, nervous system disorder from an unknown date and unknown if ongoing. The patient had unknown allergies Darvon. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included umeclidinium bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); valproate semisodium (DEPAKOTE); paliperidone (PALIPERIDONE). All taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK9231) via an unspecified route of administration in Arm Left on 07Jan2021 17:00 (age at vaccination 60years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced after second dose pain/heaviness in left ram, sweats, chills, diahrea, nausea 3 days. Weakness and fatigue for 3 weeks, low tolerance to sound and light, vertigo, feeling cold, headaches, muscle/joint pain in all extremities, diminished sense of taste, blurred vision, confusion, mood changes, increased sleep, physical agitation, difficulty breathing. These lasted 5 weeks. Mood changes, breathing difficulties, vertigo, muscle and joint pain persist. Aggravation/exacerbation of underlying neurological/ pulmonary conditions. Pain in injection arm persists on unspecified date. Therapeutic measures were taken as a result events which included injection of a medication with high NSAID levels. AE resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was recovered with sequelae in 2021. No follow-up attempts are possible. No further information is expected.

I started feeling bad about mid May, May 15 2021. I was feeling very out of sorts. I had started coughing, some of the coughing was to the point where I could not breath. I went to the DR and they put me on antibiotics. May 18th 2021, that was when I went to the DR. Then on June 1st 2021 I went to the DR as well and I think that is when they put me on Z-Pack. I continued to cough and get very exhausted regardless of the medication. Then July comes along - through the rest of June I could not even walk without getting winded and panting for my own breath. So then on July 6th 2021 I just couldn't go anymore and decided to go to the ER, at the Hospital and I was admitted. They did tests and I was in the hospital until July 8th 2021. My heart is apparently not pumping as it is supposed to. I thought maybe I had bronchitis because of the coughing but apparently not. The DRs say I have Cardiomyopathy, never having heart problems before I was really taken aback by this news. I was sent home with a life vest for my heart now that is scary too. The DRs tell me I am not allowed to do much of anything, basically sit around. I see an electrophysiologist and I see a heart DR. I saw my PCD on the 19th of July 2021 as well. I will see the electrophysiologist on August 10th 2021 as well. Oh I was also put on four new medications: Entresto 2x daily, Carvedilol 2x daily, Atorvastatin 1x daily, Spironolactone 1x daily. I was also taken off of Vyvanse and now I just kind of play the waiting game.

Epiglottis; Developed tightness in my throat; Chills; Muscle aches; This is a spontaneous report from a contactable consumer. A female patient 60 years old female received BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Formulation was Solution for injection, Lot Number: EW0180), dose 2 via intramuscular in left arm on 08-Jul2021 11:30, DOSE 2, SINGLE as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient medical history and concomitant medications were not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-VACCINE, Formulation was Solution for injection, Lot Number: EW0180), dose 2 via an unspecified route on 17Jun2021 01:30, DOSE 1, SINGLE as single dose for COVID-19 immunization. On 10Jul2021 04:00 AM patient developed tightness in her throat, and it felt like her airway on the right side was closing. This was after developing chills and muscle aches that began early on Friday morning, approximately 15 hours after her second Pfizer shot. She went to the emergency room and was diagnosed with epiglottis. She received two shots of epinephrine, an IV and CT scan and prescribed antibiotics, a steroid and antihistamine. She had only mild side effects after the 1st shot sore arm after the first shot. Patient was allergic to penicillin only. The outcome of all events were recovering. Information on the lot/batch number has been requested. Follow-Up (19Jul2021): Follow-up attempts are completed. No further information is expected.

excruciating pain in the bones; sharp neck pain; Headache; sore throat; Difficulty swallowing and breathing; Difficulty swallowing and breathing; Swollen and blistered on the right leg; Swollen and blistered on the right leg; itch and hurt; itch and hurt; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration in Arm Right on 04May2021 10:00 (at the age of 60 years old) as single for COVID-19 immunisation at Hospital. Medical history included lupus erythematosus, rheumatoid arthritis, fibromyalgia. Concomitant medication received within two weeks included baclofen (SOLOFEN), clonazepam (KLONOPIN), trazodone hydrochloride (TRAZODON) all taken for an unspecified indication, start and stop date were not reported and Plasma Capilar. The patient previously took tramadol and experienced allergies, ultacit and experienced allergies, ultram and experienced allergies. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Arm Right on 13Apr2021 08:00 (at the age of 60 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced excruciating pain in the bones, sharp neck pain, headache, sore throat, difficulty swallowing and breathing, swollen and blistered on the right leg, itch and hurt on 06May2021 16:00. Event reported as, After three days excruciating pain in the bones. Still sharp neck pain. Headache and sore throat. Difficulty swallowing and breathing. Swollen and blistered on the right leg. They itch and hurt. The pain in the neck is excruciating. Adverse events resulted in emergency room/department or urgent care. Treatment given for adverse events included toradol, sodomedrol, ataraxia, norflex. Patient did not tested for COVID post vaccination. Outcome of all the events were not recovered. Information about/lot batch number is requested.

Difficulty breathing; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration (at the age of 60-years), administered in arm right on 12Mar2021 08:45 as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma and diagnosed over 20 years ago. Concomitant medications included sertraline hydrochloride (SERTRALIN [SERTRALINE HYDROCHLORIDE]) taken for anxiety from 03Mar2021 to 08Mar2021. On 12Mar2021, the patient experienced difficulty breathing. Patient received the first dose of the Covid-19 vaccine on 12Mar2021. She had asthma and thinks she could have had an asthma reaction and is following up. There were 20 steps or more to the waiting room. As she sat down she had diff breathing. She thought it could be asthma. She doesn't do well climbing stairs. The difficulty breathing subsided in a minute or two. She did not take off her N-95 mask though she wanted to in order to catch her breath. She did not have to use her rescue inhaler. She did not have it with her. She tends to worry and over reacts. She was due to get the second dose on 02Apr. She thinks this could have been a reaction, her family received the Pfizer vaccine and no one had any issues. Her sister said she was panicking. The difficulty breathing ended after one to two minutes. She had the second shingles vaccine on 28Jan2021. When providing concomitant medications, she started taking Sertraline HCL on 03Mar2021. It caused her to be more anxious. She was jittery and restless. She did not like how it made her feel. She called her doctor and he said she could stop. Product is filled in pharmacy bottle. NDC, Lot and Expiry are not listed. The doctor said this was common and it goes away in 2-3 weeks. She did not like how it felt and stopped. She wanted to rule out that something else wasn't going on. How does she know if its a side effect and what does she need to do about second dose? The adverse event does not resulted in emergency room and physician office visit. The patient was taking Covid-19 vaccine for Covid protection. Description of Product Complaint: taking Sertraline HCL caused more anxiousness, jitteriness and restlessness. Product strength and count size dispensed: Sertraline HCL 50mg . Additional lot numbers: NDC, Lot and Expiry are not on pharmacy bottle. Is a sample of the product available to be returned, if requested: Yes, caller will retain as a prepaid fedex mailer may be sent in 3-10 business days Packaging sealed and intact was not applicable. The outcome of the event was reported as recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

pneumonia; loss of consciousness; difficulty in breathing; feeling weak; diarrhea; Arm fracture; Fall; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer. (MFR Control No. # 21K-163-3955081-00). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 26Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation; adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen), subcutaneous from 03Apr2020 (Batch/Lot number was not reported) to Mar2021, at Citrate Free (40 mg,1 in 2 wk), subcutaneous from Mar2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for Ulcerative Colitis. Medical history included tobacco user: one pack of cigrette per day (Started 1978), abstains from alcohol. Concomitant medications included tizanidine; carvedilol (COREG); pregabalin; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS). The patient previously took hydrocodone. The patient experienced loss of consciousness on May2021 with outcome of recovered on May2021, pneumonia on 05May2021 with outcome of recovered in 2021, feeling weak on 27Apr2021 with outcome of unknown, difficulty in breathing on 27Apr2021 with outcome of unknown, diarrhea on Mar2021 with outcome of recovered in 2021, arm fracture on 27Feb2021 with outcome of recovering, fall on 27Feb2021 with outcome of recovering. Clinical course: In 2021, the patient experienced chest tube had been drained and removed. On 27Feb2021, the patient experienced broken right arm in two different places and fell. In Mar2021, the patient experienced diarrhea. in May2021, the patient experienced loss of consciousness. on 05May 2021, the patient experienced pneumonia. in May 2021, the loss of consciousness resolved. in 2021, the pneumonia and diarrhea resolved. Covid-19 vaccine was also considered suspect. the patient shared that she fell in 27Feb2021 and broke her right arm so she went to the emergency room. Her x-ray revealed that she broke her arm in two different places. she was then asked to meet with an orthopedic surgeon and was scheduled for an out-patient procedure to repair her broken arm with pins and plates on the second week of Mar2021. she was sent home and was given hydrocodone for pain. she also added that the physician placed her humira on hold two weeks prior and after the procedure. because of humira was placed on hold, she experienced diarrhea for a week until it resolved. she received her first dose of her covid-19 vaccine in 26Apr2021. she noticed that she started feeling weak and had difficulty in breathing the next morning. she was rushed to the hospital in 05May2021 because her weakness and difficulty of breathing worsened. a series of unrecalled tests had been performed including chest x-ray which showed that she had pneumonia. she was then admitted and was hooked up to a machine because she had difficulty in breathing. she added that she could not recall any other treatments or diagnostic tests that was done to her because she was unconscious for three weeks and was monitored in the intensive care unit. she added that her chest tube had been drained and removed the day she got released in the hospital. she was sent home in 25May2021. alternative etiology of pneumonia, weakness, loss of consciousness, difficulty breathing were reported as covid-19 vaccine.it was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. Causality for humira 40mg/0.4ml(adalimumab)-the reporter's causality for the event(s) of loss of consciousness, broken right arm in two different places, pneumonia, fell and diarrhea with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of chest tube had been drained and removed was not provided. Programs opinion is that there is no reasonable possibility that the events of loss of consciousness, broken right arm in two different places, chest tube had been drained and removed, pneumonia, fell and diarrhea are related to humira 40mg/0.4ml(adalimumab). COVID-19 VACCINE (COVID-19 VACCINE)(Injection) (COVID-19 VACCINE), Causality: Loss of consciousness-Causality as per reporter (Drug/Vaccine): Probable; Arm fracture-Causality as per reporter (Drug/Vaccine): Not Related; Pneumonia-Causality as per reporter (Drug/Vaccine): Probable; Fall-Causality as per reporter (Drug/Vaccine): Not Related; Diarrhea-Causality as per reporter (Drug/Vaccine): Not Related. The reporter's assessment of the causal relationship of the events (feeling weak, difficulty in breathing) with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the plausible temporal relation, the association between the events of loss of consciousness, pneumonia, asthenia and dyspnoea and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factor for the event of pneumonia is the co-suspect drug Humira Due to implausible temporal association, the events of diarrhoea, arm fracture and fall are assessed as unrelated to BNT162B2 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.

congestion in the throat and upper lungs; congestion in the throat and upper lungs; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular on the left arm on 21Dec2020 09:30 at a single dose for COVID-19 immunization. The patient's medical history included herpes 2. The patient was not pregnant. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 26Dec2020 09:00, the patient experienced congestion in the throat and upper lungs. Oxygen level was 98 and temperature was 97.7. She had a good diet, no dairy, and no Christmas junk food, so for the patient, it was inexplicable. She was also consistent at mask wearing and all the precautions. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.; Sender's Comments: Considering the temporal gap between the vaccination and the event onset, the Company considers the event pulmonary congestion is unlikely related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Reported feeling minor SOB and felt like her throat was closing about 30-40 minutes after receiving the vaccines. States that she was driving home when she started having DOB. She took OTC Benadryl PO and the issue resolved.

The individual was premedicated with 25 mg of Benadryl IM in the L arm. She was given the COVID Pfizer vaccine approximately 10-15 minutes after receiving Benadryl. Reported feeling like her throat started closing about 10 minutes after receiving the vaccine. She was provided with 2 doses of PO Bendaryl that she would take home with her. Instructed to take Benadryl PO q 8 hours for the next 72 hours. Family came to pick her up to take her home. She reported feeling better prior to leaving.

worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.

Employee received vaccine at 8:10AM. Slight throat tightness was reported at 8:24AM. Patient given Benadryl suspension 25 mg at 8:26am. Patient then reported throat felt, "a little better". Vital signs BP=189/88; P=90; Oxygen saturation 97% room air; Temp 97.3. At 8:30 patient reports throat feels "worst". Pt. noted to have bumps on tongue - 1 size of chick pea and smaller bumps on back of tongue. Oxygen sats 91%. Epi pen administered at 8:37am and EMS called. 8:45 SAFD on site.BP = 207/81; P=110;oxygen sat = 100% room air. 8:41 Bumps on tongue decreased in size. Oxygen sats 99% room air. 8:52 Paramedics arrive and patient taken to hospital.

Euphoria began ~2hours after vaccine lasting ~2.5 hours. Unable to process information, irritability, anxiousness, generalized not feeling well around 5pm day of; went to bed. Woke up at 10:30pm with headache, took Tylenol. Wednesday didn't feel well in general, left work at noon, went home to bed. Thursday felt better but not baseline self. Friday generalized not feeling well. Saturday went to ER due to feeling much worse generally, SOB. Tests Urine, blood. Everything within normal limits.

24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair

Nausea, chest pain, difficulty breathing following first dose of Pfizer COVID-19 vaccine 0.3 mL IM in right deltoid. Went to outside ED and placed on BiPAP. Given diphenhydramine, epinephrine, and steroid (unknown doses). Prescribed outpatient epinephrine in case of flare of reaction once stabilized.

Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ

Patient seen on 1/8, 1/9 and 1/11 in ER at Hospital for Chest pain. Work up negative for acute coronary syndrome. This started hours after 2nd dose of COVID 19 vaccine. Pleuritic type pain. She was sent with aspirin and monitored. On her 3rd ER visit was given medication for anxiety and to aid in sleep (ativan). Symptoms continued and she was off work the week of 1/11 because of this. Seen in Clinic on 1/18 and symptoms had stopped on 1/17.

she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.

1. SOB 2. Flushed 3. Tremble 4. Decrease in blood pressure EpiPen was administered. Attending physician was contacted and advised to send to ER for follow-up and monitoring.

Pfizer-biotech COVID-19 Vaccine EAU Expected extreme sleepiness, could only stay awake for 20 minutes at a time for next 24 hours. O2 saturation went down as low as 91 but mostly was at 93, heart rate 112 on Jan 13, along with a 100.1 oral temp. I did not Check on Jan 12. Morning of Jan 14: 99 oral temp and 95 O2 saturation. By evening temp and O2 were back to normal: 98° and 98%. Jan 17 I experienced some wheezing. I did have COVID with pneumonia Sept 2020.

After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.

sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.

Patient received Pfizer Vaccine #1 today at 0951 and was waiting her predetermined 30 minutes post vaccine secondary to history of anaphylaxis to shellfish. At 1015 patient reported that her "throat felt funny - like it was closing." Patient reported it was similar to when she had anaphylaxis to shellfish in the past. Patient observed for an additional 4 minutes where she reported it was worsening. Epi 0.3 mg SQ was given while waiting on the Rapid Response Team.

Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.

Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.

Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium

12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt, RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl. 1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied. 1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport. 1323 Pt sitting in chair, calm & no distress, cont. to re-assess. 1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.

Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with heart monitor on patient. EKG WNL B./P 140/97, HR 57 o2 Sat 100 %Ambulance transported patient to Hospital.

facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.

30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing

Patient reports feeling unwell after injection. She felt like "throat was swollen." Also reports having nausea/vomiting, fatigue and headache that persisted until 2/9/2021 (approximately 2-3 days after injection). She did not eat Saturday and Sunday (day of the injection and day after injection). She was finally feeling able to eat on 2/9/2021. She also reported sensation of heart going "fast" up to 93 on Sunday (2/7/2021). She denies any fevers or diarrhea. She also developed soreness in left arm at area of injection site, but did not have any redness at injection site.

On Thursday,1/21, I felt fine and was working. At 1530, I began having rigors and SOB and called 911. At the ED my temp was 103.

Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and pressure lasting about 12 hours. No treatment. Dull headache with numb forehead lasting several days. Took Advil for 3 days Wheezing and shortness of breath lasting 6 hours and the same symptoms the following day lasting about 6 hours. No treatment Did call the doctor with my reaction and concerns for second dose recommendation.

Patient was administered vaccine at 11:00 AM in the left deltoid muscle IM. Patient reported feeling chest tightness, heaviness as if someone was sitting on her chest, pressure on her chest, and found it a little hard to breath at 11:10 am. Patient had a history of congestive heart failure and suffers from anxiety, but wasn't sure if the chest pain was due to her past medical history or the vaccine. At 11:17 am the chest pain remained the same. At 11:30 she was still feeling chest pressure and her right arm was feeling weak. At 11:30 Heart rate was 56, Blood Pressure was 138/72, and respiratory rate was 12. EMS was called at 11:35. Patient was taken to the hospital once EMS arrived.

61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.

This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45. At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80. At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.

Over a 3 day period, I had chills, fever, entire body aches (I could barely move), nausea, EXTREME labored breathing. Symptoms were more severe than the actual covid virus I had.

15 minutes after receiving Pfizer 2nd dose COVID-19 vaccination developed swelling of tongue, stridor and respiratory distress. EPI pen administered right away and employee was transported to ED stat by rapid response team.

Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and dizziness, along with difficulty breathing normally.

2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10:50am, Temp 100.3F at 5:15pm Temp 101.3F at 9:10pm and took tylenol and regular medications, Temp 100.6F at 10:55pm and went to sleep. 2/11/21: woke up with temp 98.7 at 10:00am, had body aches, red and feverish area where vaccine was given in upper left arm. The red, itchy and feverish area about 3 inches x 2 inches on upper left arm lasted about 5 days, also got a lump under left arm that lasted about 6 days and all of these went away by 2/17/21. But I've had more fatigue, and shortness of breath since this 2nd vaccine. Misses my doctor appointment on 2.17/21 due to the winter storm, not going anywhere , we were having all last week.

Pt with marked hoarseness, SOB, & Wheezing. O2 sat 89%, O2 applied. Benadryl 25mg given PO, Solumedrol 125mg given IM, Epi pen administered x2 doses. Transported via ambulance to hospital.

chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional. A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization. The patient medical history included bilateral lung transplant on 23Jun2017, lymphangioleiomyomatosis, hepatocellular carcinoma, antibody mediated rejection of lung transplant , bronchiolitis obliterans syndrome, grade 0P, major depressive disorder, RLS (restless legs syndrome), chronic insomnia, long term current use of systemic steroids OSA (obstructive sleep apnea), iron deficiency anemia, bilateral sciatica, hoarseness of voice, memory change, laryngeal stridor, pure hypercholesterolemia senile nuclear cataract, bilateral myopia of both eyes, osteoporosis without current pathological fracture, alopecia, immunosuppressed status, all from an unknown date and unknown if ongoing. Concomitant medication included acyclovir (formulation: capsule, strength: 200 mg) oral at 200 mg twice daily, salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath), atorvastatin (LIPITOR, formulation: tablet) oral at 80 mg once a day, azithromycin (ZITHROMAX, formulation: tablet)oral at 250 mg (every Monday, Wednesday, Friday), bupropion hydrochloride (WELLBUTRIN XL, formulation: tablet, strength: 150 mg) oral at 150 mg once a day, calcium citrate/cholecalciferol (CALCIUM + VITAMIN D, formulation: tablet) oral at 2 dose form once a day (every morning), everolimus (ZORTRESS, formulation: tablet, strength: 1 mg) oral at 2 mg twice a day, fluticasone propionate/salmeterol xinafoate (ADVAIR, strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation), gabapentin (NEURONTIN, formulation: capsule, strength:100 mg) oral at 300 mg daily (by mouth nightly), loratadine (CLARITIN, formulation: tablet, strength: 10 mg) oral at 10 mg as needed, metoprolol tartrate (LOPRESSOR, formulation: tablet, strength: 25 mg)oral at 50 mg twice daily, minoxidil (ROGAN, strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia, ondansetron (ZOFRAN, formulation: tablet, strength: 4 mg) oral at 4 mg as needed for nausea, pantoprazole sodium sesquihydrate (PROTONIX, formulation: tablet, strength: 40 mg) oral at 40 mg once a day, prednisone (DELTASONE, formulation: tablet, strength: 5 mg) oral at 5 mg daily (every morning), sertraline hydrochloride (ZOLOFT, formulation: tablet, strength: 100 mg) oral at 100 mg twice a day (every morning), sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday, Wednesday, Friday), tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night), salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath), salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) , salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath), ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL, formulation: tablet) oral daily. The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported event may possibly represent intercurrent medical conditions in this patient. 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.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities

Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed coughing spells, non productive after 2-3 minutes after the vaccine administration, she states she felt like fainting. Lung sound checked - no wheezing. Pulse Oximetry checked 96%. Observed for 30 mins in the field. Intermittent coughing still noted. Pulse oximetry remained 96%, no shortness of breath or difficulty breathing. After 3 0 mins, patient continue to cough , states she feels tickles in her throat that makes her cough and she has a headache. Patient given Benadryl 25 mg p.o. and monitored for 30 mins. Patient felt better after 25 mins of observation and minimal coughing , pulse oximetry @ 96-98% denies SOB or difficulty breathing . Patient sent home with husband and advised to rest at home and call 911 if she develops SOB or difficulty breathing. Followed up call over the phone at 5: 00 PM , patient states she fell asleep when she went home and no cough , no SOB or difficulty breathing.

About 10 minutes after receiving the vaccine, patient reported feeling somewhat short of breath and itchy. She presented to the clinic somewhat short of breath because of her asthma, but the itching was completely new. Gave the patient an age appropriate dose of Benadryl and symptoms resided within 15-20 additional minutes of observation time.

arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.

Pt received vaccine and was being monitored following receipt. After ~30 minutes, developed right sided chest pressure with shortness of breath. Used her inhaler, which helped with shortness of breath. EMS was called and patient was transported to the ED where she also endorsed a headache. EKG showed some ST depression with T-wave inversion that was not present in 2008. Patient was monitored for a few hours - had 2 negative troponins and repeat EKG and was discharged home.

shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself. A 61-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly on 20Jan2021 at 14:45 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included restless leg syndrome from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within 2 weeks of vaccination) included tretinoin (RETIN A; skin cream), biotin, vitamin D NOS, calcium and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced shortness of breath, tingling feeling in lip and face, all on 20Jan2021, all reported as non-serious. The events did not cause hospitalization. No treatment was received for the events. The clinical outcomes of the events shortness of breath, tingling feeling in lip and face were all unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then some shortness of breath, that lasted less then a minute approx 5 minutes later a bad headache started then I felt extremely tired the headache lasted about 5 minutes the tired about 15. Nothing was needed everything got better on its own.

Ears felt clogged, slight feeling of swelling in throat that lasted about two hours. Did not go to doctor.

still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!

On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.

Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, took a big swig of Benadryl, went to Fire station, transported by ambulance to ER, blood pressure got way too low on ambulance ride, difficulty breathing/taking air in, IV applied - hospital by 6:30 PM, breathing still difficult, blood pressure better until it dropped again, IV given and monitored. Stable and discharged around midnight. Friday - Tuesday - very tired, heavy arms and legs, sore throat and tongue, limited to soft, bland. foods.

Patient received vaccination at 12:10. At 12:25, patient complained of tongue thickness. EMS called. Difficulty breathing. Developed seizures. Epinephrine 0.3 administered. Seizures continued on/off for approximately 1234. Tongue swelling did improve. Transferred to hospital setting via EMS at 1245.

Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after 30 minutes so I was allowed to leave the vaccination facility shortness of Breath started 35 o 40 minutes after injection. When I was was walking out to my car My daughter was in area and picked me up and she had Benadryl Took 2 Benadryl Shortness of breath started to improve after An hour of Benadryl. Hoarse voice improved some but continued to improve after second dose of Benadryl. Now on March 11 I still have a slight hoarse voice but so much better. I?ve been taking Benadryl every 4 to 6 hours regularly per my Dr I don?t have shortness of breath anymore but my chest does feel a little tight

Shortly after receiving vaccine, patient began to experience shortness of breath and throat itching/tightness.

February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a strong medicine taste in throat. Lasted 45 minutes - 1 hour. Approximately 9:55 am slight feeling of throat closing, which lasted about 45 minutes. Approximately 10:00 am headache, which lasted until approximately 4:00 pm, February 26, 2021. Arm soreness evening of February 25, 2021 lasted approximately 2 weeks. February 26, 2021 approximately 6:00 am diarrhea, headache, chills, legs aching, and fatigue, which lasted until until approximately 4:00 pm.

Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.

Tacycardia and shortness of breath, followed by chills. Duration of 10 minutes until resolved. Subsequent abdominal pain with mild diarrhea and then extreme fatigue for 5 hours. Similar to a food allergy reaction

Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

She also experienced shortness of breath/out of breath; heart out of sync; new heart rhythm abnormality; she has heart rhythm problem (premature atrial contraction); feeling exhausted; This is a spontaneous report from a contactable Nurse (patient). A 61 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249), via an unspecified route of administration on 19Jan2021 (at the age of 61 -years-old), single dose for COVID-19 immunization. Medical history included covid infection over a year ago. The patient had no concomitant medicines were not reported. The patient She had flare ups when she took Hep b vaccine before and did not get the 2 remaining doses because of the reaction. She has had so many vaccines over the years and had her flu shot every year. Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 19Jan2021. Consulted the doctor 01Feb and told she has heart rhythm problem (premature atrial contraction). She also experienced shortness of breath. Not sure if it is vaccine related or due to her age. She will have the 2nd dose on 09Feb2021. Stated that she was feeling exhausted (29Jan2021) and out of breath. Stated that the doctor told her that her heart rhythm out of sync. Stated that in Dec she had her heart checked and it was okay. Stated that her other Covid is due to be given 09Feb. Does not know if the vaccine is contributing to her heart rate's bivalvular rhythm. Stated that she had Covid infection over a year ago. Stated that she is worried that the vaccine caused an abnormal rhythm to her heart. Stated that she has a new heart rhythm abnormality. Stated that she had all of her lab work done on 11Jan2021 and it was okay. Stated that on 27Jan-28Jan that she tried to pick up a watermelon and was short of breath for no reason. Stated that it happened a couple of times. Stated with her rhythm being out of sync that it feels like her heart is failing. The outcome of the event dyspnea was recovered, heart disorder and fatigue was not recovered, other events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported arrhythmia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.

I am retired handicap-MS. I was doing light housework. I started getting pain in right lung, over course of 2 hours pain became very severe. Only in right lung. Felt like blood clot or pulmonary embolism (which I had 15 yrs ago). Went to hospital, check X-ray no clot/embolisms. Blood work showed no clotting factor. Was admitted 4 days. We treated possibility of MS reaction (solu-methyl) as well as heparin in event of unknown clotting issue. Here?s why this is strange: If this was MS flare/relapse, I would have muscle lockup, drop foot, sight issues, sever balance issues ...(i always have sight issues).. with this even it was only severe lung pain. Did not appear to be MS driven issue. Being educated ?high analytic person, in reflection, My ms is very territorial, it fights anesthesia, colds/flus/covid when my husband had it. My MS gets cranky when my immune system is attacked. I suspect the second covid injection was doing its thing, dna modification, and I had some lung inflammation and my MS compounded the reaction with crippling issue. I was in hospital 4 days, IV fluids, heparin, and steriod IV. Within first 36 hours the extreme lung pain disappeared and I got better. I do have cats scan, mri, X-rays from stay. Cat scan clear, X-ray, normal, mri-classic ms history. Was this Ms event? I?m not sold as I didn?t have other normal MS flare symptoms. Was this injection aggreviated? Perhaps... I?m sharing this because I think tracking auto immune disease people is important data gathering. Feel free to call if more dialogue is necessary

[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, tremors, headache, tachycardia, and hypertension, all without fever.

My face became numb within 10 minutes of the injection. My throat started to close making it somewhat difficult to swallow, but not to the point of having trouble breathing. It has been 12 hours since the injection and my face still feels numb, but swallowing is just starting to get a little easier. The numbness is mostly around my nose, cheeks and forehead.

At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.

Throat closing, SOB, tongue/lips swollen. Evaluated by EMS-Transported to Emergency room/department or urgent care.

Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma attacks. One was severe taking 2 hours to resolve. Worse on 3/20 than today on 3/21. I?ve taken 2 Tylenol and used my rescue inhaler 4 times. The inhaler improves my breathing, but I don?t feel normal yet. Oxygen saturation between 93-96%. If still experiencing symptoms will call PCP and/or go to urgent care. If I?m still coughing I will have to reschedule a hematologist appointment.

Patient reported to nurse after receiving first dose of Pfizer that 3-5 minutes later her left side of neck/throat felt tight and tingled. Nurse alerted Doctor and myself to assist patient. We arrived to patient's car in front of garage at 10:55 AM and walked beside car as the husband pulled forward to park. Patient stated she received her vaccine about 10:45 and then as her husband started pulling forward, she told him about her symptoms. Dr. assessed patient and stayed with patient until 11:13AM. Patient left in passenger seat with her husband driving stating that she no longer felt the tightness in her neck or throat.

throat tightening and some difficulty breathing, given epi .3mg, paramedics called, went to ER for obs

Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.

About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness in my throat and chest and shortness of breath. (This was occurring while I was driving myself home from the vaccination site.) I administered my Epipen. And I then drove myself to the Emergency Room, which is near my home. At the ER, I was injected with cortisone, Benadryl, and Pepcid, and had my heart and blood pressure monitored for about 3 hours and then I was released, with a prescription for 50MG Prednisone (1q/day) and 10MG Pepcid (2q/day) x 5 days (for both scripts). I finished the prescriptions, but am still feeling some discomfort in my throat and some dizziness.

SOB Narrative: Pt reported itching and SOB at 1247. BP 134/88 HR 71 SAT 99% RA. RRT called at 1253, cetirizine 10mg PO AT 1253, epi-pen administered at1253, diphenhydramine 50mg IM at 1257. Pt was then transported to ED. While in ED, given nebs and 125mg solumedrol. Intermittent chest tightness, given albuterol inhaler with good response. Patient was discharged with prednisone 40mg x5 days, cetirizine 10mg x5 days, famotidine 20mg x5 days, albuterol inhaler upon resolution of wheezing.

Throat tightness with difficulty swallowing, tingling to face and head. Lasted approx 10-15 seconds. Went to the emergency room and was stable at the time. Toward the latter part of the ER visit, I was given prednisone, Pepcid, and Benadryl. Have had no issues since then.

Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.

3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.

Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.

Swelling of throat and neck pain, shortness of breath, headache progressed for 1 hour after shot. Went to ER at Hospital. Took 25 mg Benedryl, declined prednisone, but left ER 2 hrs later with prescription for epipen and prednisone. Took Zytec at home and slept. Symptoms were gone next day.

at 3am I woke up with a racing heart rate and mild burning in my belly. I couldnt go back to sleep. The next day the burning in the belly got worse. My stomach became bloated and I was having shortness of breath walking short distances. The racing heart and chest pain ebbed and flowed. I made a video appointment with my PCP group on Thursday and they prescribed omeprazole and asked me to come in for physical exam the next day. When I went in the symptoms persisted, they did blood work, did a chest x-ray and sent me over to the emergency room. At the ER they did an EKG, more blood tests and recommended I have a abdominal CT on an outpatient basis. They couldnt say my symptoms were a result of the Pfizer shot but they could not rule it out that it was related to the shot.

Mild asthma flare and mild itch on face 60-90 minutes after injection. Symptoms resolved with no medical treatment required.

Pt had throat tightening as well with vaccine similar to her taking Sulfa. Gave Benadryl and she felt better with no problems swallowing vitals 143/98 O2 sat 98% HR89 with pt observed after IM benadryl. Felt better will not have her get second Pfizer vaccine

She states on Saturday, 27th that she woke up having trouble breathing. She used VaporRub on her nose and throat and turned on her vaporizer. After about an hour, she started to feel better. But during that time, she felt like her throat was "closing" up. Her nose did not feel congested.

Pt had itchy eyes, coughing and increased dyspnea. She has a hx of allergic reactions and this began much like other reactions she has experienced in the past. She was aware of the change and called for help. She was given benadryl and 125 of solumedrol en route to the ER. Pts SpO2 dropped to 95% and was placed on NC at 4LPM. Pt states her eyes still itch and she feels the need to clear her throat, but no longer feels the shortness of breath.

Following day: major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme tiredness (stayed home from work) 2nd day: big headache; very light headed; some coughing; short of breath; nausea (stayed home from work). Not restful sleep. 3rd day: pressure headache; very light headed (went to work). Very tired at night. Hard time sleeping. 4th day: light headed; pressure in head; short of breath when going for a walk; hard time sleeping. Since 4th day, haven't slept well; light headed; on-and-off headache; at work but moving slow. Feels like when I returned from being out with Covid + double pneumonia 6/30/2020-7/23/2020.

3/25/21 sore arm, tired achiness, headache, lite headedness-throughout day & night. 3/26/2021 same as previous day. 3/27/2021 at 6:30 am awaken unable to breath.- Both ears felt closed, throat felt closed. Immediately took a Benadryl, put Vicks on neck-throat area, used steamer for moist air through nose. Lasted close to one hour. 3/27/21 most of afternoon & evening extreme tiredness. 3/28/21 morning ok, by afternoon extreme achy tiredness again. 3/29 to present headaches.

Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we gave 50mg of Diphenhydramine orally, patient condition worsened, she described her throat starting to swell up, and had noticeable difficulty breathing and shortness of breath. We administered Epinephrine at 10:55am and within 5 seconds patient reported improvement. Patient remained stable until EMS arrived about 5-10 minutes later. Patient was advised to be taken to the hospital for monitoring and agreed. She remained stable and reported an "itchy back" upon exit.

Woke up very dizzy, light headed, felt like diarrhea, hot, sweaty, passed out approximately 4 times, had a harder time breathing, than normal being on oxygen. Stayed in bed for approximately 27 hours, just couldnt function well. Didnt contact Dr. About it, had family stay with me for couple days. I know it was from the vaccine.

Feeling of heat in mouth, numbness in mouth, swelling in throat (not severe), difficulty swallowing (not severe), tongue swelling, Day 3 post injection: hives on upper left arm just above elbow, Day 4: headache (severe), numbness/tingling in jaw, neck and face, swelling of lower legs.

Within 15-minutes of their second vaccination, the patient reported shortness of breath and that their throat was closing. EMS evaluated the patient on-site. Patient was slightly hypertensive (144/78). EKG demonstrated Pacer rhythm, rate 60bpm, no ST elevation. The patient was placed on 4LPM O2 via nasal cannula. EMS administered 50mg IV Benadryl, 125mg IV Methylprednisolone/Solu-Medrol, and .5L IV Saline en-route. In the ED, the patient reported shortness of breath, difficulty breathing, tongue swelling, and throat swelling. EMS stated that they did not administer epinephrine. The patient was in stable condition without angioedema or signs of respiratory distress. The patient was discharged with a diagnosis of Allergic Reaction and prescribed a 4-day course of 40mg Prednisone BID.

Approximately 5 minutes post vaccination, patient complained of throat tightness and difficulty speaking. EMS was activated. Pt was given 50mg Benadryl. Patient was then re-evaluated and symptoms improved. Patient reports allergies to nuts and fish but no other known allergies. Patient refused transport by EMS and released in greatly improved condition with precautions

Feeling a little SOB, history of asthma. Did not use inhaler in morning. BPs 175/79 (pulse 86), O2 sat 96%; 152/71, O2 sat 96%. Took albuterol.

Pt reports having a sensation of throat tightness during her waiting period after the vaccine. However, she did not tell anyone at the site, and was able to breathe well. She left the site without informing anyone. She continue to have the sensation for that day, then it resolved. However, since that time she has had an unusual feeling of ill-defined shortness of breath and frequent throat clearing

pt states her arm felt like it was on fire as the vaccine was being administered. She became very dizzy and had a headache. On 3/16/21 her arm was sore at the injection site. Her throat hurt and when she swallowed she would have a sharp pain right between her eyes. Her left arm became very painful and every time she tried to move it would cause pain in her chest. She had diarrhea, sweating and had 101 fever. On 3/17/21 she had to have someone help her our of bed on this day. She felt like she was going to pass out. She had this feeling on at least 3 occasions. Pt had pain when opening her eyes, trouble breathing and having heart palpitations. She called her cardiologist with her symptoms and was told it was related to taking the vax. She had a televisit w/ PCP and she was sent to have a Covid test which was negative. She was told to drink plenty of fluids and rest. By 3/20/221 pt started feeling better at this time.

Wheezing, severe lung pain with difficulty breathing, swelling inside mouth. Have been able to treat at home with Benadryl, rescue asthma inhaler, and steroids?hydrocortisone that I take for adrenal insufficiency

Pt reports severe left arm pain. Pt also reports left sided chest pain and difficulty getting a full breath.

-SLUGGISH, HEAVY, SHORT OF BREATH -WEAK, UNSTEADY -INSIDES FELT 'BURNING' -WENT TO URGENT CARE NEXT DAY FOR TEST; NEGATIVE -BREATHING TX; STEROIDS; INHALERS PT STATES SHE IS BETTER NOW.

Chest pains, migraine, difficulty breathing with mask on, out of breath easily,low grade temp, chills and body aches, runny nose ear pain Started with chest pains 4am 3/26 and lasted about 2 1/2 days

Her face started swelling and turned red and her throat felt tight.. She was given .3 cc of epinephrine . She felt better then we had to repeat the dose in about 15 more minutes. She could still breath easily but she did not feel better after the second epinephrine shot. She was sent to the ER in an ambulance

Injection site swelling, redness, pain, itching, headache, tiredness, chills, fever, nausea, feeling unwell, difficulty breathing, weakness

Pt reported after her 1st dose 3 weeks prior, approximately 40 minutes after leaving the clinic she felt her tongue swell and throat thick. Reports taking a Benadryl and contacted PCP. Pt presented to clinic on 4/5/21 with paperwork from PCP stating patient to receive 2nd dose of vaccine "benefits outweigh risks." PCP did not recommend premedicating for 2nd dose. After receiving 2nd dose approx 15 minutes later, patient reported feeling of tongue swelling. Patient took her own Benadryl 50mg PO. At 2:28PM, pt reports feeling full throat. Placed on monitor, Pulse Ox 96%, HR 90's, BP 189/119. Pt transported to Emergency Room. Was able to speak clearly on arrival in ED, Dexamethasone 10mg IV push and famotidine 20mg IV Push administered. Patient symptoms resolved, diagnosed with minor vaccine reaction and discharged to home with instructions to f/u with PCP.

Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofen, severe fatigue, could not stay awake more than half hour, fuzzy headed feeling, constant ringing in the ears , day 4 of effects couldn't catch my breath when walking more than 10 feet. Day 6 still have ringing in ears, some fatigue, breathing better but not 100%.

Called to car approx 10 min post vaccination where PT reported "my nose and mouth are itchy" "my throat and eye feel itchy". VSS. Offered benadryl po 25mg. PT accepted. 15 min later, pt reported "my throat is tight" "some trouble breathing ". Breath sounds clear bilat. Sao2 = 96 - 99. As precaution, EMS on site consulted. Advised pt that "she looked stable" and gave her options for further obs or d/c home, calling 911 if there was further distress. PT reported feeling better and opted for d/c home. Vital signs stable throughout.

Patient said she woke up the next day and her arm hurt very bad and it was hurting even in her chest. It got worse throughout the day. She noted that her blood pressure was high as well. She tested it and it was over 180 sbp. She called me on the evening of 4/9/21 to let me know the chest and arm pain was getting worse. She told me her current systolic blood pressure was over 160 and she normally does not have elevated blood pressure. I advised her to go to the ER. She called the next day to let me know at the ER she found out that she had fluid around her lungs. They told her this was from her immune system's response from the vaccine.

Mild head ache and lightheaded ness started within a few minutes. Fast heartbeat followed. After my 15 minute wait time before leaving, I told them my experience. They took my blood pressure which was 175 over something. They let me leave when it was down to 144 over something. Within a few minutes after we left I experienced a severe hot flash, my air cutoff, and I felt weak/faint. I experiencedy airways close, then open again. Nothing like I have experienced before with an asthma attack. This was different. My husband pulled over and I was able to call 911. My heart was racing. The paramedics asked me about the rash on my chest which I new nothing about until he mentioned it. Said my face was flushed? And

Upon receiving 1st dose, pt ambulated to observation area w/ unsteady gait. Pt sat down in observation area w/ noticeable labored breathing, inspiratory stridor, cough, dyspnea. Pt was pale and diaphoretic. Pt was offered vitals check by medical staff, pt refused, stating she recently had an AMI and this was normal for her. Pt stated she carried EpiPen due to latex and iodine allergies, and "if this was an allergic reaction," she "would have known by now." Pt was told to notify medical staff of symptom changes. Throughout her 15 minute wait, pt produced violent coughing and could be seen with noticeable SOB. Pt stood up and ambulated with unsteady gait for approximately 5 ft, where she stopped and was assisted into w/c. Pt was wheeled out to vehicle, where she was asked to stay for another 15 minutes given her symptoms, pt refused. Pt was offered vitals check, pt refused, stating she is "just a minute away from home" and if she would place herself "on low oxygen" upon arrival. Pt drove off, returning approximately two minutes later. Pt c/o throat swelling, SOB, w/ inspiratory stridor, hoarse voice, and violent cough. EMS was called at this time. EMS transported to local hospital.

Received vaccine on 04/07/2021 at 07:47 AM; Presented at ED on 4/08/2021 at 8:29 am and received prednisone 60 mg and diphenhydramine HCl 50 mg: chest tightness and throat swelling that began yesterday afternoon. She explains that she has h/o anaphylaxis to flu vaccine. She got the first dose of Covid19 vaccine yesterday, she did premedicate with benadryl. She was monitored on site for an hour and felt some left neck pain and jolt of pain down left arm, but it resolved and she went home. Shortly after, she began feeling like she was having asthma attack, wheezing, chest pressure and throat swelling. She used inhaler and took benadryl. Last dose of benadryl at midnight, took Zyrtec D at 7am this morning, last nebulizer and symbicort at 6:30am. She states she still feels chest tightness and throat swelling. She feels like her tongue was very swollen but improved after benadryl. States her voice is different. Feels a little harder to swallow but she is able to drink fluids. She took pantoprazole this morning. States this does not feel like her usual asthma. Rates chest tightness a 4/10 on pain scale, states it feels like something is sitting on chest or squeezing chest. States it does feel a little better in anterior chest now, but she feels it on lateral lower chest still. Denies h/o cardiac issues. Denies h/o MI. No jaw or arm pain at this time. Discharged from ED at 9:27 am and reported to ED at 10:03am on 4/08/2021. Received famotidine 20 mg and discharged home at 1206pm on 4/08/2021 with prednisone, Pepcid, EpiPen

Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.

Two days after receiving the vaccine, the front of my neck developed a very itchy, warm rash, my lymph glands on the right side of my neck swelled so much that it was difficult to swallow even liquids without pain, and I had a fever of about 100. The itchy area on my neck continued to worsen, and despite the application of OTC anti-itch medications and me taking Benedryl, it got larger and warmer, and the itching became even more severe. At one point my throat was so swollen, I started to think it was closing up and that I'd need to go to the hospital. The discomfort continued into the next day when I contacted Teledoc, and was prescribed an antibiotic, and prednisone, which helped. The itching is still present, but managed by regular spraying of an aerosol cortisone. And the swelling has gone, but there are slight scars like one would get from a scrape. My throat is much better, and my fever is gone.

had an immediate reaction of dizziness, lightheadedness and throat closing within 10 minutes of getting the Pfizer vaccination. Was given two zyrtec and that improved. She did have the symptoms for about an hour after and then was completely back to normal. States she has had a reaction to Miralax in the past and has not taken it since that reaction. States she is also allergic to Sulfa medications. Will refer to allergy

At approx. 9:22 AM on 4/2/21, I began having problems swallowing my saliva and felt my throat begin to close. I also began having problems breathing, began coughing and choking, chest pain, and dizziness. The nursing staff at Hospital immediately got a wheelchair and rushed me next door to the ER. The nurses had called ahead so that the ER doctors were ready to assist me. I was given Epinephrine, steroids, nubilizer treatments, Bendryl, IV fluids and oxygen. After some time I began feeling a little better but then the reaction restarted and treatments had to be re-administered several times. It was quite frightening. I also had a severe headache and tightness of the chest . The ER doctor believed that I should be admitted which was done on 4/2/21 and was kept thru 4/4/21.

Loss of breath. Very hard to breathe; Vision degrade; Heart rate increase over 100 BPM; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 12:30 (at the age of 61-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. 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. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. On 13Mar2021 00:45, the patient experienced heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath. As a result of the events, a visit was made to the doctor or other healthcare professional office/clinic with the patient's heart rate, blood pressure and oxygen (level) were checked. As of 14Mar2021, the clinical outcomes of the heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath were resolved on an unspecified date in Mar2021. The expiration date of the lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Chills, nausea, headache, body ache, mildly labored breathing, loss of appetite, slight fever (no more than 100 degrees). All happened in a 24 hour period, with nausea, fever and loss of appetite lasting on and off for several days.

This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in. On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club. Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.

Developed chest pain, fever, chills, dyspnea, and diarrhea beginning a most immediately after the vaccination

headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; fever of 102; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; headache 1st 24 hours. very tired into the next 48, then 4 days later violent vomiting, Diarrhea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible horrible migrain; very tired and exhausted; This is a spontaneous report received from contactable consumer. A 61-years-old female patient had taken BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955), via an unspecified route of administration at the right arm on 23Mar2021 18:00 at single dose for COVID-19 immunization. The patient's medical history included thyroid disorder, severe asthma, osteoporosis, heart disease (previous heart attack). The patient had allergies to penicillin, zpac, sulfa drugs, symbicort, hydrocodone, kiwi, shellfish. Concomitant medications included amlodipine besilate, simvastatin, levothyroxine sodium, fluticasone furoate. The patient had headache 1st 24 hours and very tired into the next 48 (on 23Mar2021), then 4 days later (on 27Mar2021) violent vomiting, diarrhoea, shaking badly with chills, fever of 102, heart racing, shortness of breath, horrible migraine (not prone to migraines), was sick for about 36 hours and have been exhausted every since. It was reported that patient was homebound for the most part and no one in my house was sick but me. The patient was not diagnosed with covid prior vaccination not tested since vaccination. Outcome of events was reported as recovered with sequel. No follow-up attempts are needed. No further information is expected.

anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.

DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.

severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.

Pt received her vaccine and completed the 15 minute observation period with no adverse event. She felt dizziness upon standing. She drank a bottle of water, but remained dizzy. Pt was escorted to the restroom by medical reaction nurse, at which time she reported ongoing dizziness. She was brought to medical observation unit at 2:33pm. Associated symptoms included shortness of breath. SPO2 was 86 upon arrival to medical observation unit. 2:39pm- pt reports resolution of SOB; 2:44pm- pt reports resolution of dizziness while lying supine; 2:52pm- pt reports slight lightheadedness while sitting upright; 3:00pm- pt denies dizziness/lightheadedness while sitting upright; 3:02pm- pt denies dizziness/lightheadedness while standing PT discharged home at 3:04 by herself Vitals as follows: 2:34pm- HR- 74, RR- 18, BP- 174/75, SPO2- 96 2:39pm- HR- 66, RR- 16, BP- 166/90, SPO2- 97 2:44pm- HR- 69, RR- 18, BP- 147/93, SPO2- 96 2:52pm- HR- 69, RR- 18, BP- 164/80, SPO2- 95 2:55pm- sitting- HR- 70, RR- 16, BP- 156/96, SPO2- 96 3:00pm- sitting- HR- 70, RR- 16, BP- 151/85, SPO2- 97 3:02- standing, HR- 79, RR- 16, BP- 144/86, SPO2- 96

face and throat swelling and redness; face and throat swelling and redness; mild face swelling; lymph nodes swelling in armpits; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number: ER8737 and expiration date was not reported), via an unspecified route administered in right arm on 31Mar2021 at 12:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient had no known allergies to medications, food or other products. The patient's medical history included ductal carcinoma in situ (DCIS). The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; Lot Number and expiration date were not reported), via an unspecified route of administration, date and dose for COVID-19 immunization. The patient was not pregnant. It was reported that no other vaccine was given in four weeks but patient had received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced mild face swelling and lymph nodes swelling in armpits on day 1 (01Apr2021) after vaccination. On day 2 and 3 after vaccination, the patient had only mild face swelling. On day 4 (04Apr2021), the patient experienced severe face and throat swelling and redness. The patient rushed to the emergency room (ER) but conditions reduced by 80% by the time of arrival at the ER. The patient took diphenhydramine (BENADRYL) tablets and the doctor prescribed an epinephrine autoinjector (EPIPEN) and told her to keep on hand. From day 5 to day 8, mild facial swelling still exits. On day 9 (09Apr2021), patient had just a trace of facial swelling. It seems like conditions were getting normal. The outcome of the event facial swelling was recovering at the reporting time. The outcome of lymph nodes swelling in armpits and severe face and throat swelling and redness was recovered at the reporting time on Apr2021. No follow-up attempts are possible. No further information is expected.

Chest tightness, mild diff breathing. EMS administered albuterol. Pt felt relief. Pt alert and conversing properly.

Red blotchy skin within 20 minutes, itching. raised hives. Next 5 days followed by red flushing skin. Itching. Swollen throat and tongue.

Approximately ten minutes after receiving vaccine. Patient began experiencing an itchy throat, dizziness and throat tightness. Offered Benadryl, which patient refused. Was monitored for 30 minutes with resolution of all symptoms.

on 04/25/21 patient complained of cold like symptoms, mild fever, upset stomach, headache, and shortness of breath 04/26/21 tested positive for Covid

I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.

She will be deceased, most likely, if she does.; arms really heavy, can hardly lift them; arms really heavy, can hardly lift them; She feels sick and unwell; face little swollen; chest pain; pressure in chest; ears ringing; Difficulty breathing; Migraine headache; heart palpitations; Chills; nausea; really red face, cheeks; back pain a lot worse; very high fever; This is a spontaneous report from a contactable consumer (patient) A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation . Age at vaccination :61 years. Medical history included ongoing epilepsy (started at 16 years old. Has not had a seizure in years, maybe 20 years) ,herniated disc and chronic back pain from 2003 and ongoing , Heart septal defect (repaired) and seizure disorder.Concomitant medication(s) included carbamazepine (CARBAMAZEPINE)at 200 mg, 1x/day taken for seizure from an unspecified start date and ongoing. The patient experienced "she will be dead, most likely, if she does" on an unspecified date , difficulty breathing on 10Apr2021 with outcome of unknown , very high fever (on 08Apr2021 with outcome of recovering , migraine headache on 10Apr2021 with outcome of recovering , heart palpitations on 10Apr2021 with outcome of not recovered , back pain a lot worse on 08Apr2021 with outcome of not recovered , ears ringing on 10Apr2021 with outcome of recovering , chills on 09Apr2021 with outcome of recovering , nausea on 09Apr2021 with outcome of not recovered , pressure in chest on 10Apr2021 with outcome of not recovered , chest pain on 14Apr2021 with outcome of not recovered , arms really heavy, can hardly lift them (non-serious) on 15Apr2021 with outcome of recovering , really red face, cheeks on 09Apr2021 with outcome of not recovered, face swelling on 14Apr2021 with outcome of not recovered and She feels sick and unwell on 14Apr2021 with outcome of not recovered. Clincal course was reported as follows:On 08Apr2021 she had her vaccine. She is running a fever and has every side effect on the template from the pharmacy. She is not doing good and should probably be in the hospital. She can not drive her self, or have anyone else drive her. She feels really bad and is afraid of a clot. This is from the first shot and she is not getting another. She will be dead, most likely, if she does.She can hardly lift her arms up. She did not see this in list of side effects and doesn't know what that is.She tried to make a claim with Covid compensation number, but was unable to connect with them. Her symptoms started 3 days ago. She did this in case she had to. She read she has to keep her fever down. She just took some Tylenol.She didn't look for few days at the paperwork provided to her after the vaccine. She was seeing side effects and she got nervous, this is why she didn't call earlier.She is having trouble breathing now and has never been so sick. Caller asking how long the side effects last and needs to talk with Medical Information.Her Mother recommended she receive the vaccine and told her of all these people coming across the boarder and that they may bring Covid with them.She had a septal defect repaired in her heart. She doesn't know if there could be something wrong with that, but her doctor and heart doctor said she is fine. They haven't found anything from the testing she had had.Her difficulty breathing is on and off. It started 2-3 days after, and she doesn't know with her heart palpitations and if there could be damage. That's why she called the Covid compensation.The first day, she had a very high fever and headache. She didn't take her temperature, but she knew it was a fever. Today it is not as high as it was, it's not bad.She had a migraine and took something for it and it went away for hours. She took aspirin, Bayer Back and Body, and her fever and headache went away for hours.She experiences heart palpitations. Every time she eats they get worse. She has reported this to her physician. Her Physician said to take Tylenol and gets exercise. She recommended she doesn't lay up and caller thinks she wanted her to go to the hospital. Caller's mother can't drive and her sister is dying of cancer. Caller lives near her mother but she can't drive. She's older and caller can't ask her to do that.Her palpitations are sometimes there.She has a back injury from someone hitting her from behind. It is extreme back pain. It worsens after she gets a vaccine. She gets on the heat pad. She doesn't have anything for it, just some patches.Her ears are not ringing now and might be getting better. She had chills, but they're better today.She had nausea. It's better today. Yesterday, when talking to her doctor caller was advised to exercise. That makes her feel worse. It's not a big thing. She feels sick and unwell.Her face is really red and maybe a little swollen. Her Physician was thorough and she even asked about it, and commented it sure is red.Caller lays in bed and keeps her feet up. She knows she's got to move around, her Physician told her to.Caller is concerned about a blood clot. She is having pressure and pain in her chest. It has been the same. What's new is chest pain yesterday and did not feel bad, but it is noticeable. She hopes it doesn't get worse. What is new is her arms feel really heavy and she can't hardly lift them.Her facial redness worsened with her fever. The Tylenol is working, her fever is going down, but her arms are still heavy, but better.Treatment received for arms really heavy, can hardly lift them and very high fever.Additional information:Vaccination Facility Type: Pharmacy/Drug Store . No COVID Prior Vaccinations

ANXIETY, DRY COUGH, DIFFICULTY BREATHING. FIRST BP 195/86, SECOND BP 163/86. SYMPTOMS IMPROVED, REFUSED TRANSPORT, AMA SIGNED.

Pt presented to ED w/N/V, coughing, headache, fevers, fatigue x 1 week and inability to keep PO intake down. Started developing symptoms on 4/16, tested negative for COVID on 4/19. Was found to be COVID positive despite getting Pfizer vaccines (3/11/21 & 4/1/2021). Was admitted for additional management of acute hypoxic respiratory failure due to COVID-19 pneumonia and N/V/D with electrolyte imbalances. Treated w/remdesivir and dexamethasone. Her N/V and electrolyte imbalances improved w/IVFs and zofran. Was discharged on 4/28 w/follow-up in 5-7 days.

Allergic Reaction at testing site transported to ED via EMS from home. Throat and facial swelling , tight breathing Treated with Benadryl and Epinephrine

May 1, 2021, Patient was admitted to the hospital with Blood clots in both lungs. The hospital is unable to figure out what has caused the blood clots. We do not know if this is related to the vaccine but would like to know if it is.

14 hours after injection, I experienced prickling sensations and tightness around my windpipe and prickling, tingling sensations in my back behind my shoulder blades. These were mild and lasted for 2 hours.

Muliple segmental and subsegmental low risk pulmonary embolisms presenting with dyspnea and hypoxia. Succesfully treated and patient on treatment with a DOAC

Almost fainted from struggling to breathe; abdomen swell quite a bit; nerve burning/nerve pain; Diarrhea; Losing some weight; Almost fainted from struggling to breathe; This is a spontaneous report from a contactable consumer (patient). A 61 Years female (no Pregnant) patient received 1st dose of BNT162B2 (Lot number: EN6208) Intramuscular on 25Mar2021 at single dose on Left arm for covid-19 immunization. Medical history was not reported. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination was Vitamin C and D and a multi vitamin. Past drug included Allergies to Codeine, Cipro (Cipro gave me central nervous system toxicity). Patient stated that I could immediately taste the shot. Two hours into receiving the shot I could feel it attack my right side. Almost fainted from struggling to breathe. It made the right side of my abdomen swell quite a bit to the point where I felt I almost needed to ice it. It also gave me nerve burning. It has been 3 weeks and I still have some nerve pain from it. Diarrhea. Losing some weight. Unsure if I dare get the second dose. No treatment. Outcome of the event was unknown. Prior to vaccination, patient was not diagnosed with COVID19. Since the vaccination, patient had not been tested for COVID 19. No follow-up attempts are needed. No further information is expected.

Day 2 & 3 after my vaccine, I had fatigue & shortness of breath. On Day 3 , it began with a little nausea that became worse, along with shortness of breath. Ado I also pain followed, & no medication or rest with a heating pad helped. After 7 hrs. I sought treatment at Emergency Room. After several tests, and an abdominal cat-scan, it revealed that I had appendicitis, and would need an appendectomy soon. At 5:30 am I received an appendectomy from . I stayed overnight in the hospital.

Pt. stated, "I felt short of breath 3 minutes after getting vaccinated." Vital signs done: BP 132/84, O2Sat 96%, HR 78, R 16, glucose 134. Pt. also stated, "I have asthma but I forgot my inhaler at home." "I live near here, I will use it when I get home." At 12:20pm pt. stated, "I feel better and I don't think I need to go to the hospital." "As soon as I get home, I will use my inhaler." At 12:25pm pt. went home with family member.

Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or smell, Congestion or Runny Nose, Diarrhea; Vomiting. Prednisone (DELTASONE) 10 mg tablet; Take 2 tablets (20 mg total) by mouth 2 (two) times a day for 4 days-Azithromycin (ZITHROMAX) 250 mg tablet; z pack. 500 mg day one 250 mg day 2-5. -Albuterol HFA (PROVENTIL;VENTOLIN) 90 mcg/actuation inhaler; Inhale 2 puffs every 6 (six) hours as needed for wheezing for up to 7 days.

Tongue numb - Still numb today. I want to know if my tongue will ever recover. Throat swelled. - Took Benadryl. Right arm pain for 4 days. Bad headach for 3 days.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Patient developed paroxysmal atrial fibrillation. Upon date of death- pt husband reported SOB, incontinence, gasping for air, slumped forward and died upon 911 arrival.

After about 5 minutes, lips started to tingle - they then felt swollen and hurt. I had difficulty breathing (mild), and difficulty swallowing. Symptoms increased until about 15 minutes. Then leveled out. They were mild to moderate. I spoke to the EMT (not helpful). I waited 30 minutes and left. Took a Benadryl 25mg tablet (generic) after getting to my car. The symptoms lessened. By the time I got home (30 minutes) the only thing that bothered me was painful lips. That lasted a few hours. My allergist has advised against the 2nd dose.

Respiratory symptoms - Burning pain when inhaling in lower trachea and upper chest. Feeling of weight on upper chest. Breathing was not obstructed. Chills but not fever, hypothermia (97.1 F), body aches, dizziness, spots and floaters in vision, tiredness, slight nausea. Note this related find from internet research: A team of researchers have found that exposure to the SARS-CoV-2 spike protein alone was enough to induce COVID-19-like symptoms, including severe inflammation of the lungs. https://medicalxpress.com/news/2021-04-sars-cov-spike-protein-lung.html Messenger RNA vaccines work by instructing cells to create "spike proteins." These proteins simulate part of the SARS-CoV-2 cell structure and trick the body into believing it's infected with the virus.

61 Year old female presented with shortness of breath and was found to have a platelet count of 11 k/ul ( She had a platelet count of 184 k/ul 12 days prior). She received 2nd dose of Pfizer vaccine 21 days prior to the event. She received steroids with improvement in platelet count.A diagnosis of immune thrombocytopenia ( non thrombotic) was made.

By 12:50 hands were starting to swell; chest pain; heart palpitations; pulse felt like her heart was racing very hard; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; blood pressure was up; throat felt like it was starting to tighten; eyes itchy; eyes itching much worse; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date: unknown), via an unspecified route of administration in left upper arm on 22Apr2021 12:10 (at the age of 61-year-old) as unknown single for COVID-19 immunization. This report was not related to a study or programme. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events following prior vaccinations was first time had flu shot made her very ill, next year doctor suggested she should just have half of a shot instead of full shot to see if she tolerated it and she was able to tolerate that. She had not any other problems with flu vaccines in general. Some of the other vaccines, she was just supposed to take Benadryl with them because of some of the filler ingredients people put in things. She had previously had the 1 dose shingles vaccine, but she had gotten probably shingles probably a couple of months after that so they encouraged her to get the 2 part shingles vaccine at a later date and told her to do the pre-medicate routine like Benadryl day before, day of and at least 2 days after shingles vaccine doses and if any major problems call for help. She did not have a noticeable problem from the 2 part shingles vaccine. Some of the times depends on what filler ingredients people use. She was allergic to nutmeg which was used as an emollient oil or it's called Myristicin something or other oil; if something has too high a dose of mannitol it can cause a problem. She has a very long list of allergies and high sensitivities; if it was a high enough sensitivity it goes in allergies list, even though it may not be a true allergy. Family has lots of allergies. Regarding prescribed indication additional details: She had 3 doctors who initially advised her to get the vaccine including her primary care physician, oncologist and haematologist; this was because she was a high risk person because of various health issues. Her haematologist 2-3 months ago when she had her last appointment with him he was saying to get the shot and prescribed the epi-pen at that time; no one was having it yet, but he expected she would have some sort of reaction to it not able to be covered by Benadryl alone. Medical history included ongoing platelet disorder Verbatim: Unidentified platelet disorder, Lots of allergies, cardiac murmur, ongoing asthma, osteoarthritis, glucose tolerance impaired, hypoglycaemia slow thyroid and back and neck pain. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity (50mg taken as needed), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for hypersensitivity (10mg daily), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma (250/50 twice daily), levothyroxine sodium (SYNTHROID) taken for hypothyroidism (137mcg-1 tablet daily), methylphenidate hydrochloride (RITALIN) (20mg tablet twice daily), salsalate, colestyramine (QUESTRAN LIGHT) (2-500mg tablets 3 times daily), sucralfate (CARAFATE) (1mg tablet 4 times daily-dosage verified with caller as milligrams and captured as provided), loperamide hydrochloride (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) (2.5/0.25 takes 2 tablets of that 4 times daily), calcium carbonate (CALCIUM OYSTER SHELL [CALCIUM CARBONATE]) (Alternates dose of 500mg and 1000mg on days takes Vitamin D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) (250 mg), vitamin D (50,000 units every other day taken), vitamin B12 (1mg injection every 14 days), clonazepam (KLONOPIN) (2-1mg tablets at bedtime), montelukast sodium (SINGULAIR) taken for asthma (10mg tablets at bedtime) and cefixime (FLEXERIL [CEFIXIME]) taken for back pain, neck pain (10mg tablets 3 times daily as needed). On 22Apr2021, Onset time: She had a note saying her eyes itchy at 12:20, but they were itching before that because she waited long enough to report it; so onset time was less than 10 minutes when her eyes started itching. Then her pulse; she could feel chest pain; heart palpitations; pulse felt like her heart was racing very hard. They did check her pulse while she was in their initial observation and her pulse was only in the 70s, but oxygenation was at 96%.When at doctors office less than 1 hour before that reading, oxygenation was at 98%.Recorded at 12:30 eyes itching much worse, throat felt like it was starting to tighten, heart felt like it was starting to race. By 12:50 hands were starting to swell. She had already been pre-medicated with Benadryl before this before she went down to get the Pfizer Covid-19 Vaccine, she had Benadryl in her system. She had that same morning with her morning meds had taken Zyrtec and Benadryl in anticipation of getting the possibility of getting the Pfizer Covid-19 Vaccine because she has to pre-medicate for vaccines just in case she starts to react in anyway. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines was not administered on same date of the Pfizer Suspect. Emergency Room taken from the location where vaccine administered-they gave her Pfizer Covid-19 Vaccine shot had her sit for basic observation then sit for extended observation. In that time period telling them her symptoms were going on, increasing. They gave her another 50mg Benadryl even though she had already had 1 before and then called emergency room, took her down, left her in waiting area even though she had heart and chest palpitations. Physician Office seen prior to event on 20Apr2021, seen after event 27Apr2021. Primary Care Physician didn't hear anything in lungs either visit. Not admitted to hospital; seen in emergency room, theoretically she got treated; however her basic blood pressure and stuff even with what they were doing was higher than when she was triaged in the ER; blood pressure was up and something else,oxygenation level moderately reduced from when she came down to when she was just let go; however her symptoms were worse when she was leaving than when she got there. She knows what they gave her while she was there was IV of normal saline, solumedrol and IV Benadryl. Thinks they later gave her Tylenol tablets. Finally got them to do an EKG because kept saying her chest was getting worse but that was several hours after she was back there even though came there having chest pains. In her opinion this hospital was not taking reaction seriously. Not admitted to hospital even though symptoms were worse and blood pressure higher on discharge, well above her normal levels. Currently trying to get them to explain why they took so long to do anything for her. Finally did a chest x-ray on 22Apr2021:discharge papers say abnormal x-ray and they gave a couple of different possibilities as to what that might be so Primary Care Physician wrote a prescription to get a follow-up chest x-ray to make sure that everything is fine and back to normal and not ongoing or progressing or anything because they gave some strange things: what their impressions were: findings: there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. It says the left lung appears clear; cardiomediastinal silhouette is within normal limits; impression restates non specific right findings there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. This was from front and lateral views of the chest x-ray at 19:00pm 22Apr2021. 2 ECGs: She guesses this is what they call EKG not, relevant point is that in the notes there for the records: Says abnormal ECG compared with blah blah blah, hard to find when exactly they wrote this, trying to get the exact wording for each of the two. Machine results CED, which caller explained is what they call themselves now instead of ER, notes for MD interpretation; one done at 17:53 , other at 21:32. They both say there was slightly different readings, however both say abnormal ECG. One of the wordings that is in both. She had no further details to provide regarding relevant testing/investigations. She had to be in the ER back in the room for several hours before they would do the EKG and that's only because she said I have chest pain and standard procedure is to do an EKG, had been back there for hours, they had done no tests, the only thing they did was basic blood panel, had not done a troponin or heart enzymes test, had not done EKG that's why she knows they were not taking her seriously at all; if someone says chest pains and you don't do anything in the standard protocol they are not taking you seriously. On this Monday, 2 days ago she had gone down to pick up the records from the ER to go to Primary Care Physician appointment 27Apr2021, finally actually got to speak to someone who said they would get back to her on 27Apr2021 to look into why the EKG tests were not done for someone having chest pains. That's one of the first things you do for someone having chest pain, no matter what the source. Frustrated with them because they're still not communicating back, they had not taken her seriously while she was there; unknown if they were actually going to be reporting, as they were still trying to convince her to get the second dose of Pfizer Covid-19 Vaccine. If she reacted to the first dose in first 10 minutes, second dose could be much more of a reaction. With the amount of anti-histamines in her system with Benadryl and Zyrtec and she was still starting to react in under 10 minutes. It's possible to be one of the inactive ingredients but she doesn't see anything in the pamphlet provided that she could identify at first glance as being the culprit to the problem other than 2 possibilities: potassium chloride and other is monobasic potassium phosphate. There is a possibility of her having a reaction to those because she was known to react to certain potassium products; sometimes it was the inactive ingredients. She definitely would have wanted to get the second part of the Pfizer Covid-19 Vaccine series until after she was not getting the medical attention she needed after reaction to the first dose. Because ideally you're supposed to have it at the same location, that just made her very nervous at the prospect of worse reaction at location that did not take her serious the first time. She was a big fan of Pfizer thought they do a great job; she had not known it was a 2 parter, not that it should make much difference. When her Primary Care Physician was saying second dose of Pfizer Covid-19 Vaccine was out of the question and she had been saying to people that she did not think it would be prudent to take the second part, they kept trying to say oh you need to get the second part, talk to so and so so they can convince you to get it, and doctor is going no. She reacted to ringers lactate or lactated ringers whatever the name is, her retired nurse sister sat and watched her getting some ringers lactate prior to surgery for her tear duct and saw her starting to break out in red splotches, patient said she was itching. Action taken in response to the events was drug withdrawn. The outcome of the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient looked lethargic during her 15-minute monitoring period. She stated she felt like she couldn't breath, "she felt high." Administered oxygen. Provider instructed to give EpiPen 0.3mL. Patient transported to hospital.

Numerous blood clots in both lungs; This is a spontaneous report from a contactable consumer (patient reported for herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8730, expiry date not reported), via an unspecified route of administration, administered in left arm on 09Apr2021 09:00 AM as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included degenerative disc disease, fibromyalgia, hypothyroidism, migraines, known allergies to tape and anise allergy. The patient had negative nasal swab on 07Nov2020. The patient had no covid prior to vaccination. Concomitant medications included morphine at 15 mg, twice a day; oxycodone (XTAMPZA ER) at 36 mg; and heparin; all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 as COVID-19 immunization on 19Mar2021 09:00 AM (at the age of 61 years old) (brand Pfizer, lot en6208) administered on the left arm. The patient had no other vaccine in four weeks. On 30Apr2021 09:00 AM, patient had numerous blood clots in both lungs. On 01May2021 to May2021, she was admitted to the hospital for 2 days with numerous blood clots in both lungs. After several tests (May2021), they could not find any reason for getting these clots. So, thinking the only other thing patient did different was get the covid vaccine. The event was reported as serious medically significant, life threatening, and had caused hospitalization from 01May2021 to an unspecified date in May2021. It resulted to emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the event which included Heparin IV. The patient had not recovered from the event numerous blood clots in both lungs.

2/22/21 Had Nuc scan to eval for blood clots/ there was no evidence 5/12/21 ct scan finds PE post vaccine. in with cough and SOB

Fast heart beat with palpitations; Tightness in chest felt like burning; Tightness in chest felt like burning; Shortness of breath; Extreme nausea; This is a spontaneous report from a contactable other HCP (patient). A 61-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration on 31Jan2021 at 10:45 in right arm as 2ND DOSE SINGLE for covid-19 immunization. Medical history included asthma, coronary artery vasospasm. The patient took lidocaine and experienced allergies. The patient had received unspecified medications within 2 weeks of vaccination. 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 not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previous vaccine included first dose of BNT162B2 (COVID Pfizer vaccine, solution for injection; Batch/Lot Number: EN1204) on 10Jan2021 at 10:45 in right arm for COVID-19 immunization. The patient experienced fast heartbeat with palpitations, tightness in chest felt like burning (coded to chest discomfort and chest pain), shortness of breath and extreme nausea on 31Jan2021. Five days later also she had shortness of breath felt like asthma. She also experienced fast heartbeat with palpitations. The events were reported as non-serious. The patient did not receive any treatment for the adverse event. The outcome of all events was not recovered/not resolved. Follow-up attempts are completed. No further information is expected.

After vaccine, 2 hours later my eyes, lips were swollen. They said acute dehydration and my heart started pounding wildly. I went home and took Benadryl the next day I had breathing problems, 3rd day woke up with numb arm and went to ER and developed arm and left numbness and tingling that's still there today. I still have swelling in face and tongue and sores in my mouth and I have to ice myself at bedtime. and still wake up with difficulty breathing. I'm scheduled for an MRI because doctors said it's an adverse event to vaccine and I've also had hives. I will probably go back to ER because I'm having asthma issues again. I checked with my doctor about my medical records to know if I should get the vaccine and was told to get the vaccine. I have left side numbness and that's why I'm getting the MRI to rule out everything.

Pt is a 61 yo female with recurrent granulosa cell tumor (s/p secondary debulking/whipple in 2019), stage II colon cancer, and stage IA cancer s/p radiation on tamoxifen/megage, with history of short gut on chronic TPN. On admission (5/4) she presented with weakness, diarrhea, and fever. Pt was tachypnic to 40s, 1L NC with O2 sat > 90% on admission. RR improved and she was eventually weaned to room air. The COVID PCR on admission resulted positive. She is s/p full Pfizer vaccination: first dose on 2/25 and second dose on 3/18. Pt remained stable on room air for the rest of her stay and received remdesivir for 5 total days.

Patient received 2nd Pfizer COVID Vaccine on 05/07/2021 and patient reports two days later she began to feel increasingly short of breath and was found to be hypoxic at 66% requiring increased supplemental oxygen, thought to be due to sudden COPD exacerbation, requiring IV Solu-medrol, Duo-nebs and Albuterol. Required hospitalization for 2 days and discharged on antibiotics and prednisone.

itching; brain is on hold; localized injection site urticaria; generalized prickle sensation; Bilateral Wheezing; hoarse voice; Generalized Urticaria; Generalized erythema; coughing so bad she vomited: first dose; broke out in a rash; croupy cough; rhinorrhea/runny nose; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm on 22Mar2021 08:00 (lot number EP7534) at single dose for COVID-19 immunisation. Medical history included Latex allergy, Penicillin allergy. Patient previously experienced allergies with allopurinol (ELAVIL) and amitriptyline. Concomitant medications included triamcinolone acetonide (KENALOG), famotidine (PEPCID), and multivitamins. Patient reported that when she first got her vaccine, she broke out in a rash on 23Mar2021, nothing productive, no fever no nothing. She took care of the rash with a little prednisone, antihistamines. She stated the day she got her first one was 22Mar2021. Her arm got red the next day 23Mar2021, nice little whelp around it, her arm started getting kind of bumpy and a little itchy, then she noticed it on her back and her chest then around her waist, just patches, whelps. She started on Hydrocortisone and it just never went away. Then after, started 29Mar2021 or 30Mar2021, she got a croupy cough, the coughing lasted a few weeks, it ended sometime in the end of Apr. She thought it was seasonal allergies, but the coughing was so bad she was actually vomiting from it. She stated she actually thought she had COVID but she didn't run a fever and didn't lose taste or smell, just the way she was coughing and it was in her chest. She stated just some coughing, no fever, no production of anything, just coughing, very raspy. She had a dose pack, she took it, took Benadryl, Antihistamines, the rash was still there, but not as bad. She states the first one stayed on her back and chest and a little bit on her arms, back, arms and so forth. Then the second shot (in her left arm, LOT: ER8732), she was head to toe in a rash and she got the second shot 12Apr2021 in the left arm at 08:00. The rash never even went away, it just got worse. She stated it was serious enough because of all the medication, Benadryl, antihistamines, Atarax. The patient also experienced runny nose in Mar2021. She stated it's like her brain is on hold since the shot. She stated the coughing so bad she vomited started the first of Apr. The cough had just gotten so hard, no matter what kind of cough medicine she took, it just did not help it. She stated flat out croupy cough. Cough Medicine: she just did the Mucinex DM for the congestion and she did Dayquil and Nyquil that type of thing. She stated when she got on the steriods, that did help with that. She stated she was on her fourth dose of steriods, oral steriods, she had one IM dose. She had to go to doctor to get an IM steriod and other three have been oral. The treatment medication included: Hydrocortisone (EXP: Nov2023, LOT: 20W319, NDC:0031713-03): Cortisone 10. It's the cream she's been using, the itch relief cream, to help relieve the itching. She's been using regular Hydrocortisone cream, she's used a lot of that. Prednisone (LOT: UJ200503B, EXP: Mar2022, NDC: 42806-400-21) pack currently on, she stated this is the third pack of tabs. Prednisone shot: she went to the doctor office and got a prednisone shot the week before last, so last Wednesday on 28Apr2021 or 29Apr2021. Two previous steroid packs. Benadryl (LOT: P83332, EXP: Jun2021): 25 mg tablets, takes two of them about every 3-4 hours. Loratadine (LOT: 0BE2611A, EXP: Oct2021, NDC: 49348-818-56): 10 mg tablets, she takes them first thing in the morning, by mouth. She stated it's been tough between taking magnesium sulfate (EPSOM) salt baths and avena sativa (OATMEAL) baths. Patient was not seen in the emergency department, no hospitalization required. Respiratory: Bilateral Wheezing, Dry cough, hoarse voice, rhinorrhea. Dermatological/Mucosal: Generalized Urticaria, Generalized erythema, generalized pruritus with skin rash, generalized prickle sensation, localized injection site urticaria. Patient did not receive any recent vaccines for any other conditions prior to the event being reported, did not receive any recent vaccines for SARS-COV2 other than the Pfizer- BioNTech COVID-19 Vaccine prior to the event being reported, did not receive any other vaccines around the time of Pfizer- BioNTech COVID-19 Vaccine vaccination. Lab data included COVID test: unknown result on unspecified date. The outcome of event rash, itching was not recovered, outcome of cough, vomiting, rhinorrhoea was recovered in Apr2021, outcome of other events was unknown.; Sender's Comments: Based on information available, the reported serious event rash was likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to the temporal relationship and known safety profile of this product.

Patient presents to the ED with shortness of breath, chest pains and palpitations. Has noticed rapid heart rates for last 2 months, started immunotherapy. Started on diltiazem and symptoms resolved. Diagnosed with Afib and COPD exacerbation. Recently diagnosed with left lung squamous cell carcinoma. patient will start on eliquis, digoxin and diltiazem. Discharged with symptoms resolved.

14:08, pt presenting with complaint of "lips feel like they are swelling", pt has history of medication allergies & adverse reaction to lidocaine; per EMS S.O., 2-Benadryl-25 mg tables were given. Pt was asked to stay another 30 minutes after taking the Benadryl.

Woke up at 5am on 5/7/21 with severe lower abdomen/back pain & severe cramping; took Ibuprophin & used heat pad. Pain subsided by noon but still slightly sore when, got up & moved around that day then I went to bed that night still slightly sore. Woke up again at 6am with severe pain like morning before; took Ibuprohin and heat pad. Tried to get up around 8am but had to return to bed by 10am. Pain got worse to point where I could not breath with SEVERE cramping in lower back/abdomen. Called for EMT to transport to ER. Was given muscle relaxer OTW ER. After about 1 hr in ER was given another muscle relaxer and pain med (Morphine). (NOTE: this form will not allow use of Continuation Pg)

Routine screening. for Covid-19. Asymptomatic. Date 2 developed shortness of breath with exertion, dry cough and afebrile. Day 5 same symptoms, plus temperature of 100 to 101.1 F

Came in with a chronic cough (since January 2020), patient states her cough got worse since after getting the covid vaccination. Patient states she sees a pulmonologists on a regular basis, was diagnosed with asthma.

Patient complained of being dizzy, couldn't breath, unable to move L arm. L side of back numb also complained of legs hurting but stated legs had hurt all week. BP 138/70 HR 81 O 2 sat 97% glucose per fingerstick 212 equal grip, PEARL, Respirators 22 Transported to local hospital via ambulance for health care

As of 6/1/2021, pt presented with 3 weeks progressively worsening dyspnea on exertion and associated lower extremity pitting edema up to hips and was found to have acute bilateral pulmonary emboli, including a large thrombus seen in the left main pulmonary artery. Also admitted to nausea, orthopnea, PND, chronic leg swelling no worse than usual, and a productive cough with creamy white sputum.

Pt reported severe anxiety and syncope when receiving injectable medication and blood draws. Pt was agreeable to receive vaccine and a plan was made ahead of time to administer to her in her vehicle with the seat laid flat. Upon receiving the vaccine, the pt immediately stated, " I don't feel good" and began to hyperventilate and complaint of tingling in all extremities. Pt then vomited and an EMS crew on standby was notified to evaluate the patient. The patient was eventually transported to the ER due to near syncope and hypotension.

he received Pfizer vaccine 2/5 and got symptoms a few weeks after the vaccine. She experienced a lot of chest pain at work and went to healthcare facility and was diagnosed with pleurisy. She received steroid treatment and a steroid shot and then received another 3 rounds of steroids - this was through February, March, and April. She saw a pulmonologist 5/20 and CT scan done again and CXR. She was diagnosed with pulmonary edema and elevated calcium levels. She was started on some pain medicine at that time and a steroid. After she came off steroids, was in a lot of pain and had to stop working. Diagnosed with recurrent pericarditis.

arm still hurts; shortness of breath; her right arm hurt a lot at the injection site; Numbness on right side of nose, mouth, chin, and jaw; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Expiration date: Not reported), via an unspecified route of administration, administered in arm right on 12Feb2021 (Batch/Lot Number: EL9262) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she reported online that the shot did not hurt, states soon after, her right arm hurt a lot at the injection site, on 12Feb2021 evening around 19:00 the right side of her nose went numb, states then the right side of her mouth went numb, states the numbness continued down into chin and jaw on 13Feb2021 (Saturday) and 14Feb2021 (Sunday). Sometimes she feels like she was having shortness of breath, (13Feb2021) started 24 hours later. Reported everything but the shortness of breath online. On an unknown date, the patient reported that her arm is still very achy at site of injection and she doesn't feel like herself. . States the numbness has dissipated. The outcome of the events her right arm hurt a lot at the injection site, arm still hurts was unknown, shortness of breath was not resolved, numbness on right side of nose, mouth, chin, and jaw outcome resolved on an unknown date Feb2021. Follow-up attempts completed. No further information expected.

Joint pain; Tiredness; muscle pain; swelling of face; swelling of throat; difficulty breathing; Diarrhea; This is a spontaneous report from a contactable consumer. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history included sjogren's syndrome, arthritis, fibromyalgia and systemic lupus erythematosus. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 18:30, the patient experienced Joint pain, tiredness, muscle pain, swelling of face, swelling of throat, difficulty breathing and diarrhea. The events were not treated. The patient was recovering from the events. Amendment: This follow-up report is being submitted to amend previously reported information: Relevant Med History 2, the verbatim was updated from Arthritis NOS to Arthritis and Relevant Med History 4, the verbatim was updated from Lupus syndrome to Lupus and Narrative regenerated per original source document. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Cough This is a new problem. The current episode started in the past 7 days (x3 days. Possible covid exposure to covid 2 weeks ago. Had had both covid vaccines. Seen at clinic this week and started on antibiotics for bronchitis. Did not get tested for covid and wants covid test.). The cough is productive of sputum. Associated symptoms include headaches, myalgias, shortness of breath and wheezing. Pertinent negatives include no chest pain, chills, fever or sore throat. Associated symptoms comments: Decrease in taste. N,V,D.. She has tried a beta-agonist inhaler (antibiotics, phenergan) for the symptoms. Her past medical history is significant for COPD. Vomiting This is a new problem. The current episode started in the past 7 days (x3 days). There has been no fever. Associated symptoms include abdominal pain, coughing, diarrhea, headaches and myalgias. Pertinent negatives include no chest pain, chills or fever. Risk factors include ill contacts (No traveling.). Treatments tried: phenergan. The treatment provided mild relief.

Fatigue, chest pain, pam post exertional malaise, PBC's, shortness of breath and abnormal baseline heart rate, hypotension

Firs stop shot 3/27/2021, second 4/17/2021Lightheaded, accelerated INR of 4.7within 48 hrs. Of first shot.Low grade fever on and off sometimes accompanied wit chills. Increasing fatigue and leg weakness, eventually shortness of breath, pain in center of chest when breathing, couldn?t lay down due to pain in neck and chest, diagnosed with pericarditis May 31 2021. Out of work since may 28 2021

Component Results: Component Your Value Standard Range Flag; Troponin T, 2 hr., 5th gen 1923 ng/L<=10 ng/L<=10 ng/L H; Consider acute myocardial injury 2H Delta 862 ng/L ng/Lng/L;2H Delta Interp Changing Evaluate for acute myocardial injury; Troponin T, 6 hr., 5th gen; 2104 ng/L; <=10 ng/L<=10 ng/L H; Consider acute myocardial injury; 6H Delta SEE COMMENT ng/L ng/Lng/L; Test cancelled. Specimen not received within delta timeframe.; 6H Delta Interp SEE COMMENT; Test cancelled. Specimen not received within delta timeframe. General Information-Ordered by, M.D., Ph.D._____________________________________________________ Your Admission - 03/30/21Printer friendly page--New window will open-Admission Summary-Notes-Clinical Notes H&P by M.D., Ph.D. at 3/30/2021 3:55 AM-Status: Signed-CARD 3 Admission Note-SUBJECTIVE- CHIEF COMPLAINT= Chest pain. HISTORY OF PRESENT ILLNESS Patient is a 56 y.o. female who presented to the Emergency Department due to chest pain. She has experienced this pain each evening for the past 3 evenings, and states that it starts in her right arm then migrates through her shoulder and across to her chest. The pain can last for anywhere from 5 minutes to 4 hours. This has come on at rest, but in the setting increased personal life stressors as well as uncontrolled hypertension. She states that she is normally on hydrochlorothiazide for hypertension, but ran out of this medication about a week ago. When she checked her blood pressure at home it was in the 230s/120s, therefore she presented to the emergency department locally. Her medical comorbidities are notable for poorly controlled hypertension, mixed hyperlipidemia that is untreated, current tobacco use (1-2 packs per day for 40 years), and medically complicated obesity. In the emergency department she was found to have mild polycythemia with hemoglobin of 15.2 and leukocytosis of 13.7. INR, D-dimer, and BMP were normal. High sensitivity troponin T was found to be 770 ng/L. ECG showed normal sinus rhythm with T-wave inversion in aVL that was not present on 08/25/2004. Chest x-ray was largely unremarkable. Her chest pain resolved, but given the elevated troponin ECG changes she was treated for NSTEMI with heparin infusion, and loaded with aspirin and clopidogrel and directly admitted to the Hospital Cardiology service. Upon arrival she remained free of chest pain but continued to have significant hypertension. I have reviewed and updated the following: Past Medical History, Family History, Social History, and Allergies. Current Outpatient Medications on File Prior to Encounter: hydrochlorothiazide (HYDRODIURIL) 25 mg tablet, Take 1 tablet (25 mg total) by mouth daily., Past Week at Unknown time; Lorazepam (ATIVAN) 0.5 mg tablet, Take 0.5 mg by mouth daily as needed for anxiety., More than a month at Unknown time. REVIEW OF SYSTEMS Pertinent items are noted in HPI; all other review of systems was negative. OBJECTIVE VITAL SIGNS Temperature: [36.8 °C-36.9 °C] 36.9 °C; Heart Rate: [83-117] 83; Resp Rate: [20-26] 22; Blood Pressure: (164-195)/(81-129) 164/106; SpO2:[92 %-97 %] 95 %;Weight: [104 kg-106 kg] 104 kg; Pulse Rate: [90-109] 94. PHYSICAL EXAM General: Alert, oriented, no acute distress; HEENT: Mucous membranes moist, JVP difficult to assess due to body habitus; CV: Regular rate and rhythm without murmur; Lungs: Clear to auscultation bilaterally; Abdomen: Obese, soft, nontender, nondistended, normoactive bowel sounds; Extremities: No peripheral edema appreciated; Neuro: No focal deficits appreciated. DIAGNOSTICS I have reviewed labs and imaging from the past 24 hours. ASSESSMENT / PLAN Patient is a 56 y.o. female who was directly admitted to the Cardiology Service from Emergency Department due to NSTEMI and poorly controlled hypertension. She also has untreated mixed hyperlipidemia and is a current smoker. We will continue to trend troponins and treat NSTEMI was heparin infusion, aspirin, and clopidogrel. I will start a statin and initiate low-dose lisinopril and carvedilol for blood pressure control with plans to up titrate as tolerated. I will update a lipid panel in checked for diabetes. I will obtain a TTE in the morning and keep her NPO for probable coronary angiogram pending negative COVID swab. #1 Non-ST Elevation Myocardial Infarction; #2 Poorly controlled systemic hypertension; #3 Mixed hyperlipidemia, previously untreated; #4 Medically complicated obesity (BMI 38-trend troponin- loaded with aspirin and clopidogrel- Aspirin 81 mg daily- clopidogrel 75 mg daily- moderate intensity heparin infusion- rosuvastatin 20 mg daily- lisinopril 2.5 mg daily, up titrate as tolerated- carvedilol 6.25 mg twice daily, up titrate as tolerated- holding home hydrochlorothiazide in lieu of lisinopril and carvedilol- lipid panel - hemoglobin A1c- TTE- NPO for probable angiogram (not-ordered)- cardiac rehab consult ordered;#5 Abuse Tobacco Smoking- nicotine patch- nicotine inhaler as needed- nicotine cessation consult; #6 Anxiety She is prescribed lorazepam 0.5 mg which she takes when she has a panic attack which only occurs a couple times per year. For now we will just monitor. Diet: NPO; Tubes/lines: PIV; VTE prophylaxis: heparin infusion; Code status: Full Code; Disposition: anticipate discharge to home when clinically stable. Counseling was provided face-to-face at bedside regarding the plan of care as stated above. I personally spent over half of a total 70 minutes in counseling and coordination of care as documented above. M.B.B.S. at 3/30/2021 10:58 AM Status: Signed. SUBJECTIVE HISTORY OF PRESENT ILLNESS Patient is a very pleasant 56-year-old female who is owner of multiple nursing facilities who presented with chest pain and hypertensive emergency. She ran out of her hydrochlorothiazide last week, was fairly busy managing all her nursing homes with COVID pandemic and vaccination program. She was having intermittent chest pain, chest pressure radiating to the right arm. In this setting she checked her blood pressure, and it was noted to be 240 systolic over 140 diastolic. In this setting was sent to the ER and subsequently sent here. Initial troponin was 770. Subsequently, it went up to 1923. Delta was 862. ECG showed sinus rhythm with clear ST depression in the inferolateral leads. Patient currently is chest pain-free. She was initiated on carvedilol and restarted her home hydrochlorothiazide. Blood pressure is better. She had a good night's sleep. OBJECTIVE PHYSICAL EXAMINATION; Vital Signs: Noted.; General: Alert and oriented x3. Cardiac: S1, S2 normal.; Lungs: Clear.; Abdomen: Soft.; Extremities: No edema of feet.; Vessels: Peripheral pulses well-felt.; DIAGNOSTICS Creatinine is 0.7. Bicarb is 30. ASSESSMENT / PLAN Patient, is a 56-year-old female with obesity, hypertension, smoking, presented with hypertensive emergency. Blood pressure is better controlled now. She did have clear ST-T changes with troponin elevation, and we will treat it as NSTEMI at this point. Certainly, this can be demand ischemia in setting of hypertensive emergency, but she has multiple risk factors which would warrant coronary artery disease evaluation. We will plan for an angiogram today. We will get an echo today. Post that, we will reassess and see how things go. It appears that this was in setting of medication noncompliance. However, if this happens again, we may also look for other secondary causes of hypertension, especially with the fact that her bicarbonate was 30. All her questions were answered. DIAGNOSES: #1 Hypertensive emergency; #2 NSTEMI; #3 Obesity. M.B.B.S. DD: 03/30/2021 08:54:32 CT; DT: 03/30/2021 09:13:15 CT; Job ID: 914158020/mjb. Sedation Note by HCP at 3/30/2021 10:22 AM Status: Signed. INTERVAL HISTORY AND PHYSICAL PRE-PROCEDURE UPDATE H&P reviewed. The patient was examined and there are no significant changes to the H&P. PRE-SEDATION ASSESSMENT Consent Consents Obtained: written. The benefits, risks and alternatives to the procedure and the potential need for sedation or anesthesia as well as the names, roles, and responsibilities of healthcare team members performing significant interventional tasks were discussed with the patient and/or decision maker: yes. Indications / Reason for Visit. Procedure / Reason for Visit: coronary angiogram with possible intervention. Presedation Assessment. The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, family history, medical history, social history and problem list: Yes. Review of Symptoms pertinent ROS negative. Physical Exam Mallampati: II - soft palate, uvula, fauces visible. Assessment Plan ASA Physical Status: class 3 - patient with severe systemic disease Sedation Plan: moderate sedation. Patient seen, evaluated, and approved for sedation: yes. Cardiology Fellow 11053 Discharge Instr - Referrals / Follow-Ups by HCP at 3/30/2021 11:18 AM Status: Written Take a copy of this after visit summary to your appointment(s).---------------------------------------------------- Monday, April 5th, 2021:-- 12:30 p.m. -- Hospital follow-up with Dr. primary care provider, at Medical Center------------------------------ --------------------------- You may have outpatient appointments at Clinic that changed during your hospitalization. Refer to your Clinic Patient Visit Guide (PVG) for the most current schedule of appointments and detailed instructions of tests/procedures. Call, if you did not receive an PVG or need to CANCEL any Clinic appointment(s). H&P by HCP at 3/30/2021 12:33 PM; Status: Signed; CARDIOLOGY 3 H&P HISTORY OF PRESENT ILLNESS; Patient is a 56 yo F with history of hypertension, dyslipidemia, smoking history, and obesity who presents with chest pain, found to have NSTEMI. She owns and runs 4 assisted living facilities. In the past three days, she has had chest pain at rest following dinner, while sitting in the living room. It has lasted from minutes to hours and was relieved on its own. Yesterday she was prompted by her husband to present for medical attention. She has smoked 1-2 packs daily for the past 40 years. She is on hydrochlorothiazide 25mg daily for her blood pressure. Blood pressure was 171/129 here in the ED. Troponins rose from 770 to 1061 to 1923. Current Medications: [MAR Hold] acetaminophen tablet 1,000 mg (TYLENOL), Q6H PRN; acetaminophen tablet 1,000 mg (TYLENOL), TID PRN; [START ON 3/31/2021] aspirin chewable tablet 81 mg, Daily; [MAR Hold] aspirin DR tablet 81 mg, Daily; atropine injection 0.5 mg, Q5 Min PRN; bisacodyl suppository 10 mg (DULCOLAX), Daily PRN; [MAR Hold] calcium carbonate chewable tablet 400 mg of calcium (TUMS), Q2H PRN; carvedilol tablet 25 mg (COREG), BID with meals; [MAR Hold] Clopidogrel tablet 75 mg (PLAVIX), Daily; [START ON 3/31/2021] Clopidogrel tablet 75 mg (PLAVIX), Daily; docusate sodium capsule 100 mg (COLACE), BID PRN; fentanyl injection 25 mcg (SUBLIMAZE), Q2 Min PRN; fentanyl injection 25 mcg (SUBLIMAZE), Once PRN; flumazenil injection 0.2 mg (ROMAZICON), Once PRN; heparin (porcine) 1,000 unit/mL injection 3,200 Units, PRN **OR** heparin (porcine) 1,000 unit/mL injection 6,400 Units, PRN; heparin (porcine) 100 Units/mL in NaCl 0.45% 250 mL infusion, Continuous; [MAR Hold] lisinopril tablet 2.5 mg (PRINIVIL,ZESTRIL), Daily; Lorazepam injection 1 mg (ATIVAN), Once PRN; midazolam (PF) injection 0.25 mg (VERSED), Q2 Min PRN; midazolam (PF) injection 0.5 mg (VERSED), Once PRN; midazolam (PF) injection 0.5 mg (VERSED), Q2 Min PRN; midazolam (PF) injection 1 mg (VERSED), Q2 Min PRN; NaCl 0.9 % bolus 250 mL, Once; NaCl 0.9% infusion, Once PRN; naloxone injection 0.2 mg (NARCAN), Once PRN; naloxone injection 0.2 mg (NARCAN), PRN; MAR Hold] nicotine 10 mg inhaler 1 puff (NICOTROL), PRN [MAR Hold] nicotine 21 mg/24 hr. 1 patch (NICODERM CQ), Daily; ondansetron (PF) injection 4 mg (ZOFRAN), Once PRN;[MAR Hold] polyethylene glycol powder packet 1 packet (MIRALAX), Daily PRN; promethazine injection 6.25 mg (PHENERGAN), Q6H PRN; [MAR Hold] rosuvastatin tablet 20 mg (CRESTOR), Daily at bedtime; sodium chloride 0.9 % injection 10 mL, PRN; sodium chloride 0.9 % injection 3 mL, PRN; sodium chloride 0.9 % injection 3 mL, Q12H SCH. OBJECTIVE BP 143/83 | Pulse 71 | Temp 36.6 °C (Oral) | Resp 21 | Ht 165.1 cm | Wt 104 kg | SpO2 94% | BMI 38.19 kg/m². Intake/Output Summary (Last 24 hours) at 3/30/2021 1212. Last data filed at 3/30/2021 1130. Gross per 24 hour Intake 323.71 ml; Output 700 ml; Net-376.29 ml; GEN: Pleasant, no distress CV: Regular, no extra heart sounds, JVP is flat; PULM: Clear bilaterally; EXTR: No edema, strong R radial pulse ; ;EKG: NSR, nonspecific changes. ASSESSMENT / PLAN NSTEMI, s/p PCI to circumflex 3/30/21; Hypertension, uncontrolled; Nicotine dependence; Dyslipidemia; Obesity. She has an NSTEMI with significant elevation in her troponin. We will proceed with coronary angiography for this and anticipate PCI. We will intensify her antihypertensive regimen. Nicotine cessation is critical and we will consult our cessation specialists. We will refer her to cardiac rehab. DAPT for 1 year. Plan:1. Coronary angiography with intervention today; 2. High intensity statin, uptitrate carvedilol, keep lisinopril 2.5mg, restart hctz later this evening.; 3. Nicotine cessation referral. Cardiac rehab referral; 4. F/u TTE. Addendum: Angiography demonstrated her culprit lesion to be in the circumflex for which she received a 2.5 x 16 mm synergy stent. Mild disease elsewhere. She will require DAPT for one year. The patient was seen and discussed with the attending consultant, Dr. and PA. M.D. Cardiology fellow 3/30/2021 Consults by HCP at 3/30/2021 1:51 PM Status: Signed Consult Orders 1. Cardiac Rehabilitation consult (hospital) [2222776702510] ordered by M.D. at 03/30/21 1136; 2. Cardiac Rehabilitation consult (hospital) [2222776391034] ordered by M.D., Ph.D. at 03/30/21 0343 Cardiac Rehabilitation Referral. Reason for Visit: Cardiac Health Clinic consultation for referral to cardiac rehabilitation. Liaison met with the patient/family to discuss cardiac rehabilitation referral. Patient/family was provided with progressive verbal and printed home-going exercise guidelines. Patient/family understands and agrees with the exercise guidelines.1. Participation in a Phase II cardiac rehabilitation program is recommended. Patient was informed about what cardiac rehabilitation has to offer and why it is beneficial. The plan of care for the rehabilitation program consists of risk factor modification, monitored and supervised exercise and assistance in the recovery process with ongoing education and support. Patient is interested in attending a cardiac rehabilitation program.; 2. Eligibility: MI and PCI; 3. Exceptions/exclusions: None;.4. Referral: Patient agreed with referral to a cardiac rehabilitation program. Please see discharge order and/or letter for program details. Clinic Health System Phone:; 5. Appropriate referral information will be sent to the receiving cardiac rehabilitation program as applicable. Patient provided verbal authorization to send relevant materials to the cardiac rehab program. Recommend that the patient check with insurance company to verify coverage of the cost of cardiac rehabilitation program visits. Discharge Summary by PA at 3/31/2021 10:20 AMStatus: Addendium CARDIOLOGY HOSPITAL DISCHARGE SUMMARY DATE OF ADMISSION: 3/30/2021 DATE OF DISCHARGE: 3/31/2021 Discharge Provider: M.B.B.S. Discharge Provider Team: RST CARD 3 PRINCIPAL DIAGNOSIS Non-ST Elevation Myocardial Infarction. DISMISSAL DIAGNOSES #1 Non-ST Elevation Myocardial Infarction; #2 Poorly controlled systemic hypertension; #3 Mixed hyperlipidemia, previously untreated;#4 Medically complicated obesity (BMI 38); #5 Abuse Tobacco Smoking, Nicotine Dependence; #6 Anxiety. RECOMMENDATIONS FOR FOLLOW-UP APPOINTMENTS CBC and Basic metabolic panel; Cardiovascular risk factor modification; Cardiac rehabilitation participation (set up); Nicotine cessation; Blood pressure monitoring and management; Plavix for one year, aspirin lifelong; Assess right radial access site. *Statin Therapy Initiated: *A fasting lipid profile showed: Total Cholesterol 173 mg/dL, Triglycerides 218 mg/dL, HDL 39 mg/dL, LDL 90 mg/dL. *Baseline LDL is [ ] mg/dl. Please titrate to meet goal lipid levels.*Please recheck lipids and ALT/AST in 6 to 8 weeks.*Goal of statin therapy is a LDL less than 70 mg/dl or a 50% reduction in LDL. FOLLOW-UP APPOINTMENTS For appointment details refer to your Patient Appointment Guide. HOSPITAL COURSE Admission Weight: 104 kg; Dismissal Weight: 103 kg; BMI: Body mass index is 37.82 kg/m².Patient is a 56 y.o. female who presented to the Emergency Department due to chest pain. She has experienced this pain each evening for the past 3 evenings, and states that it starts in her right arm then migrates through her shoulder and across to her chest. The pain can last for anywhere from 5 minutes to 4 hours. This has come on at rest, but in the setting increased personal life stressors as well as uncontrolled hypertension. She states that she is normally on hydrochlorothiazide for hypertension, but ran out of this medication about a week ago. When she checked her blood pressure at home it was in the 230s/120s, therefore she presented to the emergency department locally. Her medical comorbidities are notable for poorly controlled hypertension, mixed hyperlipidemia that is untreated, current tobacco use (1-2 packs per day for 40 years), and medically complicated obesity(BMI 38.19 kg/m2). Intravenous heparin was initiated for the heparin nomogram. She was Plavix loaded and received aspirin. Carvedilol, lisinopril and Rosuvastatin were initiated. She proceeded to coronary angiogram with drug-eluting stent to the left distal circumflex artery. Transthoracic echocardiogram demonstrated ejection fraction 63%. Nicotine dependence was consulted and provided cessation information and prescriptions for nicotine replacement therapy. TEST RESULTS PENDING AT DISCHARGE :Pending Labs; None; DISCHARGE DISPOSITION: Home or Self Care [1]; CONDITION ON DISCHARGE: Stable. DIET AT DISCHARGE: Cardiac diet consisting of low sodium (1500 mg to 2000 mg per day), low cholesterol, low fat. No alcohol, (or discuss with physician).PRIMARY PROVIDER Patient Care Team:D.O. as External Primary Care Physician (Family Medicine) Primary Care Providers: Pcp (General); No address on file Primary Care Provider Phone Number: None Primary Care Provider Fax Number: None MARGIN CODE Operative Note Report Case/Log ID: 1507626443 Case Time: 10:44 AM Procedure Information CORONARY ANGIOGRAPHY Laterality N/A; Left Heart Catheterization Laterality N/A; Percutaneous Coronary Angioplasty Laterality N/A; Stent Placement Laterality N/A. Surgeons Surgeon Role M.D. Primary M.D. First Assistant, M.D. First Assistant, Diagnosis. Pre-op diagnosis: Non-ST Elevation Myocardial Infarction , Morbid Obesity Body Mass Index >= 35 with Comorbid Condition. Post-op diagnosis: Non-ST Elevation Myocardial Infarction , Morbid Obesity Body Mass Index >= 35 with Comorbid Condition. Anesthesia Type Moderate sedation (rn). Surgeon Documentation. No notes of this type exist for this encounter. Specimens None. Implants Implant Name LRB; Site No. Used; Manufacturer Mfr No.; Serial No.; Status; Type STNT SYNERGY XD DE 2.50X16 - LOG1507626443 N/A; Coronary Scientific H7493941816250 Implanted Cardiac Stent; Drains None Estimated Blood Loss None. Worsening shortness of breath COVID-19 positive on 06/06, Sxs started on 06/01 HPI: This is a 61 year old female who presents with complain of worsening Shortness of breath, COVID-19 positive PMHx Kidney transplant for glomerulonephritis, 1998, 2nd transplant in 2009 on Cellcept and prednisone and recurrent UTIs since then and since then when she gets UTI, she starts Cipro or Keflex HOCM myectomy 2009. Just saw yesterday. Denied CP/ SOB/ orthopnea/ cough/ leg swelling/ syncope/ PND. stated " no gradients across LVOT. At acceptable risk for planned procedure. Afib in 2009, Legally blind, Gout, Hand amputation 2017 at work , Hip replacement Ventriculostomy - cyst removed 1999] Pt completed COVID vaccination series (Pfizer 2/25/21, 3/18/21) but has been on immunosuppression 2/2 renal tx. Her symptoms have been persistent since 6/1. She states that she has been having fever morning and evening, cough, fatigue. She states that over the past 1-2 days prior to presentation to the ED she has had hypoxia to 85-89% on home pulse ox and intermittent episodes of fever, pt reports worse dyspnea w/ ambulation. Pt called her nephrologist on 06/01 and recommended course of Amoxicillin w/out improved, given worsening and not improving sxs her nephrollogist recommended to presented to the ED, On arrival to the ED she was initially tachypnic with ambulation to the bed, but has since improved. On initial exam she is not in any acute respiratory distress. CXR showed finding of viral PNA, Creatinine 1.17 baseline < 1.0 Sodium 126 This is a 61 year old female who presents with complain of worsening Shortness of breath, COVID-19 positive PMHx Kidney transplant for glomerulonephritis, 1998, 2nd transplant in 2009 on Cellcept and prednisone and recurrent UTIs since then and since then when she gets UTI, she starts Cipro or Keflex HOCM myectomy 2009. Just saw Physician yesterday. Denied CP/ SOB/ orthopnea/ cough/ leg swelling/ syncope/ PND. Physician stated " no gradients across LVOT. At acceptable risk for planned procedure. Afib in 2009, Legally blind, Gout, Hand amputation 2017 at work , Hip replacement Ventriculostomy - cyst removed 1999] Worsening shortness of breath COVID-19 positive on 06/06, Sxs started on 06/01 On arrival to the ED she was initially tachypnic with ambulation to the bed, but has since improved. On initial exam she is not in any acute respiratory distress. CXR showed finding of viral PNA, Creatinine 1.17 baseline < 1.0 Sodium 126 Active Problems: Active respiratory failure dute to COVID-19 Hypoxia Symptomatic 6/1, tested positive for COVID infection 6/6. Currently sat 93-95% on RA; States she sats down to 85% at night. Short of breath on ambulation Xray findings suggestive of atypical viral/Covid 19 pneumonia. Plan: - dexamethasone, remdesivir, mucinex - Oxygen NC to keep SpO2 >94% - IS q1h - ID consult appreciate recommendations - Mucinex,Sch, robitussin PRN and albuterol PRN - Incentive spirometry Kidney replaced by transplant Aki Increased creatinine 1.77 baseline Hyponatremia Hypochloremia - Creatinine 1.17 from 0.95 possible d/t dehydration. - Na 126, Cl 94 Plan: - Normal saline bolus - Hold cellcep - Continue tacrolimus - Prednisone hold, due dexamethasone for tx of COVID infection - Hold lasix, allopurinol, lisinopril - Continue valgancclovir - Avoid Nephrotoxic agent - renally dose meds - Gentle IVF NS 75 ml/hr - Usodium and Uosm Hypertension Hypertrophic obstructive cardiomyopathy (HOCM) (HCC) Atrial fibrillation (HCC) DVT prophylaxis - Normal sinus rhythm on EKG Plan: - Heparin - Continue atorvastatin, ASA, coreg - Monitor for palpitations, dizziness, headache, SOB - Holding Lisinopril and Lasix in setting of Aki - Continue Coreg Gastritis - currently asymptomatic Plan: - Protonix while on Steroids Prediabetes - Hgb A1C 6.1 4/3 Plan: - Low carb diet Legally blind - Patient moves about room without difficulty

NURS- Registered Nurse Specialty: Registered Nurse Nursing Note Addendum Encounter Date: 6/16/2021 Addendum Hide copied text Hover for details Patient 61 y.o. year old Date of incident: 06/16/21 Time of incident: 16:16 Pertinent patient history: History of anaphylaxis to multiple medications and foods (none to any components of the COVID-19 vaccine) Description of incident: Following administration of COVID-19 vaccine, patient experienced congestion/stickiness in throat, some coughing and reported sensation of tightness in the throat. She also began dry-heaving. Initial Vitals at 16:17 Blood pressure: 162/74 Pulse: 104 Respirations: 22 O2 saturation: 99 Actions taken: Provider summoned, 25 mg IM Benadryl administered per provider orders. Nurse came and administered Solumedrol 10 mg and EpiPen per provider orders. Orders initiated per RN protocol: EpiPen administered per protocol, by RN, IM Benadryl administered per protocol by this writer, IM Dexamethasone 10 mg administered by MA. Patient outcome: Patient reported improvement in nausea although she continued to experience the sensation of congestion/tightness in throat. Re-Check of Vitals at 16:23 Blood pressure: 120/82 Pulse: 90 Respirations: 20 O2 saturation: 99 Patient left vaccine clinic via Patient Transport: Ambulance: EMS Called by MA at at 4:27 PM Other notes: Provider who evaluated patient suggested that patient be premedicated with steroids and Benadryl prior to next vaccine. RN .................... 6/16/2021 4:54 PM

Diagnosed with bad sinus infection after returning from (May 8-15). Masks were worn at all times (inside and out) except when stationary and eating or drinking. It was HOT and humid. I had a lot of trouble breathing. I was given a rapid COVID test which was negative. I was given a shot of prednisone and a course of 15 pills orally. I was also given a 10-day course of antibiotics. I felt better, but I started having a lot of lung congestion and a bad cough. I went back in two weeks later, and I was given another COVID test (negative) and a lung x-ray (not pneumonia). I was told that my immune system was having trouble fighting the infection because of wearing masks for a year and that the cough would have to run it's course. I still have a cough and I'm coughing up nasty yellow green stuff. It is getting better slowly.

Patient received COVID-19 vaccine (Pfizer) on 3/17/21 and 4/7/21. On 6/22, she required admission to hospital due to SOB. Pt presented with "gradually worsening SOB in last 10 days with frequent wheezing and productive cough of white sputum. She is a former smoker; quit 1 month ago. Desatting to 80s with fever." COVID-19 positive on 6/22; COPD exacerbation also noted. Seen in outpatient pulmonary clinic on 6/14: "Patient is on 1.5 L O2 during the day and 2 L during the night since last year." Hx of ILD. Patient still hospitalized at this time for COPD exacerbation and NSVT. Reporting due as a breakthrough positive case per EUA requirements.

On March 31 I woke up and had a hard time breathing. My DR told me to go to the ER immediately so I did. So when I got there, I was put on the bypap and had the respiratory issue, my EKG changed where I had heart problems. My liver enzymes were elevated and my kidney enzymes were elevated. I gained 10 pounds of fluid in three days of being in the ER. I went to intensive care for worsening conditions, ended up having severe migraines and not being able to see correctly. They gave me Benadryl 50mg IV along with epinephrine, all within the first two days. I was in the hospital for a week that I can tell you. Within three weeks later my liver enzymes did go back to normal. I did go to my PCD for follow up, I saw an allergist specialist as well. I couldn't walk correctly, and had a hard time breathing as well. It was like all my organs were affected. Even right now I am still fatigued and I only got the first vaccine, back in March. These all are worsening symptoms as well. I also lost my hair as well. All my nails broke, it was just like, everything happening at once.

About 40 minutes after vaccination, started a tingling in the right side of my face tongue and cheek, throat closing, swollen lips and face on right side. Swollen in areas of the right side of my face. I called urgent care who said start Benadryl every for hours. Found I was allergic to polysorbate 80.

was so sick with fluids in her lungs, and she was gurgling and trying to cough it up; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; Terrible side effects she is very sick and got bad stuffs; she is bedridden; got helped to her do everything; his wife was up all night; his wife has thrown up a few times; having body aches; Rash; This is a spontaneous report from a contactable consumer (patient husband). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 61-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included patient got crushed up in a car wreck and lost 53% of her pancreas and had a bad heart valve. Concomitant medications were reported as none. Patient did not receive any other vaccines on the same day as the COVID shot. On 18Mar2021, after her first dose of Covid shot, she was up all night last night because she was so sick with fluids in her lungs, and she was gurgling and trying to cough it up and she stated that she was going to get better, but she was still in bed today. Reporter stated that his wife had fluid in her lungs and stuff, that maybe her heart couldn't push it out and did not get out of bed yesterday to sit on the couch and see the grandkids, but she wanted to be in bed. She was ok but had terrible side effects she was very sick and got bad stuffs, she was bedridden and got helped to her do everything. She had thrown up a few times and was just really sick and also experienced rash on an unspecified date in 2021. He stated that he hopes his wife does not have any permanent damage from this, as she just had a lot of things already, his wife was sick and disabled, having body aches, and is not planning on getting the second dose and he stated his wife does think that she will get well again. Patient did not receive any treatment for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Sore throat; Throat got tighter and hoarsed; Throat got tighter and hoarsed; Chest started to get a little tight; Headache; This is a spontaneous report from a contactable consumer (patient). A 61-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN 6202), via an unspecified route of administration, administered in left arm on 03Mar2021 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient's medical history included multiple sclerosis, rheumatoid arthritis, breast cancer female from 2014 to an unknown date breast cancer 2014 and 2021, food allergy, seasonal allergy. Concomitant medication and in two weeks included gabapentin (NEURONTIN), lamotrigine (LAMICTAL), levothyroxine sodium (SYNTHROID) and prednisone. The patient had allergies with Rituxan, seafood, pineapple, watermelon, seasonal allergies. The patient had no other vaccine within four weeks. 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 03Mar2021 16:05, the patient experienced headache with 5 minutes, at 16:15 started out as sore throat but the throat got tighter and hoarsed, chest started to get a little tight. She ended up taking Tylenol about 1/2 hour later and took Benadryl about an hour later. The patient received treatment. Outcome of the event was recovered. No follow-up attempts are possible. No further information was expected.

mild tightening in my throat; slight discomfort in swallowing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 10Mar2021 14:15 (at the age of 61-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included high cholesterol, hay fever (seasonal) allergies. No other known allergies reported. Concomitant medication included Atorvastatin 10 mg daily. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and had not covid tested post vaccination. On 10Mar2021 15:30, about an hour after the injection, patient felt a mild tightening in throat and slight discomfort in swallowing. Enough to notice but not cause any real difficulty in swallowing. It lasted for about an hour and a half. Patient did not receive any treatment for adverse events. The outcome of the events was recovered on 10Mar2021. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

She completed the series of Pfizer vaccines on 4/14/21. She was tested covid positive as outpatient on 6/21/21. She developed chest pain, dyspnea, dry cough watery diarrhea, and she was admitted to the hospital on 7/3/21. She is currently still hospitalized.

high fever; trembling; pain when breathing; bone pain; severe sweating; nausea; diarrhea; weakness; loss of appetite; back pain; stabbing pains in my lungs; headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep6955), via an unspecified route of administration in the right arm on 23Mar2021 at 11:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Medical history included scleroderma and crest syndrome. Concomitant medications included losartan (MANUFACTURER UNKNOWN), carvedilol (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and isosorbide (MANUFACTURER UNKNOWN); all for unspecified indications from unknown date. The patient did not receive any other vaccines within the four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 03:00, the patient experienced high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of high fever for 3 days, trembling, pain when breathing, bone pain, severe sweating, nausea, diarrhea, weakness, loss of appetite, back pain, stabbing pains in my lungs and headache were not recovered. No follow-up attempts are needed. No further information is expected.

Incoming TC from patient, reporting possible COVID-19 side effects / adverse reaction: Pt reported Friday 6/4 after 2nd dose Pfizer, felt chest pain and trouble breathing, stayed 20mins for observation at vaccine site, then pulled over on her way home. States she felt better after 10mins and drove home. Did not seek emergency care. Reports earlier 6/7/21 had episodes of same symptoms. Reports difficulty breathing, dizziness, and abdominal cramping. Advised to seek emergency care or call 911. Pt agreed, has family to drive her to ED.

My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; I had a bad reaction because of any other medication consider allergic to it.; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via intramuscular route of administration in Arm Left on 14Jun2021 as single dose for covid-19 immunization. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included propanol taken for hypertension, start and stop date were not reported. In Jun2021 patient had her 1st shot of vaccine, 3 weeks ago and just, had a, she thinks, a had a bad reaction because of any other medication consider allergic to it. Her arm had a rash on it and its swollen. It was always on her arms and hands. It went up to her throat so, and she was sick right away after she had this. She had really awful three days after she had the shot. This does not mean that she was having allergic reaction, she stated. She stated she should not get the second shot. Patient stated it started hours after the shot. The person actually right away, I don't know it was the vaccine necessarily or the person giving me the shot but I am wondering if he or his arm, start turning black and blue. She doesn't have the vaccination card. 13Jun, 14Jun I guess she confirmed as 14Jun2021. Consumer stated, her second shot is due. The LOT number for the first dose, this, she can tell this person had very bad handwriting. It's look like EW0101. Treatment taken for Adverse Event with Benadryl, Diphenhydramine 50 mg, Norco 10/325 mg. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.

Numbness and tingling on lips and tongue, fatigue, throat tightening, back of thigh swelling, feverish, and pain. lasted at least 3 days but resolved. All issues completely resolved in a week.

wheezing; out of breath/i had trouble catching my breath; felt terrible like i had COVID; This is a spontaneous report from a contactable consumer reported for herself. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo188), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 14:00 (at the age of 61-years-old) as a single dose for covid-19 immunization. Medical history included cerebrovascular accident (stroke 5 years ago), drug hypersensitivity- known allergies: penicillin, covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication(s) and received within 2 weeks of vaccination included baclofen fluoxetine oxybutynin clonidine benazepril. The patient had no other vaccine within four weeks. On 17May2021 22:00, the night she had vaccine she was wheezing and out of breath when used the bathroom. The next 2 days had trouble catching breath and felt terrible like had COVID again. She had it at christmas for 2 weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment. The seriousness of the event was considered as non-serious by reporter. Outcome of the event was recovered, at the time of this report.

Got sick the night got the vaccine. Sore arm, nauseaous, couldn't breathe, didn't want to move; Got sick the night got the vaccine. Sore arm, nauseaous, couldn't breathe, didn't want to move; Got sick the night got the vaccine. Sore arm, nauseaous, couldn't breathe, didn't want to move; Got sick the night got the vaccine. Sore arm, nauseaous, couldn't breathe, didn't want to move; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after first dose,, the patient experienced got sick the night got the vaccine. sore arm, nauseaous, couldn't breathe, didn't want to move. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

chills; shortness of breath; started running a high fever; This is a spontaneous report from a contactable consumer. This 61-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 17:00 (Batch/Lot Number: EW0150, Solution for injection) as second dose, single for covid-19 immunisation. Medical history included rheumatoid arthritis from 2007 and ongoing Verbatim: RA Additional Information for Other Conditions: diagnosed way back in 2007. The patient's concomitant medications were not reported. Historical vaccine includes bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 14Mar2021 (Batch/Lot Number: EN6207, Solution for injection) covid-19 immunisation. Consumer states she is calling about the Pfizer COVID vaccine and had a reaction but it was a full day or almost a day after she got the 2nd dose of the vaccine; states about 5:00pm was when she got the 2nd dose of the vaccine on 03Apr2021. States then on 04Apr2021 the next day which had to be around 9:00pm she got chills, shortness of breath, and started running a high fever that started at 99.4 and then about an hour later she took her temperature and it was 100.7 degrees Fahrenheit. Consumer states these symptoms completely resolved and lasted about 8 hours. States the highest temperature she took was 101.4 degrees at 3:40am this morning so she took an ice pack and put it behind her neck and let that stay there for awhile under each arm and under each armpit and alternated behind her neck again with the ice pack and did this for about 3 hours because she did not want to go to the hospital. Consumer states she then took her temperature about 6:00am this morning and it was 99.4 and she went to sleep and woke up about 10:00am and her temperature was 98.4 degrees so it went down and she is feeling fine now and has no issues and no chills or shortness of breath. Consumer states she had no treatment for the reported events other than the ice pack. States her 1st dose of the Pfizer COVID Vaccine was administered in her right arm on 14Mar2021 with lot EN6207 and her patient card has no NDC or expiry dates written; states her 2nd dose was administered in her left arm on 03Apr2021 and has lot number EW0150 which she confirmed from an email she received from her facility. States her 1st dose was at 10:30am and her 2nd dose was more like 5:00pm. States she had no vaccines prior to the Pfizer COVID Vaccine but does have RA and gets an Orenzia infusion and got the 1st one on 17Mar2021 and the dosage is 750; states she has no lot numbers to provide for the Orenzia. The patient underwent lab tests and procedures which included body temperature fluctuation: 99.4 fahrenheit on 04Apr2021 99.4 F at around 9:00pm, body temperature fluctuation: 100.7 fahrenheit on 04Apr2021 100.7 F about an hour later, body temperature fluctuation: 101.4 fahrenheit on 05Apr2021 101.4 F at 3:40am, body temperature fluctuation: 99.4 fahrenheit on 06Apr2021 99.4 F at about 6:00am, body temperature fluctuation: 98.4 fahrenheit on 06Apr2021 98.4 F at about 10:00am. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

Five minutes after vaccine patient had itchiness around eyes, itchy throat and mild shortness of breath. Later, patient reported swelling around eyes and lips.

1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED

I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to sleep at 730pm I had severe chills and fever and had to go to bed. The next day I still wasn't feeling well and I was called in to get covid tested and I went to the ER on the 21st and took a rapid covid test that was positive. I was stable and had good oxygenation and was discharged. I have fever nausea vomiting I also had problems with O2 stat i was in the 80s and realized I was having respiratory failure so I was admitted on the 27th and I've been here ever since. I had kinetic storm and infusions my O2 stats were bad and I was sent to the covid unit and put on high flow oxygen and negative for a PE, I'm still on the covid unit but I feel much better today

Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.

Within 10 minutes of receiving vaccine, patient stated that she felt a little short of breath. Pt used her rescue inhaler and, after 45 minutes of observation with no exacerbation, she felt her sxs had resolved and she left. I communicated with her on 1/11/21 and she stated that she felt fine and had no lingering symptoms.

shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.

Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat and tonsils. Patient did sip water and was verbally communicative and was texting on phone with pale, anxious appearance with not obvious shortness of breath noted. 911 was called to Center per vaccine clinic protocol at which ems initiated IV and took patient to ED.

some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Day after receiving vaccine: fatigue, fever, headache, body aches, shortness of breath, Two days after receiving vaccine: extreme fatigue, racing pulse, high blood pressure

No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen 4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days. On 1/8/21 at 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At 0850 when they attempted to reposition the resident, she was not responsive. Licensed nurse assessed her and no heartbeat heard or pulse found.

Tight sensation in her throat, tongue felt tingling. Temp increased to 99, blood pressure increased to 179/99

0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. EMS ON SITE. VS: 168/71, p: 58; 97% O2 SAT R.A.; 0954: BP: 168/71, P: 58, 98% 02 SAT R.A. 1015: LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED

Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.

~ 10 minutes after vaccine, patient started c/o chest tightness and SOA. Pulse ox was 95%, BP 204/79, P-83. Patient stated that she experienced same symptoms when she went to ED for chest pain and was given Morphine. At 10:04 AM Patient was given Pepcid 20 mg, Benadryl 25 mg, and Zyrtec po. She had difficulty swallowing those pills. Lung sounds clear. Oriented X3. EKG was normal. After about one hour of observation with no relief, she was transferred to UKED. BP was 131/50, P-97 and Pulse ox 98% just prior to transfer.

Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was noted to have some throat clearing but denied any concerning symptoms. At 9:40 she began experiencing fluttering in her chest and at 9:41 she was noted to have some chest tightness and wheezing. She was given Benadryl 50 mg oral at 9:42 but then symptoms began to progress and she started to have angioedema of her upper lip and her hands/arms started itching and she was noted to have some early hives. Epipen 0.3 mg was given at 9:45. She continued to have some swelling of her upper lip and chest tightness and soulmedrol 125 mg IM was given at 9:49 and then she was placed on O2 via NC at 2 L. At 9:50 she stated that her throat swelling was starting to improve and her chest tightness and wheezing was getting better. EMS arrived at about 9:51 and report was given and care turned over to them. They left the clinic at 10:00 without further incident.

A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.

Pt began to have tightness in throat, heart palpitations, nausea after 10 minutes past administration of vaccine. Approx 5 min later noted color change in lips.

minutes after injection started reacting with, palpitations, shortness of air and nausea. went to Ed and received IM epi\listed vaccine as allergy

1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath

Patient c/o shortness of breath and "throat closing up"after receiving Covid vaccine at 10:00am.. O2 started at 4l/min via n/c at 10:10am. , BP taken and advised to administer her Epi pen that she had with her due to allergy to Gelatin, administered Left thigh by patient.at 10:15am. 911 called at 10:20am. BP 152/93 HR 80 at 10:25am, 154/105 HR 75 at 10:27am, 148/92 HR 75 at 10:30 when departed to Medical Center. 02 sat remained at 99%. Skin warm and dry and remained alert through out process.

BP at 179/99; Tongue felt tingly; felt a tight sensation in her throat; Temp elevated at 99; This is a spontaneous report from a contactable other HCP. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9231), intramuscular in left arm on 13Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. The patient had no covid-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unknown date COVID-19 immunization. On 13Jan2021 10:15, the patient experienced tongue felt tingly, felt a tight sensation in her throat, temp elevated at 99, BP at 179/99, and HR 62. No hives, no wheezing, and no angioedema. The events recovered on an unknown date in Jan2021. The patient received Benadryl 50 mg as treatment and had ice pack behind neck, laid down for 30 mins. The patient was not tested for COVID-19 post vaccination. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

HA; Fatigue; DOE; Chest pressure; Fever 100.2; Sudden coughing spell; This is a spontaneous report from a contactable Nurse (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number=EL3248) on 12Jan2021 18:00 at SINGLE DOSE on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history included essential hypertension (Essential HTN), cardiac output (PLR). Concomitant medication received within 2 weeks of vaccination included lisinopril. The patient previously received first dose of BNT162B2 (Lot number=EL1284) on 23Dec2020 07:00 PM at SINGLE DOSE on Left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Headache (HA), Fatigue, Dyspnea on effort (DOE), chest pressure, fever 100.2, sudden coughing spell that lasted hours during the night on 13Jan2021 06:30 AM. The outcome was Recovering. No treatment received for the adverse events. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

approximately 10 minutes after receiving vaccine patient complained of fullness in throat and difficulty swallowing, also felt tremulous and like heart was racing, some visible swelling of lower lip, initial vitals revealed pulse ox of 99, bp 151/70 and hr of 107, lungs clear without wheezing, no urticaria, given 25mg po Benadryl with gradual resolution of symptoms and normalization of vital signs

I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy history. I was advised by the allergist to take Allegra an hour before receiving the vaccine. About 10 minutes after receiving the vaccine, I started to throat my started to feel dry and tickling, it felt like it swelling starting from the left side to the center, I started having difficulties swallowing my salvia and any fluid. My blood pressure was checked and it was elevated. I started to have difficulty breathing. They transferred me over to the ER. They gave me IV medicines Benadryl, Prednisone, Pepcid (I think). After 6 hours I was able to go home. Everything went back to normal besides the pain in the left arm at injection site. I had a telemedicine visit today with my primary care physician to follow up.

Left side breathing difficulty. Painful to take a deep breath on left side only. I?ve had pneumonia in the past and painful on same side as vaccine. Shortness of breath, winded when talking.

Patient started to feel some tightness in her throat about 5 minutes post vaccination. EMS offered medical transport, that was refused and her husband drove her to the nearest medical clinic.

Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21

Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus headache for a couple of days, low grade fever for about 12 hours , achy all over felt like pin pricks up and down my body to the bottoms of my feet. At one point my air passage felt blocked possibly by something that I threw up.. had trouble regaining my breath. I was surprised at how fast and furious this came on.

On 1/8/2021 2 days after I received the Covid vaccine I started to have SOB and coughing. I started to used my inhalers and it would give some relief but I was using it more than normal. I had not had asthma attack for more than a year. My asthma is very controlled that I don't use any inhalers whether daily or as needed. I went to work as usual since at that time my symptoms weren't getting worse but also not getting better. On 1/19/21, I was feeling more out of breath and having more dry hacking cough that when I called EH I was told to do the Covid testing. That same day I called my Asthma doctor and did a video call and was prescribed Breo inhaler, spiriva inhaler, xoponex nebulizer treatment and xoponex rescue inhaler. I couldn't go to work because of my shortness of breath and coughing. The treatment didn't work. On Tuesday 1/26/21, I called my asthma doctor again and another video call was made. She changed my inhaler to symbicort, still continue spirirva inhaler and nebulizer treatment. I also contacted my primary doctor who asked that I schedule an appointment with him so he can see me. On 1/28/21, I saw my primary doctor who did blood works to see if I have any blood clot and to see how my heart was doing. I was given phenergan with codeine to help with my coughing and it did help me to go to sleep. My blood works came out negative and he ordered CAT scan of my chest since I can't get rid of my SOB and coughing. I had the CAT scan on 2/3/21. He called me the next day and I was told that I had mucous plugging. He told me to go home and he prescribed Duoneb nebulizer treatment 4x a day and spiriva inhalers 2x a day. I started to get rid of the mucous that I had and started to breath better. It took 4 days of 4x a day nebulizer treatment and inhalers before I started to feel

The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.

Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.

I received the shot at 11:30, 11:40 tongue started to feel swollen, shortly after lips were tingling, sought medic, was observed for a few minutes then troat started closing and symptoms of bad asthma attack was offered an epi-pen but chose to use my flyp nebulizer with albuterol and was transported to ER. Face started itching(minor). Was able to breathe normally after several minutes in the ER bp was elevated to 144/93 was keep until about 1:20 given prescriptions for Hydrxyzine pamoate 25 mg, famodine 20 mg, prednisone 20 mg and sent home

Within an hour, I started getting a dry throat and had a dry cough for a few days. A little breathing problem - it was almost like my reaction to bees that I had before - where my throat was closing up but that was just for about an hour. The second day, I had also (three days) of really bad diarrhea.

PT STATES SHE IS EXPERIENCEING THROAT TIGHTENING. THROAT AND UVULAT APPEAR TO BE SLIGHTLY EDEMATOUS. PT DENIES ANY SOB, OR RESPIRATORY DISTRESS. PT ASSESSED BY PHYSICIAN, BROUGHT TO OBSERVATION ROOM FOR FURTHER ASSESSMENT AND TRATMENT. PT PLACED ON TELE : SINUS RHYTHM. PT DENIES ANY CHEST PAIN, PALPTATIONS, PRESSURE, N/V/D. SL 20 GUAGE PLACED BY EMS. VSS HR 75, RR 17, BP 160/88, SATING 98% RA. PT ADVISED TO GO TO ER. PT REFUSES TO GO TO ER AND HAVE EPINEPHRINE AT THIS TIME, BUT AGRESS TO RECIEVE IV BENADRYL AND DEXAMETHAZONE VIA IV X 1. 1519 BENADRYL AND DEXAMETHAZONE GIVEN, PT TOLERATED WELL. 1535 S/S STILL THE SAME. PT AGREES TO HAVE EPI AND GO TO ER AT THIS TIME. 1535 EPINEPHRINE X 1 GIVEN. PT TOLERATED WELL. PT TRANSFERED BY AMBULENCE. PT REMAINS STABLE AT TIME OF TRANSFER.

I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.

15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something. (I had already had lunch and a snack). That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired. I had some problems catching my breath when climbing stair and and at one point felt hot and clammy. Headache was better.

pt. presented to the ED at hospital with SOB, that didn't resolve with inhaler, and generally not feeling well. ED note attributed to the COVID vaccine

9 minutes after receiving Pfizer vaccination, while in the recovery area, c/o feeling of throat / tongue swelling, with noted redness in the upper neck region just below the chin. Able to speak without difficulty, denied SOB/pain or dizziness. Vitals were taken, WNL, AA0 x3, received ongoing monitoring. 911 was called as patient continued to c/o throat swelling, called at 1648, arrived @ 1658, patient was assessed, recommended transport to ED to ensure no further progression, patient declined transport, Husband was on seen at all time, agreed not to transport, waiver signed by patient. DC from recovery area @ 1705 w/Husband, ambulating freely and with clear communication/speech.

Inside of body felt like it was on FIRE!! Mouth burning! Heart racing with minimal movement, shortness of breath,

Patient has allergies to several medications and keeps epipen on hand with her always. Was asked to sit for 30 minutes after vaccine. At minute 27 she started getting swelling and redness of her lips and face slightly. She normally takes Benadryl when this happens so gave her a Benadryl 50mg one dose. Her throat then became tight in a few minutes and she said that she needed an epipen because she was starting to have a little bit of trouble breathing. Gave epipen and her symptoms resolved within a few minutes. Kept her for 15 minutes. She stated that she knew she would be ok and asked if she could leave. I stated she needed to see the ER if she had any more trouble. I also consulted with her to check with her doctor about getting the 2nd dose because more than likely it's not recommended.

Pt. voiced hx of difficulty breathing and rash after taking miralax.Pt states her PMD recommends she get CODID-19 vaccine, Our medical director consulted and agreed to give with 30 min wait time, near onsite paramedics. I vaccinated pt. next to paramedic. 10 minutes later pt. c/o dizziness, SOB, trouble breathing . Paramedics assumed care, Epi Pen administered. Ambulance called pt. soon felth better after O2 and Epi. No LOC. Pt. left in ambulance talking and thankful.

Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program. A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. 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.

Arm Pain (injection side) ...Within 5 minutes of injection. Mild neck and torso stiffness...Began 2 hours and 40 minutes after injection. Wheezing...Began about 4 and a half hours after injection. Shortness of breath occurred overnight. 8 hours after injection. ...checked oxygen level at 93 Moderate widespread aching...8 hours after injection. 15 hours after injection...oxygen level at 88 15 hours after injection...Temperature of 99

Same day mouth and throat swelling, rash appeared several days later, not getting betting with steroids, Benadryl. Petechial rash diarrhea several days later.

A couple of days after at 10:30 PM I had a fever of 101.5 with a headache in the front on top of my forehead. I stayed home from work the next day and my fever was 100.0. Tylenol helped. I felt tired but better. It became difficult to breath. It felt like I had chest pains especially on exertion. It improved if I sat down. It lasted aa week. My doctor sent me for a chest x-ray and blood tests. I had contracted Covid-19 on the third week after my first dose of the vaccine. Positive test results on 01/11/2021.

AT TIME OF INJECTION - SENSATION UP ARM & NECK & LEFT SIDE OF HEAD. PT STATED FEELING SWELLING IN MOUTH/THROAT - PT STATED HARDER TO SWALLOW

Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.

Reported chest pain, shortness and of breath, and headache. Transferred to the ED. Symptoms resolved. Followed up with PCP.

About 30 minutes after vaccine, started to have a hard time breathing, short of breath & "chest felt heavy" while at work at desk. Called an ED response- taken to ED was monitored for 4 hours, then released to home. That evening experienced fatigue, headache, muscle/body aches, feverish, which continued on 1/19 ,1/20, 1/ 21. felt better on 1/22/21 afternoon.

Shortly after 1st dose Pfizer vaccine given patient complaint of "throat swelling" without difficulty swallowing or breathing. Given 5o mg of diphenhydramine and albuterol inhaler, then transferred to ED. Per ED note: "Her main complaint to me was feeling of swelling in her throat. I do not see objective evidence of this on exam, she is not in respiratory distress, thus epinephrine was held. She was given IV methylprednisolone and famotidine, already received benadryl. After about 10 minutes she started to feel better and her symptoms resolved in ED. Tryptase and C4 sent per protocol (within normal limits). She was observed for 5 hours with no recurrence of symptoms and was discharged with a prednisone burst x 4 days. I recommended she take benadryl every 4-6 hours for the next 24 hours and then as needed after. She already has an epi pen."

First DaY immediately after the shot: Strong itching around mouth; 40 minutes later: runny nose; strong sense of back of throat and esophagus burning; sensation in lungs like...pulsing slight burn--If you can imagines a sparkler (yep, the kind from the 4th of July) being in your lungs that is only a little painful, more like a wiggle, than a painful sensation, that would describe it. 2nd day: really tired by 4PM, feeling feverish. Very tired . Tired enough that I accidentally left the house for a job interview wearing one white sock and one black sock. Which isn't normal for me. 3rd day: muscle aches. 4th days feels like a really mild virus. This is not me but another person from my former job said she had spontaneous canker sores from the Pfizer shot.

Headache at 5 pm, then severe difficulty swallowing and breathing and HBP started at 7:00 pm, went to ER, release at 2 am still having symptoms, not as severe. After 48 hours all symptoms gone.

1;55 pm during observation post vaccination, complaint of tongue tingling and numbness BP 148/94, P 112,RR 18, SPO2 97% on room air, Lung sounds CTA. 2pm Benadryl 50 mg chewables given. EMS activated 220pm complaint of throat swelling and tightness BP 160/108, HR 114, RR 22, SPO2 9% Epinephrine 0.3 mg IM given, left thigh EMS arrival 2:34pm, EMS took over care,2;44 pm started IV access, IVF , Administered Benadryl 50mg IVP and Methylprednisolone 125mg IVP BP 144/94, HR 120, SPO2 100%, RR 20 Ems transport to Winthrop Hospital Emergency room, Patient alert and oriented, GCS 15 in no apparent distress.

Woke up with bad headache in back of head. Throat was hurting & swollen. Chills, achy muscles all over. Knee joint hurting bad. Not hungry. Slept a lot after taking Tylenol. Next day by 12:00 pm, I felt better.

Waited at the facility for 30 minutes after my shot. Left the premises of the hospital approximately 8:30am on 3/19/21. On my home approximately 15 minutes into my drive, my throat started closing, I was near Urgent Care, they treated my condition with urgency and I was given 25 mg of Benadryl and 40 mg of prednisone. After about 20-30minutes all swelling in throat had decreased tremendously. The Doctor at urgent care, Dr. I would be ok and stated that I should get the second dose on April 9, 2021. He also recommended that I take another 25mg of Benadryl within 4 hours, in which I did. I also called my PCP, and he stated the same. They both told me not to take any medication prior to the shot. They state by taking the cough drops which contains antihistamine May have cause the allergic reaction. I am feeling fine now. My

Waited 30 minutes. A little dizzy. Son drove me home. Arrived home 450. 5 pm eyes and cheeks swelling throat felt like olive stuck in it I called Kaiser. Talking to them chest began stinging hurting pressure. Told to call 911. I hung up walked two blocks to urgent care. Chest really hurting feeling dizzy face eyes swelling throat lump getting larger. My breathing rate normal , blood pressure normal , oxygen normal. They took me back gave me epinephrine and depo modral shot in right buttock cheek. After few minutes felt better chest stopped increasing in pain throat started feeling better, face still swollen. Told me good thing I walked instead of waiting for 911. Very scarey. Told to remain up for 24-48 hours give epi if needed again. Taking 180-360 mg 24 hr Allegra daily. I stayed up 36 hours drank water . Told can not take second shot. No vaccines until I get tested for what caused allergic reaction. Today March 23 face still off and on swelling and eyes. Seems when I begin to move around swelling starts again.

Pt received 2nd dose pfizer @ 0800 Pt found by observer @ 0802 with increased WOB, pale skin, pt unable to speak in full sentences due to SOB. Lungs sounds assessed and noted to be wheezy, x1 does Epi administered, 911 called. 0803- BP 100/60, HR-100, RR 32, SPO2- 92, Pt breathing improved after 2 mins, pt verbalizes decreased WOB. Second set of vitals- BP 110/70, HR 106, RRR- 20, SpO2, 96%. 0809- AMR arrives and assumes care of pt

Three hours after the injection I felt my throat getting sticky / constricting and my heart started pounding. Resting pulse got up to 112 bpm, and when I arrived at the ER, my blood pressure was 202/85.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: carries APIS tablets which she uses if feels like have an anaphylactic episode. Waited an hour and left with no complications

Pt was admitted on 3/27/2021 with c/o chest pain and new sob and new sinus tachycardia x 3 days. saw pcp who felt she had an abnl ekg and sent her to ER. troponin was neg. She was found to have new sinus tachycardia with out cause associated with chest pain. she will be following up with cardiology for echo and stress test.

difficulty breathing and slight light headiness. Took two puffs of inhaler. breathing a little better, light headiness still on going.

30 min. after shot, I got a tingle in my left arm, fingers, face, throat, and head. Then my lips, tongue, and throat began to swell. My voice changed. I was driving home. I went to a store , bought Benadryl, took 4 tablets, waited 35 min. then drove home. My swelling started going down. I was nauseated for several days after the shot.

After taking the vaccine, that evening my breathing worsened and I also had a gout flare-up. The gout pain was so intense even after taking two pain pills, it kept me up all night. I was unable to report to work the next day and had difficulty walking for the next 3-4 days and breathing for the next week. I was even getting up 2-3 times on some nights gasping to breathe.

Home apron 15-30 min felt chocking lying down sat up hard to breathe began wheezing continuing to get worse rapidly. Had received flowers i thought oh no allergic to flowers too them outside still difficult breathing wheezing chocking. Took breathing treatment. Brovana then Budesamide not relieving, take Prednisone 10mg. Seem to calm little but still wheezing Took Incruse inhaler. Repeat few hours later all above wheezing and SOB return. Continued next day doing treatments and prednisone more frequently than suppose but I know I have a DR Apt Friday an she will give me shot get me over hump. Fri very bad almost call 911 repeated all treatments above drove to DR given More Breathing treatment and Steroid injection but not getting relief To hospital for admit most likely from vaccine not flowers yikes Hospital 6 days IV Steroids Pepcid ataraxic breathing treatments.

fever, chills, severe headache, body aches, lymph system pain, severe rash and pain - lower extremities, shortness of breath, chest discomfort fever and chills lasted 3 days, all other symptoms lasted at least 2 weeks and rash is still healing after 4 weeks

After 15 minutes of waiting and as we were leaving I started with a headache and had problems breathing. By the time we reached the car, I felt worse and went back inside to the paramedics. At that time I was having heart palpitations, problems breathing, BP was 194/120, felt lightheaded and dizzy. Was having problems with walking. The next day I woke up and my hands were curled up, hips were sore, body aches, hard to walk shuffling instead of lifting feet.

Arm numbness extending to wrist, immediately after injection. 48 hrs. later patient states experienced "upper body" swelling, "heart racing", "throat swelling", "lymph nodes" swelling, "trouble swallowing", "kidney pain"

Patient c/o nausea, arm pain, chest pressure after vaccination. Upon patient examination did not appear to be in acute distress and no labored breathing noted. Plan discussed with patient and husband to transfer to ED for further workup and monitoring. In the ED patient complained of shortness of breath, and received an ECG and XRAY which were normal. Patient discharged

Patient arrives by private vehicle with left anterior chest discomfort. Patient received the first dose of her 2 part COVID-19 Pfizer vaccine series this morning. Shortly after receiving the vaccine she developed left anterior chest pain under her left breast. Patient was evaluated by EMS personnel at vaccine clinic, and refused transport at that time. Shortly after, patient then arrived by private vehicle to Emergency Department with chief complaint of chest pain, left shoulder blade pain, and some shortness of breath per nursing notes. She reports she overall did not feel well. She felt sweaty and short of breath shortly thereafter. She denies having had the COVID illness in the past **At time of submission of report, patient is still in ED with results pending**

chills, extreme headache, dizziness, nausea, chest pain, racing heart beats, racing thoughts, can't sleep, left inner ear pain, blurred vision, pain in left elbow, numbness in left hand for 12 hours, shortness of breath, general weakness - adverse events have lasted over 48 hours - Advil taken with minimal reduction in symptoms

About 45 mins after taking the vaccine I felt as if I had a tightening in my throat.This sensation lasted for about 8 hrs.Then it subsided.....no other adverse side effects were felt.

Throat felt tight, flushing/sweating. Used patient home inhaler albuterol 2 puffs 5 minutes after symptom onset. BP 138/67, HR 89, RR20, O2 99%. Upon discharge, BP 133/70 P77 RR20 O2 96%, lungs clear bilaterall, no respiratory distress.

Pt was given Pfizer vaccine 2nd dose to the right deltoid at 1253pm. Pt called nurse over at 1315 stating that she felt slight tightness in her throat. Pt vitals are 90% room air pulse of 82. At 1320 patient was give 25mg of liquid benadryl per standing orders. Nurse rechecked at 1335 patient stated the tightness in her throat was much better and patient was then transported home by her husband.

I experienced on 01-14-2021, I had a spiked fever. I went to the Hospital due to shortness of breath and excessive coughing and chest pressure. I was positive for Covid in March 2020, the symptoms I experienced were very similar to the symptoms that i had when I had Covid back in March 2020. At the hospital, EKG, echo stress test and cardiac enzyme tests were performed. I was prescribes an albuterol advent inhaler and started on blood pressure medication. I am still using the inhalers and blood pressure medication, still being treated.

First Vaccine Pfizer EN6206 Wednesday Night 3/17/21 Bumps on Throat, hard to swallow, tongue felt swollen and warm, Took Tylenol PM (has Benadryl in Tylenol) Thursday 3/18/21 Bumps on Throat, tongue felt swollen and warm, NO TASTE, Headache, Queasy Stomach, Lightheaded. Friday 3/19/21 Bumps on Throat, No Taste, Headache. Taste Returned Friday Night Saturday 3/20/21 Bumps on Throat, mild headache.

5 hr following receiving injection stated unable to raise arm; 1.5 days later noted lymph node pain under both ears--stopped after 2 days. 3.5 days lymph nodes under arm and breast area painful--lasted 2 days and stopped. After that had diarrhea for 2 days. Throughout the entire time noted above had heart palpitations and shortness of breath. She was advised at time of 2nd dose (4/14/21) was advised to contact PCP and share above information prior to getting 2nd dose.

N17.9, N18.9 - Acute kidney injury superimposed on chronic kidney disease (CMS/HCC) E87.5 - Hyperkalemia R06.00 - Dyspnea, unspecified type R53.1 - Weakness R73.9 - Hyperglycemia E11.10 - DKA, type 2, not at goal (CMS/HCC)

Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of breath, myalgias, cough, headache, and chest pain. Hospitalized with acute hypoxemic respiratory failure secondary to COVID-19 infection: administered steroids, antivirals, and anticoagulation. Patient currently hospitalized.

Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.

20 minutes after the Pfizer vaccine injection, I experienced swelling of the interior of my throat and facial swelling at the site of previous Juvederm injections. This persisted for 10 minutes and stopped. 10 minutes after my first vaccine injection, I experienced a mild tingling in these same areas for about 3 minutes.

starting at 930 pm the day of vaccination I started to have SOB and chest pain. I tried to take 2 puffs of my ProAir inhaler, this did nothing to help the SOB. Within the hour I could not get a full breath at all. the chest pain was only tolerable if I was leaning forward. My husband took me to the ER. They did testing and found that I had Pericarditis and Pleuritis. They informed me that I should NOT get any further COVID vaccines because it could kill me.

After initial two days of side effects of temp and fatigue, nausea, continued side effects of extreme fatigue, nausea low grade temp for ten days, fatigue got worse; resulting in extreme shortness of breath. i went to the emergency room where i was diagnosed with AFIB. I spent 6 days in hospital. No previous condition of AFIB. An exam and physical in July did not reveal any health issues.

4/4 2021 - Red raised Rash at the injection site about the size of a quarter 4/5 2021 _ Itchy raised rash, sore to the touch about the size of a dollar piece 4/6 2021 - Itchy raised, hard and hot. sore to the touch about 3" round 4/7 2021 - Itchy raised, hard, sore to the touch about 3 1/2" round Called Dr. Was told to take Benadryl, Tylenol, compress If no improvement the next bay then I had to come in to the office. I started to see some improvement-not as red. over the next two day it continued to itch less, redness was fading, still itchy and hard. By the 11th they swelling was down to the size of a quarter and redness was gone but still itchy. 4/18 it was about the size of a pea still a little itchy but doesn't hurt and no redness. However, on 4/13 around 6:30 pm I had to be rushed to the hospital couldn't breath, vision and speech was declining . was admitted for blood clot that cut the oxygen to brain causing a mini stroke

Almost 2 days after vaccination. Headache Pain upon deep breathing Increased pain at injection site so that arm could not be lifted easily. Pain mid-back in kidney area, bilateral. Pain in upper chest. Fatigue

Adverse reaction: Sudden severe shortness of breath when I exerted myself, severe constant headache that tylenol couldn't dull, fatigue and weakness, weak shoulders could keep them raised for more than a few seconds, swelling of abdomen, rapid fluid retention, lack of appetite, chest felt constricted, nose bleeds, black sticky stools Treatment: 2 units of blood, ferrouse sulfate IV, saline IV, protonix IV, endoscopy Outcome:health back to normal, after blood transfusion, will continue to take pantoprazole for six weeks and Iron Note: used to have ulcers years ago due to H. Pylori bacterium suspect Pfizer mRNA vaccine interacted with H. Pylori antibodies as has been found in other patients with H. Pylori.

3/18/2021 - Lot ER2613: 11:50 am First Dosage Beginning the same day as the vaccination, I experienced severe Vertigo for 3 days. 4/14/2021 - Lot ER8735: 12:45 pm. Second Dosage Within 5 minutes of receiving the Vaccination, I experienced Shortness of Breath, Dizziness & Numbness on my Left side. There was an EMT present who brought me to a cot, took my Blood Pressure (164/104 ) and Pulse (48). After 20-30 minutes of No Improvement, I was transported to the hospital & was discharged approx. 6:15 pm with Symptom improvements.

INFLAMMATION ALL LEFT SIDE OF BODY,PAIN IN LEFT ARM,SPREAD TO SHOULDERS,NECK AND RIGHT ARM,TACHYCARDIA,THROAT TIGHTENING,DIZZINESS ON STANDING,HEADACHE,FEVER,NAUSEA,UNBEARABLE MUSCLE PAIN,WEAKNESS ALL OVER BODY STILL TODAY,PAIN BETWEEN AXILLA AND LEFT BREAST,DECREASED APPETITE,I GET TIRED QUICKLY,AND EVEN TODAY,,NAUSEA,DIZZINESS BODILY WEAKNESS,HEADACHE,AND I STILL HAVE INFLAMMATION....I THOUGHT I WOULD DIE!!!!,THE ADVERSE REACTION WAS EXTREMELY HORRIBLE

After the first dose within 10 minutes, I had itchy throat and mouth, heart palpitations, eyes felt like a fullness. After the second dose within 20 minutes, I had tightness in tongue and throat, upper eyelid swelling and redness and beet red flush like rash over cheeks. Next day swollen arm and small rash at injection site.

Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on 4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21.

The expected soreness in my arm developed throughout the afternoon of the morning (Friday) I had the shot along with a fever. I had fever and chills all night - my teeth chattered all night. The fever continued throughout Saturday and my nose was congested. My chest felt tight. Of most concern my neck was so stiff Saturday and Sunday that I could not move it or turn it in the slightest. The pain radiated down through the shoulders but no further. The overwhelming fatigue I had felt when I had Covid in late March-early April was back. I could not stand long without having to sit down and walking around made me feel breathless. I stayed in bed all weekend. The fever broke Sunday night and by Monday morning I could move my neck, but it was very tender and I did not have my normal range of motion. My congestion turned into a runny nose on Monday which cleared on Tuesday. By Tuesday my energy level was close to normal and I had full range of neck motion, although still tender. I never had a headache at any point over those four days.

Patient received Pfizer vaccine and presented with history of allergic reactions to Sulfa and Contrast Dye. Patient is Type II Diabetic. Post-vaccine patient stated tingling and discomfort, respiratory distress, lethargy, difficulty speaking and chest pain. Vitals: B/P - 197/102, Blood Glucose - 138. Paramedic and RN agreed to dispatch for EMS as symptoms were not improving. Emergency responders arrived at 11:20am, patient transported to Hospital -

First reaction, feet and hands became red and swollen. Then trouble breathing and I began wheezing. The Emt's were called. Dr was the attending. He administered Benidril. After 15 minutes he had an Emt attempt to administer an EpiPen. She partially administered the Epi and pulled it out too soon. Dr. administered a second EpiPen. An ambulance was called and I was transferred to Banner University Medical Center.

Patient came in for vaccine was given vaccine by staff, pt seemed fine, about 10 minutes later pt and husband come back to the consultation window pt is in a wheelchair which she wasn't before and husband stated pt had fainted. We asked if she was okay, if she needed anything or if we needed to call ems. Husband states she is fine and looks at pt she said she was fine and while we were confiming she didn't need anything pt was passing out again. We gave her a bottled water, a wet paper towel and called 911. Once ems arrived they checked her out, asked her if she wanted help getting to the car and her husband to take her home when she started gasping for air so ems took her on the hospital.

4/8/21 ? rapid heartbeat 5 minutes after injection, lasting several minutes, followed by chills for hours. I woke that night with pain in my left wrist and right elbow. I sweat at night and wake up sneezing, with itchy eyes, sore throat and sinus congestion. Sneezing and congestion are less during the day. The roof of my mouth was also itchy. I had diarrhea for several days after the vaccination. Tightness in my chest and shortness of breath throughout the day, lasting a week or more. My arm was sore for a week. 4/16/21 ? a 4? red rash developed at the injection site and was very itchy. It was gone by Monday. 4/23/21 ? a rash appeared at the injection site this morning. It is mildly itchy and feels sore. The size is 2-1/2? x 1-1/2?

First dose 3/11/21 no problems. Nurse at clinic placed sticker for dose 2 over dose 1 lot number so unreadable. Dose 2 : headache, fatigue, body aches and throat very swollen at 24 hours. Within 72 hours developed hives starting in middle of back and spread to cover entire body including scalp. Not on palms or soles of feet. Eyes became very red and hives and eyes and swollen throat took several days to return to normal. Took benedryl, Allegra, Claritin for allergy symptoms. Very remarkable and thought about going to ER .

Patient gradually developed a dry cough and complains of some throat tightness. States she does not feel that throat is "closing" but rather that it is related to the coughing. Patient asked to remove mask and was given warm water to drink per patient request. RN notes some mild lung congestion upon auscultation but otherwise clear lung sounds. Patient states it feels similar to asthma related symptoms and states she hasn't been taking her seasonal allergy meds regularly and also that she has had a lot of life event stress with deaths in family. Patient requests benadryl stating that whenever she has asthma symptoms her "inhaler doesn't work but Benadryl always does". RN gives 25mg of liquid benadryl to patient. Approximately 3 minutes post-benadryl administration, patient cough decreases and continues to decrease over the next 10-15 minutes of sitting in observation area. VS WNL. Patient is able to talk without coughing. Patient, who is an RN, states that she is feeling better and she wants to go home. Patient states that she will call her family and let them know she is on the way home. Patient knows to call 911 if symptoms return/worsen. Patient states she will let her doctor know and check in about whether she needs new inhaler prescription. Family member waiting at home for patient. Patient stable and not coughing and states she feels "a lot better" as she is leaving facility.

My tongue began to swell around 4pm. I took a Benadryl. The swelling did not resume until 8pm. I took a second Benadryl around 8:30 pm. By 9pm the swelling began to impede my breathing. Sought medical attention at hospital at 9:30pm where there was no ED. A security guard called 911 and paramedics transported me to a second Hospital ED arrived approximately 10-10:15pm. ED triage staff came to talk to me I sat upright on the gurney, vomited and my airways closed. I managed to say "I can't breathe!" and remember nothing until 36-48 hours later during sleep/wake cycle in ICU. I had to be intubated nasally upon admission. **See more on Continuation page** I had to be intubated nasally upon admission. Doctors said my airway was almost completely blocked with only a sharpie pen sized passage to insert the tube. I am still recovering from my IUC stay. Regaining endurance, strength, stamina as well as vocal range and strength.

per my immunologists I took a benadryl before the injection at 4pm, I developed a red rash all over my left lower forearm around 7- 730pm it eventually faded.( I had the fever, aches and chills for 2 days after the shot and injection site pain) for about 1 -2 weeks after the shot I had intermittent episodes of shortness of breath and tachycardia, this lasted for approx. 2 weeks after the injection, These episodes were like the ones I experienced during my contraction of covid in 12-2020, Except these episodes were much shorter in duration.

Severe anaphylactic-like reactions to foods started /Throat swelling, closing; Numbness of lower part of face; throat constriction, lasted for 45 minutes; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 10:00 AM as single dose in right arm for COVID-19 immunisation. The patient's medical history included auto-immune disease, RA, Hashimoto. Patient had no prior allergies except to bee venom. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. 60 minute after the shot, throat constriction, lasted for 45 minutes. On 20Mar2021, the patient experienced severe anaphylactic-like reactions to foods. Patient experienced throat swelling, closing, numbness of lower part of face which resulted in emergency room visit and physician office visit. Reactions are muted since taking antihistamines but persisted even on 08Apr2021. Adverse events treatment included Allegra, Zyrtec. All allergy tests were negative. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not recovered.

Nausea, dizziness, lump in throat, rapid heartbeat, suppressed breathing, headache, muscle pain, chills, joint pain, fever, injection site swollen, hot, and red size of 50 cent piece

I can't walk around anywhere; I have allergies too; It was bad, getting hard to breathe.; she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine.; she can't talk, it's closing up her throat,; she can't talk, it's closing up her throat,; taste sodium in my mouth constantly; coughing; got home and I've been sick ever since.; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0150; Expiration Date: 31Jul2021) via an unspecified route of administration administered on right arm on 07Apr2021 at 13:30 (at the age of 62-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing Allergies with This was under control, ongoing asthma with This was under control, meniere's disease from 1989 and ongoing with This was under control, have 2 broken knees. Patient knows how to control this condition, she didn't need Prednisone prior to onset of these adverse events, Low immune system with She has an immune deficiency so her immune system very low, like 300., Respiratory illness, Genetic/chromosomal abnormalities, Endocrine abnormalities with endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant to AE reported as None. History of all previous immunization with the Pfizer vaccine considered as suspect reported as Both doses of product documented in Pfizer Suspect Vaccine and Vaccination fields. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiry date: 31Jul2021) via an unspecified route of administration to the right arm on 13Mar2021 at 13:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine other than dose 1 of 2 of the Pfizer-BioNTech Covid-19 Vaccine. Regarding concomitant products and other medical conditions patient reported none other than just her inhalers which doses of had to be increased in response to symptoms after first and second doses of Pfizer-BioNTech Covid-19 Vaccine. Concomitant medication included tiotropium bromide (SPIRIVA) taken as Dose increased to twice in the morning daily for an unspecified indication from an unspecified start date and ongoing, (Lot number: 0014678, ; Expiration Date: Jan20230); fluticasone propionate, salmeterol xinafoate (ADVAIR) 500 taken as Dose increased from once daily to twice daily an unspecified indication from an unspecified start date and ongoing; azelastine hydrochloride (Lot Number: 3N2E, Expiration Date: Feb2022), fluticasone propionate (DYMISTA) taken for an unspecified indication from an unspecified start date and ongoing (Lot number: GA00510, Expiration date: May2022); prednisone (PREDNISONE) taken for an unspecified indication with quantity of 27, Dose: 3-20mg daily for 7 days, then 2-20mg daily for 2 days, then 1-20mg daily for 3 days and Ongoing therapy. She also used a nose spray that didn't work so they switched her back to Dymista nose spray. Consumer stated that she received both doses of Pfizer's COVID vaccine and had reactions to both of them. Consumer stated that, "The second dose was even worse. They put her on Prednisone. She did not know if she should be tested again or not? She was sitting up but she could not walk around anywhere. She had 2 broken knees. She could not walk anywhere. After the second dose, they had to bring her to the hospital because she couldn't even walk to her car. She got home and she had been sick ever since. She had allergies too. She could not do anything. she had a hard time breathing. she was hesitant to get the 2nd one, but everybody said to get it. Her IgG level was down to 300 something. She was also tapering off of prednisone and she did not want to be tapering off it because it was worked well for her. She could tell by her breathing that it was helped her. She could taste sodium in her mouth constantly since she had got the vaccination." Second dose completed her prescribed therapy. Dates for Symptoms From 15Mar2021 to Ongoing Reported seriousness for Symptoms reported as Unspecified and the Symptoms was reported as worsened. Patient's doctor dropped her last week, told her she didn't know what to do with her, and that this was too stressful. Onset of symptoms following first dose of Pfizer-BioNTech Covid-19 Vaccine was on 17Mar2021. She couldn't breathe very well when she went in for the first dose of Pfizer-BioNTech Covid-19 Vaccine. She was ok the first day after the first dose of Pfizer-BioNTech Covid-19 Vaccine, seemed ok, arm didn't hurt; but then had onset of symptoms. She has been in bed the whole time since onset of symptoms, was in bed for over 2 weeks. She slept for 2 days straight, only got up for water and the bathroom. It was bad, getting hard to breathe. She had to use her emergency inhaler. The Pfizer-BioNTech Covid-19 Vaccine messed up her Meniere's disease. Doctor started patient on Prednisone for these symptoms, and Prednisone is really the only thing that clears up Meniere's disease because her ears was full and she could not get up. Prednisone helped her and I relayed in her 'rescue' inhalers (treatment) because she did 2 in the morning, two inhalers anyway when she started to feel better, she got her second one and it made her worst. She did not eat anything salty or anything, the barometric pressure was not bad. It was really funny because she had just finished everything and it was a few days before she had to go get her second dose of Pfizer-BioNTech Covid-19 Vaccine shot. She was just starting to feel normal, at least normal for her, she could get up normal and drive. They gave her the second shot of Pfizer-BioNTech and it was like a double. She clarified as she got like double the amount of symptoms that she had experienced following the first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tasting sodium in her mouth from the Pfizer-BioNTech Covid-19 Vaccine. She can't have much sodium which struck up the Meniere's disease really bad the second day after the second dose of the Pfizer-BioNTech Covid-19 Vaccine; her allergies in her head went bonkers. She could not talk, it was closing up her throat, she was coughing every time she eats or dinks, and she's having a "really bad" adverse reaction to the Pfizer COVID-19 vaccine after the second dose. They had to take her out of the hospital to her car in a wheelchair "right after" getting the second shot. She could not get more than 1000 mg of sodium a day, she tastes it in her mouth constantly, she could not get rid of it and it was "going through her system". She wanted to know what to do, since her doctor told her to contact Pfizer. She wanted to know what part of the vaccine is doing that, she assures it is sodium, because sodium is in her mouth 24/7 and she could not get it out, she could not have that much sodium in her body. It was still getting really hard to breathe. She is still taking the Prednisone she was initially prescribed and started on for the symptoms that started after her first dose of Pfizer-BioNTech Covid-19 Vaccine. She is tapering off of Prednisone, and she shouldn't be tapering off, she thinks she needs to be Prednisone for some more days, maybe 3 more days, then she would be ok. It was prescribed as a 7-day burst of Prednisone. She mentioned that the only Prednisone that works on her is the Actavis manufactured Prednisone; her pharmacy orders it for her because they know that. She called the emergency room Saturday when she was really bad. They said they had a line there and it was going to be at least a 4 hour wait. With patient's low immune system, Meniere's disease and that she could hardly breathe she did not go to the emergency room because she could catch something and die while waiting. She decided she would just stay at home and rest. She has not had any Physician's office visit relative to event; she has a telephone appointment tomorrow to see if the doctor is going to be her doctor. She had to cancel her appointment with the doctor today because if she has something she doesn't want to spread it, she feels worse now and with the Meniere's she is tasting sodium in her mouth constantly from the Pfizer-BioNTech Covid-19 Vaccine, she does not eat a lot of salt. The flu shot takes her a couple of days, then she is right back up and Vaccination Last dose on Oct2020. Consumer stated that she has 'Meniere's' disease (History) and it made her worse. The patient underwent lab tests and procedures which included IgG level: 300. Reporter stated the seriousness for the events was Unspecified. Seriousness of event Meniere's disease aggravated was medically significant. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

went in and out of consciousness, RN reported dry heaving and throat tightness. was sent to the hospital ED for further evaluation

My nasal passages, throat, and bronchial tubes started to swell up; feeling faint; general malaise; My nasal passages, throat, and bronchial tubes started to swell up; My nasal passages, throat, and bronchial tubes started to swell up; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 62-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 14:00 (Batch/Lot Number: ER8729) (at the age of 62-years-old) as single dose for covid-19 immunization. Medical history included known allergies: penicillin from an unknown date. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2, dose 1, administered in arm left on 18Mar2021 01:45 P.M. (Batch/Lot Number: ER2613) (at the age of 62-years-old) for covid-19 immunization. The patient did not get COVID prior vaccination and did not receive COVID test post vaccination. About five minutes (as reported) after the patient received the shot, she started feeling faint on 08Apr2021 02:15 P.M. Her nasal passages, throat, and bronchial tubes started to swell up on 08Apr2021 02:15 P.M. Taking a decongestant when she got home helped that. For a few days she had congestion and brain fog along with general malaise. Treatment received included she took decongestants. The outcome of the events was resolved in Apr2021. No follow-up attempts are possible. No further information is expected.

hives on face; facial flushing; swelling of lips, tongue and throat; swelling of lips, tongue and throat; swelling of lips, tongue and throat; known allergy clearly the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer. A 62-year-old female consumer reported that she received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) intramuscular into the left arm on 01Apr2021 at 09:00 am (at the age of 62-year-old) at single dose for COVID-19 immunization. Concomitant drugs included vitamins only. Known allergies included all shellfish, Percocet, adhesives on bandages. On 01Apr2021 at 09:15 am the patient experienced facial flushing, hives on face, swelling of lips, tongue and throat. As per reporter the AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient was treated with IV with epi, solu-medrol, prednisone and Benadryl. The patient reported as known allergy 'clearly the Pfizer Covid vaccine'. The patient recovered from the events on an unknown date.

I received the second vaccine about 2:10pm on May 1, 2021. Around 8:00 pm, my arm started hurting intensely. I felt very tired and had a headache. I went to bed at 9:30 pm, but was woken up with an intense headache, back ache, and rapid breathing/heart rate. I had no problem with the first vaccine injection; this was the second one. I started running fever between 100 to 101 F, became nauseated and extremely fatigue, and cannot lift my head without pain. I have been sipping water as I don't have much of an appetite. It is now May 2, 2:20 pm and the symptoms are still present. The headache, nausea, and back ache have not changed. 100 fever is consistent. I am extremely fatigued and cannot get out of bed or off the couch. I have not taken any OTC meds yet.

She got the vaccine, she's healthy. Within minutes they took her VS and showed no signs of anything happening at that point. She had a care ride. At approximately 4:00 PM the EMS was at the facility, she could not breath or talk and EMS was called and it got worse in the ride to the ER. She had a severe headache to the point that somebody grabbed her around the throat and her eyes were popping out of her head. She had chest pains, and given nitro for that, and had trouble breathing. She had no voice. The attempted to give her aspirin in applesauce. Her temp was taken and it was 97, by the time she was admitted it was elevated. In the car, EMS was trying to get her veins and 11 attempts were made and she was bruised. She has waited a year and a half for surgery as she needs right knee replacement, and has spine, joint issues and was not able to move due to extreme weakness. She was given Epinephrine in her leg and it did not do anything. She was admitted to the hospital and was there a couple of days until she was able to help her walk. She had no anxiety and had anger over the nursing staff, attending physician and the way she was treated. She is a licensed CNA and has worked in 3 hospitals and has a grievance due to the lack of care that she received while in the hospital. The ER nurses were good, but going to the 6th floor was another issue. Her Dr. on Saturday ordered a swallow test as they could not determine why she had no voice and could not swallow. It was done and she was still having difficulty getting food down, but it was slow and did go down. Since he has been back at ALF she is now better, able to walk, talk and go about her life. While in the hospital she was having a hard time getting her medications, and was given a breathing treatment in the ER, and was still having problems on the floor and was having problems with them getting her medications so that she could breath. She finally got their attention and told her that she was not okay with her and the lack of the nursing staff care. She fought to get her Flonase, and by the time she was ready to leave on Saturday she had been given one treatment of Symbicort. She did have blood tests done to the point that it was excessive, but she had veins that were blowing and there was no access points. On Friday she refused them as she had been stuck 11 times. On Saturday morning they came to get more blood and she refused on Saturday evening when she was being discharged, and she was prescribed a multivitamin to take, which she has never taken one before. She has no heart issues and no chest pains but was discharged home with nitroglycerin. She states that she will not be getting the 2nd vaccine.

? Weakness - Generalized ? Dry Mouth Patient is an 62 y.o. female who presented to the ED for evaluation of 1 week history of progressively worsening shortness of breath generalized ,weakness, fatigue, dry cough , chills,and vomiting associated with abdominal pain, and she was found to have COVID-19 viral pneumonia in the ED.

4 days after the vaccine my MG flared up. First I spent about 9 days too tired to get up. Droopy eye lids, double vision, too weak to even drive my car and problems swallowing. But then the heavy duty stuff starts. Swollen glands for 4 days with a rash, along with the Myasthenia gravis symptoms. So I think I am on the way to mend 4 days later and my glands re-swelled up and the rash came back. This happened a total of three times. Now I am at the 30 day mark. Vocal cords keep collapsing causing my throat to close when I speak. My one eye wont even open at this point. I am so weak I am teaching the dogs to use the vacuum plus drowning in mucus. Before I took the vaccine I was almost completely off my medication and now I am taking it every three hours.

Client reported feeling shortness of breath during observation period and for a period totaling approximately 45 minutes. She denied any other symptoms including HA, chest pain, tingling of mouth, lips or throat. She did not notify paramedic and EMT during observation period.

Left jaw is swollen so huge and it's just hard and now it's going into my lip; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; Lower lip is numb and it's going down into my throat and up in my ear and it's very painful; I am in severe pain; short of breath/I can't breath; am still not well, Bad condition here; am still not well, Bad condition here; dizziness; tired; deltoid starts swelling; lost feeling in my mouth; Left jaw is swollen so huge and it's just hard and now it's going into my lip; my stomach was upset; my jaw was sore; The initial case was missing the following minimum criteria: ICH-unspecified product. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid. A 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 11Mar2021 in left arm at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the context, it was reported that consumer stated, I took the vaccine (Unspecified Vaccine) the first dose on Thursday and right now my left side, they gave it into my left arm and my left jaw is swollen so huge and it's just hard and just like really hard and now it's going into my lip, my lower lip is numb and it's going down into my throat and up in my ear and it's very painful; she was in severe pain. Consumer stated, I took the vaccine 11Mar2021 and next day i.e. on 12Mar2021 I get up and my jaw was sore and then my stomach was upset and then as the day started on my jaw started swelling really big. I took it on 11Mar2021 and I am still not well, Bad condition here, I have lost feeling in my mouth and I can't breath either. It was the first vaccine and this is the very last I am not taking again. Consumer stated, I had a trip to the emergency room. Regarding lab data, consumer stated, No, they documented how swollen was my jaw was, I didn't know I was short of breath until I start back exercising and then I can't breath in there. Consumer stated, Well I just wanted to know how long this is going to last then because I have lost feeling in my mouth. Consumer stated, I got a vaccine back in March and I called Pfizer then because I had, my deltoid starts swelling and I had to go to the emergency room because that's what the paper says if you have facial swelling. So now my deltoid is still swelling, it will go down some and it will start swelling again, I have got numbness in my lips and my chin, dizziness and it hurts. So, I just wanted to know what you can do for that and along with that if it's normal. Consumer stated, Well I have been on hold for an hour, just to get this number, can't you just type the information in have them contact me. When tried to probe for further questions, Consumer stated, I have already documented and I just need to talk to somebody that know what to do to get my job back, like it was. Consumer stated, I went to the emergency room, the paper that they gave it to me vaccine was (name withheld), it's a drive through and they vaccinated it was the first vaccine I got, and I did not go back and get another one because I haven't recovered from that one yet. My face is out swelling up, my lips numb, my cheeks numb and numb. I am just tired and dizzy. The outcome for the events swelling face, lip swelling, hypoaesthesia oral, pharyngeal hypoaesthesia, hypoaesthesia, pain, general physical health deterioration, malaise, abdominal discomfort, pain in jaw,sensory loss, swelling, dizziness and fatigue were not reported and for the event deltoid starts swelling it was reported as not recovered/not resolved. Information about batch/lot number had been requested.

pt experienced SOB and was seen by pcp and referred to ER where evaluation identified PE and DVT of There is deep venous thrombosis present within the left popliteal vein which is nonocclusive and may be acute on chronic. Acute appearing deep venous thrombosis is present within both of the left posterior tibial veins which is occlusive. Likely acute deep venous thrombosis is present within the proximal aspect of a left peroneal vein focally.

difficulty breathing chest pain-unable to comfortably lie down swelling of my face and throat fast heartbeat red face bloodshot and swollen left eye-felt something irritating in left eye insomnia-that night only injection site pain tiredness headache chills and hot flashes joint pain nausea dizzy mental confusion After about 20 hours post shot and one I took some allergy medication I started to improve, it took a full week to feel normal.

Patient reported facial flushing, intermittent SOB and chest discomfort/tightness 15min after 1st dose of COVID-19 Pfizer vaccine. Patient was given 10mg PO Zertec. Vitals stable. Lung sounds clear. Symptoms slowly resolving. Patient monitored for 1 hour by triage RN and PA . Patient discharged home with Husband. Educated to report to ED for eval if hypersensitivity reaction worsens or she has any type of rebound allergic reaction while at home.

3/21/21 - SOB, some wheezing, and dizziness Over the following week: local injection site pain and rash; pain in chest exacerbated by deep breaths; other musculoskeletal pain - knee pain; L ear pain; R hand/wrist forearm shooting pain; pain in R axilla (prior h/o LAD there, possibly worse after the vaccine) - Prednisone for msk pain (increased from 3 to 6 mg - at 6 mg for a couple of days) - Flovent HFA 110 2-4 puffs/day may have helped but s/e hoarseness 4/1 to 4/2/21 Patient updated me and I recommended: Flovent Diskus instead of HFA to see if it is tolerated better (less hoarseness / dysphonia) Discussed options for pain control Ordered SARS-CoV-2 spike Ab to help provide guidance about antibody response with one dose (caveat: normal values are unknown) - she plans to get it next week Large local reaction has resolved (was present for about one week). Today, she still has SOB and pain in her rib cage; pain between shoulder blades. She also feels somewhat fatigued. Feels better if she can take a deep breath. These symptoms wax and wane. Better somewhat with Flovent Diskus 1 puff BID, acupuncture, pain relievers, lidocaine patches, and muscle relaxant.

Less than 24 hrs after vaccine I began to have daily headaches (I rarely if ever have headaches), sometimes 3 a day (lasting 4+ weeks) followed by intermittent headaches about every other day this past week. Within 3 days from vaccine came dizziness, tiredness, racing heart with even slight movement (and many times when just sitting or laying down to sleep) and shortness of breath throughout the day...every day. Primary physician felt it was a direct result of vaccine and I was sent for stat CAT scan to check for blood clot (nothing) and referred to cardiologist (never had heart problems before). Now wearing heart monitor for a week w/scheduled ECHO this coming Monday to check for damage. Today marks the 5th week since vaccine and symptoms seem to we lessening, tho I still have racing heart and shortness of breath w/slightest daily activity, headaches, and dizziness.

green stools; difficulty breathing; nausea; headache; dizzeyness; loss of appetite; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: paa156051), dose 1 via an unspecified route of administration, in Arm Left, on 27Jan2021 12:30pm as single dose for covid-19 immunisation. Vacination facility was Other. Medical history included High blood pressure, Low potassium and High cholesterol. The patient had no allergies. Concomitant medication's included Lisinopril, potassium and simvastatin. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. The patient previously reported her adverse events but forgot to add that on 29Jan2021 at 06:00pm she have had green stools since the vaccine along with the 3 episodes of difficulty breathing, nausea headache dizzeyness and loss of appetite this was from wed of injection until friday 9 days later. The patient was terrified of receiving the second dose because these symptoms happened on the 3rd day and later. If she does not take the second dose what are my chances of surviving the virus if she should come down with it. She tried calling and was on hold for 4 hours and no one picked up. Events resulted in emergency room. The patient underwent lab tests and procedures after vaccination which included COVID-19 (sars-cov-2) test: negative on 05Feb2021. Patient did not received any treatment for the events. Outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

6 days of shortness of breath, chest pain, cough productive of sputum, low-grade fevers, chills, nausea, vomiting, and diarrhea. See history and physical for full details. She was diagnosed with COVID pneumonia and admitted to the hospital.

Patient with hoarsness, stridor, shortness of breath. 50 mg/mL of benadryl administered intramuscularly. 0.3 mg of epinephrine administered intramuscularly.

Breathing difficulty within 2 hours required increased inhaler usage. More tightness overnight requiring dr visit. Nebulizer Rx/ chest X-ray/ antibiotics/ new inhaler

She got her vaccine, and immediately had a sodium taste in her mouth. She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth. Her Meniere's medicine is not helping at all, and she is not able to drive. She is really weak and went to the ER twice and they did some chest X-rays that were fine. They took blood and told her that her sodium was fine, and she feels that was wrong it should be low. She has a lot of problems with sodium. The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment. They told her that it was something like her inhaler, and didn't give her anything else. She was then discharged after 3 hours. She is too weak to walk so is in a wheelchair. She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD. The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired. She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair. She has an APT on Tuesday with a pulmonary specialist.

Chills, fever (102) lasting 36 hours, weakness, rapid breathing, muscle pains, nausea, headache (three days), malaise, injection site pain, arm pain. Excepting the injection site pain and arm pain, all very similar to when I was getting COVID (Dec. 2020), with which I had 17 days of fever and illness with severe cough, positive COVID test (Dec. 2020).

Patient received covid vaccine in February and was immunosuppressed on methotrexate and Remicade. She tested positive for COVID and received pharmaceuticals in ER on 05/10/2021. Patient has mild fatigue and shortness of breath.

patient experienced shortness of breath, sweating, and feeling warm after waiting for observation for 12 minutes. Patient stood up and symptoms started and resolved after another 10-15 minutes of sitting

She got her vaccine and within 10 minutes she felt like her heart did a big woosh and was sitting with her husband and told him that it was hitting her blood stream as she had not had the reaction since starting some medication due to lupus. The first hour it was fairly overwhelming wooshing sensation that made her feel uncomfortable and restless, and then got less. Over the course of the week it continued to happen and did not feel right. She called her PCP and by the time she got to see him on 5/20/21 it had been a month, but had not worsened to go to the ER. She had an EKG that showed acquired long QT syndrome, and told her that she could not get the 2nd vaccine. He said that if she got hte 2nd vaccine that there was a likelihood that she would develop Torsades de pointes and that it could be life threatening. Now he has to be careful on what to treat her due to this condition. He told her to take really good care of herself and to continue take her medications and if it got worse to go to the ER. She will FU with him in a month and he would continue to check EKG's to see if it will go away or not. She is more tired and if she goes up and down the steps she is out of breath much quicker than before this condition. She had several normal EKG's in the past that he compared the last one with and she did not have this condition on previous EKG's. She wishes that they would put out information for people who have autoimmune issues to publish these reactions to be watchful of reactions. Feels they need to update the website to report similar side effects.

Axillary adenopathy L, total size of squashed golf ball, painful. 48 hr of fever then chills, headache, fatigue. Elevated resting HR and occasional chest ache. 11MAY reported to Dr elevated HR & chest aches. Continuing and spreading adenopathy L., 20MAY short of breath, cough, chest aches. Nodes swollen above & below L. clavicle. 22MAY headaches, chest pains sharp 4 times. Bed-rested except 30 min. walk until chest pain then sat until recovered then back to bed. Today total axillary is size of squashed baseball beginning impingement of muscles.

She got her vaccine in the left arm, and felt fine. She went shopping in the store and noticed that she was short winded when she was leaving, but felt that it was possibly asthma and left. She had a temperature between 102 and 103 for a couple of days and having fever and chills as well. She continued with the shortness windedness, and had company and on 5/9/21 they left and she started having severe pain, felt like it was either on the right side kidney or the lung, and was spasming horribly and knocking her down with the pain. She went to the ER and they did a CAT Scan thinking it was kidney stones, but told her that she had three blood clots in her lungs, lower base right and lower base left and mid right and part of her lung has apparently died due to this. They put her on blood thinners, Xarelto. She was admitted on 5/10 early morning and released on 5/12/21. The doctor in the hospital said that it did not make sense that she had blood clots in her lungs, but nothing in her legs. She told her that she was short winded, and he told her to report her reaction. Since being home she has been coughing a lot due to possibly the blood clots. She was told that she will be on the Xarelto for a very long time. She was also informed that she had lymph node enlargement as well.

headache, congestion, runny nose, sneezing, burning eyes, watery eyes, higher than normal blood pressure, fever, chills, body aches, shortness of breath, coughing, muscle pain, injection arm pain, tiredness, feeling unwell, no energy, swollen lymph nodes under arm and below ear lobe,

"Pt w/ hx of allergies/intolerance to Librium, Iodine, and Codeine (upset stomach). Pt w/ hx of anxiety/depression, Asthma, Hyperlipidemia, HTN. Pt had unscheduled MH visit the morning of vaccination. Pt c/o respiratory distress. BP 161/83, HR 90, RR 27, temp 99.1. Pt evaluated for anxiety. Pt stable and released from the vaccination site. Current Outpatient Medications: ? acyclovir (ZOVIRAX) 400 MG tablet, 3 times a day for 5 days as needed for cold sores (herpes) outbreak., Disp: 45 tablet, Rfl: 0 ? acyclovir (ZOVIRAX) 5 % cream, Apply 2 times daily, Disp: 15 g, Rfl: 0 ? acyclovir (ZOVIRAX) 5 % ointment, Apply to affected areas every 3 (three) hours., Disp: 15 g, Rfl: 0 ? albuterol sulfate (PROVENTIL HFA;VENTOLIN HFA) 90 mcg/actuation HFA inhaler, inhale 2 puff by inhalation route 4 - 6 hours as needed, Disp: 18 g, Rfl: 4 ? aspirin 81 MG EC tablet, Take 81 mg by mouth daily. , Disp: , Rfl: ? atenolol (TENORMIN) 100 MG tablet, Take one tablet by mouth one time a day., Disp: 90 tablet, Rfl: 3 ? atorvastatin (LIPITOR) 80 MG tablet, Take 0.5 tablets by mouth at bedtime., Disp: 45 tablet, Rfl: 2 ? cetirizine (ZYRTEC) 10 MG tablet, Take 1 tablet by mouth daily., Disp: 90 tablet, Rfl: 3 ? fluticasone propionate (FLONASE) 50 mcg/actuation nasal spray, Inhale 1 spray into each nostril daily., Disp: 16 g, Rfl: 4 ? hydroCHLOROthiazide (HYDRODIURIL) 25 MG tablet, Take 0.5 tablets by mouth daily. **Need to make appt with MD for more refills **, Disp: 90 tablet, Rfl: 3 ? hydrocortisone 2.5 % ointment, Apply to affected areas 2 (two) times daily. use as directed, Disp: 28.35 g, Rfl: 3 ? ibuprofen (ADVIL,MOTRIN) 600 MG tablet, Take 1 tablet by mouth every 6 (six) hours as needed (headache)., Disp: 50 tablet, Rfl: 0 ? lamoTRIgine (LAMICTAL) 150 MG tablet, Take 1 tablet by mouth at bedtime., Disp: 30 tablet, Rfl: 2 ? lamoTRIgine (LAMICTAL) 200 MG tablet, Take 1 tablet by mouth daily., Disp: 30 tablet, Rfl: 2 ? lamoTRIgine (LAMICTAL) 25 MG tablet, Take with Lamictal 150 mg to make 175 mg at bedtime, Disp: 30 tablet, Rfl: 2 ? predniSONE (DELTASONE) 20 MG tablet, Take 2 tablets by mouth daily for 5 days, Disp: 10 tablet, Rfl: 0 ? valACYclovir (VALTREX) 1000 MG tablet, Take 1 tablet by mouth 2 (two) times daily., Disp: 20 tablet, Rfl: 0"

Lethargic; sneezing and coughing is so severe that it makes her makes her pee; Low pulse ox reading; Difficulty breathing; Sneezing; sneezing and coughing is so severe that it makes her makes her pee; Congestion; Severe sore throat; This is a spontaneous report received from a contactable consumer (patient herself). A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left upper arm on 23Apr2021 11:45 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing GERD (has had this since her injuries, so about 10 or 11 years), ongoing asthma (she was diagnosed with this probably 15 years ago on the job), ongoing Bi-valve of her aorta, it is a leaky valve diagnosed in 1994, multiple injuries (sustained on the job; had accidents and different things, and surgeries too; injuries were cumulative over 22 years on the job), bronchitis (started because she had pneumonia in 1996 then any respiration issue turned into bronchitis; has had repeated bronchitis over the past 17 years; been using her inhaler), environmental allergies, adverse reactions to opioids and pain medicine, LS fusion in 2010, CS fusion in 2012, left shoulder surgery in 2012, gallbladder removal in 2016, total hysterectomy in 2005, tonsillectomy/adenoidectomy in 1977. She had no relevant family medical history. Concomitant medications included montelukast sodium (SINGULAIR) taken for allergies from 2006 and ongoing; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from 2016 and ongoing; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for hypersensitivity from 2016 and ongoing; dexlansoprazole (DEXILANT) taken for indigestion from an unspecified start date and ongoing; cyclobenzaprine hydrochloride (FLEXERIL) taken for pain and muscle relaxant for multiple injuries from her job from 2013 and ongoing; and ibuprofen (ADVIL) taken for pain and aches from an unspecified start date and ongoing. Patient previously received amoxicillin and was allergic. The patient had no prior vaccinations within 4 weeks. She was not sick at the time of vaccination and that she was unbelievably healthy. In the early evening of 10May2021, the patient experienced severe sore throat that was persistent to worsening. In the evening of 11May2021, she experienced coughing and congestion. On 12May2021, the patient had low pulse ox reading and she was feeling crappy. Her pulse ox has not gotten above 95% since last night and that it was 93% at the time of report. It occurred late last night and hasn't gone up. She checks it every night. Pulse oximetry taken around 22:00 on 12May2021 was 93%. Patient said she knew this from over the years she's had bronchitis. She also reported worsened difficulty breathing in the morning, sneezing and coughing was so severe that it made her pee. It occurred in the morning and she had to change her jammies. It happens when the coughing and sneezing was severe. She thinks the congestion was causing the coughing. She was lethargic a few days after the first dose; she felt crappy. She was so tired and she wondered if her immune system dumped and that's why she got sick. She says the lethargic feeling occurred mid morning a few days after the first dose, but exact date was unknown, then clarified she does not know if event started one or two days after the shot. She could not find the NDC number, LOT number, or expiration date on her vaccination card. She called her lung doctor and couldn't get in. She will be calling her primary because they weren't open yet. When asked if the events required a visit to the Emergency Room, the patient said "no, not yet." She confirmed that her next dose was on Friday 14May2021, and mentioned: I lost my days-further details not provided. Patient wanted to ask if she should proceed with that schedule despite how she's feeling. Outcome of severe sore throat was unknown, and of remaining events was not recovered. Information about the batch/lot number has been requested.

heart began 4acing and pounding; problems breathing; wheeze; asthma attack; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot no.: EN6204) via unspecified route of administration at single dose on 10Mar2021 10: 00 AM at left arm for Covid-19 Immunization. Medical history included splenectomy from 2002. The patient has not reported any allergies. Concomitant medication within 2 weeks included 10 mg of fluoxetine hydrochloride (PROZAC) every other day. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested positive for COVID-19 after vaccination. On 11Mar2021 after 4 hours of sleep patient woke up and went to urinate, returned to bed at that time (reported as 3hich time) her heart began 4acing and pounding like nothing she had never experienced before. Event start time was 11Mar2021 12:45 AM. The patient slept another 12 hours. At hour 16 after cardio event, she had problems breathing and began to wheeze and had an asthma attack. No therapeutic measures were not taken for the events. Patient had recovered from the events on an unknown date in 2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. No follow-up attempts possible. No further information expected.

Saturday June 5th Pain in left arm that spread to a bigger area. Sunday, June 6th All Day Body aches (muscles and joints), head ache, fatigue, labored breathing, chills, nausea and diarrhea Overnight sweats Monday, June 7th I still have fatigue, labored breathing and diarrhea. Everything else is lessened (pain in left arm) Gone are all of the aches and chills and nausea

soreness in the arm where the injection was given; nauseous in her stomach; headache; weakness in her arms and legs; tingling in her arms and legs; fatigue; rash; Itching; Hives; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in Arm Right on 15May2021 09:30 as SINGLE DOSE for COVID-19 immunisation. Patient medical history included ongoing severe allergies, ongoing fibromyalgia, sciatica, and carpal tunnel. No family medical history relevant to AE. It was described about unspecified other condition; patient was diagnosed many years ago when she was young that it had to be over 20 years ago. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergy, start and stop date were not reported. Patient was treated with allergy pill, which was the generic Zyrtec, a 10mg tablet and maximum strength cortisone ointment, hydrocortisone, 1%. Patient reported that on the very first day (15May2021) she experienced soreness in the arm where the injection was given, the soreness resolved in about 2 or 3 days, stated that her arm started getting less sore on day 3. Clarified it recovered completely. Later that day she felt nauseous in her stomach, that lasted about one day, it was only on the day of the shot. She has had a headache ever since she received the vaccine, but she did not know if it is from her allergies or not. She said that it was hard to determine the onset, but she had been having a headache every day. She did not remember when it started exactly because of her allergies, but she knows for the last couple of weeks that she has had a headache almost every day and it was hard to determine because of all the pollen. She was also been having a lot of weakness in her arms and legs, which had been going on for the last two weeks. She was also been experiencing fatigue and tingling in her arms and legs, but she cannot remember when this all started. She continued to describe the events that she experienced after receiving the first dose of the vaccine as having a rash, itching, and hives happened twice to her now. Clarified that it happened once last week, although she did not remember the day and that it happened to her today for the second time. She woke up at 05:30 AM, she said that this event wakes her up for some reason and they come out. She gets really bad itching and that she took pictures because it was really bad. She confirmed that this happened in late May 2021 and again today. When asked about the outcome of the rash, itching, and hives, she stated that, it happens once a week, so it was strange, and it was difficult to breathe with it too. She clarified that the difficulty breathing started with the rash, itching, and hives last week. She stated that all of these gone away eventually. She stated that once she gets up and gets like that she immediately jumps in the shower, takes an allergy pill, and puts cortisone all over it. She said that two hours later her symptoms start to fade away so she cannot get to the doctors office, but she took a picture of her leg and sent it to her doctor on the portal, was waiting to hear back. She stated that she was due to get her second COVID shot on Saturday and wanted to know if she should get it and also asked if she should file another report with her side effects with the other reporting agency listed on her vaccination card. No history of previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced events soreness in the arm where the injection was given and nausea on 15May2021; remaining events experienced on an unknown date in May2021. The patient was not visited to Emergency Room and Physician Office for the events. The outcome of the events soreness in the arm where the injection was given was recovered on an unknown date in May 2021; nauseous in her stomach was recovered on 15May2021; outcome of Headache, weakness in her arms and legs, tingling in her arms and legs and fatigue was not recovered; outcome of the events rash, Itching, hives and difficulty breathing was unknown. No follow-up attempts are needed. No further information is expected.

Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Severe, Systemic: Joint Pain-Medium, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Pt started experiencing syncope, chest pain, and neck pain on 5/31/2021. On the following Tuesday, she developed palpitation. On Wednesday, she was taken to ER by ambulance. At the time, she had rapid heart rate at 127 bpm. She was on IV fluid. On Friday, pt visited her cardiologist. She still experiences chest discomfort, lightheadness, and out of breath.

pleurisy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08Mar2021 12:45 (Batch/Lot Number: EN6199) at the age of 62 years old as 1st dose, single dose for COVID-19 immunisation. Medical history included high cholesterol and Ulcerative Colitis that has been in remission for 11 years (not taking any medications). The patient had allergies to penicillin and "GOLIGHTLY." The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (medications the patient received within 2 weeks of vaccination) included estradiol, lovastatin, plecanatide (TRULANCE) and abaloparatide (TYMLOS), all taken for unspecified indications, start and stop dates were not reported. The patient received the first dose of Pfizer-BioNTech COVID-19 Vaccine on 08Mar2021 (Monday) at 12:45. The next day (on 09Mar2021) at 23:45 (11:45 PM), she went to urgent care and was diagnosed with pleurisy and the X-ray results showed "biapical pleural thickening." She wanted to know if this has been reported before. 1000 mg TYLENOL or ibuprofen beforehand (as reported). She is trying to figure out if this event was actually a side effect from Pfizer-BioNTech COVID-19 Vaccine or coincidence. It would be very odd because they have not seen this event, did not know of anyone else who reported that with the Pfizer-BioNTech COVID-19 Vaccine but she wanted to ask Pfizer directly because they know more about the product than the urgent care would. The Urgent care doctor told her to take ADVIL before the test and now her doctor says take TYLENOL 1000 mg, curious if anyone with Pfizer could provide information about this recommendation and event. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the diagnosis of pleurisy was COVID 19 vaccination related. Adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received included IV anti-inflammatory and IV fluids and aspirin. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; lump in throat; 2 asthma flare-ups; face swollen; itching on face, head and around eyes; itching on face, head and around eyes; Occasional waves of feeling very warm; burning feeling around elbows; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 07Mar2021 13:30, at 62 years of age, (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included contrast media allergy, asthma, hypertension, hypothyroidism, glucose tolerance impaired (pre-diabetic) and allergy to erythromycin, cefaclor (CECLOR), penicillin, cefalexin (KEFLEX), neosporine, polysporin, sulfa drugs, eggs, tree nuts, peanuts, fish, shellfish, mushrooms, mustard, chocolate, some melons, raw apples (rashes of hives reactions). The patient didn't receive any other vaccine in the four weeks previous to COVID-19 vaccine. The patient received unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested from COVID-19 post vaccination. On 07Mar2021 at 13:45 the patient experienced itching of tongue, mouth and throat, sometimes lump in throat, 2 asthma flare-ups, face swollen, itching on face, head and around eyes, occasional waves of feeling very warm and burning feeling around elbows. The patient began treatment with famotidine (PEPCID) and diphenydramine hydrochloride (BENADRYL), contacted Doctor's office, then went to ER the day before this report. The physician assistant in ER prescribed 20 mg prednisone daily for 5 days. At the time of the report the reported events had not resolved yet. No follow-up attempts are possible. No further information is expected.

after getting my first one, I couldn't breathe very well; Everything that I have taken my mouth is feeling terrible; It's hurting my muscle and my arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration, in arm left on 13Mar2021 13:30 PM (at age of 62-year-old) as single dose for Covid-19 immunization. The patient did not take any vaccine four weeks before getting the first shot. The patient's medical history included asthma, ongoing Meniere's disease, and allergic to iodine. The patient's concomitant medications included iodine taken for meniere's disease. On an unspecified date in 2021 (after her first shot), the patient was having a side effect, started feeling symptoms, and could not breathe very well hence they gave her some steroids. She was taking steroids but she had Meniere's disease so she could not have lot of sodium but in that sodium and iodine were there and she was allergic to Iodine. She further added that everything that she had taken in her mouth was feeling terrible, as they gave her steroids after her first one. While asking about the route of administration the patient stated that "It was hurting her muscle and her arm." When probing for mailing address of the facility the patient stated, "No, she have to look it up she have no idea." The patient received treatment with steroids (unspecified vaccine) for the event breathing difficult. The patient underwent laboratory tests and procedures which included blood work showing normal result as her doctor could not find anything but had low sodium and was not gaining so much weight also. The outcome of the events was unknown.

The next morning I had trouble breathing and I went to the urgent care. They diagnosed me with COVID Pneumonia. The prescribed me an antibiotic shot, steroid shot, cough medicine, and nasal pill. I might have picked it up from the facility I received the vaccine.

I did not suffer with constant angina issue before the vaccination. I am experiencing constant ongoing chest pain, which I never had a problem with before as well my throat and neck swelling, causing me to have swallowing problems. I still not get any relief for these issues.

Patient is a 62 y.o. female with a history of HIV on retroviral therapy, CAD status post CABG presenting to the emergency department with generalized fatigue and chest pain. Patient reports feeling unwell ever since receiving her second dose of the Covid vaccine on May 28. Describes decreased appetite, burning constant chest pain and shortness of breath worsened with exertion. Reports that the symptoms are similar to prior heart attack. Also reports intermittent burning epigastric/right upper quadrant abdominal pain sometimes worsening with eating, denies other exacerbating factors. Endorses nausea, no vomiting. Also reports productive cough, loss of taste and smell

Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks. She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath. They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.

Ultimately diagnosed with non ischemic cardiomyopathy with an ejection fraction of 25%. Was tested for Covid and was negative at the time of shortness of breath and when became ill.

slight swelling of face near eyes; faster heartbeat than normal; redness on one side of tongue; nausea; feeling a bit of tightness in the throat; tightness in the chest; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 25Feb2021 at 15:30 (at the age of 62-year-old) as unknown, single dose for COVID-19 immunisation. Medical history included diabetes type II, allergies to nuts and cefzil. Concomitant medications included clindamycin HCL, citalopram, rosuvastatin and pioglitazone hydrochloride (PIOGLIT). The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 26Feb2021 at 03:00, the patient experienced slight swelling of face near eyes, faster heartbeat than normal, redness on one side of tongue, nausea, feeling a bit of tightness in the throat and tightness in the chest. The patient stated none of the symptoms were stopping her from working. The patient took some Benadryl and feeling a bit better. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Itching on tongue, throat, asthma attacks, swollen face, redness in face, itching on skin, lump in throat. Initial event(Itching on tongue, throat, skim). The other effects occurred in the days following, some events re-occurring (particularly facial swelling) for over a month.

Pfizer dose #1 administered at 1030 AM, Pt was given 10 ml Zyrtec prior to her injection today due to her reports of allergies and sensitivities to some medications and history of allergic reaction to Humira and local reaction of swelling at inj site with Prevnar 13 and Tdap in past. Says she had a reaction to flu vaccine years ago and unsure of what caused the reaction. Depart: 1045 pt began to complain of "not being able to take a deep breath" and lightheadedness and weakness in legs. Pt has history of asthma, said she did not feel like her breathing felt like asthma, lungs sounded clear to ausculation. Vital Signs: BP 120/80 O2 sat 99 Pulse 99 Resp 16 Epi given 0.3 mL IM L Deltoid and pt was transported to ER via wheelchair by ER RN.

Starting approximately 4 hours after injection: Extremely rapid heartbeat, 164 bpm, elevation over 100 bpm persisted approximately 4 hours Lowered blood oxygen saturation, 88 percent, less than 90 percent persisted approximately 2 hours Light-headedness and shortness of breath, likely related to the above, persisted approximately 2 hours Minor: Pain at injection site immediately and persisted 4 days.

Extreme respiratory distress, Steroids and injectable Benadryl, outcome: reduction in respiratory distress start time Time lapse: 11:30 AM - 6:10 PM

heart pounding between her clavicle and jugular vein in her neck; shortness of breath/breathing problems; high pulse; feels like she wants to cough; This is a spontaneous report from a contactable other health professional (nurse/ Licensed practical nurse reported for herself). A 62-years-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in right upper arm on 07Mar2021 between 13:00-15:00 (at the age of 62-year-old), as a single dose for covid-19 immunisation. The patient medical history included ongoing arthritis, which she was diagnosed unspecified years ago and ongoing high blood pressure, which she was diagnosed 12 years ago. The patient did not have family medical history relevant to events. The patient concomitant medications were reported as none. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left upper arm on 14Feb2021 (at the age of 62-year-old), as a single dose for covid-19 immunisation. There were no events reported following prior vaccinations. No additional vaccines administered on same date of the Pfizer Suspect. There were no Prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. On an unspecified date in 2021, after the vaccination, the patient experienced heart pounding between her clavicle and jugular vein in her neck, shortness of breath/breathing problems and high pulse. The patient stated that she took the Pfizer vaccination, both doses, but the second one, she had her heart pounding between her clavicle and jugular vein in her neck. The patient stated that she could hear her heart pounding and she went to the physician office and told him what was going on. She stated that she had shortness of breath and she asked her doctor to give her a nebulizer because her breathing was so bad. She had been using that one but everyone told her to report what was going on and so she was calling to report what was going on. The events did not require a visit to Emergency Room. The patient stated that her primary care physician referred her to a heart specialist because of the fast palpitations in her heart so they took her to "(Withheld)". The patient underwent lab test included echocardiogram was normal on an unspecified date in Jun2021 and doctor said everything was okay and said he will have to do the stress test. Patient stated that she had problems with her breathing, the breathing in her lungs, and she felt like she wants to cough. She stated that inside she feels something, she wanted to cough but she could not cough sometimes, so the doctor gave her a nebulizer for the breathing problem, which started after the second shot. The patient stated that she did not use the nebulizer a lot because her medical doctor told her not to use it a lot because it increases her heart. Patient stated that one month ago she woke up with her heart pounding and the pulse was high. She said that the second time it happened was two weeks ago. The patient reported she would be having a stress test on an unspecified date (tomorrow at 11:30am) and she was going to take it from there. It was not reported that which event prompted her to go to the physician office. The reporter seriousness was unspecified. Investigation assessment was done. The patient stated that if she knew she would have all of these problems she would not have taken the vaccine. She was so hesitant to take it because she was scared of the side effects and now she took the vaccine and she cannot do anything about all these problems that came to her. Patient stated that she wanted to get the right information so she was going to the doctor tomorrow and will get a print out and call back to provide the right information for the report about her echocardiogram. When asked the results, the patient stated that her doctor said everything was okay and said maybe the heart was enlarged but he will have to do the stress test. The outcome of the events was unknown at the time of this report. PSCC Communication: Full details unable to be obtained.

This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was 62-year-old) as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications included Singulair. The patient stated that she got the COVID-19 shot a couple weeks ago, had a 102.3 fever on an unspecified date. The patient stated she was concerned about shortness of breath that she experienced for 12 hours after. Wanted to know if she could do anything else besides her inhalers. Wanted to know if she could take an extra Singulair pill that has to do with the lungs, or she should take other drugs such as Pulmicort and Levalbuterol tartrate. Therapeutic measures were taken as a result of shortness of breath. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.

Initially diarrhea for a few weeks and fatigue, then heart fluttering, dizziness,,mild shortness of breath for several weeks . Like an arrhythmia .; Initially diarrhea for a few weeks and fatigue, then heart fluttering, dizziness,,mild shortness of breath for several weeks . Like an arrhythmia .; Initially diarrhea for a few weeks and fatigue, then heart fluttering, dizziness,,mild shortness of breath for several weeks . Like an arrhythmia .; Initially diarrhea for a few weeks and fatigue, then heart fluttering, dizziness,,mild shortness of breath for several weeks . Like an arrhythmia .; Initially diarrhea for a few weeks and fatigue, then heart fluttering, dizziness,,mild shortness of breath for several weeks . Like an arrhythmia .; Initially diarrhea for a few weeks and fatigue, then heart fluttering, dizziness,,mild shortness of breath for several weeks . Like an arrhythmia .; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported herself that, A 62-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot Number: EPp7533), via an unspecified route of administration on 30Apr2021 16:30 (at the age of 62-years-old, non pregnant), in right arm as dose 1, single for COVID-19 immunisation. The patient's medical history was mild hypothyroid. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient diagnosed with COVID-19 neither prior to vaccination nor after the vaccination. The patient had an appointment to get 2nd vaccine, it has been 6 weeks, and her family was pressuring her to get it. In May2021, the patient initially diarrhoea for a few weeks and fatigue, then heart fluttering, dizziness, mild shortness of breath for several weeks. Like an arrhythmia. The event arrhythmia and heart fluttering was serious (medically significant). The patient visited physician office for adverse events. On 30Apr2021, electrocardiogram was performed which was normal. The outcome of the events was unknown. This is a follow up (PRD11Jun2021)-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: Additional Context: Caller states, "I have a heart arrhythmia, I can feel it in my chest and when I take my pulse, of course my doctor did a quick EKG and I wasn't having it at the time the test was done. I saw the PA and all the lab work was normal. They talked about some kind of monitor. Maybe the PA will follow up with the Dr and they will call me next week about it." Caller also states,"my friend is vomiting her guts out and she needs to get her 2nd shot" Caller states she reported her symptoms this morning. Caller states people are not reporting, they think their doctors are reporting for them. I have an appointment to get my 2nd vaccine, it has been 6 weeks, and my family is pressuring me to get it. What if I do and I am never normal again?" Caller states, "I don't trust Pfizer anymore after this morning. I have been on the phone now for over 30 minutes trying to find out where my vaccine lot# was manufactured. Pfizer has done unethical things with this vaccine and I heard about all of it this, morning. "I already reported my information this morning. No follow-up attempts are needed. No further information is expected.

pt developed SOB, CP, dx with pleurisy; pt developed SOB, CP, dx with pleurisy; pt developed SOB, CP, dx with pleurisy; This is a spontaneous report received from a contactable healthcare professional. A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0165), via intramuscular on 07May2021 at 12:00 PM (at the age of 62-years-old, non-pregnant at the time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history included HTN, elevated cholesterol and new onset DM2. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's concomitant medications within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) and atorvastatin. The patient was not pregnant at time of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, on 27May2021, the patient developed SOB, CP, dx with pleurisy and on 28May2021, the patient was seen at local ED and hospitalized for 2 days. No prolonged hospitalization. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was CT scan, labs, IVF, CXR, needed o/p antibiotics. On an unspecified date, the patient underwent lab tests and procedures which included CXR, resulted as unknown and CT scan, resulted as unknown. The outcome of the events was recovering. Batch/Lot number was obtained. Further information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Tasted a metal taste, panic attack, shaking all over, hard to breath, increased blood pressure, tingling in back

Tingling/strong tingling in the arms, legs, and around mouth; Short breath; Fast heartbeat during midnight or early morning; it weakened her up; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 62-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 16:30 (Age at vaccination: 62-year-old) as single dose, for covid-19 immunization. Medical history included thyroid replace medicine from an unknown date and unknown if ongoing. Concomitant medication included ergocalciferol (VIT D), levothyroxine sodium (LEVOTHYROXINE SODIUM), calcium (CALCIUM) and unspecified medications all taken for an unspecified indication, start and stop date were not reported. and It was reported that a few minutes after the first dose she felt some tingling and the next day it was rather severe and it weakened her up, this never happened before, she went to ER and everything seemed okay. After the second dose, she developed muscle weakness and severe tingling, she is not sure if it is related to the vaccine, but she has felt this almost every other day, she was weak because of the tingling, it is limiting and has been there for some time, on the face. The tingling increased at night. She went again to ER the day before yesterday, the doctor found everything was normal except the potassium, which was at 3.4 (limit 3.5) and she thinks it may not be related. After that, she started taking potassium supply tablets but they did not help. Patient wanted to know how many days after the vaccine was the fatigue reported. Upon date 01Mar2021 it was reported that patent stated, Muscle weakness, muscle tingling on face and my arms, sometimes face, most of the time it was limbs. She want to get some advice on what is going on there. Also reported after the vaccination, she feel muscle weakness. Upon date 13Mar2021 it was reported that wake-up by strong tingling in the arms, legs, and around mouth with short breath and fast heartbeat during midnight or early morning, and the tingling last during the day. First event occurred the night after 1st dose; then after the 2nd dose, the episodes occurred almost every other day (sometimes, every day). Occasionally there was strong muscle ache in the arms and legs. She was still having those symptoms. She could not sleep for most of the nights due to these episodes. she can not live normally since the vaccination. Patient was not tested for covid post vaccination. Adverse event resulted in physician office visit or ER visit. Outcomes for the event was reported as not resolved. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238818 same reporter/patient/drug, different events/vaccine dose

I have tried to report this several times to this site, doctor, vaccine provider etc without success. Last time i tried to fill out here, i finihed and it would not let me submit. I emailsed to ask if they recieved my report, but ? Primary concerns have been fluttering, irregular, rapid heart beat; chest pain; shortness of breath. Additionally, mainly mild headaches and pressure behind eyes. These symtoms were not noticed hours after the vaccine, rather intermittently for weeks following. As far as symptoms within days of the vaccine: diarrhea, severe depression, and a few near faint spells - as very sudden onset whoosiness-as perhaps a rapid loss of blood pressure or something, but they resolved within a minute of breathing /rest. regretfully, i did not go to the ER for heart rate, chest pressure, and breathing issues, as I felt was likely called for , but i hoped to make it to a cardiologist or to my primary. I dod see P.A. at my primary, but she did nto think it was related to the vaccine. I feel certain that it is.

Lungs hurt when deep breathing; discomfort in bronchial area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: ENC 207), via an unspecified route of administration on 18Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril 25mg (MANUFACTURER UNKNOWN) and sertraline hydrochloride 75mg (ZOLOFT), for unknown indications from unknown dates. The patient previously received penicillin (MANUFACTURER UNKNOWN), cefadroxil (DURICEF), doxycycline (MANUFACTURER UNKNOWN), nalidixic acid (NEGGRAM) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 16:00, the patient's lungs were hurting when deep breathing and the patient had discomfort in bronchial area. The patient did not receive any treatment for the events lungs hurt when deep breathing and discomfort in bronchial area. The clinical outcomes of the events lungs hurt when deep breathing and discomfort in bronchial area were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

blood pressure went up to 180/blood pressure was 188 over something, she forgot the bottom number; rash, hot flash on her face; rash, hot flash on her face; mouth and lips began to swell; mouth and lips began to swell/lips started to swell; had difficulty in breathing; tongue started to swell; hair on her arms raised up; she got red; This is a spontaneous report from a contactable consumer reporting for herself. This 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), (Lot number: EN6205, Expiry date not reported) via unspecified route of administration in right arm on 12Mar2021 14:00 (at age of 62-year-old) as single dose for COVID-19 Immunization. Patient medical history included ongoing hypothyroid, ongoing idiopathic swelling. Patient had allergic to allergic to sulfa drugs, shellfish, mangoes and eggs. Allergy to sulfa, she reports she had a urinary tract infection, and they gave her Bactrim. She's going to say it was in the year 2000 and she broke out in hives. She stated that the shellfish might have something to do with high iodine content interacting with her thyroid meds. Family history included her husband had stage 3 kidney failure. It was reported that, when probing for adverse events with prior vaccinations she reports when she was little, she had 2 shot records full of shots because her dad was working and they traveled all the time, that was in the 1960's. She had to have a vaccine for everything. Her husband was working also. She did not like shots and probably hasn't had a vaccine since 1985 and it was probably for yellow fever or something like that. Patient concomitant medications included levothyroxine (125mcg 1 tablet per day) used for thyroid from 20-30 years and ongoing, hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) 75-50 (1 tablet per day) used for idiopathic swelling from 20-30 years and ongoing. 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 not been tested for COVID-19. Caller stated that she got the Covid 19 vaccine on 12Mar2021 and had a reaction within 2 minutes. she had a reaction where the hair on her arms raised up. Then her lips and tongue started to swell. She got red, rash, hot flash on her face and her blood pressure went up to 180 or 188 over something, she forgot the bottom number. She stated that she had difficulty in breathing due to the swelling, mouth and lips began to swell. Emergency medical technicians monitored her at the facility after the vaccine. She stayed for about 45 minutes after receiving her vaccine. Her blood pressure went down and the swelling in her mouth went down. The Emergency Medical Technicians told her to call her doctor to see if she gets the second Covid 19 vaccine. She was not sure if she should get the second one, if she gets the second Covid 19 vaccine, she should get it at a doctor office or at the hospital in case she needs an epinephrine pen or if the reaction was worse. She reached out to her doctor on Monday,15Mar2021 and yesterday,17Mar2021, and doctor advised that she not get the second Covid 19 vaccine. They asked her if she wanted to go to the hospital, she said no. That would mean more needles and an IV. The Emergency medical technician talked about her taking a Benadryl when she got home but she did not take the Benadryl because she was feeling better. Patient underwent lab test and procedures include blood measurement was 188 over something/went up to 180 on unspecified date. Patient did not visit any emergency room. The outcome of the events blood pressure increased, tongue started to swell, hair on her arms raised up and she got red resolved on 12Mar2021, while the event lips started to swell was recovering and all other events was unknown. No follow-up attempts are possible. No further information is expected.

complains of sore throat, left ear ache, chills, painful knees, stomach ache, productive cough, and shortness of breath.

I woke up with lung pain when taking a deep breath, sharp pain in my chest and lungs. I got hold of my cardiologist and he said to take Ibuprofen 3-4 times a day. The Ibuprofen really helped right away and after the holiday weekend I did not have lung pain but I did have the chest pain. I then went to see my PCP after the holiday weekend, she told me to continue taking Ibuprofen, the suggestion was that I might of had pleurisy. I then began to take Ibuprofen when I started to feel chest pain, around my heart area and because of my pace maker. I felt lousy for the month of June. I also had few days of low grade fever which went away. On the first week of July, I feel like I am coming out of a fog and stopped taking Ibuprofen on 07-07-2021 and I have been fine ever since I had lab work, echocardiogram, EKG and all my tests show I was fighting off something. I did not get tested for Covid. I felt like almost I had the flu, fever, body aches. Been to doctor but no diagnosis. I feel fine for over a week and a half now. All my symptoms happened 6 weeks post vaccination.

20 minutes after injection I felt lightheaded. After drinking some water and sitting for 40 minutes I drove home. My body felt impaired as though I wasn't fully cognitive, my heart rate increased and it was harder to breathe. I stayed home and watched tv all day and felt those symptoms subside. I went to bed that night and woke up at 1 am. I went to the bathroom and had a small bowel movement and afterwards my lower abdomen became hard and swollen as if there was a half a melon sticking out. My pain was intense at about an 8 on a scale of 1-10. I drank some detox and digestion herbal tea to try to help. The pain lasted about 3 hours. About 2 days later, I went to the bathroom and what looked like dead cells came out in the toilet through my rectum. My doctor thinks that it may have been the lining of my intestines from the inflammation. This was from the first vaccine and for the record I will not take another.

Felt like a board in her chest; Trouble Breathing; Coughing and Couldn't Quit; Wheezing a bit when she breathed in; This is a spontaneous report received from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206, Expiry Date: Unknown), via an unspecified route of administration, in the left arm on 11Mar2021 11:00 as dose 1, single for covid-19 immunisation. Medical history included asthma from 2014 and ongoing, under control as long as she did not eat anything that triggers it. Family medical history included patient mother would have severe reactions to everything and it got worse the older she got. The patient's concomitant medications were not reported. No history of all previous immunization with the pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect. The patient did not received any vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced a reaction that felt like a board in her chest, trouble breathing, and wheezing. Appointment was at 11:00, so shot at 11:30, home by noon, started within 15 minutes of that, so about 12:15 to 12:30 pm. Caller stated her reaction started an hour after she got back home. Caller stated it first felt like a board in her chest and then she started coughing and couldn't quit. Then she noticed she was beginning to wheeze a bit when she breathed in. She had a similar reaction with wheezing when she has had a shot of Penicillin or Sulfa medications in the past, so she thought, oh gosh, she was having an allergic reaction, so she took Benadryl and it worked. Caller stated she was too scared to take the second one. Caller stated the reaction stopped within 20 minutes of taking the Benadryl. She did take a flu vaccine back in 2005 and she didn't have a reaction. Caller reported she did not have a primary care doctor anymore as he recently died. Caller has not yet received the second dose of the vaccine due to CDC website recommendation to not take second vaccine after experiencing wheezing with the first. Patient had received treatment for event was Benadryl. Adverse event did not require a visit to emergency room or physician office. Outcome of all events was recovered on 11Mar2021.

feeling out of breath hours later that lasted for 3 days; She was shaking and shivering in a heating blanket; irregular heartbeat after 20 minutes; blood pressure dropped; ringing of ears; body temperature dropped 2 degrees; heart palpitations; She was shaking and shivering in a heating blanket; she felt like she had been hit by a car.; This is a spontaneous initial and follow up report from a contactable consumer (patient). A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735; Expiration Date: Jul2021) via an unspecified route of administration in Arm Right on 10Jun2021 15:30 as single (at the age of 62-year-old) dose for covid-19 immunization. Medical history included hypothyroidism-Diagnosed in the 90's, maybe 30 years ago she was taking medication for that. Hypothyroidism she can responds a little worse than someone else to an illness because of her metabolism being lower. Patient states that why she was alarmed at first. She can feel a little more sick or drained than other people. She had allergies when she was younger and had to get allergy shots. Those allergies do not bother her anymore, like dust and pollen. She was overweight. She states she does have bad reactions to a few drugs, but she doesn't take those, things like a couple of antibiotics and a few other different things but nothing life threatening. Family history includes that her mother had lymphoma, but she was 80 something went through chemo but was fine now. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't have adverse event prior to vaccination. On 10Jun2021 15:50 she experienced irregular heartbeat felt like a skip or a thump and started about 20 minutes after injection. She waited there at the clinic for 15 minutes and then left. She says by the time she got home it was happening every 10-15 minutes. She states it wasn't life threatening because she was still alive. She had felt a skipped heartbeat from time to time in her life prior to the vaccine. She now has an irregular heartbeat a few times per day and heart palpitation. After vaccine between 16:00-18:00 blood dropped about 20 points and only lasted few hours. Her body temperature dropped 2 degrees. She states she started feeling worse a couple of hours after getting the vaccine. Caller states that she went home and felt so terrible and out of breath, she could hardly breathe. BP and temperature were back to normal the next day. Caller states that she got the shot around 3:30pm and all of this was occurring at supper time and she went to bed around midnight. Ringing in ears lasted 3 days, it was really loud. Sometime on 14Jun2021, she was feeling better. She thinks it has recovered and if it was going on it was minor, and she did not notice it. Around 18:00 midnight patient had chills and feeling out of breath she didn't do much that night. She noticed the shortness of breath a lot more on the next day. She says she was walking around huffing and panting for breath just to walk to the bathroom or to the kitchen. She wouldn't have been able to work. She was shaking and shivering in a heating blanket and she felt like she had been hit by a car. Patient states that she got the shot around 3:30pm and all of this was occurring at supper time and she went to bed around midnight. If this was a bad reaction and she thought it was bad because her heart was involved. She has talked with her doctor but says no one knows what to do. She does not want to go into shock or have her heart be even worse. The health officer who was monitoring situations, told her to get a blood test for antibodies to see if she was protected and she could wait a few months for the second vaccine. She would have to contact her doctor to get an order for that so she can see if the first vaccine worked and if she has antibodies then she has some protection. She doesn't know if she had an allergic reaction or if this was normal. She did not want to get the second vaccine and die. The patient did not visit Emergency Room/ Physician Office due to the events. The outcome of the events irregular heartbeat and heart palpitation recovering, BP dropped, and body temperature recovered on 11Jun2021, and the events shaking and shivering in a heating blanket, out of breath recovered on 13Jun2021. The outcome of the events ringing in ears and she felt like she had been hit by a car was unknown. Information on Lot/Batch number was available. Additional information has been requested.

On 7/12/21 started getting sharp pains left side it felt like it was in my heart then on July 13, 2021 I want to hospital. The ER they did bloodwork many test chest x-ray the final diagnosis was pleurisy. I have never had any lung issues in my life except asthma when I was a young child which I out grew it as a teenager. I am following up with a pulmonologist on Monday, July 19, 2021 as advised.

After vaccine, extreme blood pressure fluctuations, trouble with dizziness, lightheaded, feeling like fainted (fainted once), trouble catching breath, significant weight gain because unable to exercise/move as normally. Referred to cardiologist because migraines and chest pain.

Meniere's disease; I can't breathe because of it and I am tired; I have no energy; I got worse Meniere's disease; I couldn't breathe very well and so they gave me some steroids, I am taking steroids and I have Meniere's disease so I can't have lot of sodium you have iodine, I am very allergic to Iodine; It's running through my blood stream, my symptoms are getting worse; I don't want to die; I am getting is more symptoms, because it is running through my bloodstream and making me very sick; It took my whole body, I can still feel my arm sore where they shot me; it is going to my neck my ear; I can't breathe because of it and I am tired; I have no energy; I got worse Meniere's disease; Asthma; Allergies; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number EW0150; expiration date: 31Jul2021) via intramuscular, administered in left arm on 07Apr2021 01:30 PM as dose 2, single for COVID-19 immunization. Historical vaccine included dose 1 of BNT162B2 (COMIRANTY; Solution for injection; Lot number EN6207; expiration date: 31Jul2021) via intramuscular, administered in left arm on 13Mar2021 01:30 PM as single for COVID-19 immunization. Medical history included ongoing asthma 32 years ago, Meniere's disease, iodine allergy. There were no concomitant medications. The patient did not received any prior vaccinations within 4 weeks. The patient experienced i am having a side effect and is getting worse, i couldn't breathe very well and so they gave me some steroids, i am taking steroids and i have Meniere's disease so i can't have lot of sodium you have iodine, i am very allergic to iodine , it's running through my blood stream, my symptoms are getting worse; i don't want to die; i am getting is more symptoms, because it is running through my bloodstream and making me very sick, it took my whole body, i can still feel my arm sore where they shot me; it is going to my neck my ear, i can't breathe because of it and i am tired; i have no energy; i got worse Meniere's disease, Meniere's disease, asthma and allergies on an unspecified date. AE required visit to Emergency room, Physician office. Consumer stated, "she started feeling symptoms after getting my first one, she couldn't breathe very well and so they gave her some steroids (Unspecified Vaccine), she was taking steroids and had Meniere's disease so she was very allergic to Iodine. "It was running through her blood stream and symptoms were getting worse and worse after the second one, it was absolutely and she had symptoms started to unbelievable. She went to the ER twice, to primary 4 time and doctor had now dismissed her she had nothing to do with patient. Patient did not had doctor anymore because of it. Patient had lots of questions, the symptoms were getting worse and worse and nobody was doing anything about it. Patient was 62 years old, was trying to get some aid and all she was getting more symptoms. Because it was running through her bloodstream and made her very sick." She further stated, "she could die tonight in sleep all she wanted to do had track of all of these, it took her whole body, she felt her arm sore where they shot her. It went to her neck and ear. she couldn't breathe because of it and was tired, had no energy, got worse Meniere's disease, her doctor did not even wanted to see her." The patient underwent lab tests and procedures which included blood test: sodium low allergy in iodine, chest x-ray: ok , ear, nose and throat examination, Ok all on an unspecified date in 2021. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Visual disconnect, dizziness, ringing in ears, anxiety, depression, hard to get a deep breath, fatigue, shaking, heart racing, face and ear discomfort, brain fog The only thing that has helped is going to an medicine dr for therapy and lots of natural supplements. I am a healthy, vibrant and athletic women who plays competitive tennis, hikes, helps run a family business. This has completely changed my life in the negative. I have not been able to do any of my usual activities. Felt suicidal at times. I HAVE NEVER FELT THIS WAY!

Pt reports that she had a globus sensation and some shortness of breath PRIOR to receiving the vaccine. She was monitored 15 minutes post-injection without incident. When she walked out to the hallway to go home she reported that she felt like she was going into anaphylaxis and a Rapid Response was called overhead. She was complaining of feeling like her hands and feet were swelling and that he voice was hoarse. Her lips were noted to be large and her husband confirmed that they looked larger than normal. She was found to be hypertensive to 196/109 so analyphylactic shock was ruled out and she was not treated with an epi pen. She was transferred to the ER. Exam found scattered wheezing, mildly protuberant lower lip, no tongue swelling, no drooling. She was treated with IV solumedrol 125mg, IV benadryl, IV famotidine, and a racemic epi nebulizer. ENT came and visualized her airway via NPL and found no oropharyngeal or laryngeal edema. She was admitted to the MICU for 48-hour anaphylaxis observation and continued on steroids and anti-histamines. By the following morning she was feeling well.

On Sunday night I started to feel tired but I had been busy during the weekend so I thought it was just that. Also, I drove for 2 hours. I got home and I unpacked my bag. Later on I felt like I was having a headache. On Monday morning I went to work and I had a dry cough and I felt congested. I got off work and the next day the cough was better and my congestion was worse, I could not breathe okay. I made it through work. My coworker told me to get a Covid test. I called the doctor's office. When I went they took my tempt. They did the Covid taste and it was positive. They gave me 3 prescriptions.

weakness on her left side; her left side and foot feels numb; her heart was off the charts; Feels like from her foot from the ankle down, is swollen on the left side; Felt like her throat was burning down to her chest; anaphylaxis; had a hard time breathing; could not swallow; Ungodly taste in her mouth, god awful taste in her mouth; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jul2021 10:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included cerebrovascular accident from 1995 to an unknown date , surgery from 1995 to an unknown date , splenectomy from an unknown date and unknown if ongoing , urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication(s) included lamotrigine (LAMOTRIGINE) taken for seizure from 2019 and ongoing; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; melatonin (MELATONIN) taken for somnolence from an unspecified start date and ongoing; valproate semisodium (DEPAKOTE) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced urticaria, heparin and experienced drug hypersensitivity, penicillin nos and experienced drug hypersensitivity, sulfamethoxazole and experienced gastrointestinal tract irritation. The patient experienced anaphylaxis (anaphylactic reaction) (medically significant) on 02Jul2021 with outcome of not recovered , had a hard time breathing (dyspnoea) (non-serious) on 02Jul2021 with outcome of not recovered , could not swallow (dysphagia) (non-serious) on 02Jul2021 with outcome of not recovered , weakness on her left side (asthenia) (non-serious) on an unspecified date with outcome of not recovered , her left side and foot feels numb (hypoaesthesia) (non-serious) on an unspecified date with outcome of not recovered , ungodly taste in her mouth, god awful taste in her mouth (taste disorder) (non-serious) on 02Jul2021 with outcome of not recovered , had to monitor her heart because it was off the charts (cardiac disorder) (non-serious) on an unspecified date with outcome of not recovered , felt like her throat was burning down to her chest (burning sensation) (non-serious) on 02Jul2021 with outcome of not recovered , feels like from her foot from the ankle down, is swollen on the left side (peripheral swelling) (non-serious) on an unspecified date with outcome of not recovered. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of had a hard time breathing (dyspnoea) , had to monitor her heart because it was off the charts (cardiac disorder). Information on the lot/batch number has been requested.

I have a positive ANA. My auto immune system acts up. I had a elevated heartbeat. I had fatigue and was out of breath. I went to my doctors about it. They did Echo exam and a stress test. Last week they did a Nuchal cardiac stress test. I have an appointment on Thursday to find out the results.

chest pain on her left side; itching; chills; shortness of breath; Nauseated; she is breaking down with a sweat; I don't feel good, I don't feel right; tired; This is a spontaneous report from a contactable consumer. A (62-year old (age at vaccination) female patient with height 165 cm and weight; 77.56 kg received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number; EN6207) dose 2 via an unspecified route of administration on 09Apr2021 in left arm as DOSE 2, SINGLE for covid-19 immunization. Medical history included cardiac disorder, diabetes mellitus, blood cholesterol increased and was mentioned that she takes medication for all, Blood pressure high, gastritis, congestive heart failure, arthritis (dates unspecified). Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on 19Mar2021 as single dose in left arm for covid-19 immunisation. Concomitant medications were not reported. On 09Apr2021, the patient experienced itching the same day as the vaccine and she took a teaspoon of benadryl. On the Saturday, experienced chills, shortness of breath, tired, chest pain on her left side, she is breaking down with a sweat. Consumer stated, "I'm calling to tell you about Pfizer, I had took last one, Friday 09Apr2021 that was on Friday. so next day on Saturday I started getting side effects. I started itching, short of breath, chills. I was getting short of breath, itching and don't know what else is going on. I feel kind. This morning I had a little chest pain." Consumer further stated ‘' Nauseated. Last Friday. I had the 2nd one. On 09Apr2021.". Consumer stated, "Right now I don't feel good. I don't feel right." Consumer stated, " this is serious, they had it on the news this stuff giving people side effects." I had the 1st on 19Mar2021. Apr I had the last one, 09Apr2021.". Probed for 2nd shot COVID vaccine LOT number, consumer stated, "EN6207, yes." Probed for expiration date: consumer stated, "I don't see expiration date." Anatomical site of administration: consumer stated, "Both on the left arm. Left arm." Probed for medical condition, consumer stated, " I take medicine only for asthma (Further clarification unknown), The 81 the low dose." Consumer stated, "I have arthritis too. In my right knee, I use cream on my knee. My doctor prescribe some cream (Further clarification unknown) for me to use for the knee, for the pain. In July2021 I have knee replacement too." Consumer stated, "I took Benadryl when I start itching.'' Therapeutic measures were taken as a result of itching (pruritus). Investigation assessment; no. The outcome of event pruritus, Chills was recovered on an unspecified date, dyspnoea was not recovered, fatigue, chest pain, hyperhidrosis, feeling abnormal and nausea was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. Follow-up (13Apr2021): New infromation recieved from a contactable consumer. This 62-year-old consumer reported for herself that which included: Patient details (age and age at vaccination, height, weight, medical history) added, suspect drug details (lot number, anatomical location) added, event details (new events feeling abnormal, nauseated) added outcome of event 'shortness of breath' was updated as 'Not recovered/Not resolved' and clinical information added. No follow up attempts are possible. No further information is expected.

Tongue tingling; inner lip swelling sensation; inner lips itchy; Mild tightness in throat and bronchial; Red dot with pink circle on forehead; Shoulder pain; Diarhea; Slight headache; mild temperature 98.4 two days; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 28Mar2021 at 13:30(at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included unspecified conditions. The patient had unspecified allergies to medication, food or other products. Concomitant medications included calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and vitamin b complex (MANUFACTURER UNKNOWN) all from an unknown date for an unknown 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 28Mar2021, 2minutes after the vaccination, the patient experienced tongue tingling, inner lips itchy swelling sensation. On the same day, 5 minutes after the vaccination, mild tightness in the throat and bronchial. On the same day, 1 hour after the vaccination, the patient experienced a slight headache and mild temp 98.4 usually her temperature was 97.3. On the same day, 3 hours after the vaccination, the patient experienced red dot with pink circle on forehead and shoulder pain. On the same day 18 hours after the vaccination, the patient experienced diarrhoea. On 28Mar2021, the patient underwent body temperature and the result was mild temperature 98.4. The patient was not treated with any medications for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events tongue tingling, inner lips itchy swelling sensation, mild tightness in throat and bronchial, a red dot with a pink circle on the forehead was recovered on 28Mar2021 after the duration of 1 hour. The clinical outcome of the events shoulder pain, diarrhoea, slight headache and mild temperature 98.4 was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.

Pt p/t ED on 6/6/21 w/multi trauma injuries 2/2 MVC. Was medically stabilized and admitted to inpt rehab (6/10). Readmitted on 6/25 for add'l procedures and ultimately discharged to inpt rehab on 6/28. Despite having a COVID negative test upon admission (6/6) and had received Pfizer COVID vaccines (1/13 & 2/3), pt developed a cough on 7/26 and her COVID test returned positive (7/26). She was ultimately discharged home on 7/26/21 w/add'l follow-up.

Approximately 1 hours after injection, I felt an unusual feeling at base of throat. It progressively got worse and I felt throat swelling and my voice was effected. No itchy throat like my anaphylaxis reaction to shellfish only swelling. I mildly panicked and wanted to take Benadryl. About 1/2 hour later by the time I got home reaction was over. No repeat of symptoms ever again.

I have just been fitted for a CPAPand have been using it for 11 days with no ill effects. Last night at roughly 3:15 am I woke up because I was having difficulties breathing. I had trouble on the inhale but the worse part was not being able to exhale with the CPAP on. I could only exhale through the mouth. I had to take the CPAP off so as I could breath. I also got out of bed to get in a sitting position. At this point my breathing seemed somewhat ok. About 30 minutes later I took my blood pressure and pulse. BP was 123 over 70 and my pulse was 70.

Tightness on the chest Blood Pressure was high 185 or 198 Dry Mouth Hard time to breath After 1 hour I started itching

Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative: Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.

Tachycardia, shortness of breath, and nausea with second dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. vitals stable. Monitored in clinic for 1 hour and then sent to ED for further evaluation. ECG normal. Patient able to discharge in stable condition.

Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, she had a COVID test which was negative. On 1/11 she had vomiting for hours after taking Tylenol. On 1/13 she still has a headache, but also SOB and body aches

Bells Palsy 1st injection on 12/20/21 symptoms started 1/7/21, 2nd dose on 1/10/21 immediate numbness in mouth and tightness in throat which triggered bells palsy symptoms immediately

Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed prednisone and Benadryl. I was diagnosed with Anaphylaxis.

12/22 Vaccine 12/23 ER. Admitted to hospital for 7 days. Dr stated was due to fluid. Radiology stated no fluid present. Couldn't breath. Pulmonologist put on 2nd inhaler. Coughing a lot. Not able to walk more then 6 steps without stopping to catch breath. *Has had 2nd vaccination on 1/13/2020

12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided weakness; transported to ER. I couldn't lift left leg, 1" off bed and couldn't do the push pull. 1-2 hours symptoms lasted. Everything went back to normal, sent home. 12/30 huge flare up with fibromyalgia; lasted couple days. Flare up occurred the following week. Getting second shot 1/19/2021

Patient monitored for 15 min after her 2nd dose of vaccine and she experienced no symptoms before leaving the clinic. She returned 2 hours later with anxiety, hyperventilation and paresthesia. Vital signs showed improvement before symptoms resolved.

itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.

respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a

Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.

428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated shortness of breath was another symptom that she had from COVID and is continuing somewhat especially when I was a mask for work - but had not put it in the first report). Chills on Friday morning in the middle of night; woke up and my temp was 101.3 and I was feeling bad all day; had headache and went back to bed. Still have pain in hip/knee and joints and those pains got really bad after the vaccine - increased. Doctor vist told me to use Ibuprofen to 3 times a day for that pain. Shortness of breath continues from Covid symptoms and so does the hip/joint pain - it has decreased.

heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization. Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER). The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.

Beginning 24 hours post vaccine I had Fever, headache, body aches, chills for 24 hours. For 36 hours fatigue. All resolved at 48 hours when mild asthma began.

Pt began complaining of itching and tingling. Made contact with patient and within a few minutes she developed a rash and difficulty breathing

Patient started complaining of tongue swelling, same as when she had an anaphylatic reaction to strawberries. Patient was given 1 epi pen at 11:07am in the left thigh at the clinic. EMS transport Patient is a 63 y/o F with h/o environmental allergies and asthma who presents to the ED via EMS for evaluation of an allergic rxn that began at 1030 today. Pt was at hospital and had just received her first COVID vaccine when she developed a facial rash and swelling to her tongue and throat. She also c/o dizziness. She was given Epi, Solumedrol, and Benadryl via EMS with improvement. Pt currently receives an allergy shot monthly for tx of her environmental allergies. She has never used an Epi pen previously. Pt denies fever.

Very sore arm Tightness in high chest, near collarbone only on right side Felt like I needed to cough but couldn?t. No true shortness of breath.

Side effects began with mild shortness of breath, mild body aches chills and fever increasing in severeity throughout the day lasting until midnight.

After approximately 8 minutes in the "after vaccine" waiting room, my tongue began to feel strange. I notified the staff and an EMT person took me to a private room. My lips, tongue and the back of my throat began to swell. I was given a Benadryl, epinephrine shot, IV solumedrol were given at the vaccination clinic. I was taken to Hospital ER. They gave me IV pepcid and observed me for a few hours until the symptoms decreased. I was discharged from the ER with a prescription for an Epi pen and instructions to use Benadryl. I will call my primary care doctor Monday 2/15/20201.

Extreme tiredness; blurred vision and mental fog; heaviness in the chest; difficulty breathing; mild headache; pain in my toes feeling like they were broken; chills; sweating. Lasted from 3-7 pm although 4-7 I was in a sound sleep but aware of the symptoms I was feeling. It was a very unusual feeling of unconscious then conscious delirium feeling.

My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours , and chest pains for 5 days and unable to lay on side while sleeping chest was enflamed, shortness of breath

Patient became nauseated and felt a swelling sensation in her throat approximately 15 minutes after receiving her second dose of vaccine. She was treated with 25mg of benedryl and 10mg of cetirizine.

Client received dose of vaccine at approx 1225. Was sitting in parking lot for monitoring. Summoned attendance d/t report of heart racing, slight SOB, "weird feeling in chest". RN and NP were called. By their arrival, pt reported s/sx beginning to resolve. At 1240 BP 100/78, HR 72. At 1250: BP 100/78, HR 80. At 1300: BP 108/70, HR 72, R 18. Pt was instructed to go home and rest. Was allowed to leave site. RN called pt at 1435. Pt reported all symptoms had resolved. Was doing fine. RN

The injection was at 10:06am. At 10:07am felt nauseated and dizzy. Waited 15 minutes before proceeding home. At 10:31am throat began to close and tongue became swollen. Lips and gums were numb. Breathing became difficult as was swallowing. Rapid heartbeat. Called 911. Pt was taken to the hospital. Administered Benedryl and possibly a steroid. Stayed overnight in the hospital.

Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vaccine). She arrived at emergency/symptoms reporting station at 1129 hours. She denied tongue swelling, denied rash, denied difficulty speaking. No rash was seen by medics either. Pt did not have wheezing or stridor. Medics on scene and student medics under the direction of Medics, placed the patient on the monitor. Her HR was stable in the 70s and her sats were 99-100% on room air, with a strong pulse and RR of 16. The pt became more anxious and demanded that someone assist her with her Epi pen administration. RN explained sxs of anxiety and sxs of anaphylaxis. Pt became agitated and again remained adamant that medics give her Epi. At 1132 hours a student medic under the direction of Medics administered the pts own epi pen to her. Vitals signs after epi were HR of 88, BP of 170/97, RR 22, sats 100% . A transport unit was called as precaution and to potentially transport. Pt appeared to have an increase in agitation as indicated by her speech with medics being short and her stating that she was "irritated" with "everyone talking", that she "can't hear everyone all at the same time", that this is just "too much" and waving her hands in the air. Pt was transported to the ER via Medics for continued care and follow up.

FELT LIKE I HAD COVID AGIAN . BODY PAIN ,FEVER , GI UPSET . SHORT OF BREATH ,FATIGUE LASTED FOR 4 DAYS

(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES. PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST. PATIENT DENIES BREATHING TROUBLE AT THIS TIME. EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM. THIS IS GIVEN AT 1034 RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED. AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM. PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF. PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS). ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD. PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING. PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR. PATIENT REPORTS SHE IS STARTING TO FEEL BETTER. PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.

10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no swelling noted to throat/lips/face. Pt's HR 74, BP 150/90. Ambulance called to scene and pt reporting improvement in symptoms upon ambulance arrival. Report provided to Paramedic, pt transported via ambulance to local hospital.

PATIENT HAD A SEVERE ALLERGIC REACTION TO THE VACCINE. A COUPLE OF HOURS AFTER THE VACCINE, SHE HAD SHORTNESS OF BBREATH, CHEST TIGHTNESS, NAUSEA AN VOMITING, FACE NUMBNESS AND TINGLING, AND HIGH BLOOD PRESSURE.

Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management. Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction. Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.

No issues during 15 minute observation period after receiving the vaccine. So I left the facility to go to my car. Then about 15 minutes later my face started to get really hot with slight swelling. Then after several more minutes throat became tight and started to experience extreme difficulty swallowing. I was still in the parking lot so I immediately went back inside to the vaccination area asking for help. I did not experience any breathing difficulties during the entire time but did experience extreme difficulty with swallowing and throat tightening. The staff did the usual checks. I was not too awarre of all the things they did but I was given a benedryl tablet which I was able to swallow thankfully. I was told my vitals were very high. Not sure of exact times but sometime shortly after the benedryl things started to fell better. The throat/swallowing started to get better. Face burning started to cool. Stayed in this area for about 20 or 30 more minutes and then told I could go with a comment that I should see my doctor about my high blood pressure. Which I explained I do not have high blood pressure and when checked later in the day it was back to my usual 115 - 125 range . I was concerned about getting the second shot later and was told to take a benedryl either just before I get the next shot or right after.?????? After checking the online cdc guidelines that does not jive at all.

Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles all lasting to 30 hours after vaccine. Itchy Rash on arm and hard sport for 4 days.

Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over, joint pain (esp. wrists & knees). Was hospitalized for 3 days 3/20 - 3/23/2021.

12:20PM THROAT 'FEELS SWOLLEN'. DENIES ANY SOB, DYSPNEA OR DIFFICULTY SWALLOWING. 12:35PM BENADRYL 50MG GIVEN PO. A/O, W/D, RESP REG WITH EASE. COMFORT GIVEN. 12:44PM STATES 'FEELING BETTER NOW'. 1:10PM SON HERE TO DRIVE PT HOME. PT TO EXIT PER W/C. NO ACUTE/OBVIOUS DISTRESS NOTED. 3-5-21 3PM TC - 'FEELING BETTER TODAY. TOOK BENADYL X2 YESTERDAY AND X1 TODAY TO BE SAFE'.

Coughing about 15 minutes after vaccine, eacalated to asthma exacerbation; given benadryl, used albuterol 2 puffs, no response. Taken to ED and given 2 duo-nebs, 40 mg prednisone, chest xray. Dischargedbhome

pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.

Pfizer-BioNTech COVID- 19 Vaccine EUA Approximately 5 minute post vaccination, patient experienced chest pain radiating down left arm, shortness of breath, and nausea. Patient also endorses numbness to left upper arm and left lower leg. Denies any wheezing, throat swelling, facial swelling, diarrhea, urticaria. Vitals: BP 104/65, Pulse 78, SpO2. On chart review, she had similar symptoms in the past with full stroke workup that was ultimately determined to be conversion disorder. Admitted for observation to rule out ACS. EKG and serial troponin unremarkable.

All over body aches and soreness, headache, heaviness in lungs with shortness of breaths, cough, and hypersensitivity on skin. Took tylenol and rested. Lasted about 4 days.

11:18 am-Patient stated she felt as though throat was swelling. Clearing throat often- she said more often than usual. Voice slightly hoarse sounding. Patient states it is more hoarse sounding than usual and husband agreed. Vital signs: B/P 150/90, pulse 75, pulse ox 98%, lung sounds bilaterally, slightly coarse sounding (pt has lung cancer), No wheezing noted, No stridor noted. 11:29 am- 25 mg Benadryl given. Monitored patient. 11:41 Vital signs B/P 154/86, Pulse 75, pulse ox 98%. No changes in lungs sounds with auscultation. 12:08pm - Advised client to proceed to ER due to current lung cancer treatment and recent prednisone. Client refused ambulance. 12:13- Patient left for hospital ER, with husband driving.

While waiting in the lot, patient stated she experienced sensation of heart racing, slight SOB, mild anxiety. Monitor called RNS and NP. Patient reported to them that s/s were resolving. Vital Signs were monitored. B/P 100/78, HR 72. RN stayed with patient for 20 minutes. Patient ambulated steadily. Denied further s/s. Left lot at approximately 1300. B/P 108/70, HR 72 Respirations 18. Instructed to continue to monitor and to seek medical attention if symptoms return. RN called patient ! 1435. Patient reported no further s/s. Also mentioned that sehhad hypothyroidism and that synthroid dose had been decreased within that past week.

Patient started to have mild queasiness about 20 minutes after vaccine was given. Within a few minutes of the queasiness, patient started to feel dizzy and nauseous. Patient endorsed feeling "not quite right". Patient was brought over to paramedics for further observation. VS taken over the course of ~1 hour prior to patient being transferred to ED. Transport occurred on date of vaccination. On post-vaccine Day #1, pt continued to endorse some dizziness. Also noted to have SOB, headache, and mild body aches with a brief episode of chills. On post-vaccine Day #2, pt still felt SOB, more upon exertion. Pt had to use rescue inhaler every 4 hours, which helped pt "breathe and relax a little bit."

Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, chills, fever of 100.2, injection site left arm throbbing, tired and weak, slight headache and nausea. Tired and weak, achy and slight headache when woke up on 3/18. Still somewhat painful to take a deep breath and injection arm painful. Tylenol 2 tablets at 8:30 am and 2:30pm on 3/18

Immediate taste in mouth. Rash on neck and face. Slight throat swelling, slight difficulty swallowing. Very faint dizziness, fatigue.

When I first got it, I felt okay, but as I was walking out, I felt disoriented and had to sit down. I was very lightheaded and uneasy. I stayed about an hour because I was scared to drive. I later got chills and fever for about 24 hours. I eventually developed shortness of breath, headaches, dizziness, tightness in my throat, bruising in my legs and painful lymph nodes in my neck and arms. One day, I felt like I was having a mini-stroke. It only lasted for a brief period and then went away. That has occurred multiple times. My doctor thinks some of my issues were due to anxiety, but I don't agree because I'm fine now.

Noted after about 15 minutes, felt "heart racing" and some shortness of breath. BP 148/98; pulse 80; p ox 98%. Monitored and gave water; able to swallow fine. Noted 5-10 minutes later, some "heaviness" in chest--between throat and upper 1/2 of sternum. Vital signs remained the same; husband with her. Continued monitoring; still with heaviness 10 minutes later--slightly less. Called Rapid Response team, heaviness improved; heart no longer feeling of racing. Patient refused ED monitoring, stayed another 10 minutes and felt comfortable leaving. Knows to follow up with provider; seek medical attention if symptoms worsen.

Patient had Pfizer vaccine 1st dose on Tuesday AM . Later that night, starting into Wednesday morning started to feel terrible - sore arm, headache, severe body aches, fever, chills, nausea. Continued through to Thursday. Pt started to feel intermittent SOB, difficulty with getting in air. This subsided after some time. NO rash, hives, tight airway, vomiting. Patient reports today feels a little better but entire body still has burning sensation. Going to Urgent care for evaluation.

APPROXIMATELY 20 MINUTES AFTER THE PATIENT RECEIVED THE VACCINE SHE DEVELOPED DYSPNEA, SUBJECTIVE DIFFICULTY SWALLOWING AND MENTIONED TONGUE SWELLING/PARESTHESIA OF THE LIPS. SHE WAS RAPIDLY ATTENDED TO; AN EPIPEN WAS ADMINISTERED IN LEFT THIGH AND SYMPTOMS PERSISTED. EMS WAS CALLED AT 5:20PM. VITAL SIGNS WERE MONITORED AND RECORDED. SHE LATER REPORTED CHEST PRESSURE; EMS ARRIVED AND SHE WAS TAKEN TO THE HOSPITAL.

coarseness, SOB, Itchy throat, swelling to the tongue, normal Vital signs and alert and oriented, hx of anaphylactic reactions given epi, Benadryl and famotidine

I started coughing for about an hour around 10pm while I was on a phone call; then developed a fuzziness in my throat and felt like I had mucus in my chest. I took 120 mg Allegra. I started to feel relief after about 10 minutes. I had to relieve my throat of mucus this morning. Other than muscular aches, especially at the site of the vaccine and behind my shoulder, I am ok. About 10 - 11 hours after my first vaccine on 2/26/2021, I developed a similar reaction, however much milder, and took Allegra, which relieved the symptoms.

Lip tingling, SOB for few seconds that resolved prior to my evaluation, feeling jittery/anxious. Vitals taking, pt reassured, symptoms resolved within minutes

racing heart.. dizziness.. felt like she was going to pass out said tongue was swelling and hard to breath

at 2 1/2 weeks after first injection had severe asthma attack that caused right posterior chest pain, fatigue, chills- increased use of albuterol with nebulizer 3 times per day

chills, extreme fatigue, severe sore throat, shortness of breath rhinorrhea, cough that lasted more than one month

Received vaccine on 1/10/21 and 2/21/2021. Tested positive for covid on 3/02/2021. Admitted to hospital on 3/23/21 for difficulty in breathing.

10 minutes after receiving vaccine pt reports throat swelling and hoarse voice. Mouth assessed, no swelling noted to throat/lips/face. Pt's HR 74, BP 150/90. Ambulance called to scene and pt reporting improvement in symptoms upon ambulance arrival. Report provided to Paramedic, pt transported via ambulance to local hospital.

After receiving second dose of COVID vaccine, patient began experiencing swelling of face and throat and was taken to ED. Patient reported having similar reactions to vaccines in the past. Patient received 20mg Pepcid PO BID, Loratadine 10mg PO once, and prednisone 50mg PO once in ED and had subsequent resolution of tongue pruritis and improvement in throat tightness. Was discharged with prescription of prednisone.

Within 2 hrs of Pfizer covid injection I developed chest tightness with difficulty taking a full breath. Significant substernal chest pain radiating to between shoulder blades. Sent to ER around 6:30 pm. Cardiac ez troponin negative, CBC, BMP normal, 2 12 lead EKGs normal, CXR normal. BP and HR slightly elevated but stable. Acetaminophen 650 mg po given. ER physician dx vaccine adverse effect.

She had the vaccine on 01/07/2021 afternoon. Then morning of 01/08/2021, she had acute onset of hypoxia/dyspnea. This lasted for several hours requiring supplimental oxygen and clinical monitoring. It subsided without other intervention.

Throat swelling, tongue tingling Narrative: Code 99 called to the second floor auditorium where this simply received her second coronavirus vaccine. Approximate 10 minutes later she developed tightness around her neck and her tongue started to swell. No chest pain or shortness of breath. No rash. Didn't have a problem with her first vaccine. Epinephrine 0.3 mg 1M and Benadryl 50 mg 1M given. The patient started to feel better. Tip of the tongue was slightly swollen and red. Patient spoke in normal sentences. No stridor. Appears well and resting completely in the wheelchair. Brought to the emergency department for further evaluation and observation. ED provider note: 62 yo FEMALE w/ Wo multiple medication allergies p/w possible allergic reaction. Pt recieved her second covid vaccination today @ approxately 1330 and reports nearly inmediate onset of sensation of "like a pill is stuck in your flu-oat" and feeling like her throat was swelling. Then states that she developed an abnormal sensation on the tip of her tongue described as tingling and swelling. Denies any n/v, abdominal pain, sob or difficulty breathing. Pt received 0.3 mg of 1M epi as well as 50 mg of 1M benadryl. Pt observed in ED for 6hrs,She was given steroids and Pepcid in the ER. She has an EpiPen at home due to an allergy to bee stings. I told her that while a recurrence of her reaction is she should pay close attention to any new or worsening symptoms and return to the ER immediately for chest pain, shortness of breath, oral swelling, GI symptoms, or any other new symptoms she develops that she is concerned about. She expressed understanding of this plan. She was given a short course of steroids and instructions for scheduled Benadryl for the next 24 hours. Other Relevant History.

fatigue, body aches, congestion, shortness of breath- appear to be typical response. Refill inhaler at this visit and follow up as needed

Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Swelling of the injection site, jaw spasm, high blood pressure-Mild, Systemic: Hypertension-Mild, Additional Details: Patient started to have swelled injection site arm after about 30 minutes of vaccination but patient remained responsive. 11:40pm - BP 198/100, HR 72. 12pm- BP 198/100, HR 72 & complained of dystonia symptoms so we called 911 paramedics came within 5 minutes. 12:15pm- BP 240/110, HR 72. Called patient's daughter at 2:01pm (patient still in the ER), at 3:16pm (left message to voice mail). Patient did not mention she has history of dystonia after getting any vaccine when asked prior to vaccination

Patient is a 63 yr/o female who presents to the emergency department complaining of dizziness since 0400 this morning. She endorses nausea, vomiting, and headache. Her symptoms are worse with position changes. She states that she has a hx of vertigo with her last episode being 11 months ago. She states that she does not normally have a headache with her episodes of vertigo, but today she developed one. Denies chest pain, sore throat, visual disturbance, or diarrhea. She reports chronic shortness of breath. She is a former smoker. Denies alcohol use. No other complaints at this time.

Fatigue within 24 hours--as expected. Sunday, March 28, bronchial type cough with lung pain, and pain between shoulders. I hope this is just my frequent bronchial response to allergens, but given the proximity to the vac I am reporting. I added guafinessan every four hours at 9 a.m. on March 28, 2021, and am taking it every four hours. It is not lasting a full four hours. I plan to add albuterol, which I have for PRN usage.

She got the vaccine, went home and noticed soreness in her arm and rash. During the night she had chills and fever, hard to breath as if she had the flu. She did not take anything as she is allergic to too many things. She is still having the rash on her arms, it is not sore anymore, but is going to contact her doctor.

about half an hour after injection flushed blurry vision racing heart gasping for breath felt like I needed to crawl out of my body twitches went to urgent care received a shot of Benadryl and stayed under observation and sent home Dystonic reaction

pt. c/o feeling little tightness on her throat. She is able to swallow. seems anxious resolving. Hx - anxiety

Received the Covid-19 vaccine. She reports symptoms of Other: Shortness of breath and "feeling funny.". I have observed patient feeling anxious and uncomfortable. Treatment/intervention /vitals taken: B/P 124/82, pulse 104, RR 16, Oximetry 98%. Recheck p- 82, oximetry 100%. Lungs were clear bilaterally. Patient stating that she was feeling much better. Offered her water to drink. Staff remained with patient until she was feeling comfortable enough to leave. When leaving, she stated that she was fine and needed no assistance. Ambulatory.Agency report submitted: yes Agency Report number:

Noticeable lung tightening within 10 minutes of shot. Cleared within the next 10 minutes. Noticeable but slight shortness of breath for the next 2 days, followed by sharp lung pain in the right lung on day 3 which lasted for about 2 hours, then subsided and there were no more issues.

I went to urgent care on my way home about 20 minutes after receiving the vaccine because I had difficulty breathing and was turning red all over. They took my vitals and then gave me an epi shot, connected an IV with steroids and antihistamines. They called an ambulance and I was transferred to the ER of the nearest hospital. The doctor administered more prednisone and antihistamines. I was released after about 5 hours. Got prescriptions for prednisone, antihistamines and an epi pen. I am still experiencing redness, headache, nausea, chills , mild shortness of breath today.

She waited at the stadium for mandatory 15 minutes after the vaccine. On her drive home, she developed numbness and swelling in the back of her throat. She had difficulty swallowing. She had no difficulty breathing. She monitored the symptoms and they resolved after two hours. She then had some tachycardia and headache later that day - resolved as well.

breathing issues, tightness in chest, fatigue, joint pain, fever, chills,, migraines all lasting more than 4 weeks.

Pfizer COVID Vaccine EUA Patient received 1st dose of Pfizer vaccine 3/11/21. 3/27/21: Patient is a pleasant 63-year-old female past medical history of anxiety, documented history of hyperlipidemia came in from outside facility with complaints of dyspnea, COVID-19 pneumonia, bradycardia. Clinical picture started on the 17th patient tested positive for COVID-19 at that time was having symptoms myalgia, subjective dyspnea reportedly went to the emergency department, saturations were good she was discharged home with conservative measures. At home became more symptomatic and pulse ox was measuring in the low 80s so she went back to the hospital and was admitted to Hospital on 03/25. Per records patient was started on Eliquis, dexamethasone, azithromycin, remdesivir, p.r.n. Tylenol, p.r.n. Zofran, p.r.n. Toradol along with supplemental oxygen. Oxygen requirement was 5 L at the facility. However overnight and prior to arrival providers at outside facility started noticing bradycardia patient's heart rates were dropping into the 30s. Patient was asymptomatic during these episodes not complaining of any lightheadedness or chest pain. Reportedly cardiologist saw patient QT and QTC were reportedly appropriate recommended monitoring. However overnight heart rate continued to go down into the 30s, reportedly on telemetry was noted to be developing Mobitz 2 second-degree block, patient was administered atropine x2 and heart rates improved to the 70s however a year started going down again to 30s and 40s after a couple of hours. Outside facility requested transfer to another hospital for further management and possible EP intervention. Bedside patient is lying comfortably in bed currently denies any lightheadedness, dizziness, chills, fevers, nausea, vomiting, diarrhea, chest pain, palpitations, paresthesia, swelling of extremities. Though is she gets winded after exertion, is okay/comfortable on supplemental oxygen at rest. Patient was increased to 8 L during ambulance ride, was id saturating however medics increased because of bradycardia. Otherwise denies tobacco, recreational drug/marijuana, over-the-counter/herbal medication use. Social consumption of alcohol will have 1-2 beers a year. She reports sick contact 1 of her close friends was diagnosed with COVID earlier this month, husband also positive. She reports she received 1st dose of COVID-19 vaccination around the 10th or 11th of this month 1 day prior to known exposure. Otherwise no medication changes is only on sertraline. Currently no antihypertensive medication or rate-controlling agents. 4/1: Patient was admitted after developing significant bradycardia after receiving remdesivir for COVID-19 pneumonia. Remdesivir was held and patient received convalescent plasma on 03/28. Dexamethasone was started at the outside hospital on 03/25. With also completed 5 days of empiric doxycycline and Rocephin. Patient CRP and D-dimer were followed and trended down at the time of discharge. EP Cardiology was consulted and initially the patient was on dopamine for the 1st 2 hospital days. Was able to be stopped and the last 2 hospital days the patient had no bradycardia. She will have a Holter monitor as an outpatient. Patient wore her BiPAP at night. Oxygen requirements trended down and was able to be on room air at the time of discharge. Home O2 evaluation was performed and did not require oxygen. She will continue on 5 further days of Decadron 6 mg daily. She will follow-up with her PCP.

Within 15 seconds of second Pfizer CV19 vaccination, given at appropriate interval from 1st dose, patient experienced cough. I noted that the patient coughed as she exited the vaccine area to the observation area that was manned by a Registered Nurse. The RN came to the vaccine area to ask me to help with the patient while she waited in the lobby with another RN. The patient was sitting in a chair, flushed, distressed, experiencing shortness of breath and repeatedly coughing. EMS was already called. I pulled up 0.3mg of epinephrine which was administered IM in the right lateral thigh and 25mg of diphenhydramine 25mg which was administered IM into the upper left deltoid, the opposite arm from the vaccination. EMS arrived and took the patient to the emergency room approx. 1 mile from the clinic. She received methylprednisolone 125mg IV, famotidine 20mg IV, and nebulized race-epinephrine upon arrival. She was discharged home with prescriptions for prednisone 20mg daily x 5 days and an Epipen.

She got the vaccine, was fine within the 15 minutes and while driving home within 10 minutes her neck, arm and chest got extremely red. She went numb around the mouth and lips and her throat felt like it was closing up and itchy. She was able to breath ok and took Benadryl for a couple of days and then had a really bad rash, small that covered her entire chest, stomach and back, but they were little prickly-heat looking rash. The rash cleared after 5 days of taking the Benadryl. She was also taking a steroid cream at that time that she had been given by a dermatologist in the past. She called her doctor and informed him of the reaction and he informed her that she should not take the 2nd vaccine due to her reaction unless she felt that maybe something else triggered the reaction.

Dizziness and shortness of breath for 10 minutes, dissipated, then came "whoosing" back for 5 minutes, 3 more times over the next 40 minutes.

First day a little sore arm,(Monday) The second day was BAD.(Tuesday) As the day went on it got worse. That evening I did not sleep all night. I was having very intense throbbing pain from my wrist, up my right arm (same arm as the shot was given), up the right side of my neck, pain down my right side of my back and into my lung area. The pain just spread until it was on a scale of 1-10 it was an 11. It also spread to my lower back. The next day,( Wednesday) I still had all of the pain. Thursday I just have soreness in my upper shoulder blade area. This was very scary! I even took some aspirin incase of blood clotting. Tylenol did nothing. If I would have had a very strong pain pill I would have taken it. Now I am afraid to get my second shot which is scheduled for April 26th. I need some guidance from you on this.

We didn't adminster the vaccine at our location, however, she alerted us of her reaction that started immediately after getting vaccine: Per patient:"I had a generalized reaction. My face swelled, turned red, got hot; my throat had some swelling; I had to remove my mask to breathe. I had to stay an hour and a half before they would let me go home. My face swelling diminished over the next 24 hours."

pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.

Reported mild shortness of breath like having symptom of asthma. She has a history of asthma but not active prior vaccine. BP- 157/87, O2sat- 97%, PR-62- regular rhythm

Patient got an instant reaction after receieving the vaccine. She had an anaphylactic reaction, she stated throat swelled up and couldn't breathe, BP was elevated and she started to experience hot flashes. Pain at the injection site. Patient took a benadryl and about 20 minutes later the symptoms started to subside. No c/o fever, headache, n/v. As of 4/8/21 @12pm patient is not experiencing any symptoms only slight pain at the injection site. No medications were taken as far as Tylenol/Ibuprofen. 4/11-Follow up call -Patient feeling better but is apprehensive taking second vaccination due to anaphylactic reaction from first vaccination, even though she is aware that it is not recommended. No signs and symptoms at this time.

I have been hurting constantly since my 1st vaccine on March.23,2021...For a couple of days afterward I had achy flu-like symptoms all over my body which seemed to subside by days 3 & 4, Then I started having shooting pains between my shoulder blades that felt like I was being stabbed. My flu-like aches sky-rocketed until I had to start sitting perfectly still - any movement at ALL caused me wrenching, agonizing pain. I thought I might be having a heart attack! I went to my Doctor - on Monday. My BP was really good, my heartbeat was strong, my lungs were clear except for a touch of wheezing due to asthma, etc. Right after this visit I got in my car to drive home, and I could hardly move! Same thing happened last week after a GYN appt... Could hardly drive home! Two weeks ago I came home hurting with acute pains and I was laboring to draw my breath... Then the pain was so strong that I had to sit it n the same spot for 3 hrs unable to move!

Immediately raised heart rate to 90+bpm, GI nausea, shortness of breath. 50mg Benadryl within 10 mins of vaccine. After 25 mins of Benadryl 79 bpm, shortness of breath decreased. Rash on legs after 30 mins vaccine. Later in day rash/itching on both arms/torso. Aggressive arm rash/itching on both arms for 4 days requiring 50mg/4hour Benadryl. Day 5 50/mg 6 hours. Day 2 only great fatigue. Day 3 thru 5 "covid fingers" with symptoms ranging from red finger tips, red nail area, purple fingers to knuckle area and bright red palms. Day 6 no symptoms and no longer on Benadryl

Pt rec'd Pfizer COVID vaccine @1457. At 1522, Pt c/o feeling dizzy, heavy chest, and SOB". VS WNL. Reports Hx asthma, states current s/s "unlike asthma attacks which she gets every spring when the dogwood's bloom and which she feels in her throat". Takes daily Allegra which she did not take today. Reports Hx reaction to shingles vaccine with arm swelling and throat swelling. Has epi pen with her today. Pt monitored for 30 min post vaccination per risk assessment and 15 extra minutes. VS remained WNL and pt reported her SOB resolved and dizziness remained. States she "remembered she just started new doubled dose of duloxetine last night".

04/14/21@0816-Call received from, MA to birng emergnecy med kit. Emergency Med kit obtained, noted pt with stridor and gagging. Epi-pen 0.3 mg immediatley administered IM anterolateral. Called, RN for assistance. Pt's O2 sat 92 % room air pulse 128. O2 4 LPM given via nasal cannula until airway cart in then pt placed on O2 8 LPM via non-rebreather. IV started to left AC with 20 gauge insyte. 911 called by staff. 0820- Solumedrol 125 mg IV given, flushed with saline 0824-Benadryl 50 mg (diluted with 5mL saline) IV given then flushed with saline. Ambulance arrived report given and pt transported to the hospital. Pt's stridor gone after administration of medications. O2 decreased and pt put on nasal cannula by ambulance staff.

Trouble Breathing Blood Pressure spiked to 170/110 Lightheaded Confusion Slept from 6pm Friday after the shot till Monday morning @ 7am. Awake for short period of time 2 or 3 hours intervals Night sweats and bad dreams Left arm never hurt at all Neck pain on left side Pain moved to my back Entire body aches and soreness Trouble seeing clearly Today - Thursday April 15th I am feeling much better this afternoon Blood Pressure back down to 134/78 All other symptoms have subsided

Lyme symptom flare up including, fever, swollen throat/lymph glands/parotid glands, headache, eye ache, joint inflammation, nausea, malaise, dizzy, lightheaded, shortness of breath. Came on within the first two days, left me bedridden for 5 days. Ran low grade fever off and on and symptom flare ups for the next 20 some days until I began to feel better. Went in to get scheduled 2nd vaccine and was turned away. Asked to return with epi pen in hand and feeling strong.

has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart rates; She'll have a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night.; When probing for specific event information she reports it's kind of like she coughs a little more and she is a little more short of breath and it's happening more often; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 63 years, via an unspecified route of administration on 27Mar2021 04:06 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included asthma, hysterectomy, dark chocolate or red dye (she starts coughing and has an allergic reaction and shortness of breath), bursitis (in her right). The patient's concomitant medications were not reported. The patient previously took penicillin, experienced allergy and had really ad hives (several years ago) she was given a cream to put on. She had to get another medication and she doesn't remember the name. That medication made her dizzy and she couldn't even get out of bed so they had to half the dosage. When she had her hysterectomy she learned she couldn't take any types of "cillins" medications. The patient had been watching her heart rate with a device and since getting the Covid 19 vaccine she's noticed her heartrate was always higher than it normally is. Her heartrate was going crazy, the device was not recording right. She reports that for the last 2 days the device has been telling her she has possible atrial fibrillation. This is worrying her. She doesn't feel anything different. She was usually hyper. Her resting heartrate was higher. Normally her resting heartrate was in the 80s (beats per minute) Now it's going up to the 90s (beats per minute) then her heartrate drops to 40 something (beats per minute) Then the device said her heartrate was 118 and 107 and she's not even doing anything. She hasn't even worked out yet. She doesn't like to take medicine. Medications don't work out with her. She had a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night. It was reported that she feels fine. She has no other symptoms. She's been reporting online. Clarified she's reporting online through the V check through the CDC. She's been trying to get the Covid 19 vaccine forever. She did research on all the Covid vaccines and she felt more confident with the Pfizer Covid 19 vaccine. Her daughter was against the Covid 19 vaccine. Her daughter thinks the vaccine was just going to kill her. She reports she was healthy and she works out 6 days a week. She recently tried to get a CT scan for her heart. Her husband's cardiologist recommended her husband have a CT scan of his heart and she decided she needed a CT scan too. She's also watching her heartrate on her watch. Her husband's heartrate is completely normal and stable on the device so she knows the device isn't messed up. It was also reported that the device will tell her she has too much muscle movement and she's standing completely still. Then she'll get the device to record her heart rhythm and it goes sporadic. The device tells her 90 beats per minute at resting then over 100 beats per minute. Her heartrate on the device was going up and down a lot. When she's been watching the device record her heart, it looks like it's going crazy. Her heartrate goes way up and way down like in the 40s (beats per minute) She noticed when her heartrate is in the 40s (beats per minute) and she's never had her heartrate go down that far, it's really really weird. She thinks maybe she'll get back to normal. She keeps watching hear heartrate. She reports she noticed her heartrate right away on Saturday evening after she received the Covid 19 vaccine. Her heartrate was higher than normal for resting, it was in the 90s (beats per minute). Her resting heartrate is usually in the 60-80s (beats per minute) and it was the in 90s. Now the device says possible atrial fibrillation. It was further reported that she received the Covid 19 vaccine in her left arm because she has bursitis in her right. If she hit her arm the second day after the Covid 19 vaccine, her arm would hurt. Her arm felt better the next day. She clarifies, on Sunday, 28Mar2021, she noticed her arm felt like a bruise and that was it. Then the next day on Monday, 29Mar2021, the feeling was gone. She didn't have any redness. The outcome of the events her arm felt like a bruise and arm would get hurt was recovered on 29Mar2021, irregular heart rates, dyspnea, cough was not recovered and unknown outcome for has possible atrial fibrillation. Information on the lot/batch number has been requested.

Patient received vaccine and 5 minutes later started hyperventilating and saying she experienced chest pressure. Daughter stated that patient had history of anxiety attacks. Nurse coached patient with breathing exercises and patient stated she felt better. Medics on the scene took vitals at 1037, blood pressure was 174/79. Patient signed Medical form.

developed blood clots in lungs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: CP6955), via an unspecified route of administration into the left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Patient was not pregnant. There were no concomitant medications. The patient previously took amoxicillin and experienced drug allergy. The patient developed blood clots in lungs on 27Mar2021 09:45. The patient was brought to the emergency room and was hospitalized for 3 days. The event was reported as life threatening. It was also reported that the patient was given treatment (unspecified). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 27Mar2021. Outcome of event was recovering.

throat tightness; axillary node lymphadenopathy; myalgia; fever/a high fever of 103; chest wall erythema; This is a spontaneous report from a contactable physician. A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER8727) as SINGLE DOSE for covid-19 immunisation. Medical history included leukaemia, seasonal allergy, anaphylactic reaction, drug hypersensitivity. Concomitant medication(s) included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma from an unspecified start date and ongoing; azelastine hydrochloride, fluticasone propionate (DYMISTA) taken for hypersensitivity from an unspecified start date and ongoing; dasatinib monohydrate (SPRYCEL, NDC: 0003-0524-11) taken for chronic myeloid leukaemia from 2013 to an unspecified stop date; spironolactone (SPIRONOLACTONE) taken for fluid retention from 2017 to an unspecified stop date; mirabegron (MYRBETRIQ) taken for hypertonic bladder, start and stop date were not reported and unspecified medications for leukemia. The patient previously received Epipen for anaphylactic allergies to foods, drug, and environmental allergies. Caller was calling about the Pfizer BioNtech COVID vaccine. She has had a plethora side effects since her second dose 24Mar2021. It all started with chest wall erythema then it moved to axillary node lymphadenopathy the she got a high fever of 103 and then there was myalgia all across her torso, abdomen, and and upper back, she clarifies her trapezius area. She confirmed on 24Mar2021 the chest wall erythema began that afternoon, 24Mar2021. Axillary node lymphadenopathy began Thursday, she confirms 25Mar2021 ongoing improved. The fever began Wednesday, she confirms 24Mar2021 and it was still ongoing. Yesterday she woke up and it was 103 today it is a bit better, it is 101.2. She confirms today it seems to be improved a bit but yesterday she was taking hand fulls of Ibuprofen to try to get it down. The myalgia she noticed Thursday 25Mar2021 and it was ongoing, it was some what improved. She has environmental allergies. She had some throat tightness the day of the COVID vaccine that dissipated late that afternoon and that was for both doses. She carries an Epipen because she has food, drug, and environmental allergies. She has had anaphylactic allergies to foods. She clarified she was far from needing to use an Epipen with the her doses of the COVID vaccine, the throat tightness just dissipated. She does not think an Epipen would have helped a fever and body aches anyway. She said she takes Spironolactone for fluid retention from the Sprycel. She tried to look up to see if there was any interaction between the vaccine and Sprycel but she couldn't find any thing. Her husband was in the pharmaceutical industry as well and they have looked up available information of duration of side effects and they couldn't fine anything and she was just surprised that after 4 days of it she was still waking up with fever and still having myalgia. She was wondering if the agencies had reported or maybe they have not unmasked any data yet of duration of things reported that are listed. It just seemed extremely unusual. Caller reported fever after her second dose of the Pfizer BioNtech COVID 19 vaccine. She said yesterday she was taking hand fulls of Ibuprofen to try to get the fever down. Today the fever was a bit better but it was still ongoing. The outcome of the event fever, myalgia were not recovered, chest wall erythema was recovered on 27Mar2021, throat tightness was recovered on an unspecified date and axillary node lymphadenopathy was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Tightness in throat, difficulty swallowing. I took 1 or 2 capsules of benadryl 25mg and symptoms gradually subsided.

HEADACHE,WEAKNESS, NAUSEA, CHEST PRESSURE LASTING 4 DAYS UP TO AND INCLUDING TIME OF ER VISIT. ALSO COMPLAINED OF DYSPNEA ON EXERTION.

SOB AFTER VACCINATION, DAUGHTER STATES HAS HX OF RESP ISSUES, AND HAD SAME S/S WITH 1ST DOSE. NO OTHER S/S TO SUGGEST V-V REACTION OR ALLERGIC REACTION PER ON-SITE MD. VSS EXCEPT ELEVATED BP DURING OBSERVATION. ESCORTED TO EXIT WITH NO ISSUES AND S/S RESOLVED OTHER THAN INCREASED BP, WHICH INSTRUCTED TO MONITOR WITH HOME BP CUFF AND SEEK FURTHER EVAL/TREATMENT IF UNRESOLVED/WORSENED. 1122 INITIAL BP 167/91 HR 74 SATS 100% RA 1132 BP 162/85 HR 79 SATS 100% RA 1137 SITTING BP 157/96 HR 74 SATS 99% 1142 STANDING BP 162/106 HR 75 SATS 99%

Tachycardia, dizziness, tinnitus in both ears, back of hands itch, low-grade fever, chills, SOB, PEM, Runny nose, Miialgia, Feels like moderate to severe COVID infection.

I'm very worried my reaction could be worse after the 2nd shot-----+++In the past Ive had anaphylaxis to Cat Scan Dye- symptoms were immediate nose, ear blockages, hoarse voice, felt like breathing through a straw, chest tightness. ***on day of 1st shot I waited for 30 mins, felt fine. Within 2hrs of shot, while I was home I experienced throat tickling/itchiness, one side of my nose felt the same, and the other side ear felt stuffy I took a benadryl and used my inhaler, while I have prednisone I didn't think I was suppose to take it after the vaccine, so I did not. The symptoms didn't get worse Spoke with my dr., we did a conference call with cdc, they couldn't tell me to get the 2nd or not, said to contact VAERS

Since day 3 after the vaccine I have had cramping and twitching in arms, legs, feet, hands. Since Day 7 I have had a tremor in my neck and face. At times my throat /neck feels like it is swollen. I have had tinnitus since about Day 7. I have had no treatment. Drs. do not know what to do.

Reporting Per EUA Covid 19 positive, admitted to hospital, transferred to higher level of care after 3 days for respiratory failure

4/21/2021 Patient was observed post Covid-19 immunization for 15 minutes . During the observation period, she experienced an adverse reaction with the following symptoms: swelling of face and throat. Assessment : Time of assessment 1445. Swelling of lips and nose. Actions taken: Vitals sign taken EMS called at 1520. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 1530. VS at 1445- BP- 144/90. P- 101, O2- 99% VS taken at 1506- - BP- 165/88, P- 84, O2- 100%, Medications administered: Diphenhydramine (Benadryl) 25 mg capsule, by mouth. Time: 1445 and 1507. Administered by RN x 2 doses. Disposition: 911 called and patient was evaluated, she refused transport to hospital by EMS, she reports that husband will transport her. Observation time increased to 30 minutes Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 2:08 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735

Patient received vaccine at 08:30. Patient waited 30 minutes, exited the building did not leave site. patient returned to clinic at 09:10 with complaints of "feeling like her throat is closing". Dr. assessed patient, Dr. gave Epi 0.3 auto inject right thigh at 09:16 am. EMS was called at 09:23 am. RN gave 50 mg Benadryl IM left deltoid at 09:30 am, EMS arrived at 0930. Patient was alert and orientated talking to EMS. Patient and EMS left Facility at 09:37am. VS 98% RA, 155/66, Pulse 79, RR 18-20. Patient Stated she had a reaction after first dose at home, she

about a month + I got Covid as did my daughter and her kids and it came from my other grandsons daycare Shortness of breath Extreme tiredness Wheezing Cough

mild asthma attack 10-15 minutes after shot while waiting in store. Light headed and richness in my chest. Used my levalbuterol inhaler, which resolved all my symptoms within 15 minutes.

Same day mild symptoms of pain at injection site, numbness on tongue and facial area; Day 2 symptoms mild fatigue, muscle pain in extremities and headache; Day 3 symptoms more severe headache and fatigue; Day 4 symptoms dry cough and neck pain; Day 5 feverish, neck pain, cough, shortness of breath, night sweats; Day 6 worsening cough and shortness of breath...went to urgent care facility; Took Tylenol each day but little to no relief

her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient). A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation. Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported. On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient with chills and wheezing. Pt says she is a very active person and doesn't like to sit down. The patient was brought back to the provider tent and examined. BP 154/93 P 73 RR 18 PO2 99% RA. Patient was provided water and cookie but refused.

Patient experienced progressive facial palsy and ophthalmoplegia, respiratory failure requiring intubation. possible diagnosis of Guillain-Barre syndrome, likely Miller-Fisher +/- Bickerstaff variant. Still in hospital

Fever of 102, 101, 100; chills; body aches; headache; severe cough; Sore arm at injection; shortness of breath; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EP7533/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 09:45 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6204/expiration date: not provided), via an unspecified route of administration, on 12Mar2021 at 09:30 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included hypertension and hypothyroidism. The patient had known allergies to hydromorphone (DILAUDID). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 at 18:00, the patient experienced fever of 102, 101, 100, chills, body aches, headache, severe cough, sore arm at injection and shortness of breath. The patient did not receive treatment for the events and did not require hospitalization or a physician's visit. The outcome of the events fever of 102, 101, 100, chills, body aches, headache, severe cough, sore arm at injection and shortness of breath was not recovered. Since the vaccination, the patient had not been tested for COVID-19.

First Day: Slight pain in arm. Slight headache. Second Day: Very tired. Slept most of the day. Third Day: Woke up with a bad back pain. Felt tired. Around 2:00 pm had a severe stabbing pain in back. The pain went to ribs and then right lung. Took Tylenol and rubbed CBD oil on back. Pain subsided in 30 minutes, but hard to breath deeply. The rest of day had less severe stabbing pain in lung off and on. Fourth Day: Very tired , light headed . Pain in right lung when breathing deep. Oxygen saturation was low when walking around. Brain fog. Feel uncomfortable. Fifth Day: Only slight pain in lung when breathing deeply. Feel much better.

I got Covid 19 several weeks after my second dose and I?m having lingering effect of extreme tiredness and shortness of breath, wheezing. Made the effects of my chest tubes worse. No appetite

Pt reported ear pain, nausea, and dizziness, along with chest congestion ("inflamed" per pt) feeling and cough. Pt stated she "feels like her wind pipe is inflamed." Feels SOB, eases some when she coughs. Pt was instructed to go to the ED on 5/5, where she was found to have oxygen saturations in the mid 80% range. Pt was diagnosed with "pneumonia due to COVID-19 virus" and admitted.

her head felt tight, it was not a not clear headache, her head head was like if someone blew up a balloon, tight tight tight in her head.; body ache; had a little bit of vertigo; She was miserable/ feeling was unknown, strange, an unusual sensation; So so sick, she thought she was going to die/ feeling very sick; strangely tired, unusally tired/ exhausted/ all tired; arm was hurting a little bit; Lightheaded/ dizzy/felt like she was going to faint; feels that she was missing air, she couldn't breathe well; Nausea/ badly nauseous, wanting to thrown up really bad; body was freezing, she started to feeling like her blood was going away, she felt like she was frozen; she was shaking; felt like her head was going to explode; she threw up bile; she has no strength of anything, she couldn't even move her hands/ couldn't move; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6205) via an unspecified route of administration, administered on the right arm on 12Mar2021 14:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She said she was so so sick, she thought she was going to die, it happened the next day 13Mar2021, exactly 24 hours after getting the shot. She got the shot 12Mar2021, the next day 24 hours after exactly was when she got sick. Caller reported that right now, she doesn't feel sick, but there were days when she felt strangely tired, unusually tired, but she was normally a very high energy person. On the 13Mar2021, she felt good, her arm was hurting a little bit, she felt herself, she went to do her errands, and while she was in the supermarket, that was when she started to feel lightheaded. There were moments when she still feels lightheaded. So that day she finished her shopping, she decided she was not going to continue, she just got a couple of things, and she directed herself to pay because what she was feeling was unknown, strange, an unusual sensation. She felt that something was not right. She went to car, drove, all of a sudden, halfway, about 10 minutes before she got home she felt that she was missing air, she couldn't breathe well. Everything started at 2:30 pm, and she knows that because the shot was given to her 12Mar2021 at 2:30 pm. Then immediately she started to get dizzy, nausea, badly nauseous, her body was freezing, she started to feeling like her blood was going away, she felt like she was frozen, she was shaking, she got to the parking lot by a miracle and she was doubting how she was going to get home, she felt like her head was going to explode. All this time she was having these symptoms, she was wanting to throw up really bad. She was frozen, and doesn't know how she made it home, she lived on the second floor, she got straight to the bathroom, she felt like she wanted to throw up so bad, she tried and tried, nothing come up, she felt like she was gonna die. Finally she threw up bile. She had no strength of anything, she couldn't even move her hands, she was holding herself by the toilet, she laid down in the bathroom, she felt like she was going to faint. She didn't know if she was going to die or faint, she took a deep breath, laid down in bathroom, couldn't move, and then later on she crawled to her bed. She was able to crawl, but every time she moved, everything was moving around her, she was extremely dizzy, no strength, she says thank god her bed was very low. She called her son and she told her son that she was feeling very sick. Her son said he was going to call the number, he is a nurse, call these number so they can tell you what you can do. It was some number to call if someone was having a bad reaction from the shot. Her son told her that she was supposed to feel this way. She wondered how could that be. Patient stated that her son told her that feeling would pass in couple hours, and to just rest. Her son was checking on her every 10 minutes, every 20 minutes, and then she fell asleep for 3 hours. When she woke up, she was not feeling so bad anymore but her head felt tight, it was not a not clear headache, her head was like if someone blew up a balloon, tight tight tight in her head. At that time, when she woke up, it was almost 11pm, and she was feeling just a little tiny bit better. So she moved her feet, she wondered if she could make it to the refrigerator to get water? She got to fridge, opened it, smelled food, went to bathroom to throw up again. She says also, her body aches. She was miserable that day, 13Mar2021, and after that she exhausted for about a week, she was lightheaded, had a little bit of vertigo and was all tired. She went to bed early because she was exhausted. She was scheduled to get second dose on the 2nd. She was going to talk to her doctor. She will definitely call her doctor but she wanted to know why she got this way. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events did not require a visit to emergency room and physician office. Outcome of the event arm was hurting a little bit recovered on 15Mar2021, while unknown for the other events.

Patient presented for 2nd Pfizer vaccine at 1010 today. After administration of vaccine she was waiting 15 minutes in the waiting room and started to feel that her throat was swelling, heart racing, and felt "weird". The patient was brought back into the exam room to monitor. Vitals were blood pressure 144/80mmHg, pulse 71bpm, O2 99. The patient was given water to drink and applied ice pack to back of neck. Retook vitals: blood pressure 134/78mmHg, pulse 78bpm, O2 99. Patient was observed until 1030, offered Benadryl 50mg IM per provider, patient declined, and went to waiting room to wait another 15 minutes. After a few minutes in the waiting room the patient decided to have the Benadryl 50 mg/mL IM injection, given at 1050. The patient then proceeded to have increasing chills, numbness on the left side of the face, and "felt weird". EMS was called per provider the provider to transport to the emergency department. While in the emergency department, the patient received famotidine 20mg IV push once, methylprednisolone 60mg IV push once, and sodium chloride 0.9% 500mL.

incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was tingling; she thinks that it was the beginning of anaphylactic reaction; she was just tired; type 1 hypersensitivity; a little soreness; It was like heaviness on her chest; having trouble breathing; allergic contact dermatitis; This is a spontaneous report from a contactable consumer (patient) and a physician. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 10:00 (lot number: EP7533) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing nickel allergy for decades which was under control and panic attacks. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, it was reported that the patient didn't have any of the normal side effects such as fevers or chills but she was just tired and went to sleep early that night. She woke up on 15Apr2021 at 05:00 with incredibly horrible itching under her Fitbit that she wears to bed. She has a history of nickel allergy and she bought this particular Fitbit on purpose because it doesn't have any nickel in it that touches her skin and she has had no problems all year with the Fitbit. The itching was unbelievably bad and when she took the Fitbit off she had a horrible whelp under a tiny piece of metal that isn't even supposed to touch her skin. She thought well if it has exacerbated her nickel allergy then maybe it is doing something else to her body. On that day (15Apr2021), she thought that she had a panic attack and upon reading some information online, she thinks that it was the beginning of anaphylactic reaction because the symptoms are the same. She was thinking that the vaccine is doing something with her nickel allergy. It had used to be bad until she got it under control and she had it under control for many years. But with the things under the Fitbit she was blaming or associating it with the COVID vaccine so she took it off and then finally fell asleep again. But when she woke up in the morning, just a few hours later (15Apr2021), the bad whelp was still there and then her lips had started swelling and her tongue was tingling so she decided to look some more on google and she thinks that this is another version to an allergic reaction. She has had panic attacks before and she knows what they are now and she has learned through a therapist on how to get past and manage them but this was different for her. It was like heaviness on her chest and it felt like something was on top of her chest and she was having trouble breathing; both on an unspecified date in 2021. Her husband knows when she has a panic attack but this one was different she can't really explain it. She asks, what is the difference between a panic attack breathing and this type of breathing and later mentioned that she also had a little soreness (2021). In addition, the physician also called to report that this patient was complaining about 2 types of symptoms. The first was more an allergic contact dermatitis (2021) which the physician is not worried about. The second was lip swelling and tongue tingling which could be a type 1 hypersensitivity (2021). The physician is more concerned about the latter and would like to know if it is okay to pre-medicate the patient with Benadryl before getting the second dose. The outcome of the event 'she was just tired' was recovered on 14Apr2021; incredibly horrible itching under her Fitbit; whelp was recovering; her lips had started swelling and her tongue was tingling was recovered on 15Apr2021. The outcome of the other events was unknown.

TONGUE SWELLING, ITCHY ALL OVER, CHEST PRESSURE AND SOB. PT SELF-ADMINISTERED ALBUTEROL INHALER. PARAMEDICS CAME, VSS, TRANSPORTED TO HOSPITAL

5/11/2021 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: dizziness, nausea and leg cramps, dyspnea, sweating. Assessment : Time of assessment Alert and oriented and skin dry. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. At 1029 VS- BP-168/98, P- 60, O2- 97 %, given water and crackers, at 1044 VS- P- 58, O2- 98%, complains of feeling anxious, and dyspnea, 1046 feeling better, no dizziness or cramping, 1050- patient reports breathing better, complains of feeling hot and cold with chills, O2- 97-98%, P- 54=55. 1103- denies all S&S, Vs - BP_ 146/83, P- 59, O2- 99%. Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1036. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 5/11/2021 9:57 AM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: EW0182

Pt c/o a "migraine" like headache in frontal region. BP 178/118 P 78. Pt commented after getting her 1st covid vaccine- she was very tired, nauseated, bad headache & labored breathing. Had to sleep sitting up & missed a couple days of work. 4:25 PM 163/122 P86 4:55PM BP 161/119 P 80 R 16 Pt feeling better & leaves without assistance. Instructed to call her PMD about her BP issues & use her inhaler at home.

PATIENT DEVELOPED FATIGUE, INANITION, WEAKNESS, WORSENED DYSPEA ABOVER HER BASELINE. WAS ADMITTED TO HOSPITAL FROM 5/5/2021 TO 5/10/2021 AND TREATED FOR COPD EXACERBATION AND DESCRIBES SEVERE WEAKNESS SHE SHOULD NOT LIFT UP HER HEAD OR PICK UP HER LEGS. NOW HAS DIFFICULTY WALKING WITH HER LEGS GIVING WAY. EXAM 5/13/2021 SHOWS WEEZES ANTERIORLY , DIFFUSE ECCHYMOSES AT PHLEBOTOMY AND CUFF SIZES AND DIFFUSE HEMOSIDERIN VENOUS STASIS CHANGES LEGS AND 1/2 PT BILATERALLY.

Weakness, shortness of breath, became COVID positive after the 1st dose of vaccination, IV meds, blood thinner, chest x-ray, staff member was hospitalized

She did not have control of her bowels when sneezed or coughing. She complained of trouble breathing and in a lot of pain. She passed away on April 3 with pneumonia

very fast heartbeat very high blood pressure at onset low blood pressure next day and after difficulty breathing arm pain and can't raise 45 degree trouble sleeping dizzy very very weakness can't open eyes nose bleeding a lot difficulty sitting difficulty chewing food brain fog and confusion muscle joint pain yellow face and palm congestion and running sneezing nose lost smell and taste it's been more than 5 weeks still can't recover most of the symptoms seems like damaged a lot can't do as heavy physical activities and house work lot more food to keep up the energy

D Dimer was high; Chest tightness; blood clots in the lungs; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 10:30 (Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing retinal tear from an unknown date (long ago, maybe 2005), Blood pressure, anxiety, reflux, irritable bowel syndrome, eye care. Three years ago, patient had a blood clot on the portal vein. She was treated with Eliquis, referring to Apixaban, for six months. Then they went into the D Dimer and found out she only had one gene for the blood clots, so they discontinued Eliquis, referring to Apixaban. The doctor said the protocol didn't call for it because she only had one gene. Eliquis, referring to Apixaban, was discontinued a year and half ago. The reporter mentioned the specifically didn't get the Johnson and Johnson shot due to blood clots. Family History included that her mother and sister had blood clots in the past unrelated to the vaccine, anxiety which her mom has. Concomitant medications included ramipril taken for blood pressure from an unspecified start date (for five to ten years) and ongoing; ongoing omeprazole taken for reflux; fluoxetine taken for anxiety (for what her mom has) taking for three years and ongoing; linaclotide (LINZESS) taken for irritable bowel syndrome taking for 3 year and ongoing; magnesium sulfate taken for eye care taking for 3 year and ongoing; latanoprost taken for retinal tear from 2005 and ongoing. Prior Vaccinations (within 4 weeks) was none. The patient previously received the first dose of the Pfizer COVID 19 vaccine on 26MAR2021 at 1000AM in the right upper arm (Lot number for first dose is ER8732; expiration date 31Jul2021). Last Wednesday she started to have tightness in her chest so they called an ambulance. She was admitted to the hospital 28Apr2021 and was discharged Saturday 01May2021. In the hospital they did a CT and it came out that she had bilateral blood clots in the lungs; the doctor said it was a shower of blood clots in the lungs, small enough not to occlude anything. They treated with a 72 hour heparin drip. They didn't do any more CT but they did put her on Eliquis, referring to Apixaban, for the rest of her life. For the Eliquis he mentioned the generic Apixaban; unknown manufacturer; caller did not see NDC, lot, or expiration date on product dispensed in a pharmacy vial. Last time she was also on the Apixaban, not the brand Eliquis but they have discarded all the old product. The patient also did an X Ray; EKG (Electrocardiogram) was normal sinus; all the blood work including the CBC (Full blood count) was normal on an unknown date; her D Dimer was high on 01May2021. The events required a visit to Emergency Room. The outcome of the event chest pain was recovered with sequelae, of blood clots in the lungs was not recovered, of other events was unknown. Batch/Lot number had been obtained. Further information has been requested

Woke up in the middle of the night and couldn't breathe. Couldn't walk and talk at the same time for 3 days. Had no energy because it was too hard to breathe. Was put in the hospital for 3 days, checking on lungs and heart. Had chest X-rays etc. Could not come up with definite reason, but my condition did not improve. I was put on 2 liter of oxygen (which I was never on prior to shot), and told to see doctor in 7 days.

The patient reports she had progressive shortness of breath for the past month, after she received her second dose of COVID vaccine. She presented to hospital on 5/22/21 with pulmonary embolism.

Airway edema; Lungs start feeling gooey and congested; Vocal chord swelling; Stuffy nose; Lost my voice; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 19Mar2021 (Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included migraine diagnosed 30 years ago, cholesterol a little bit high diagnosed about 10 years ago, slightly high, patient didn't have to take statins or anything; reactive airway diagnosed at least 15 years ago. The was no concomitant medications. Patient received the first dose of the Pfizer Covid 19 vaccine on 19Mar2021. She had a history of being very reactive respiratory wise to irritants in the air. 45 minutes after first dose, patient experienced vocal chord swelling, stuffy nose, lost her voice, lungs start feeling gooey and congested on 19Mar2021. And 45 minutes after receiving the vaccine she had airway edema on 19Mar2021, which was not uncommon for her as she had a very reactive airway. The patient usually had airway edema when she was around any sort of latex, perfumes, chemicals, things like that. She took meds (levosalbutamol hydrochloride (XOPENEX), fluticasone propionate, salmeterol xinafoate (ADVAIR), levocetirizine dihydrochloride (XYZAL), diphenhydramine hydrochloride (BENADRYL), 5mg prednisone) immediately, inhalers and everything was fine 45 minutes to hour later. The airway edema subsided in 1.5 hours. She never went into respiratory distress. The patient took daily medications but declined to provide details on them, she did not believe this event was from them as she had been taking these medications for years. Reporter seriousness for airway edema was medically significant. Outcome of airway edema was recovered on 19Mar2021, and outcome of other events was recovered in Mar2021.; Sender's Comments: Based on a strong temporal relationship, A possible causal relationship between events Respiratory tract oedema, Pulmonary congestion, Vocal cord inflammation, Nasal congestion ,Aphonia and suspect drug BNT162B2 cannot be excluded "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate."

Coughing, inability to talk, difficulty breathing in , elevated blood pressure elevated heart rate, abdominal pain, slight chest pain

9:25 tongue had slight reaction, funny taste 10:23Anaphylaxis, took homeopathic Antihistimine, and Benadryl 25mg , Throat & Tongue swelling, funny chemical taste more intense. Tired all day, and pain at injection site. Day #2 Body aches, tired Day #3 Flu like symptoms Day #4 Flu like symptoms and SOB Chemical Taste more intense Day #5 Tongue Throat swelling all week, Benadryl all week. PM Start Prednisone … Day #6 Throat better on the L side. Day #8 Tongue swollen & Chemical taste, throat esp on R, PM go to ER. shakey. Day#8-Day#14 Dry cough, more SOB, same symptoms, continue Prednisone Day #15 Saw Pulmonologist, hot w/ head rush, productive cough for 2wks; Day # 42 Not good, call for current status

Initially presented to emergent care on 4/8/21 for left arm pain, SOB on exertion, and intractable headache. Headache had been ongoing for 12 days. It was throbbing and in the frontal region with nausea. No phonophobia. No weakness. No vision loss. No speech impediment. She was somewhat less active given her severe headache. She was found to have a DVT in the left arm and bilateral PE with heart strain. Referred to Hospital and admitted. Started on lovenox 1 mg/kg every 12 hrs and elected to be transition to coumadin since her sister had another blood clot on Eliquis. Neurology started her on gabapentin. She was discharged and told to follow-up with hematology and warfarin clinic. Presented to the ER on 4/27/21 with SOB at night that had been worsening the past 2 nights. Denied dyspnea or chest pain. Sx were thought to be due to anxiety given her hx of panic attacks. She was discharged home and saw hematology the following day. Hematologist noted that her SOB was gradually improving and her left arm swelling and vascular changes had resolved. Repeat CT showed improvement in clotting burden and stable pulmonary and hepatic nodules.

5-4-21 about 6 hours after shot, I had an extremely sore left arm and tenderness under the left arm pit. Beginning about 7 hours after shot, I had chills, fever of 100.2, migraine headache and lower back pain. Did not sleep at all through the night. By morning on 5-5-21, all symptoms still present plus feeling dizzy, light-headed and nausea. Stayed in bed all day. By 6 pm on 5-5-21 (27 hours after shot) I had a fast heart rate and heart palpitations. By 8 pm, I had a tightness and pain in my chest. Difficulty breathing, although that may have been my trying to alleviate some of the pain.

hypoglycemic shock; positive for covid 19; mobility issues; gets out of breath easily; weak; couldn't remember anything which wasn't normal; WBC was elevated; headaches; went sky high into the 500s and they couldn't control it in the hospital; viral pneumonia; renal failure; Her blood sugar was 28; Covid fog; was not eating or drinking; throw up; This is a spontaneous report from a contactable consumer or other non-health care professional (patient daughter) via Pfizer. A 63-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported and expiry date unknown) via an unspecified route of administration on 25Mar2021 (at the age of 63-year-old) as 1st DOSE, SINGLE for covid-19 immunization. Patient took vaccine as she wanted to fly on an airplane and not worry as heavily. Medical history included ongoing diabetes mellitus, patient had diabetes for at least 5 years, ongoing high blood pressure from an unknown date, reporter think patient high blood pressure was more with her weight because patient was obese. Patient was immunocompromised with her diabetes. Patient had no relevant family medical history. Concomitant medication included ongoing metformin (METFORMIN) taken for diabetes mellitus. Patient has been on it for years. Reporter believed she was on the max dose that she thinks was 2000mg, but could be wrong. Patient was not eating or drinking from 03Apr2021 and did throw up. On 06Apr2021 patient was tested positive for Covid and experienced hypoglycemic shock at 11:00, renal failure and Covid fog. Reportedly, patient also experienced viral pneumonia, mobility issues, gets out of breath easily, weak, her blood sugar was 28, covid fog, couldn't remember anything which wasn't normal, wbc was elevated and headache. The patient was hospitalized for hypoglycemic shock and COVID-19 from 06Apr2021 to 17Apr2021 (11 days), then discharged and was told by her HCP to wait 8-12 weeks before getting second dose of Pfizer covid vaccine. Patient scheduled to receive second vaccine dose 15May2021. Reporter was told that it was a max of 42 days that patient can get the second dose of the vaccine, but that has obviously since passed. They want patient to come in and get a second first shot. When patient was admitted, the doctor thought patient had viral pneumonia already for at least a week, so it would have started about when she got the shot. Patient was better, she was not on oxygen anymore, but she still gets out of breath easily. Patients mobility issues started when she came down with symptoms. Patient had renal failure and was weak. Patient was not eating or drinking. Patient was diabetic and she had hypoglycemic shock which was what put her in the hospital. Reporter thought it was probably a cold or flu or something and Easter happened where she was not hungry and did throw up. Reporter thought it was something she ate that was bad. When she had the hypoglycemic shock reporter could not wake her and patient was in some kind of unresponsive state from 11:00 to about 15:45. Patient blood sugar was 28 when the paramedics arrived. They were able to get her responsive and transferred her to the hospital. They ended up putting her on a dextrose drip because they could not keep her blood sugar up. They put her on steroids and the number went sky high into the 500s and they could not control it in the hospital. There was a lot of stuff that happened. Reporter did not believe that patient has any lasting effects from the hypoglycemic shock. Patient sugar was back to normal and she was on her normal medications. Patient was off insulin which they gave her in the hospital, so that part was okay. Patient was dealing with Covid fog also. Reporter does not know if it has to do with blood sugar or how the virus attacks the body. Patient had multiple MRIs because they were worried, she had a stroke, and she said she could not remember anything which was not normal. Patient not eating and drinking started right before Easter and was much better. Reporter believed that at about 14Apr2021 or so patient started to eat better and have more of an appetite for food. Patient has recovered completely. The reporter did not notice the Covid fog until her mother was in the hospital on 06Apr2021. She does not remember her first week in the hospital, and then even when she was discharged on 17Apr2021 that whole next week she was still very foggy. The reporter would say she was better now. patient talks normally and was back to swearing which is perfectly her. Patient has recovered completely at this point. Patient mobility was better. Patient was not using the walker in the house today, and her balance was better. It was probably due to some of the side effects of the medicines they added like a beta blocker and other things to make sure she was okay. Regarding kidney failure started, reporter stated on 06Apr2021 patient creatinine was 3.99. Patient also had a high D dimer and were worried about her clotting and throwing a PE or something. That was mostly in the first few days around the 6Apr2021, 7Apr2021, 8Apr2021, 9 Apr2021, 10Apr2021 when they were not sure what was going to happen. The following week patient was still at 5 to 6 liters of oxygen, but by Friday night 16Apr2021 she was down to 1 liter of oxygen. Patient did not come home on oxygen. Reporter believed patient kidneys have recovered, but she did not know. The patient underwent lab tests and procedures which included blood creatinine: 1.47 on an unknown date, 0.97 on Sep2020, reporter does not know if it returned to 0.97, but the last number she knows of was 1.47, 3.99 on 06Apr2021, blood creatinine: 1.47 on 17Apr2021. Patient had normal bloodwork in Sep2020 and her creatinine was 0.97. Reporter did not know if it returned to 0.97, but the last number she knows of was 1.47. That would have been when patient was discharged from the hospital. Blood glucose: 500s on an unknown date in Apr2021, blood glucose: 28 on 06Apr2021. On 06Apr2021 patient was tested positive for Covid. On an unknown date patient got CT, high d dimer, CBC, MRI, metabolic function test, white blood cell count, X-ray and Chem 28. Reportedly, bloodwork were done daily in the hospital, and patient has had bloodwork once since she was discharged. WBC was elevated so they did a blood culture to make sure patient did not have an infection. The culture was negative. There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccination within 4 weeks. There were predisposing factors diabetes and immunosuppression. Patient started Tylenol pill on 06Apr2021 after vaccination at an unknown dose. They gave it to her continuously because she had bad headaches. They started her on antivirals and took her off of Remdesivir because of her kidneys. They put her on a different antiviral that the reporter did not remember the name of and a biologic. Home health just discharged patient, and she was still dealing with viral pneumonia and mobility issues. Patient was still on different medicines and she normally was not. The report is related to study or programme. The outcome of the event hypoglycemic shock was recovered on 06Apr2021 and was not eating or drinking was recovered on 14Apr2021, viral pneumonia, mobility issues, was recovering, renal failure, positive for covid 19, gets out of breath easily, weak, her blood sugar was 28, went sky high into the 500s and they couldn't control it in the hospital, covid fog, couldn't remember anything which wasn't normal, wbc was elevated, throw up and headaches was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained

Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presents for regular dialysis session with diarrhea and cough. Dialysis session not completed, patient transferred to emergency room, found to be hypoxic with rhinovirus, pulmonary edema, and fluid overload. Patient received oxygen, underwent emergent dialysis with symptom improvement, and was discharged to home medically stable.

client received 2nd dose Pfizer Covid vaccine today. Client asked EMT if he could check her blood pressure as she was feeling dizzy with shortness of breath. PHN joined shortly after. Vitals at 1531: blood pressure 132/90, pulse 62, oxygen 98%. Client stated feeling dizzy, and feeling like she "could not catch a full breath". PHN assessed for swelling, client speaking in full sentences, alert and oriented x4. Client declined feeling itchiness of throat, tingling sensation or throat closing. Per client seeing blurry, only ate breakfast today. EMT brought client juice, instructed to take small sips. Client denied any trouble swallowing juice. At 1535 client stated breathing improving. Vitals at 1537: blood pressure 116/82, pulse 60, oxygen 100%. Shortness of breath and blurry vision resolved per client. Per client dizziness improving. Vitals at 1544: blood pressure 120/90, pulse 58, oxygen 98%. Client stated all symptoms had resolved. PHN discussed with client if someone could pick her up, client stated "I feel fine to drive". Client advised to follow up with provider and ER precautions given. Last vitals at 1550: blood pressure 120/88, pulse 70, oxygen 99%. Client reports all symptoms resolved and wants to leave. Client left facility with steady gait at 1553.

Patient has history of polychondritis w recent flare of recalcitrant scleritis and painful lesions toes thought to be vasculitis and likely related to underlying polychondritis diagnosis; was under treatment for same w prednisone, humira. 4 days after 2nd COVID vaccination Pfizer patient began to report shortness of breath; After Sx persisted was referred to cardiology and found to be in atrial fib; she received cardioverson and placed on eliquis and symptoms have resolved

Throat started swelling on one side (side of injection); Face turned red; This is a spontaneous report received from a non-healthcare professional, contactable patient. A 63-year-old non-pregnant female patient received the single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6119), via an unspecified route of administrated in the right arm on 11Mar2021 at 1:00 PM (at the age of 63- years old) for COVID-19 Immunisation. The patients medical history included breast cancer, asthma and past drug history included allergic to codeine and morphine. The concomitant medications included fenofibrate (MANUFACTURER UNKNOWN) dose of 145 mg, pravastatin (MANUFACTURER UNKNOWN) dose of 20 mg and vitamin-D (MANUFACTURER UNKNOWN) of an unspecified dose used within 2 weeks of vaccination for an unknown indication. The patient did not receive any other vaccine with in four weeks prior to the vaccine. Prior and since the vaccination the patient was not diagnosed with COVID-19. On 11Mar2021 the patient experienced throat started swelling on one side (side of injection as reported) and face turned red. The clinical outcome of throat swelling and face red was recovered at the time of this reporting (Mar2021). No follow-up attempts are needed. No further information is expected.

She felt a burning sensation whenever the covid vaccine went in; muscle pain all over, her muscles felt achy; Tiredness; could not eat; pressure in her ear is from swelling; pressure in her ear is from swelling; throat tightness; could not sleep that night; muscle tightness started in the shoulder/shoulder muscle got tight/tightness went to the back of her neck, then to the front of her neck; hurting so bad; Under her chin, on both sides, there are swollen lumps; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 13:00 (Batch/Lot Number: ER8734; NDC & Expiry date: unknown) (at the age of 63 years old) as 1st dose, single for COVID-19 immunization. Patient took Pfizer COVID vaccine because of her job. She works with the public at a public library. History of all previous immunization with the Pfizer vaccine and additional vaccines administered on same date of the Pfizer suspect were reported as none. Medical history included acid reflux for years, colitis, bad sinus issues for several years and COVID-19 diagnosed on 04Jan2021. Part of her sinus issues, is that her sinuses block up and stuff drips down the back of her throat. Whenever she had COVID in Jan2021, the main thing that bothered her was a terrible sore throat. Whenever she had COVID, she went to an urgent care and the doctor told her that her throat was swollen bad. She kept spitting phlegm out in the toilet, and the doctor told her if it got any worse, she may need to go to the hospital, if her throat is starting to swell closed. The urgent care doctor prescribed her a steroid, and she took that for a week. She has a bad right shoulder; it aches all of the time. She does not like going to the doctor, so she has not had it checked out. She has frozen shoulder in both of her shoulders. She clarified that she had shoulder issues before receiving the first dose of the COVID vaccine. She constantly has neck pain. It is normal for her to have aches in the back of her neck. The pain from her shoulders goes into her neck. Patient reported that there was this thing that runs in her family. She has never been tested for it. It is a disease. Her mom and dad do not think that she has it. She thinks that is called Marie Toothe disease. Concomitant medications included fluticasone propionate (FLONASE) for bad sinus issues, famotidine for 2 years for acid reflux, and has been taking mesalazine (LIALDA) for years for colitis. She takes Flonase pretty much daily in the summer. She stopped taking during the winter. She started taking it again a couple of months ago. She started back taking it whenever things started blooming. Patient reported that she got hives from a flu shot. Flu shot name, NDC, lot number and expiration date were unknown. Hives after a flu shot happened five years ago, she has not gotten a flu shot since. On an unspecified date, the patient called to report reactions. She was concerned about getting her second dose of the COVID vaccine. Patient's weight was between 110 and 120 pounds. She was diagnosed with COVID on 04Jan2021. Because of COVID, she lost weight, she got down to 110 pounds. Now she is putting weight back on and getting back to her regular size of 120 pounds. She lost a bunch of weight whenever she was sick with COVID. She has been trying to call the CDC but has not been able to get through to speak to anyone. She received the first dose of the COVID vaccine in her left arm, because her left arm is normally better. She received the first dose of the COVID vaccine at 1:00PM. They made her sit around and wait for 30 minutes because she has had flu shot reactions before. She waited the 30 minutes and felt okay. Then she noticed at dinner time, about four or five hours after the first dose of the COVID vaccine that she was feeling muscle pain all over, her muscles felt achy. After she got the first dose of the COVID vaccine, she felt like COVID was coming back into throat. At supper time, she could not eat because of throat tightness. She had to eat soup and could not take one of her big pills: Began probably about four to five hours after receiving the first dose of the COVID vaccine. Her throat has been doing this weird thing where it feels better, and then feels tight again. It is back and forth. Right now, it is better. This Saturday, she was supposed to get her second dose of the COVID vaccine. She is worried that her throat will swell up worse. She is asking if she should get the second dose of the COVID vaccine. About one week before receiving the first dose of the COVID vaccine, her throat was sore and bothering her. She went to urgent care on 22Mar2021. She had COVID in Jan2021, her throat has gone back and forth like this. At urgent care, they did a COVID test on her and it was negative. They also did strep test on her and it was negative. The doctor looked at her throat and said he did not see anything. The doctor did not really want to look in her throat. The doctor was worried she may have COVID, so he only took a quick look. She felt like muscle tightness started in the shoulder when she received the first dose of the COVID vaccine. Her shoulder muscle got tight, then the tightness went to the back of her neck, then to the front of her neck. She also had pressure in her ear on that same side; she clarified that pressure was behind her ear. She thinks the pressure in her ear was from swelling. Shoulder tightness, back of neck tightness, front of neck tightness, and pressure behind her ear all happened at the same time. She was hurting so bad. The tightness and pressure come and goes. She is starting to wonder if wearing a mask is causing this. She wears two cloth masks at work. She does not like wearing medical grade face masks because she feels like she cannot breathe. After work, she will come home, and her throat will be a little sore. She was asking if there are lymph nodes in her throat. Under her chin, on both sides, there are swollen lumps. The left side was worse. She put ice on it, and it felt better. Began on 27Mar2021, she could not sleep that night which was weird because it comes and goes. Whenever it comes and goes, it was probably not as bad as the day that she received the first dose of the COVID vaccine. It still hurts. She was asking if this is an immune inflammatory response. She was supposed to get her second dose of the COVID vaccine this Saturday. She is freaking out about it. Everyone has told her that the second dose of the COVID vaccine is worse than the first dose. She was asking if they can give her the second dose of the COVID vaccine in her thigh instead. She is worried that if she gets the second dose of the COVID vaccine in her thigh, that she will not be able to walk after. The adverse events did not require a visit to the Emergency Room/Physician Office. She is thinking about going to see a doctor. The night that she received the first dose of the COVID vaccine, she thought to herself that if she got any worse, she would go to the emergency room. She was close to going to the emergency room. There were no prior vaccinations (within 4 weeks). The outcome of the event burning sensation was recovered, muscle pain was recovering, tiredness was not recovered, while for the other events was unknown. No follow-up attempts are needed. No further information is expected.

On the day of the vaccine, no significant side effects. When I woke up the next day, SOB,wheezing, fatigue-"I felt like I had COVID." I had covid in july and know the symptoms of covid. I was severely short of breath and wheezing. I went to my PCP and got steroid shot and oral prednisone taper. After a few days, I started to feel better. It took 3 weeks for me to feel completely better.

severe headache, between the eyes, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; very bad cough, she woke up with it, its hard to breathe with the cough, worsened; yesterday she was tired when she got her shot, yesterday morning she slept all day; she was not really hungry; yesterday she was tired when she got her shot, yesterday morning she slept all day; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 11:00 hours, as single dose (at the age of 63-years-old) for covid-19 immunisation. Patient had no medical history. Patient stated that she had no problems, no medications, no heart problems, no diabetes, she was free and clear of medication. Patient had no family medical history relevant to events. Patient stated that a couple family member been vaccinated, and they did not had a problem. The patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 07Apr2021, patient got her shot at 11:00 hours and patient were tired when she got her shot and in morning patient slept all day, she did not eat because she was not really hungry, she had a headache between the eyes and it was odd for her to not be hungry. Patient stated that it happened after the first shot. Patient had severe headache and cough happened in the middle of the night, and can't breathe (on 07Apr2021). Patient had a bad cough, she woke up with it and it was hard to breathe with the cough (on 07Apr2021). Patient asked if she could take ibuprofen for headache and she was wondering if the cough was normal and can she take cough syrup. She stated that she needs something, she was coughing and hacking. Patient stated that every time she coughs her head was pounding. She could not eat and she was an eater. Patient said that she tried to get coffee down this morning and forget it, she was not really feeling hungry (on 07Apr2021) which was unusual for her, normally she would eat whatever you put in front of her. She didn't eat anything right now. As far as tiredness she was ok, not tired right now. Patient stated that she did feel tired (on 07Apr2021) yesterday but feels uncomfortable with headache and cough. Patient had no emergency room and physician office visit. Event severe headache, between the eyes and very bad cough, she woke up with it, it was hard to breathe with the cough was worsened. The outcome was recovered for yesterday she was tired when she got her shot, yesterday morning she slept all day (tired) on 08Apr2021, not recovered for (very bad cough, she woke up with it, it was hard to breathe with the cough, worsened), (severe headache, between the eyes, worsened) and unknown for rest of the events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

4/28/21 Pt presented to the ED with complaints of a cough that started 2 weeks ago and was getting worse and weakness with several falls. She also admitted to intermittent diarrhea. She was found to be febrile with a temp to 101.1, tachypneic w/RR of 20. Sats were in the low 90's. NP was was positive for SARS-CoV-2. CXR showed bilateral opacities and she was admitted for PNA and sepsi. She was given Rocephin and Z-max in ED and both were discontinued upon admission. She was started on Decadron in ED 4/30 she had increasing hypoxemia and was placed on a non rebreather. She was transferred to critical care and given tocilizumab. Her respiratory status continued to worsen and she was intubated. She subsequently developed a pneumothorax that persisted despite 2 chest tubes. She developed a large air leak and she was not a surgical candidate. Family ultimately decided to w/draw care on 5/15/21

A cough that is different than anything I have ever heard or had. Had it over a month and it hasn't gotten any better. It chokes me sometimes and one time I stopped breathing because I was choking. Energy level very low and usually I have a lot of energy and never get tired. It is hard to do a little bit of work and I used to go go go all day. Labored breathing often. Fatigue.

A series of inflammatory events occurred which began with the first dose of the Pfizer vaccine. I initially developed a rash at the injection site of the first dose within hours of the injection. That was my only symptom after the first dose. The nurse at the vaccination site suggested that the second dose be administered in the other arm due to the rash which was still vivid. Within hours I also had a rash on the second arm as well. Over the next few days rashes appeared in the crook of my elbows and at my waistline. Shortly thereafter I developed "dry eye". My eyes were dry and sensitive to bright light. Then I started to have discomfort when I took a deep breath. On April 29, 2021 I had severe discomfort when breathing and was diagnosed by my doctor with pleurisy and possible pericarditis. I could not lie down for ten days and had to rest sitting up. Over time, and with the help of a great deal of ibuprofen I have improved. I no longer have discomfort when breathing and the rashes are 99% gone. The "dry eye" is slowly improving.

increased HR up to 130 bpm; shortness of breath; lightheadedness; fatigue; This is a spontaneous report from a contactable other healthcare professional (Nurse). A 63-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 63-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. One month after receiving the second dose of the vaccine, on an unspecified date, the patient experienced shortness of breath, increased heart rate up to 130 bpm, lightheadedness, fatigue. The patient underwent lab tests and procedures which included heart rate: 130 bpm. She wants to know if there any been any other reports of any cardiac issues one month after receiving the second dose of the vaccine. Outcome of the events was unknown. Response: Reviewed attached FACT SHEET FOR HCPs ADMINISTERING VACCINE and no information found regarding cardiac related events post vaccination. Spoke from attached FAQ-COVID-19 Vaccine-Pfizer Response to Reported Cases of Myocarditis in Recipients of COVID-19 Vaccine and Serious and Severe Adverse Events. Offered to send pdf document via email, caller declined. Referred to HCP Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, increased heart rate, Dizziness, Dyspnea, Fatigue cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.

I had to go to the ER because I was having a severe reaction to the vaccine. I had fatigue, chills, headaches, weakness, tachycardia, shortness of breathe, muscle pain.

A couple of hours or so after the second vaccine my body felt achy and feverish. Also started to get the chills and then a headache. The symptoms gradually got worse over the course of time, took a couple of Advil and went to bed. It was difficult to sleep as my legs ached so badly I could not get into a comfortable position. As the night progressed and and fell in and out of sleep, the pain and especially the chills and headache were unbearable. I woke up around 10-11 pm with my throat numb, feeling tight, my tongue was numb at the back and the front area of my tongue was numb and tingling. I was nervous and scared to go back to sleep. My family all asleep and did not want to unnecessarily awaken them. I put myself into an upright position for fear of anaphylaxis. Considered calling 911= but we live in a quiet community and waited to see if it got worse. I did not sleep all night, finally got some rest while sitting upright. The following day all the symptoms were there and fever, chills and body aches worsened. My temp was around 101. Drank a lot of water. Today, my throat does not feel the same. Feels like something is there but cannot describe the feeling. Have been tired these past couple of days. Not usual for me but cannot say it is due to the vaccine. I will comment in that I never had the chills so bad as I had experience with actually being sick. Was horrible.

headache; ears very clogged; both thighs very painful; her left arm was very painful; lower back very painful; I wanted her to rule out pericarditis before having full cardiac workup; sharp left-sided chest pain began with increased pain in groin and left hip; sharp left-sided chest pain began with increased pain in groin and left hip; sharp left-sided chest pain began with increased pain in groin and left hip; this pain in chest, especially when taking a deep breath; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in left arm on 11May2021 18:00 (Lot Number: EW0185) as 1st dose, single dose for covid-19 immunisation. Medical history included had pericarditis a number of years ago (unknown date) that lasted one year then went away and rheumatic fever at age 7 (unknown year). The patient was very healthy and felt perfectly fine prior to vaccine. The patient was not diagnosed with Covid-19. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamins nos (VITAMINS NOS reported as vitamins) and supplements. The patient received the most recent COVID-19 vaccine from a pharmacy or drug store. The patient reported that 4 hours after she got the shot (11May2021), her left arm, lower back, and both thighs very painful. The next morning (12May2021), she had headache, ears very clogged, and lower back and thighs were very painful. It was reported that 7 days later (May2021), the patient experienced a sharp left-sided chest pain began with increased pain in groin and left hip. These symptoms are still continuing to this date. The patient reported that she had pericarditis in past and this pain in chest, especially when taking a deep breath, is very similar (May2021). She called her primary care physician (PCP) to try to get appointment to see her, but she was told to go to ER. The patient did not want to get to the ER due to the deductible to meet before her insurance kicks in. She wanted to rule out pericarditis before having full cardiac workup. All symptoms were still continuing, however chest pain is not as severe. The patient does not plan to get second shot. The patient considered the events was non-serious. The patient has not been tested for COVID-19 since vaccination. The patient did not received treatments for the adverse events. The outcome of the events was not recovered.

chest tightening/ feeling of fullness in my lungs; cough; feels scratchy in my lungs; Reactive Airway Disease/Asthma; Reactive Airway Disease/Asthma; This is a spontaneous report from a contactable consumer (patient). A 63-year-old (Adult 18-64 Years) non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 and Expiration date was not reported) via an unspecified route of administration, in Arm left, on 09Mar2021 at 11:30 (at the age of 63 years), as a single dose for COVID-19 immunisation. There was no other vaccine in four weeks. The patient's medical history was reported as Migraine disease, Fibromyalgia, Collagenous Colitis, Asthma. Concomitant medications was not reported. Other medications in two weeks was reported as Clonopam, Flexeril, Imitrex. Known allergies which includes many antibiotics, metals, latex, adhesives, molds. Prior vaccination, the patient had no covid. Post vaccination, the patient had not tested for covid. On 09Mar2021 at 02:30 PM, Patient stated that within 2 hrs of injection, felt chest tightening and a feeling of fullness in my lungs. The patient had a minor cough and tightness in the chest at bedtime. Today, my cough is more prevalent, and it feels scratchy in my lungs. It was not unbearable but is not one of the listed side-effects. The patient do suffer from Reactive Airway Disease/Asthma. The patient received treatment for adverse events which includes using my nebulizer and inhalers. Outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.

She got the vaccine about 5:30 PM May 24, 2021, and initially did fine. In the middle of the night she awoke short of breath, coughing, felt she could not breathe. She denied any itching or hives. Denied any swelling in throat or mouth. Tried antihistamine. Next day, went to work, still short of breath, and in mid day came to see us in the office. She was wheezing and oxygen saturation was 89%. ( 96% is normal), and hypertensive. RR was 24-30. BP was 160/104. We sent her to ER for possible anaphylaxis to covid vaccine. In ER was treated with albuterol nebs, duonebs, prednisone, and admitted to the hospital on 8 liters oxygen. She was in hospital 5/25/21 to 5/27/21 and sent home off oxygen, on prednisone DC diagnoses were Acute respiratory failure with hypoxia Systemic Inflammatory Response Syndrome Tobacco Use elevated BP reading Chest pain Anxiety, COPD exacerbation (I would comment she has never had this before; hospitalist made that diagnosis based on cigarette use and wheezing and hypoxia)

Light headed, swollen glands on left side of throat, hurts to swallow, thick tongue, chills, not feeling well, fast heart beat and face is tingly .

shortness of breath, shaking, diarrhea, and today feeling really bad with chills with low grade fever, headache, and very fatigued and it feels like a bad flu and cough.

Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Weakness-Medium, Additional Details: Headache every day since vacination needs to take APAP every 4-6 hours to function. BP increased averaging around 160/80 (normally under 140/80). Bad fatigue, weakness in legs, chest tightness, shortness of breath. Had to stop a dose of Ozempic it caused greater weakness than normal

Case + in January 2021, received both Pfizer doses in April 2021 then became infected again + June 2021. Was hospitalized for GI bleed and tested + at that time.

I had a strong pepper feeling in my throat. It felt like a ball of pepper was in my throat. I was able to breath but I had to keep clearing my throat. My face, eyes, and throat started swelling up. I was rushed to the ER. My throat was dry. They immediately gave me the EpiPen. My body started acting uncontrollably. I was shaking and shivering and going through a bunch of uncontrolled body movements. They gave me oxygen. I had an IV in my left arm and they gave me injections in my right arm. I was very dizzy. They continued to observe me, they drew my blood. More doctors came in and they told me not to get the second dose of the vaccine. I was transported to hospital by ambulance. 2 o'clock in the morning they told me I could go home and they gave me a prescription. I was very jittery. It was hard for me to walk. I went home with the prescription. Around 7 o'clock in the morning I woke to take my prescription. I had heart problems. I was still dizzy, jittery, and nervous. I called my PCP to put in my prescription and was told to go back to urgent care immediately. My eyes, nose, lips, and throat swelled. I could still breath but my tongue felt different. After they saw me again, I got another EpiPen in my leg. I started shaking uncontrollably again. They injected me in my right arm to calm down the reactions. I was kept there till 9pm that day. It was difficult for me to walk again. I went home and laid down. They gave me prednisone for 7 days. On the 3rd day I was having heart problems again. During that time I didn't have a appetite. My intestines felt like they were trying to come out of my body. I was very uncomfortable. I had gas. I put myself on a schedule to eat soup. I was very nauseous. Those symptoms lasted for 6 weeks. I couldn't drive for 4 weeks. I was still dizzy. I was able to sleep for 4 hours. I couldn't remember things. I have a cough that hasn't gone away. My doctors told me I am anaphylaxis.

Tongue began to swell; Back of throat started to swell; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in left arm on 22Mar2021 (at the age of 63-years-old) as first dose, single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE) 10 mg once daily taking zyrtec 10 years ago when it first came out. Patient reported other allergies as hay fever, pets, that kind of thing and allergies since patient was born. Reported that patient never had a reaction to a vaccine, flu shot, or any other medicine in the past. It was reported that, on monday, 22Mar2021, patient had the first injection of the Pfizer COVID-19 vaccine. At the vaccination facility wait 15 minutes after the injection and experienced no side effects at that point. The swelling in patient tongue started to subside before the swelling in the back of throat. While patient was driving home about half an hour afterwards, patient tongue and the back of throat started to swell. Patient was able to breathe the whole time during the period when tongue and throat were swollen, so patient did not seek medical attention. Patient took Benadryl when got home on 22Mar2021 and took 2 more Benadryl later that day. (Benadryl: 25 mg capsules; Store brand; Bottle size: 100 capsules; Lot number: P110123; Expiry date: Apr2021). Patient did not visit to emergency room or physician office. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered on 23Mar2021. Patient had a question for an agent, that the CDC recommends from the reaction patient had following the first dose of the Pfizer COVID-19 vaccine that patient should not get the second vaccine. Patient reported that, doesn't know if that's true or not, that other websites have said that the vaccine mega site will have Benadryl shots and Epi-Pens and she should proceed with getting the second dose of the COVID-19 vaccine. Patient doesn't know what should do as patient was concerned that with the second dose of the COVID-19 vaccine patient may have a stronger reaction that results in throat closing. Description of product complaint: PC is not related to the populated suspect product. Patient reported that she took one store brand Benadryl capsule after she experienced throat and tongue swelling following the first dose of COVID-19 vaccine. Took two capsules later, swelling was gone the next morning. Product strength and count size dispensed: 25 mg capsules; 100 count bottles No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Nausea, exhaustion, wheezing, eyelids swelled and . Eyeballs felt like they would bust, sensitivity to light. Arm swelling. Dizziness, headaches that felt like sharp knit wing stabbed in my head. Neck sore.

throat was closing; tongue was swelling; had hives on my chest; This is a spontaneous report from a contactable consumer. This 63-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EK4176) via an unspecified route of administration into the left arm on 19Jan2021 10:00 AM (at the age of 63-year-old) as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No Covid prior vaccination nor tested post vaccination. No other vaccine in four weeks. No known allergies. On 19Jan2021, the patient reported that ten minutes after vaccination, her throat was closing and her tongue was swelling. Also, she had hives on her chest. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care and treatment was received with Epipen, Benadryl, Deltadone and Pepcid. The Outcome was resolved for all the events on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected.

Woke up Monday, June 21 feeling fine, just a sore arm, and decided to do some mild exercise. After bending at the waist for the fourth time, my heart started racing and I felt like I would faint. The palpitations began at 10:40 AM and continued for 12 hours into the evening. My normal approaches to bring them under control - bearing down, rest, homeopathic remedies and metoprolol - did nothing. Heart rate was as high as 200+ and slowing dropped to 190 for several hours, 180 for several hours, 174 for awhile and after taking the homeopathic remedy thyroidinum it finally dropped to 94 and has gone back to normal. Basically, I spent Monday day lying on my left side waiting for it to stop, trying to belly breathe slowly. I had no appetite, felt faint each time I sat up. Once the palpitations stopped, I have experienced shortness of breath whenever I go upstairs each day this week. However, as I get further away from the vaccination day, the breathlessness is lessening.

chemical taste in mouth; rash on neck; Rash on face; slight swelling in throat; slight dizziness; fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patients medical history included hypothyroidism. Concomitant medications included NP THYROID 120mcg, multivitamin (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously received toradol and experienced allergy. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 12:30, the patient experienced chemical taste in mouth, rash on neck and face, slight swelling in throat, slight dizziness and fast heartbeat. The patient did not receive any treatment for the reported events. 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 clinical outcome of chemical taste in mouth, rash on neck and face, slight swelling in throat, slight dizziness and fast heartbeat were recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

angio-edema to eyes, face lips; trouble breathing; closed throat; This is a spontaneous report from a contactable consumer (patient reported for herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in left arm, on 09Jun2021 at 13:30 (at the age of 63 years old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroid. The patient has known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182) on 19May2021 at 10:30 AM, left arm, for COVID-19 immunisation and the patient experienced hives, rash and itching which was not related to vaccine at the time. On 09Jun2021 at 16:30, it was reported that the patient experienced angio-edema to eyes, face lips, closed throat and trouble breathing. The patient received steroid, diphenhydramine (BENADRYL) and famotidine (PEPCID). The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Sunday, June 27th awoke at 2:30 a.m. with headache, body aches, nausea, fever, diarrhea, extremely tired and fatigues and shortness of breath. I slept the whole day getting up to only go to the bathroom. I did not eat or drink anything that day. I had sweats off and on throughout the day. Monday, June 28th I still have diarrhea and I am very tired and fatigued. I am eating and drinking now.

(NOTE:Baseline BP 04/01/19 Doctors on Duty 120/80 pulse 60). 5-15-21 Felt amped. 5-17 Couldn't catch breath when stood up, palpitations. 5-18 heart felt under pressure, ached. During easy run, heart rate 178, sharp pain up left side of chest. 5-19 went to Doctors on Duty BP 160/82 pulse 63. EKG normal range elevated V2 and V3. 06-01-21 Physical Dr. BP 169/75 pulse 62.BP monitored Omron 3 cuff beg.6-01-21. As high as 173/100. Pulse quickly climbs to 172 during 2 mile easy runs. Dr. Ordered 5mg amlodipine daily. Beg. 6-20-21. BP up/down 141/94 pulse 70 to 110/84 pulse 86 since. Palpitations, high heart rate when active and slight chest pain still present.

labored breathing; irregular/strong heartbeat after minimal exertion, most noticeable while resting/sleeping; feeling of 'gravel/bubbles' in blood running through body; lightening bolt across shoulders blades, chest and upper abdomen; "propeller" like feeling inside arms, chest, growing larger, then dissipating; split second loss of feeling in lower half of body as if it didn't exist; unbalanced; dizzy, losing balance while simply standing still; increased tinnitus

It has taken me months to finally feel like I am okay. The second dose started with a fever the night of vaccination, Friday night. I didn't feel sick, I just felt hot. Then the following day, on Saturday, I was taking Tylenol and could not get below 103 degrees. I contacted my insurance company that has a nurse and they told me to go to ER. My joints had started hurting very bad, it felt like I had just had surgery. I went to the urgent care, they evaluated me and told me to go to the ER. I went to the ER and was there maybe 3-4 hours. They gave me IV fluids and gave me lab work and sent me on my way, they said everything was normal but it wasn't. Another physician did tests and the lab work they got was different, they got results with protein and he told me to go to the ER to get a CAT scan. Then that hospitalization was about 8 hours and that Cat scan was negative. Then I had extensive bloodwork 2-3 weeks after the vaccine and all of my inflammatory panels were elevated. A gastroenterologist ordered this test and my cholesterol was elevated. I then started having pain in my left lung and it hurt when I breathed in. I had x-rays that did not show up with anything. I then developed more joint pain, which I had to take pain killers for. My DR had never seen levels like these before and all of this basically lasted until about two weeks ago. I also had a stabbing pain in my right arm and got an ultrasound which came back negative for any blood clots. I have literally gone from DR to DR to DR to DR to DR, it is hard to remember everything. I have seen specialists and also spoke to a cardiologist a couple days ago. He said I inflammation around my heart as well, I was not surprised, I was totally in pain everything hurt. One thing at least 4 DRs said to me, they asked me if I had Covid and I said not that I know of. I never had a positive covid test and didn't have an antibody test until Nov of 2020, when the speculation of my having covid would've been Feb 2020.

6/18/21 I woke up at ~5 AM to whistling/wheezing/crackling noise when breathing, shortness of breath, restlessness, and inability to get comfortable. I felt some constriction in my chest, unable to get a deep breath. Also felt sensation of internal itching in chest. Rear nasal passages felt full and narrowed. I felt more comfortable when standing or pacing. I dressed in case I needed to go to hospital. After some time I took loratadine antihistamine, which did not provide immediate relief. However by ~ 7 AM worrisome breathing symptoms were subsiding enough for me to lie down and sleep, feeling fatigued and achy. Made appointment and at ~10:30 AM and saw nurse practitioner. NP did not think 6/1821 Episode was related to vaccine, but possibly related to other unidentified allergen. NP prescribed methylprednisolone pack to have on hand in case of recurrence, and recommended Benadryl rather than loratadine for a quick allergic relief. NP was more concerned with mild allergic symptoms ( mild facial itching, hive)* that had occurred within one hour of vaccination on 6/13/21, and recommended that I not take the second vaccine dose. * On 6/13/21, within the first hour after vaccine, I developed itching and mild redness on forehead, small hive on left cheek, sensation of itching inside chest and mild cough. I took a loratadine antihistamine and symptoms gradually subsided.

About 20 minutes after initial injection, my face got hot. Five minutes later, I had trouble breathing through my mask, so I notified the nurses. When I removed my mask, the nurse mentioned she could see an outline left behind on my cheeks, so I looked. OMG! My cheeks were red and swollen, and my eyes were puffy. They made me stay for an hour and a half until I begged to be let go. Initial swelling lasted a good 24 hours. I also had some of the usual stomach upset, aching, etc, that many friends experienced the first day. Even though the swelling in my cheeks diminished over time, my eyes and sinus continued to be swollen, causing debilitating sinus headaches. I called my Dr, who contacted disease control, who said I could not get the second vaccine. She referred me to an allergist. The first appt was 3 months out. I got on the waitlist (which turned out to be randomly ordered!). After waiting a month, I contacted my dr again for a different allergist, also a three month wait, and got on their waitlist. In the mean time, any time I went outside, for even five minutes, fully masked, my face swelled again to the level of the initial swelling and my eyes and sinuses became intolerable. So, there I was, confined to my house, suffering from headaches and becoming depressed, not knowing if I I could ever become fully-vaccinated or if I would have to sell my house and move into an apartment. It was horrible. It lasted six weeks and two days, and as suddenly as it began, the swelling went away (mostly). I spent the next week blowing bloody snot from my sinus, and got some relief from my osteopath (my PCP was useless). After another week, I rose to the top of the 2nd allergist's waitlist, and was able to see him on 05/28/21. He prescribed an epipen and OKd me to get a J&J, which I received the next day, 05/29/21. The symptoms I suffered from that were nowhere near as dire, although it seemed to kick up some residual symptoms from the first vaccine.

Pfizer Dose 1 (lot EN6204 IM LA) on 3/9/2021- I had flushing, SOB, metallic taste in mouth, dizziness, and lower back pain right away. I went home, I had arm pain, fatigue, sneezing, congestion, coughing and headache. At night, severe arm pain, stomach pain and felt very ill. Day 2, mild fever, lower back pain, right foot started to swelling , headache, and fatigue. Day 3, started to feel better. I went to my allergist and he checked the ingredients and realized I was allergic to the propylene glycol in the Pfizer vaccine. I still wanted to move forward with getting the 2nd dose and made a plan after my allergist consulted with other colleagues. The plan would be to administer the 2nd dose in small increments into alternating BOTH ARMS over the course of 4 hours in office so that he could monitor me better. I received the 2nd dose in office on 3/30/2021. The doctor administered small amounts over the course of 4 hours alternating arms. I had no adverse symptoms or any side affects like the first dose. The next day, I had extreme fatigue and could barely function and do my activities. The following day, the fatigue worsened, my BP was very high ranging from 170-190 and my heart was pounding hard. I did take my BP medication Tekturna and atenolol but my BP remained high around 200. I found that laying on my left side would bring my BP down. The next morning BP was back to normal and every time I would take my BP medication, my BP would spike up high. My BP reading was fluctuating and as high 221/107 and I decided to go to the ER on 4/5/2021. The ER docs thinks its an autoimmune response to the vaccine. They gave me a drug called Minoxidil which brought my BP down. I took my regular BP Tekturna and my blood pressure would spike. I was admitted and hospitalized for 3 days. They could not find what was causing my blood pressure to spike. I was discharged to follow up with my cardiologist. I had a televisit with my cardiologist on 5/18/2021 and he decided to adjust my Tekturna dosage and that has not been successful in bringing down my BP. On 6/3/2021, I did another televisit with the cardiologist who decided to increase theTekurna dosage to the max limit and that is also not working. This is still an ongoing issue and my blood pressure has not normalized. My most recent BP reading was 189/88.

My throat closed up, difficulty swallowing.; My throat closed up, difficulty swallowing.; Swollen tongue; Elevated blood pressure; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration on 22Mar2021, around 3pm, as dose 1, single (age at vaccination: 63 years), for covid-19 immunization. Medical history included underactive thyroid, she has had this for over 10 years and endometriosis from an unknown date and unknown if ongoing (female problems, these started probably in her early 20's, ended when she went through menopause, which was probably 2013). Concomitant medication included ongoing levothyroxine sodium (SYNTHYROID) taken for underactive thyroid, from an unspecified start date. she had not taken any prior Vaccinations within 4 weeks. Also, there was no such family medical history reported relevant to adverse events. The patient stated that, on 22Mar2021, she was in the car with her husband and after they both got their shot, about 30 seconds after, they drove to the area they were told to sit and she had an immediate reaction to the vaccination. her throat closed up and she had difficulty swallowing (unable to swallow). Reportedly, EMT was flagged, the fire department came over and took her vitals, she had an elevated blood pressure, it was usually normal-low, but she was getting a blood oxygen level of 100%. It felt like her tongue was swollen, it was larger than normal, the EMT said he did not see anything but he did not stick around too long. They really did not know how to handle the situation, she did not know what to do at the time. The nurse said this was all new to them. She told that she opened up her car emergency pack and took a Benadryl in the car and did not know how old it was, if it was expired, but she took it and 20 minutes later she was able to swallow as she was feeling better. She did not have any information for the Benadryl, she reported it was in an emergency pack in her car that had aspirin and other things in it. Reportedly, she was not feeling confident going back to that site because she did not think they handled it well because in an emergency situation. She told that, her next appointment was on 12Apr2021 (scheduled for the vaccine on April 12th). She was also not confident on whether to take the second shot or not. She contacted her physician who told her to start a few days prior to the vaccination taking an antihistamine. Reportedly, There was no emergency room visit or physician room visit for the reported adverse events. The patient underwent lab tests and procedures which included Blood pressure measurement elevated blood pressure, it was usually normal-low, but she was getting a blood oxygen level of 100%. The outcome of the event: elevated blood pressure was unknown, rest of the events were recovered on the same day of first vaccination on 22Mar2021. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.

Heart began racing/have had palpitations on and off throughout my life but never for 12 hours/heart rate was 200+/hanging in 190s, 180s and 174 for hours; Felt faint; No appetite; left with breathlessness for the days that followed whenever going up or down stairs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 18Jun2021 12:45 (Batch/Lot Number: EW0217), as dose 1, single, at age 63 years old, for COVID-19 immunisation, at a pharmacy/drug store. Medical history included ongoing anaemia from an unspecified date, palpitations (have had palpitations on and off throughout life) from an unknown date not reported if ongoing or not, low thyroid function from an unspecified date not reported if ongoing or not due to Hodgkins disease treatment in 1997 (no reoccurrence since 1997), and damaged heart septum from an unspecified date not reported if ongoing or not due to radiation treatment on an unspecified date, and known allergies: penicillin from an unspecified date 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. Concomitant medication included sodium chloride (NATRUM MURTIATICUM 12X) taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Jun2021 at 10:45, after a brief exercise and bending at the waist, the patient's heart began racing and she felt faint. Her heat rate was 200+ and it took 12 hours to return to sinus rhythm of 91 after hanging in 190s, 180s and 174 for hours. Normal measures of bearing down, rest, and metoprolol did nothing. Treatment of thyroidinum brought her heart rate down from 174 to 91. On the same day, the patient had no appetite throughout that day, felt faint each time she sat up and was left with breathlessness for the days that followed whenever going up or down stairs. As the patient got further away from the vaccine date, the symptoms lessened and there had been no flare up of palpitations. The events resulted to physician's office visit. The patient recovered from "heart began racing/have had palpitations on and off throughout my life but never for 12 hours/heart rate was 200+/hanging in 190s, 180s and 174 for hours" on 21Jun2021 22:45, and was recovering from the remaining events. Follow-up attempts are possible. Further information is expected.

my lips were numb; throat was tight; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old 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 27Mar2021 at 12:30 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included gabapentin (GRALISE) 600 mg at bedtime. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021, 30 mins (at 13:00) after vaccination, the patient experienced numbness in lips and throat tightness. The patient had not received any treatment for the event. The adverse event had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lips numb and throat tight was recovered on an unspecified date. Information about lot/batch number cannot be obtained. No further information is expected.

Previous history covid in March 2021. After first shot reactivating of covid symptoms. Fatigue,fever,sever back pain,muscle aches,severe lethargy and headache. After second shot, shortness of breath,cough,headache,back pain and muscle weakness reactivated, cough, severe facial rash.

Around 3/10/2021, I started to notice missed heart beats. Those episodes became more frequent with SOB. I was getting them multiple times a day in addition to chest discomfort and generalized pain. I have a nursing background and notice it is ventricular in nature. Around the 1st week of April 2021, I consulted with a cardiologist and did an EKG, Stress test, ECHO and Holter monitor. The Holter monitor confirms multiple v-tach. I was prescribed a Metoprolol and Verapamil. I am being referred to an electrophysiologist and I have been out of work since 6/9/2021. Even with the new medications, I am still having cardiac issues and tachycardia.

I was having trouble breathing/she had to use her inhaler more than once; Felt nauseous in the morning; I felt fuzzy; My heart began beating rapidly (not normal for me); This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: en6208), via an unspecified route of administration, administered in left arm on 15Mar2021 16:30 (age at vaccination was 63 years) as dose 1, single for covid-19 immunization at Public Health Clinic/facility. Medical history included asthma, osteoporosis, sciatica. Patient Allergies to medications, food, or other products included Penicillin, Prozac, Darvon, Erythomycin, Codeine, Percoset, Bactrin Sulphur drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported and Clonazapin taken for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 16:45, after receiving vaccine patient stayed for 30 minutes since had a history of allergic reactions, she was fine and felt nauseous in the morning and as she worked through the day, she had to use her inhaler more than once. She had Asthma and felt fuzzy and decided to close her store early. Before leaving at 5 PM, her heart began beating rapidly (not normal for me), when she finally got into her car, she had trouble breathing. she always kept and EPI pen in her car and her bag. she injected into her thigh and within minutes, she could breathe again, and the pounding stopped. The EPI saved her life. Therapeutic measures were taken as a result of Asthma and trouble breathing and Patient received treatment for the events included inhaler more than once, while Treatment received was reported as no for all other events. The events were recovered on unspecified date in Mar2021.

hot flashes; Rapid heartbeat; very deep breathing; Tight sore throat; Post nasal drip; Some coughing; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 30Mar2021 at 14:15 (at the age of 63-years old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS). Concomitant medications were not reported. 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 an unknown date in Mar2021, the patient experienced hot flashes, rapid heartbeat, very deep breathing with some coughing, tight sore throat and post nasal drip. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events hot flashes, rapid heartbeat, very deep breathing, some coughing, tight sore throat and post nasal drip. The clinical outcomes of the events hot flashes, rapid heartbeat, very deep breathing, some coughing, tight sore throat and post nasal drip were resolving at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

both doses, throat tightness; This is a spontaneous report from a contactable physician. A 63-years-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot Number: FN6205) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, environmental allergy, chronic myeloid leukemia and overactive bladder. Past drug history included fluticasone propionate, salmeterol xinafoate (ADVAIR) 100/50 twice daily inhalation taken for asthma from an unspecified start date and ongoing, azelastine hydrochloride, fluticasone propionate (DYMISTA) 1 spray each nostril twice daily taken for environmental allergy from an unspecified start date and ongoing; dasatinib monohydrate (SPRYCEL, NDC: 0003-0524-11) 70 mg, one tablet every evening taken for chronic myeloid leukaemia from 2013 to an unspecified stop date; spironolactone (SPIRONOLACTONE) 25 mg once daily taken for fluid retention from 2017 to an unspecified stop date and mirabegron (MYRBETRIQ) 50 mg once daily by mouth taken for hypertonic bladder, start and stop date were not reported. On an unspecified date, the patient experienced some throat tightness the day of the COVID vaccine that dissipated late that afternoon and that was for both doses. Caller was calling about the Pfizer BioNtech COVID vaccine. She had some throat tightness the day of the COVID vaccine that dissipated late that afternoon and that was for both doses. The outcome of the event both doses, throat tightness was recovered on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

This is a spontaneous report from a contactable consumer (patient). A female patient of 63-years-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left upper arm on 24Mar2021 (at the age of 63-years-old) (Batch/Lot number as ER8730) at DOSE 1, SINGLE for COVID-19 immunization. Medical history includes asthma, migraine, vertigo. Concomitant medications include XOLAIR (100mg every 14 day) for asthma and her most recent asthma injection was on 19Mar2021. She had been getting the injections for 5 plus years maybe 8 years. She felt different felt like she was unwell or tired (on 24Mar2021). She stated this started within 15 minutes to half hour and was still ongoing. She stated this had improved. She stated fever started 4 hours after shot might be 3 hours and this was not still going on but at night she was having a fever (on 24Mar2021) when she was trying to sleep as she wakes up all sweated and her temperature has risen to 99 to 100. Sh stated her temperature was normal during the day then when she went to bed the fever starts to come. She stated this had improved since the fever was constant and now it was just at night. She stated nausea (24Mar2021) started about hour in a half after receiving her shot and was still ongoing and this had improved. She stated ringing in ears started 3 hours after the vaccine (24Mar2021) and was still ongoing. She stated the ringing has improved as it has gotten less loud. She stated the first three days she had a crazy amount of phlegm and coughing a lot (24Mar2021). She stated this started about 8 or 9 hours after the shot and was ongoing and this had improved. Chills and cold started 8 or 9 hours (24Mar2021) after the vaccine and stopped about the fourth day after the shot and she has recovered completely. On an unspecified date in Mar2021, coughing started three days after the vaccine and stopped around the fourth day. She stated she had recovered completely. On an unspecified date in Mar2021, tickle in back of throat started three days after the vaccine and she felt a tickle every once in a while in the back of her throat and this had improved. She stated she does have vertigo but it was almost like the vaccine kicked her vertigo up a few notches. She stated if she turned real quick or sits up in bed or turns over in bed she got dizzy. She stated she knew she had vertigo but the vaccine kicked it up few notches. She stated this started probably the evening she received the shot and was still ongoing. She stated this had persisted and was about the same. Rapid heartbeat started the day after the vaccine so on the second day within 24 hours of the vaccine she had a rapid heartbeat which was not all the time it was only when she exerts herself in the least little bit like walking to the bathroom and back to her chair and her heart was not pounding but it was like she was taking steroids and her heart was racing up a little or like the feeling when you drink too much coffee and get jittery. She stated if she sits still her heartbeat calms down but it does take a while. She stated this even happens when she was laying in bed still. She stated it was ongoing and has worsened. In treatment, there was no just been drinking a lot of water. Caller stated she got migraines and these symptoms were nothing and she did not need anything for the symptoms since she just weathers through her headaches. Caller stated she forgot this diarrhea. Caller stated this started 2.5 to 3 hours after the vaccine and cleared up within a couple of days. Caller stated she has recovered completely. AE did not require a visit to emergency room and physician office. The outcome of event Chills and cold, coughing, diarrhea was recovered on an unspecified date in Mar2021, outcome of event dizziness, rapid heartbeat was not recovered, and outcome of other events was recovering. No follow-up attempts are possible. No further information is expected.

Returned to clinic 50 minutes after vaccine complaining of tight throat and side of face and neck. B/P 165/92 P 67 oxygen saturation 92. Treated with 50 mg Benedryl and sent to the ED

Increased SOB while at Dialysis and had to discontinue dialysis. SOB/CHF warranted admission to the hospital- diuresis and supplemental oxygen.

7/23/21: patient came to ED with increased confusion, shakiness, and generally feeling unwell the past day. husband diagnosed with COVID-19 day prior. Patient tested positive for COVID-19. diagnosed with UTI, shortness of breath/cough/hypoxia. Note: patient previously vaccinated with COVID-19 Pfizer vaccine on: 4/10/2021, 5/2/2021 7/27/21: patient still admitted at the time of this report submission.

her faced swelled on both sides where her sinuses are at; Skin roughness; the side of her left thigh had a tingling sensation; she had the tingling sensation in the bottom part of her butt cheeks for the first 2-3 days after getting the COVID-19 Vaccine; her left thigh had welted up; her left thigh had turned red; she had shortness of breath immediately after she had the COVID-19 Vaccine, and the shortness of breath lasted about 10-15 minutes; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9267, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 27Feb2021 at 13:45 hours as dose 1, single (at the age of 63-years-old) for COVID-19 immunisation. Medical history included shrimp allergy for about 7-8 years, patient stated that the shrimp allergy mysteriously started, clarifying she never had a problem with eating shrimp before that time. She said she had ordered a plate of grilled shrimp with pepper and onions, and when she started to eat the shrimp, her lips and face started swelling, she had not touched shrimp again since that time, blood pressure high for about 7-8 years, obesity for about as long as her high blood pressure (7-8 years). She said her weight had fluctuated up and down over time, but she had been obese for probably at least 7 years, gastrooesophageal reflux disease (GERD) (all from an unknown date and unknown if ongoing). Family medical history was not reported. No relevant tests were performed. Patient had no prior vaccinations (within 4 weeks). Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. Patient had no chills, fever, or arm soreness after getting her COVID-19 vaccine. There were no concomitant medications. On 27Feb2021, patient had shortness of breath immediately after she had the COVID-19 vaccine, and the shortness of breath lasted about 10-15 minutes. Patient clarified for the last year she had a problem with GERD. Patient stated that at certain times when she eats, she had shortness of breath and a rapid heartbeat. She said she went to her doctor, and her doctor doesn't know why her shortness of breath and rapid heartbeat keeps happening when she eats. Patient stated that she does not had shortness of breath or a rapid heartbeat every time she eats. Patient stated that she had ate lunch before she got her first COVID-19 vaccine shot. Patient stated that she was not sure if the shortness of breath she experienced after the COVID-19 Vaccine was from the vaccine, itself, or her GERD. On 27Feb2021, patient had her faced swelled on both sides where her sinuses are at. Patient clarified that she could tell there was a difference in her face because the skin got rough up underneath her eyes. Patient had "2 little puffs" right where her sinuses begin, and noticed when she touched her skin, her skin wasn't smooth right there. Patient had no itching with the skin roughness. Patient clarified facial swelling was only for the first hour after getting the COVID-19 vaccine. On 27Feb2021 (noticed later in the day or evening), patient experienced on side of her left thigh had a tingling sensation and had welted up and turned red. Patient clarified that she noticed later in the day or evening, her left leg felt funny, and she felt welts on her left thigh. Patient had her husband look at her left thigh, and her husband said her left thigh had turned red and he could see welts. Patient still had the tingling sensation from time to time in her left thigh. Patient also had the tingling sensation in the bottom part of her butt cheeks for the first 2-3 days after getting the COVID-19 vaccine. Patient stated that the tingling sensation stopped in her butt cheeks (or the bottom part of her rear-end). Patient used her husband's prescription triamcinolone 0.1% itch cream (NDC Number: 45802-064-36, Lot Number: either 6FTO444 or 6FT0444, Expiration Date: May2018) and she was unable to read the Lot Number, he had used for a bad rash on one of his legs. She said her husband thought the prescription itch cream may help her left thigh redness and welts. Patient stated that cream worked good and she hadn't welted up since using the triamcinolone 0.1% cream. Patient stated that her left thigh was still getting the tingling sensation on and off. Patient took an allergy pill, Equate Brand Loratadine 10mg tablet, and couldn't read the NDC Number. Patient stated she needed to put glasses on to read the Loratadine NDC Number. Patient stated that she had to use her cell phone camera to take a picture of the Loratadine NDC Number and blow the picture up to read the NDC Number (NDC Number: 49035-612-95, Lot Number: either 9EE2445A (listed above the Expiration Date) or 612952EF3 (listed below the Expiration Date), Expiration Date: Feb2021). Patient was scheduled to have her next Pfizer COVID-19 vaccine dose on Saturday (20Mar2021). Patient stated that she had some reaction to her first COVID-19 vaccine dose. Patient was wondering because she had a reaction to the first COVID-19 vaccine dose, if she needed to take the second COVID-19 vaccine shot, or what she needed to do. Patient had no emergency room and physician office visit for all the events. The outcome of her faced swelled on both sides where her sinuses are at, Skin roughness, had the tingling sensation in the bottom part of her butt cheeks for the first 2-3 days after getting the COVID-19 Vaccine, her left thigh had welted up, her left thigh had turned red, had shortness of breath immediately after she had the COVID-19 Vaccine was recovered on an unspecified date of 2021, shortness of breath lasted about 10-15 minutes was recovered on 27Feb2021, recovering for the side of her left thigh had a tingling sensation. No follow-up attempts are possible. No further information is expected.

Fell dizziness; I couldn't stand up I was throwing up; my breathing was shallow; Throat was dry; Mouth was dry; Shaking uncontrollably; Heart palpitations; This is a spontaneous report from a contactable other healthcare professional, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 02Apr2021 at 09:15 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, shellfish and penicillin allergy. concomitant medications included unspecified blood pressure medicine. 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 02Apr2021 at 19:30 in the evening, the patient fell dizziness, she couldn't stand up she was throwing up, her breathing was shallow, her throat was dry, her mouth was dry, she was shaking uncontrollably and had to call EMT also was getting heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events fell dizziness, couldn't stand up she was throwing up (balance difficulty), breathing was shallow, throat was dry, mouth was dry, shaking uncontrollably and heart palpitations were recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Heat sensation at base of throat which shot up to both sides of my throat and very hot sensation in face.; Throat tightened; Hard time swallowing.; Jerky moves in my leg muscles; Very thirsty; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, Ndc: 59267-1000-01) via an unspecified route of administration in the arm left on 23Mar2021 at 11:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol, shellfish allergy and penicillin allergy. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received erythromycin base (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. 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 vaccine. On an unknown date in Mar2021, the patient had a rolling heat sensation at base of throat which shot up to both sides of the throat and very hot sensation in the face. The patient's throat tightened up and had a hard time swallowing. The patient had jerky moves in leg muscles which where do the right thought, it was as if the patient was going to have a "Charlie horse" in both calves. Symptoms calmed down by 17:00 that day. The patient was very thirsty and throat still unstable but calmer. The patient did not receive any treatment for the events. The event 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 sensation of heat, jerkiness and swallowing difficulty were recovered on an unknown date in Mar2021, while that of the events throat tightness and thirst were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

could not breath; chest pain; Really sick; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, (Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was Reported that, she got her first shot of the Pfizer Covid 19 vaccine 3 weeks ago and got really sick after that and also, she was taken to the ER as she could not breath and experienced chest pain. The outcome of the events was unknown on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Vaccine given on 12/17/20 went to ER on 12/18/20 . Started having diarrhea at 4am on 12/18/2020. Came in to work and felt short of breath and heart rate increased. She went to the ER. She was given a liter of fluid 0.9% NACL IV, and per employee all symptoms resolved and she was discharged. She reports no further problems.

Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain

Systemic: Exhaustion-Mild, Systemic: Fever-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Headache-Mild, Systemic: patient experienced pain when taking deep breaths but was positive for covid in march2020 and out of work until june 2020. last covid swab was 12/22(negative)and 12/29. temperature was 99.6 and pulse

Employee reported having SOB with chest pains, severe headache (rated pain as 8/10), excessive salivation with nausea, lightheadedness, she has a h/o migraines headaches and was incapacitated for 24 hours, Employee she was treated and sent home by end of her scheduled shift

burning of the tongue; Difficulty in breathing; headaches; Pressure in the chest area; nausea; dizziness; fast heartbeat; tiredness; Had a hard time swallowing at night from the dryness; bitter taste; her mouth went completely dry; patient received 0.45 mL, single dose (225mcg) of PFIZER-BIONTECH COVID-19 VACCINE; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 23Dec2020 15:00 at 0.45 mL, single dose (225mcg) at left arm to prevent COVID. Medical history included a bout of dry mouth about 7 years ago, no other relevant medical history (including any illness at time of vaccination). The patient's concomitant medications were not reported. There's no adverse events following prior vaccinations. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. From the time she got the vaccine her mouth went completely dry on 23Dec2020 and she kept thinking it would go away and she still had it. Event was reported as serious per medically significant. Had a hard time swallowing at night from the dryness. Patient had the bitter taste was also on 23Dec2020, but it went away. It lasted about 5-6 hours. Then after that the dry mouth started right after. It is tolerable but she still had it. Mentioned she had a bout of dry mouth about 7 years ago and it did go away, but she never got a diagnosis for it. Patient thought that something underlying may have triggered it again. Patient also experienced burning of the tongue, tiredness, headaches, pressure in the chest area similar to difficulty in breathing, nausea, dizziness, and a fast heartbeat on unspecified date. Outcome of event dry mouth was not recovered, outcome of event bitter taste was recovered on unspecified date in Dec2020, outcome of other events was unknown. No family medical history relevant to adverse events. No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Relatedness of Pfizer BioNTech Covid-19 vaccine with dry mouth and bitter taste per primary source reporter with method of assessment of global Introspection was related. Reporter seriousness for event bitter taste was not serious.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of dry mouth cannot be excluded, considering the plausible temporal relationship. 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.

shakiness, subjective feeling of tongue and throat swelling. mild tachypnea tachycardia = 80 no BP changes no rash no observed facial swelling or lip swelling but patient has dense right facial hemiparesis with preexisting asymmetry Epi pen administered, transferred to ED> solumedrol and Benadryl given IV and observation x 2 hours. home with oral prednisone x 5d dx "anaphylactoid reaction"

ER/URGENT CARE VISIT: Opening Alert charting for RETURN FROM ER (DX SEIZURE HISTORY OF). resident was sent out to the ER @ 11:54 AM after having trouble breathing following her COVID vaccination. RN administered EPIPEN, emergency services was called and resident was sent out VIA ambulance

Pain/deep pain in the chest, hypertension, SOB. Was seen at Hospital ER where they did lab work, EKG, and CXR. Employee's symptoms resolved while in the hospital and employee was realeased home and back to full duty.

ran low grade fever 12/19/2020 ,12/20/2020 Fever, fatigue 12/22/2020 sever diarrhea , 12/26/2020 feeling worse and worse and tested on 12/26/2020 on 12/28-29/2020 shortness of breath and admitted on 12/31/2020

At 9:53am patient reported "pressure" in her chest. Patient described pressure as if what she may experience with asthma. Patient denied chest pain. Vitals taken every 5 minutes. Patient declined supplemental oxygen. Patient declined IM Benadryl. Patient administered 50mg of oral diphenhydramine at 9:55am . Patient refused to go to ER. Patient was alert and oriented x4.

I had a sore throat like it was inflamed and my lymph nodes were swollen. I went to Urgent Care in about 2 weeks after the vaccine. The rapid strep test was NEG.

She described feeling of shortness of breath and self-administered Albuterol inhaler (home med). Continues feeling short of breath, now with chest heaviness. BP 148/74, HR 123, RR 26, p.ox 100%. Sent to critical bed immediately on report of chest heaviness. Treated with Prednisone, Claritin, Famotidine

Patient was at end of 30 minute monitoring and stated she "felt off, my throat feels dry." Able to sip water. Continuously monitored for additional 10 minutes when she stated her throat felt tight. BP 150/85, HR 97, RR 20, p. ox 99%. Sent to critical bed in emergency. Epinephrine, Solu-medrol, and normal saline given. Monitored until 11:18 (3.5 hours from onset) and discharged.

COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20mg of famotidine was administered around 1410. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3mg of epinephrine was administered at 1420. EMS was called. Breathing improved. Pulse ox 100%, HR 68, BP 130/89. EMS arrived and assumed patient care. Pt seen in Emergency Room 1/16/2021 1513 CHIEF COMPLAINT: reaction to COVID vaccine HISTORY OF PRESENT ILLNESS: Patient is a 64y F with PMHx significant for Myopericarditis, Anxiety and HTN who presents to ER after developing tongue swelling, wheezing, tunneled vision and shortness of breath. Patient states that she was getting first shot of COVID19 Pfizer vaccine at 2:00 pm. After getting vaccine she waited 15 minutes like she was told and recalls room getting very hot at approximately 6 minutes after getting vaccine. She also states that her tongue felt swollen. She then noticed her vision started to turn dark and then she felt dizzy. She told pharmacist about symptoms and then she was given one pill of Benadryl. This did not help and actually made her symptoms worse. She recalls wheezing. She was given another pill of what she believes was Benadryl. She also recalls pharmacist measured her BP and her husband, who was present, reported that her blood pressure was in the 140s This did not improve so she was given 0.3mg IM epinephrine shot. This significantly improved her symptoms. However, she was sent to ER. She denies any hx of recent UTI or GI infection. She denies fevers, chills, nausea, diarrhea, chest pain, generalized itching, vomiting, abdominal pain, generalized swelling, headache or syncopal episode. She denies any past reactions to vaccines. She denies current SOB and feels like her symptoms resolved. Denies hx of COPD or asthma. Physical exam did not show any recurrent signs of wheezing or tongue edema. Her SaO2 was 100% on RA and BP was within baseline 140-160s. Given episode, we decided to obtain tryptase levels. We also observe patient to ensure she did not have any recurrence of symptoms. She remained hemodynamically stable and SaO2 remained in mid 90s to 100. She was given a rx for epinephrine pen should symptoms recur though this is highly unlikely as she remained stable throughout ER stay. She was also given instructions to pick up OTC Benadryl and Pepcid. She does have antihistamines listed as an allergy but patient states that she gets tachycardic upon taking tabs, so this could just be a side effect. We will follow up with tryptase levels but even if tryptase levels return as normal, it does not mean she did not have an anaphylactic reaction to vaccine. Her clinical picture puts this diagnosis high in the differential. Teaching and instructions were given to patient and her husband. She was advised to return to ER if symptoms recur. IMPRESSION: Anaphylaxis Anxiety attack

Normal sinus rhythm but throwing PVCs; Elevated pulse with chest tightness; Elevated pulse with chest tightness; A little atelectasis in lower left lung; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left deltoid on 14Jan2021 09:00 at single dose for covid-19 immunization. Medical history included ongoing does not have a thyroid; allergies/intolerance to gluten and dairy, allergies to molds, dust and some seasonal allergies; all ongoing. Concomitant medication included levothyroxine from Feb2013 to unspecified date, from unspecified date and ongoing for "does not have a thyroid". The patient previously took codeine and experienced allergic reaction occurred at 13 years of age with unknown cough syrup with codeine, levaquin and experienced allergic reaction occurred probably while she was in her 20s (age in years). She had fallen asleep on the couch about 9:00 pm on 14Jan2021. She woke up about 9:30 pm on 14Jan2021 and had an elevated pulse with chest tightness. She had to go to the emergency room in response to elevated pulse with chest tightness. In the emergency room they were not able to do anything other than hydrate her and all of that but it took about 12-13 more hours for her elevated pulse to come down (15Jan2021). Her biggest question was that she saw where some reactions are fast heart beat but she was kind of surprised at how long after the dose was administered that she had onset of the elevated pulse. She saw Cardiologist 18Jan2021 related to this event and the Cardiologist was a little baffled by the event. She reported event as improved, although she still has a little bit of tightness in her chest which goes in a little bit of phases. The Cardiologist told her to still take the second dose as scheduled of the Pfizer COVID-19 Vaccine. She did not see her family doctor, she saw the Cardiologist only as referred after emergency room visit. She was not admitted to the hospital; she was treated and kept under observation in the emergency room for about 5.5 hours. She has a stress test scheduled for next week. She is planning to still get the second dose as scheduled of Pfizer COVID-19 Vaccine but she is a little scared to get it due to this adverse event. She thought the events were related with the vaccine, she had no problem prior to getting the vaccine. On 14Jan2021, pulse was 146 beats per minute which she checked with a pulse oximeter machine she has at home so she knows it is accurate; Chest x-ray: She reported that result of a little atelectasis in lower left lung was a little weird. On 18Jan2021, the EKG result was Normal sinus rhythm but throwing PVCs. She reported she knows her thyroid lab is normal because it was checked in the emergency room during visit starting 14Jan2021. The outcome of the events elevated pulse with chest tightness was recovering, other events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

muscle swelling; welts/hives; muscle pain; eyes swelling; tongue swelling; shut throat; blood pressure elevated; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiration date not reported), via an unspecified route of administration on 17Dec2020 15:15 at single dose on right arm for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. No Known allergies to the patient currently. The patient was not pregnant. Concomitant medication in two weeks included Rosuvastatin. The patient received the vaccine in hospital. No other vaccine administered in four weeks. The patient experienced muscle swelling, welts/hives, muscle pain, eyes swelling, shut throat/tongue swelling, and blood pressure elevated hospitalization continued symptoms now for 35 days. All adverse events (AEs) started on 17Dec2020. AEs resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization for two days. Patient received treatment (medications, IV's EKG many test) for AEs. No COVID prior vaccination. Patient did COVID tested post vaccination, COVID test post vaccination included Nasal Swab on 02Jan2021 with result of Negative. The outcome of events was not recovered.

Dizzy Heart Palpitations Shortness of Breath Tingling of Lips & Tongue Swollen Face Head Pain Throat Tightness

37 hours after Pfizer injection, experienced severe abdominal pain that caused me to have vasovagal syncope. Started sweating, and I lost my vision, then must have fallen on the floor. When I came to, felt very headachy and nauseous. went to urgent care - they ordered an abdominal scan for 2/8/21 but scan did not reveal the cause of the pain. 8 hours later on 2/5/21, started feeling asthma like symptoms. Throat felt tight, voice became hoarse, kept having to cough because airway was starting to feel thickened. went to ER, they took vitals and told me that i wasn't having an allergic reaction because my symptoms were outside the time frame for an allergic reaction. After 3 hours there, they sent me home. Next morning felt like I was having heart palpitations. that feeling eventually went away if I walked around. But the following two mornings, I had the same feeling.

Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )

25 minutes after receiving vaccine: flushing, slight throat swelling;Vitals were normal Resolved within 1 hour

After receiving the COVID vaccine at 12:43 patient stated that she couldn't breath and her arms & legs were numb at 1:10 pm. Patient received an Epinephrine pen at 1:12 pm and the paramedics were contacted.

Within a few minutes of sitting in waiting zone, I had what I thought was severe heartburn. Simultaneously I felt my heart racing and feeling flush. I raised my hand to alert attendant. Took pulse and it was very high. They called EMT. Upon connecting me to heart monitor is was erratic, Very high blood pressure. When they touched chest it hurt more. They said I was bright red. They transported me via residue to Hospital. Residual mild rash under skin for several days. Had severe headache for 14 hours.

Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to itch a little. A little itching around eyes. About an hour after, felt tightness in my throat and neck, glands felt swollen. Became slightly hoarse, had to clear my throat often. Felt a little like asthma attack. Have had similar reaction when eating seafood

Patient received vaccine at 1008. At 1038 patient presenting with c/o "throat tightness" and flushing of the skin. Pt has history of anaphylaxis with shellfish, contrast, and allergy shots. Ems notified in house. 1047: VSS: B/P 130/77, HR 77, SaO2 95-97% on RA. Appears in NAD, Skin pink, warm and dry. Patient given water and able to swallow without issues. Observed patient for 45 minutes and symptoms resolved patient cleared by EMS and discharged home.

Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - difficulty breathing and swallowing, weak, dizzy, rapid heart beat - started about 16-17 minutes after the vaccination. Lasted a little over 3 hours. Profound fatigue the next day.

Patient taken to ED by EMS after COVID vaccine. Patient with SOB, dizziness, and HA after first COVID vaccine.

Severe difficulty breathing; difficulty breathing frightened her; This is a spontaneous report from a contactable consumer (patient). A 64 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), intramuscular (on the upper left shoulder) on 27Jan2021 09:20 (at the age of 64-year-old), single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism diagnosed about 14 years ago, breast cancer from Dec2017 and ongoing diagnosed in Dec2017, ongoing asthma she was diagnosed with asthma when she was 39 years old, surgery from an unknown date, she had surgery to correct a deviated septum and her asthma got better, she has high blood pressure after all the treatment. Concomitant medication included salbutamol (ALBUTEROL). On 27Jan2021 she had the first injection. It was about 14 to 16 hours after the injection that she had severe difficulty breathing. Reported she has asthma. She was a cancer survivor, and she has high blood pressure after all the treatment. The difficulty breathing woke her out of her sleep. She had to call the doctor since she is concerned about her second dose which is scheduled for 17Feb2021. The difficulty breathing frightened her, and it was not an immediate reaction, she had the shot at 9:30 am (clarifies she received the injection at 09:20 am) and between 1 to 2 am in the night, she woke up not able to breathe. She could not use her inhaler since she could not really breathe in. She was obviously able to get some air in since she did not pass out. She contacted her doctor and he will send her a prescription to get an Epipen, so she has it on hand when she gets her second dose. Her doctor does not want her to not get the second dose. States she is concerned about other asthmatics receiving the vaccine and wanted to call and report this. She expected it to happen onsite where she received the injection but it did not. Her doctor asked her if she thought it was an asthma attack and she told her doctor that she has not felt like this in 24 years. Treatment/Outcome: She stepped out into the cold to shrink her airways and then was able to use her inhaler. Reports it was not a 2 hour episode thank god, and within 15 minutes she was able to force an inhaler dose in. Everything is fine. She is a breast cancer survivor and cannot use her right side so she had the injection on her left side in her upper shoulder, she has to wait 5 years to be considered cancer free. Her doctor suggested to use her albuterol inhaler for 4 days in advance of getting the second dose of the vaccine. She would think that would be abusing her albuterol but she will do that since she was instructed to do so by her doctor. She was terrified. She will have an Epipen on hand when she goes to get her second dose. She understands the symptoms can be worse with the second dose, she is anticipating everything should be fine. The outcome of the event difficulty of breathing was recovered on Jan2021, for the other event was unknown. No additional vaccines administered on same date of the Pfizer Suspect. No AE(s) following prior vaccinations, states she has had everything. No Prior Vaccinations within 4 weeks.