Pfizer

Patient was poorly responsive to her inhalers that she used for asthma; Persistent shortness of breath and chest tightness starting within a few days after vaccine; Persistent shortness of breath and chest tightness starting within a few days after vaccine; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received the first single dose of BNT162B2 (Solution for injection, lot number: EK5730, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 18Dec2020 04:15 for COVID-19 immunization. Medical history included allergy induced asthma, allergies to cats and dust, and occasional seasonal allergies. Concomitant medication included other vaccine/s received within 4 weeks prior to the COVID vaccine: first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX, GlaxoSmithKline) administered as single dose via unspecified route of administration (vaccine location: left arm) on 08Dec2020. There were no other medications the patient received within 2 weeks of vaccination. The patient experienced persistent shortness of breath and chest tightness starting within a few days after vaccine (24Dec2020). Patient was poorly responsive to her inhalers that she used for asthma (onset date not reported). She rarely needed the, used about once or twice a year). It was constant, but with periods of improvement followed regression. Will likely seek medical evaluation as it's been over a week now and rather concerning. The patient did not consider the events shortness of breath and chest tightness as serious. Treatment for the adverse events shortness of breath and chest tightness included fluticasone propionate, almeterol (ADVAIR), albuterol, and unspecified anti-allergy medications. Patient did not have covid prior vaccination. Patient was tested for COVID post vaccination wherein patient tested negative for COVID via Covid test rapid on 30Dec2020. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of shortness of breath and chest tightness was not recovered and unknown for the other event.; Sender's Comments: Based on the time association, the possible contribution of BNT162B2 to the events shortness of breath , chest tightness and asthma aggravated 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.

AT APPROXIMATELY 1000, PATIENT BEGAN COMPLAINING OF FEELING "VERY NAUSEOUS" AND NEEDED A BIN. PATIENT WAS BROUGHT BACK INTO THE IMMUNIZATIONS CLINIC FROM THE WAITING ROOM. ONCE SEATED, PATIENT THEN BEGAN FEELING "HOARSE AND TROUBLE BREATHING", WHICH THEN EPI-PEN WAS GIVEN AT 1004. VITALS AFTER EPI PEN BP 133/77 O2 99% HEARTRATE 103. CODE WAS CALLED SIMULTANEOUSLY. PATIENT WAS THEN BROUGHT TO EMERGENCY DEPARTMENT VIA WHEELCHAIR WITHIN THE HOSPITAL BY CODE TEAM.

Frontal headache lasting about twenty minutes. Later that night, about 4 hours after receiving the vaccine, I experienced mild wheezing for less than 5 minutes, but believe this was likely due to allergies and associated postnasal drip rather than the vaccine. The following day I had mild muscle soreness and injection site pain without swelling or redness.

Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II, non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea. .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily. Per MD note. While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.

30 seconds after receiving vaccine, felt dizzy, HR / BP increase, and pressure in throat. RN at clinic confirmed HR tachycardic, BP 170/98. Administered 50 mg IM Benadryl and transported to Hospital ER via wheelchair 2-3 minutes away.

Heart event stopped him from breathing; stroke; lack of air; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 13Jan2021 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included nut allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included zolpidem tartrate (AMBIEN) and doxepin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 13:00, the patient experienced heart event that stopped him from breathing and the lack of air caused a stroke; all reported as life-threatening. On 14Jan2021, the patient underwent lab tests and procedures which included COVID-19 test which was negative. The patient was treated for the events which included being put on a ventilator and sedation. The clinical outcomes of the heart event stopped him from breathing, lack of air, and stroke, were not recovered.

I have a reaction to the flu shot so my MD recommended that I premedicate with Zyrtec. I did one hour prior to injection. Around 5 minutes after my injection I could feel my throat swelling. I alerted the nurse and took a Benadryl tablet. The swelling stayed consistent and I was able to breathe so I waited for an hour and then went home. When I arrived home I felt and increase in the swelling so I took another Benadryl. The swelling slightly decreased but was still present for 5 hours post shot and then disappeared. The only other reaction I had was metallic taste in my mouth and extremely sore arm where injection was given for 2 days.

Pt developed throat constriction/pressure about 20 minutes after vaccine #2 of the COVID-19 series. He had no symptoms after the first dose. He denied any other symptoms. Denies SOB, cough, throat/tongue/lip swelling. Physical exam and initial vitals were normal. At 1100, he was given Benadryl 25mg po x1 dose. He reported symptoms were improving shortly after. At 1110, repeat vitals were still normal and physical exam was unchanged. Pt reported feeling better. He was discharged back to work in stable condition at 115.

Chill like sensations; Aches; Dyspnea on Exertion; General Malaise; Fever; Persistent headache that is not relieved with pain killers; other vaccine same date vaccine date 22Dec2020, dose number 1; other vaccine same date vaccine date 22Dec2020, dose number 1; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date not reported), intramuscular in the right arm on 22Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL IR), vitamin d3, calcium ascorbate (VITAMIN C), vitamin b complex, magnesium, cynara cardunculus extract (ARTICHOKE EXTRACT), and vaccinium macrocarpon (CRANBERRY EXTRACT). On 23Dec2020 07:00, the patient experienced chill like sensations, aches, dyspnea on exertion, general malaise, fever, persistent headache that is not relieved with pain killers. It was also reported that other vaccine with same date vaccine date on 22Dec2020, dose number 1. The patient underwent lab tests and procedures which included salivary sample (SARS-cov-2 test): negative on 01Dec2020 . No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.

Patient presents to ED on 1/14/2021 with respiratory arrest and started around 1300. Per EMS, reportedly told fiance that he had taken some sleeping pills and was going to go to sleep. EMS was called after the patient was found unresponsive about 15 minutes later. Family attempted to do CPR. Upon EMS arrival to the patient's home, patient had a pulse, was in respiratory distress with agonal breathing. They also reported emesis in the airway. EMS performed nasal intubation and administered 10 mg IV Narcan en route. Upon arrival to the hospital, patient was moving arms more and gritting teeth. Patient had movements of decerebrate posturing of arms intermitting with a relaxed posture. GCS was 4 on arrival. Patient is currently still in ICU and has been extubated.

2 days post vaccine Pt reports that he experienced sever flu like symptoms with the worse being fatigue, tachycardia, and shortness of breath. He reports the symptoms lasted for about 1 day except the tachycardia and shortness of breath. He reports 8 days after onset of adverse symptoms with complaints of continue shortness of breath with walking or going up stairs. At time of visit Patient positive for tachypnea and tachycardia. Wheezes audible throughout lung fields.

throat swelling, shortness of breath Patient given first dose of Pfizer COVID 19 vaccine at vaccine clinic. Within 15 minute observation window, patient reported shortness of breath, difficulty swallowing, and throat swelling. Epinephrine 0.3 mg IM autoinjector was administered and emergency response team was called. Patient was transported to ED and was fully alert, with no respiratory distress or other complaints upon arrival to ED. Was given diphenhydramine 50 mg IVP, methylprednisolone 125 mg IVP, and fluids. Blood work and chest xray obtained. No notable findings. Patient was discharged from ED with prednisone dosepak, cetirizine, and famotidine outpatient prescriptions.

Pt's significant other called nurse triage line on 3/14, stated that patient had not been eating since his second dose of the COVID vaccine and was having severe abdominal pain and was "doubled over in a fetal position and sweating profusely." Triage advised them to call EMS. Patient presented at the emergency department an hour later, was diagnosed with acute appendicitis, and was admitted to general surgery. Laparoscopic appendectomy was completed on 3/14 with successful removal of "acute gangrenous, perforated appendix" and patient was discharged home the same day with no complications.

Approximately 1-2 weeks after 2nd vaccine patient experienced dyspnea with exertion when running or walking fast going up stairs. Symptoms are still ongoing at this time.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild

Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.

2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquetball and area around chin and neck severely swollen. Developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling was administered Percocet, Fentanyl, Ketorolac, and Morphine, 2 COVID test were negative. Due to difficulty breathing issues admitted through ER to hospital critical care unit 9 days post vaccine. Hospital stay 4 days 3/27/21 thru 3/30/21. On 4/7/2021 still have hard swelling in neck and under chin area

Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness. Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity. I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg

Thursday, March 25th at 3:10pm I received my 2nd dose of the Pfizer vaccine. Thursday, March 25th at 9pm I had cold chills, headache, low grade fever, diarrhea, and fatigue. These symptoms lasted Thursday night, Friday, Saturday (March 25th - March 28th). Sunday, March 29th at 4am I woke up with severe chest pains, shortness of breath and light headed. At this time I went to the emergency room.

Pain underneath right rib cage and difficulty breathing. It got worse over two days and then I was hospitalized. Coughed up blood. Tested with Heparin drip and now I?m on Xarelto. No previous history of blood clots. This happened three days after second vaccine

Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm causing moderate to severe positional pain and some difficulty breathing. Self treated with advil and tylenol. Laid flat on the floor for several hours in a position causing least amount of pain, until cramping subsided. Cramping lasted a total of 10 to 12 hours starting some time overnight after injection.

shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen; chills; fever; fatigue; body aches; vomiting; painful to swallow; This is a spontaneous report from a contactable Other-HCP (patient). A 40-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6206, Expiration date was not provided) via unspecified route of administration at left arm on 18Mar2021 09:30 at single dose for COVID-19 immunisation. The patient medical history included type 1 diabetes and Sulfa drugs. Concomitant medications included insulin human (HUMULIN R), insulin human injection, isophane (HUMULIN N) and sildenafil. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) via unspecified route of administration on right arm on 25Feb2021 12:30 PM for COVID-19 immunisation. If other vaccine in four weeks and Covid prior vaccination reported as no. Patient tested Covid post vaccination. On 20Mar2021 09:00, 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump/lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen. The subject developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling Percocet , Fentanyl, Ketorolac, and Morphine were administered. It is also reported that the subject received antibiotics for the adverse events. 2 COVID test were negative. Due to difficulty breathing issues the subject was admitted through ER to hospital critical care unit for 9 days post vaccine. The subject was still in hospital 11 days post vaccine. The patient underwent lab test procedure included Nasal Swab (SARS-CoV-2 test): Negative on 26Mar2021 and Negative on 27Mar2021. The outcome of the events was not recovered.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between the reported, serious dyspnea and BNT162B2 administration. The impacts 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.

passed out/stopped breathing for 15-20 seconds.; passed out/stopped breathing for 15-20 seconds.; Felt faint; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 25Mar2021 11:00 (Lot Number: EN6205) as single dose for covid-19 immunisation at age 40 years old. The patient's medical history was not reported. No known allergies. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medication included loratadine (CLARITIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 14:00 (lot no: EN6200) in left arm for COVID-19 immunization at age 40 years old. On 25Mar2021 11:15, the patient felt faint, had trouble breathing, and passed out/stopped breathing for 15-20 seconds. The adverse events resulted in emergency room/department or urgent care. Treatment for the events included EMT monitoring onsite, saline and other meds (unspecified). The patient recovered from the event passed out/stopped breathing on 25Mar2021; while recovered from other events on an unspecified date in Mar2021.

I was fine for a while but on the 10th (4/9) day after taking my first shot I started feeling my throat swell up. The next day (4/10), my body shut down. I was in bed and slept most of the day. My throat was sore and swollen and had general fatigue. The third day (4/11), I brought myself to a medical clinic and got a strep test, negative; rapid covid test, negative. I also received the PCR test which turned up negative a few days later. My throat culture results are still pending. 4th & 5th day I was still coughing with a sore throat and fatigue. Day 6 is today and I am still fatigued with a sore throat but I seem to have turned a corner. I am able to get up and walk a little at a time. This may not be related to the shot but it was close enough where I felt the need to report it. I am scheduled to take my 2nd Pfizer shot on 4/20 and am curious if I should push it back or not.

On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and couldn't do more than 15 minutes. He was very winded. On March 7, we skipped exercise. On March 8, patient tried to do simple stretching exercise, and couldn't do it. He got winded and shaky. On March 9, he was seen at an urgent care where he was told he had an inverted T wave on his EKG and a very fast heart rate (125 resting pulse). He was told to not exercise and to make an appointment with a cardiologist. On March 9, I called the urgent care clinic to ask questions about monitoring his blood pressure and when to seek more medical care. I spoke with Dr, who prescribed Atenolol. Around 4:30 pm on

Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. Dizziness. Eyes being extremely sore. Fatigue. Difficulty concentrating.

Shortness of breath. Disorientation, Dizziness, Gastrointestinal issues, urinary tract discomfort, blurred vision for extended periods of time during multiple days.

ER Nursing Intervention/Reassessment [Charted Location: EMR-Emergency Rm Service] [Authored: 04/16/2021 15:18]- for Visit: 004092726008, Complete, Revised, Signed in Full, General IV: IV Intervention: ? IV IV INTERVENTION/REASSESSMENT ? IV 1 Date 04/16/2021 ? IV 1 Time 14:25 ? IV IV 1 ? IV 1 Size 20G ? IV 1 Type peripheral iv ? IV 1 Inserted By inserted per RN ? IV 1 Side right ? IV 1 Right antecubital ? IV 1 Actions flushes easily labs obtained ? IV 1 Dressing needleless valve placed, catheter secured, transparent dressing applied with date/time/initials transparent semi-permeable dressing applied ? IV 1 Response pt. tolerated well pt instructed to call RN for problems ? IV 1 Total Attempts 1 COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes (1) ? Was this COVID-19 vaccine your: First dose (1) Assessment Date / Time: ? Date/Time 04/16/2021 14:25 History of Present Illness: Chief Complaint: ? History of Present Illness allergic reaction ? Onset Time/Last Seen Normal 04/16/2021 13:15 Skin Assessment: Skin Assessment: ? Skin cool diaphoretic ? Mucous Membranes moist intact COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes ? Was this COVID-19 vaccine your: First dose ER Triage Note: ? Triage Date/Time 04/16/2021 14:21 ? Triage Chief Complaint medical, Allergic Reaction to Covid Vaccine ? Additional Triage Comments Pt states he went home after receiving his Covid Vaccine (Phizer) when he noticed he was itching on his back. Pt arrived to ED with generalized erythema, skin cool and clammy, and wheezing. Pt denies contact with chemicals or anything else. ? Have you been sexually assaulted? no ? Stroke Screening no ? Pregnant/Could be pregnant not applicable ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes ? CDC Early Warning Symptoms None Identified ? CDC Precautions standard precautions mask applied Infectious Disease: Infectious Disease: ? Have you traveled recently? No ? Do you have any of the following symptoms? none Mode of Arrival: ? Mode of Arrival private auto Height/Length - Weight for Calculation: Weight for Med Calculation: ? Height (ft) 6 Feet ? Height (remainder in inches) 0 Inch ? Height (cm) 182.8 cm ? Body Measurements stated ? Weight for Calculation (kg) 108 Kg ? Weight Method stated ? BSA (m2) 2.29 M2 ? BMI (kg/m2) 32.3 kg/m2 Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On room air ? SpO2 (%) 98 % Treatment Prior to Arrival: ? Treatment Prior to Arrival none Allergies: Allergies/Intolerances: Allergies: ?? Pfizer-BioNTech COVID-19 Vaccine: Anaphylaxis ?? tramadol: Hives Home Medications - OMR: Home Medications - OMR: * Patient Currently Takes Medications as of 04/16/2021 15:11 documented in Structured Notes ?? losartan 50 mg oral tablet: None, 1 tab(s) orally once a day, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: ?? Albuterol (Eqv-ProAir HFA) 90 mcg/inh inhalation aerosol: None, 2 puff(s) inhaled every 6 hours, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: Patient Seen Time: ? Patient Seen Time 04/16/2021 14:21 ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On Pulseox: 98 % on RA @ bedside monitor -- normal ? SpO2 (%) 98 % ? Acuity Level 3 Preferred Pain Scale: Preferred Pain Scale Numeric Pain Scale© Numeric Pain Score - Rest© 0 - No Pain Numeric Pain Score - Activity© 0 - No Pain Treatment Prior to Arrival: ? Treatment Prior to Arrival none Nursing Documentation Review: ? Triage Review I have reviewed the above Vital Signs, Nursing Documentation and Triage Assessment. Arrived From: ? Arrived From home home after leaving vaccination clinic HPI: ? HPI CC: rash/itching HPI: history from patient He describes Covid just after receiving the Pfizer vaccine, his initial dose. By the time that he returned home he had opened up a soft drink was having some slight cough, trouble swallowing and had sensation of itching on his back. He asked his mother to check his back and it was discovered that he was starting to have rash over his body. This seemed to be persistent and he returned to ER for further evaluation/treatment. He has not had reaction to vaccination in the past. He does have allergy to tramadol. He denies having any allergy to soap, detergent, or other chemicals. He denies having exposure to any chemical, fume, dust, plant material after receiving the vaccination. He denies having any new foods or drinks recently. He is not having any nausea or vomiting. He has felt somewhat sweaty. Allergy: tramadol H/O LE muscle weakness/atrophy , COPD ROS Const: No fever, chills, sweats. No unusual weakness (he does note "my leg is atrophying" when he is speaking about his LLE) HEENT: No runny nose, congestion, ear ache. Perhaps some odd sensation in the throat due to swollen uvula. CV: No chest pain, palpitations. No unusual shortness of breath. No edema to the ankles / legs. No pain with breathing. Abdom: No nausea, vomiting, diarrhea, or constipation. No abdominal pain. Lymph: No swelling to glands. Physical Exam: ? Physcial Exam A&O, nontoxic. Pleasant. No pain distress. Mild physiologic distress. Appears to be overwt adult with component of chronic illness and with acute allergic reaction/process_. Eyes: EOMI, nonicteric, conjunctiva clear. Throat: Moist mucous membranes. Symmetric rise of palate. No pharynx erythema. Tonsils normal size and without erythema or exudate. His uvula is moderately edematous and elongated. He is managing his secretions well. There is no angioedema of the tongue, soft palate, lips. No stridor. No blood in the oropharynx. No rhinitis/runny nose. Neck: supple, normal ROM, nontender. trachea midline. No cervical or supraclavicular lymphadopathy. Thyroid nontender and normal size. Back: No pain on percussion. No muscle spasm. Nontender palpation. No kyphosis. Lungs: fair to good air movement with quiet, fine primarily inspiratory wheezes in the mid to lower lung fields. nl effort, no rales, crackles, rhonchi. Normal resonance on percussion. Cough clear. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, Pedal pulses 2/4 bilaterally. No ankle or pretibial edema. Skin: cool & dry extermities. cool & moist (not diaphoretic) back skin. Normal turgor. He does have confluent macular rash to the neck, (somewhat on face), arms, back/chest/abdomen. Some mild hyperemia to the legs/ankles. No urticaria. The right deltoid injection site is involved with the hyperemia/macular rash but no urticaria at this location right now Abdom: Bowel sounds present x 4 Quadrants. Normal tympany to percussion. Soft. Non-distended. Nontender. Nonsurgical. Good muscle tone and moves all extremities. He notes he has his chronic weakness in his left lower extremity. Medical Decision Making: ? Discussed with another healthcare provider Discussed case with another healthcare provider ? Consultation Consultation 1, Consultation 2 ? Consultation 1 04/16/2021 15:54 ? Consultation 1 Comments discussed with RPh. He will come to ER to obtain additional information from patient. This is the hospital's first presumptive Pfizer vaccine reaction. ? Consultation 2 04/16/2021 15:41 ? Consultation 2 Comments discussed with Dr. we discuss presentation. he agrees pt will need monitoring with the persisting symptom/findings and the H/O COPD. 1617 Dr has been to ER and completed eval. pt to be placed on 2nd floor med/tele for additional monitoring and treatment. pt did have labs yesterday. ? Decision to Admit Based On 1446 Based on his symptoms and presentation presumptive acute anaphylaxis to component of the Pfizer Covid vaccine. We will begin treatment with 0.3 mg epinephrine IM once as well as dexamethasone, famotidine, diphenhydramine IV. We will continue to monitor with cardiac telemetry and pulse oximetry. He does have slight wheezing but this may be related to his chronic COPD. No respiratory distress at this time, but his symptoms seem to have been mildly progressive over the past hour (per his report). I believe inclusion of the epi to be prudent based on his presentation. Additionally, I will inform the vaccination clinic of this reaction. he agrees pt will benefit from continued monitoring and repeated IV antihistamine and IV steroid treatment. Pt will need IVFluid for hydration as well. Recheck: ? Recheck Recheck 1, Recheck 2, Recheck 3 ? Time 14:55 ? Recheck patient stable patient improving with treatment ? Comments He is improving. His skin is now warm and moist (not sweatty , not diaphoretic). The rash is receeding from the arms. Good coloration to the legs/ankles. Back & torso rash starting to recede. no nausea/vomiting. no difficulty breathing. still with fading macular rash on the torso and upper back. Lungs: improved air movement compared to the initial exam, nl effort, no rales, crackles, rhonchi. He has lower field (only) quiet fine inspiratory wheezes. Normal resonance on percussion. Cough mildly wheeze @ bases, with improved airflow. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, pedal pulses 2/4 bilaterally. No ankle or pretibial edema. ? Time #2 15:05 ? Recheck #2 patient stable patient improving with treatment ? Comments #2 man from pharmacy is here and recognizes patient from the vaccination clinic. Patient rash has faded from his extremities fully and appears to have faded from his abdomen still somewhat at the malar area of the cheeks as well as the neck and torso portion of the chest. His pulse is 98?99 continues to have elevated blood pressure. Pulse oximetry 98-100% on room air, normal. Pharmacist will enter the reaction into the CDC/FDA/Pfizer database. Overall pt notes he feels tired (probably related to hydration & benadryl). He notes he has returned to home about 2 weeks ago after spending some time on the road in mountains playing guitar / touring with a small band , playing music. ? Time #3 15:37 ? Recheck #3 patient stable ? Comments #3 He has been resting. No respiratory distress. His blood pressure and pulse and pulse oximetry are reviewed at bedside and they are nonfocal at this time. Overall he is improving. He notes he still has malaise and feels about the same with itching in his back and the sensation in his throat. When I evaluate his back there is hyperemia/some macular rash that is in approximately the distribution of the trapezius muscle of the back this is where he notes he has the itching. Additionally when I evaluate his throat there is still some presence of uvula edema. There is no other angioedema. Perhaps he does have some mild hyperemia to the uvula and soft palate at this time. He is clinically improving but his symptoms have not resolved fully. Skin warm and dry normal turgor. No diaphoresis Lungs initially some coarseness/mucousy breath sounds to the mid lower fields but this clears after he coughs. Good air exchange at this time. No rales rhonchi wheezes or crackles. Cough initially mucousy then clear. managing secretions well. no stridor. no respiratory distress. Critical Care Times: ? Critical Care Time of minutes excluding, separately billable procedures 35 Disposition Summary: Arrival 04/16/2021 14:21 Disposition to be admitted Disposition Decision Date/Time 04/16/2021 15:54 Does an Emergency Medical Condition Exist at the time of D/C? yes Condition at Disposition Stable Alert and Oriented Guarded Emergency Diagnosis: ?? History of COPD (Z87.09): Entered Date: 04/16/2021 15:59, ICD-10: Z87.09 ?? Anaphylaxis due to immunization (T80.52XA): Entered Date: 04/16/2021 15:59, ICD-10: T80.52XA ?? Drug reaction, initial encounter (T50.905A): Entered Date: 04/16/2021 15:59, ICD-10: T50.905A PCP Summary: ? PCP , ? Select Follow-up Physician Follow Up Physician #1 Follow Up Physician #2 ? Follow-Up MD ? Group Name Primary Care ? Specialty ? Follow-Up MD ? Fax Number ? Follow Up In 04 days Instructions: ? Other Instructions Return to ER for worsening symptoms or other concerns ? Additional Instructions Patient has had clinical improvement and stabilization although he is not fully resolved of his symptoms. He is placed into the hospital for further evaluation and management under Dr. Note Complete: Note Complete This document is complete. Affix my electronic signature. Last Updated: 04/16/2021 16:19 by (MD) References: 1. Data Referenced From "ER MD Exam and Disposition" 04/04/2021 17:40 2. Data Referenced From "1. Vital Signs - Adult" 04/16/2021 14:30

Pt notified staff in Observation that his throat getting a little tight and that was not normal for him. Having slight difficulty swallowing but no problems breathing. On assessment of Pts throat, the L tonsil, and side of throat was swollen and asymetrical. Notified on site EMS Staff immediately. EMS Staff came and moved pt to a mobile mini paramedic truck where the pts vitals were taken and pt given what looked like liquid Benedryl. Ambulance called and arrived within a few minutes and pt moved to the ambulance and departed from the site with the PT.

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium

Patient found unresponsive and transported to ED. Currently hospitalized and admitted with following issues: Present on Admission: ? Intraventricular hemorrhage (HCC) ? Bilateral thalamic hemorrhage ? Acute encephalopathy ? Abnormal eye movements ? Respiratory failure requiring intubation (HCC) ? Mucoid impaction of bronchi

Shortness of breath, mild naseau, consistent bathroom urgency (not necessarily going), diarrhea when I can go to the bathroom.

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

Awakened at 2 am 5/1/21 with acute onset of chest pain, SOB, and diaphoresis. No cardiac history; no history of similar episode. Reported that, following his second dose of COVID vaccine, he was ill for 1 day with vomiting. Chest pain continued upon arrival to ER 5/1/21 about 7 am. EKG indicated STEMI. Adm with Acute ST elevation myocardial infarction.

One day after vaccination, Fatigue. 10 days after vaccine, shortness of breath and pain while breathing. This happened both times with both shots. Fatigue the day after, shortness of breath/pain breathing on day 10 lasting 3-4 days.

Since shot last Thursday April 29 at 930 am I cannot sleep at all and have a hard time breathing. Body will not let me fall asleep. I get a rush of nervous or anxious energy and hot flashes

Had a severe colonic seizure and stopped breathing. He said he felt funny after the shot, like he was light-headed and dizzy. Then out of nowhere I heard him moan and saw he was foaming at the mouth and violently convulsing and turning blue. I did cpr and the paramedics arrived and took him to the hospital. We are following up with a neurologist tomorrow.

This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 08:15 (Batch/Lot Number: EW0171) (at age 40 years old) as single dose for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, carpel tunnel, absent vas deferens, all from unspecified dates. No COVID prior to vaccination. He underwent Covid test post vaccination (nasal swab) on 29Apr2021 with negative result. The patient's concomitant medications included unspecified prescribed and store-bought medications. No other vaccines in four weeks. On 28Apr2021 22:00, the patient experienced chest pains and shortness of breath testing of EKGs, echo, CT scan, and cardiac cath show- NStemi heart attack showing from damage to heart caused by blood clot. No problems with arteries or existing with heart. Also, lower lobe of left lung shows collapsed. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The events were considered serious: hospitalization (2 days), life threatening illness (immediate risk of death from the event), disability or permanent damage. Treatment included blood thinners- apixaban (ELIQUIS) and metoprolol. The patient was recovering from the events.

Phizer shot 1 of 2 in the left arm on Thursday 5/6. I arrived home 45 minutes after the shot was administered and went to the bedroom as my heart rate continued increasing until it was racing non-stop. As my rate increased, so did my breathing until it became rapid and shallow. It is difficult to describe how fast my heart was beating. The rapid heart rate and shallow breathing reminded me of how my breathing changed when I summited a 5800-meter volcano and there was insufficient oxygen near the peak. As my pulse increased I became weak and fell asleep, or fell unconscious. I awoke at 11:00 PM and my breathing was normal however my heart continued racing for an additional hour until midnight. I have experienced no other side effects except heart rate and breathing.

HCP indicated tracheitis; Less of a passageway; Fair amount of coughing/Dry cough; Swelling in the neck area; Fatigue; Is there any correlation between the delated anaphylaxis and ingredient?; Throat tightening with difficulty breathing; Throat tightening with difficulty breathing; This is a spontaneous report received from a contactable consumer (reported for himself). A 40-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0164) administered in left deltoid via an unknown route of administration on 16Apr2021 at 12:50 pm as 1st dose single for COVID-19 immunization. It was reported that that he received the vaccine in his left arm, the bicep muscle, or above the bicep. He states the muscle on the shoulder area. Patient states that asthma was in the lungs and chest. He has had mild intermittent asthma and gets it 4 times a year. There was no prior Vaccinations, no adverse events within 4 weeks. Medical history included asthma (patient was diagnosed 30 years ago), allergic to shellfish. The patient's concomitant medications were not reported. On 16Apr2021 patient experienced is there any correlation between the delated anaphylaxis and ingredient, throat tightening with difficulty breathing (Throat tightness and dyspnea), less of a passageway, fair amount of coughing/dry cough swelling in the neck area and fatigue. On 19Apr2021 at 10:15 HCP indicated tracheitis. The patient states that he got the vaccine on 16Apr2021 at 12:50 pm and isn't sure exactly when the swelling started because he got a little fatigued. Patient states that it was about 3-5 hours after and at a certain point he noticed it. It was reported that a half an hour to an hour later patient throat started to tighten, it gets triggered by certain stimuli, steam and vocalization, and rubbing the area. patient states that he could reproduce the issue if he rubs the area, the frequency has decreased, and in that case, it has improved. It was reported that patient was diagnosed with tracheitis on 19Apr2021 at 10:15 and it was still ongoing, or the effects of it are. Patient states that what he feels in the front of his throat near the trachea and up a little further was inflammation. Patient gets the symptoms of the tightening of the throat, and it is inflamed there is less area to breath. Patient states that his understanding of the tightening of the throat and dry cough are all symptoms of the tracheitis. It was reported that the first symptom experienced after the injection (at least 2-3 -4 hours), patient had fatigue first then probably a half an hour to an hour later the swelling started. patient believes the fatigue has gone away, but not 100 percent sure. patient states that there are times he has felt fatigue and is not 100 percent of the cause. patient states that if he does feel fatigue, he assumes it because of the tracheitis. patient states that these events happen when he needs to get area in his throat, and it might cause the fatigue. patient states that the coughing is parallel with the throat tightening, when he wants to open his airway or pass way the coughing seems to occur. Patient states he gets relief or a more open passageway and the coughing reflex or coughing bouts are less, when he gets the tightness of the throat or the inflammation he sort of goes into coughing. The outcome of the event for hcp indicated tracheitis was not recovered and unknown for the other events, whereas the outcome of the event fatigue was recovered. Follow up were needed, further information has been requested. 07May2021: Follow-up spontaneous report received from a contactable consumer. No new information was reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021524696 Pfizer

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath, cough, and chest pain. Transferred to emergency department then admitted to current facility for a management of new onset heart failure with possible etiologies of myocarditis or sarcoid. Also found to have LV thrombus, anemia, and lymphadenopathy. Patient initiated on medications to manage heart failure and anemia and anticoagulated. Patient improved and discharged to home medically stable.

In the face sensation in my mouth like anesthesia from a dentist difficult to breathe my nose was completely stuffed up I had to go to the emergency room.

Patient with swelling to left side of lip, throat, and difficulty swallowing after receiving covid-19 vaccine . Pt had vaccine on 5/22/ 2021(Saturday) and had delayed reaction on 5/23/2021 (Sunday). Pt treated in ED with Sodium Chloride 0.9 % IV Bolus, diphenhydrAMINE Inj 25 mg (BENADRYL), Famotidine (PF) Inj 20 mg (PEPCID, methylPREDNISolone Sod Succ (PF) Inj 125 mg (SOLU-Medrol PF).

SOB, Fever, fatigue, cough Hypoxia, tachycardia, HTN Admitted 5 days after the 2nd dose of vaccination Dx: Myocarditis and Pneumonitis RX: steroid, Diuretic

50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.

patient called 911 with shortness of breath and chest pain. When squad arrived, he was still oriented and awake and told squad he had Pfizer vaccine the previous day. Thought was a pulmonary embolism had occurred. Then he lost consciousness and pulses. EMS started CPR. Despite aggressive ACLS maneuvers, the patient ultimately died.

I was awoken from sleeping on the morning of Good Friday at 4:00 am. i had a very sharp pain at the front of my left shoulder that went about halfway down my left arm. Additionally, I couldn't breath - it was very painful to attempt to fully fill my lungs. This condition lasted for about 45 minutes as I tried changing positions in bed to make the pain change (either worse or less) but it was consistent and would not go away. At that time my wife and I thought I may have been having a heart attack so we went to the Emergency Room.

Pericarditis/ pericardial effusion- chest pain that radiated to arm. difficulty breathing in. went to ER and had CT scans to verify this diagnosis. Was treated with Ibuprofen and colchicine

Tightness, pressure on chest. Shortness of breath when I take short steps. Dizziness when I stand too long and shortness of breath. Blurred vision

Extreme discomfort/pressure in chest for 4 hours. Three weeks later the same intense pressure with nausea and cold sweat. Low energy and short of breath.

Sharp chest pain, shortness of breath, Extreme fatigue, pain with deep breath, lasted about five days. Took about 10 to 12 days to feel fully recovered

Chills, severe headache, muscle pain, injection location pain, tight chest, fever, rash/bumps on the arm of the injection site, tiredness, drowsiness, dizziness and difficulty breathing. Symptoms lasted approximately 24-36 hours

Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third and fourth days, he added diarrhea and headache to those symptoms. He felt awful over the weekend and spoke to his doctor on Monday, 3/1. The doctor began him on steroids and ivermectin. Over the next 24 hours his breathing began to worsen. He entered the hospital on Tuesday, 3/2, for supplemental oxygen. Things continued to get worse. He was intubated and put on a ventilator on 3/6/21 and ultimately spent 13 days in a coma. He was extubated on 3/19/21 but then had seizures on 3/20/21 and had to be reintubated to secure his airway. Pt was taken back off the ventilator on 3/24/21. He suffered vocal cord paralysis and ultimately wound up with both a PEG tube and tracheotomy. He was discharged from the hospital after 43 days and then spent 10 days in an inpatient rehab center. He continues to deal with vocal cord issues, tracheal stenosis, nerve damage in his neck and shoulder, muscle atrophy, and damaged lungs.

Patient reports chest and upper abdominal discomfort, fatigue and difficulty taking a deep breath since receiving 2nd dose of Pfizer Covid vaccine.

Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat muscles; Sore upper left arm; Weird feeling in the body; Very slight difficulty breathing; Very slight difficulty articulating some words; Nausea; Difficulty sleeping; Loss of appetite; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK8727) via an unspecified route of administration in the left arm on 24Mar2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had known allergies to penicillin and amoxicillin. 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 had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) 20mg once a day for unknown indication and from an unknown date. On 24Mar2021 at 16:45, the patient experienced increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing (but SPO2 ok at 98%), very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests which included oxygen saturation test on an unknown date and the result was SPO2 at 98%. The clinical outcome of events increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing, very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

***Please ignore 2nd vaccine listed. Dont know how to delete it. Only recieved 2nd dose covid 19 vaccine on 6/30*** Heart inflamation with chest pain, a feeling of breathlessness and a pounding or fluttering heartbeat.

The time of the schedule appointment was for 3:00pm at the local Pharmacy). Once the vaccine was injected into my left arm, I was placed into a different seating placement, to be observe for any signs of side-effects that may occur form the injection. This seating area also displayed a digital clock to notify how long each patient must be stationed for (each station is registered for each patient to wait approximately 15 minutes after injection). Once placed in the seating area and the clock was started to examine my treatment, within the six minutes of observation, the following signs occurred: Rapid-Heart Rate, Short and Shallow Breathing, Sweaty Palms including Hot Flashes (lasting 4 seconds).

Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable to eat; post-nasal drip 'dripping' into my lungs; Occasional shortness of breath; Dizzy; Unable to eat and actually zero desire to eat; Sweating/ sleep sweat; sleeping off and on; Was just physically ill/ malaise; Chills; Fever; Extremely tired/ general fatigue; I throw up the water I have been drinking all day; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 13Apr2021 at 08:00 (at the age of 40-years-old) as single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). The patient stated that it was just a standard rescue inhaler 100 mcg. The patient was vaccinated on 13Apr2021 at 08:00 and within 5 minutes his blood pressure went up to 160 and heart rate went up to 130, so they called paramedics over, who were already on site and did pulse check and blood pressure check until they knew what heart rate, blood pressure and oxygenated blood was. They did not allow him to leave for an hour because it was so highly elevated, he felt so dizzy and very disorienting. His friend dropped him home because he could not drive, there was no way he could drive. After an hour the blood pressure got back down to 140 and heart rate was still about 120, it was lower, so he went home and immediately lay down and rest the entire day. He was just physically ill and experienced chills, fever, sleep sweat, extremely tired, strangely no arm soreness at all. He got every other possible side effect and that lasted until 01:30 in the morning, after he throw up, he was finally able to get some sleep. He took rest the entire day, sleeping off and on, unable to eat and actually zero desire to eat, rapid heart rate, sweating, and occasional shortness of breath. He used the rescue inhaler as treatment, that was probably because he laid on his back for so long and also probably just post-nasal drip into lungs. At 01:30 in the morning, he throw up the water he had drank all day and felt a bit better. It was probably because he did not eat all day. He slept until noon and didn't went to work because he felt malaise, general fatigue, his arm didn't hurt. He didn't feel great on the day of reporting, but it was not like the previous day. He had to go to the emergency room, as his mom kept pushing him to go and he was like not going. He had not eaten anything on the day of reporting, so he was looking for something to (incomplete sentence). The patient took 1 gm of Tylenol (over the course of maybe 14 hours) on 13Apr2021 and was advised not to take Advil for whatever reason. The patient underwent blood volume the previous month which was normal and no STDs. He was negative for COVID. That's why he felt okay with vaccine and then before that he did a PCR test which was also negative. The patient have been in 11 countries in the previous year and might have undergone 20 PCR test. He was kind of scared taking the second shot. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

About 30 minutes after the injection my throat became swollen, and I felt pressure in my ears. I had difficulty swallowing, and some pain in my upper longs with coughing.

Dyspnea with exertion; This is a spontaneous report from a contactable pharmacist. A 40-year-old male patient received BNT162B2 (Lot Number: EJ1685), dose 2 via an unspecified route of administration, administered in arm right on 08Jan2021 at the age of 40-year-old as single dose for covid-19 immunisation. Medical history included cardiac condition, unspecified; high cholesterol; both from an unknown to an unknown date. There were no concomitant medications. The patient received first dose of bnt162b2 (Lot Number: EJ1685) on 18Dec2021 in right arm for COVID-19 Immunisation. On an unspecified date of Jan2021, 1-2 weeks after the second dose of the Pfizer Covid 19 Vaccine the patient began to experience dyspnea with exertion. It persisted and was not present before he got the vaccine. The patient has a cardiac condition, but stated that this felt different. This case was reported as serious due to medical significant. The event resulted in physician office visit - cardiologist seen for patient's dyspnea with exertion, but no emergency room visit. The patient underwent lab tests and procedures which included chest x-ray: negative in 2021, electrocardiogram (EKG): normal in 2021, stress echocardiogram: negative in 2021, lab work: negative in 2021. The outcome of event was unknown.; Sender's Comments: Based on current information available, the event dyspnea with exertion mostly represented intercurrent condition in this patient with cardiac condition, 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 RAs, Ethics Committees, and Investigators, as appropriate

About 12 hours after admin; arm, shoulder, neck pain, progressed to generalized body aches, nausea, severe headaches, cough, mass weakness, diarrhea, joint pain. Symptoms started subsiding about 15 hours after onset. Minor cough still persist with minor shortness of breath.

Approximately 15 minutes after receipt of the vaccine, I experienced tachycardia and mild throat swelling. I was placed in the Immunizations Clinic treatment room, had my airway assessed, and vital signs taken. My initial vital signs at 0950 were BP 197/99, HR 106, O2 sat 99%, temp 98.3 F, and 0/10 pain. Over the course of the next 2 hours, I repeatedly had my vital signs taken, was monitored, was provided with water, and remained hypertensive and tachycardic, although down-trending. I also experienced cottonmouth and bilateral blurred vision/dry eye. At the end of the 2 hour monitoring, the throat swelling seemed to subside, my systolic BP in the mid 140s and diastolic BP was in the mid 90s. At time of release from monitoring, I felt better, but dry eyes and dry mouth continued without difficulty swallowing. I was instructed to report to the ER if my symptoms worsened and to consult by primary care manager about the incident. Upon walking back to my office, I realized I was experiencing dizziness as well and a mild headache. I attempted to submit this form online but I received an error message, so I completed the fillable version to upload, in case a partial duplicate record appears.

Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.

Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever but fealth much worse, Heart burn, felt like my inside of body was swelled up, slight Gas, Hallusinations, Nightmare, Extreme Back pain not able to stay still, but I had slight back pain before this was 1000 times worse. I thought its coming to an end. This is exactly what happened to me when I had peak of COVID except the wheezing, I though I had COVID all over again. I took Vitamin C, Vitamin D, Zinx, Tums, Ibuprofen and fell asleep around 2 AM. I woke up at 7 AM in a pool of sweat had to remove the blankets to washer. I had no fever and nothing else it seemed like a switch is turned off and everything went away. Injection site was hurting allot during this time, but when I woke up nothing even injection site was not hurting either. It was a horrible night but seemed that nothing happened in AM.

Fever 103.8 Perspiration Generalized fatigue and weakness Mild dyspnea without cough- now resolved. Soreness at injection site right arm.

Approximately 5 minutes after receiving injection, patient reported feeling mildly short of air. 1410-BP 132/89 HR 104 SpO2 99% 1420-BP 130/86 HR 85 SpO2 99% - reports that symptoms have resolved. Denies need for further intervention. Education provided to seek medical attention for further sx Pt was ambulatory and left the clinic.

Patient developed shortness of breath approximately 10 minutes after vaccine administration. Patient received a dose of 0.3mL epinephrine IM 2 minutes later and was transported to the ED. VS in the ED were normal. Patient did not develop any other signs or symptoms of anaphylaxis. He was monitored for 1hr and discharged from the ED.

2 hours after administration of vaccine, patient reported shortness of breath, abdominal pain, and difficulty swallowing. Patient returned to the clinic where he was given supplemental oxygen via nasal cannula and EpiPen. Oxygen removed and vitals stable. Due to EpiPen administration and continued feeling of throat swelling, patient sent to ER via EMS. Patient given 1L NS and Solumedrol IV. Discharged home in stable condition from the ER.

Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other location: Right shoulder; Shortness of breath; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231, Expiry Date: 30Apr2021) via an unspecified route of administration in right shoulder on 30Dec2020 20:30 at single dose for COVID-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine on 2020 for immunization 2-3 months before this BNT162B2 vaccine, previously took flu shot in the past for immunization and got sick from it. That was about 3 years ago (2018). The patient went and got the Pfizer BioNTech about 2 weeks ago. Wants to know if side effects can start then after the vaccine. He has had chills, muscle pain, shortness of breath, and dizziness. Got this at hospital and has not been able to go to work on Jan2021 that last 3-4 days due to feeling weak. Received the vaccine on 30Dec2020 and the dizziness and shortness of breath kind of started days after that on Dec2020. The chills started a couple of days ago, about 3 days ago (Jan2021) and has been off and on. The muscle pains started today (13Jan2021). Just got a text message about getting the second dose next Wednesday. He did not get any other vaccines that day or 4 weeks prior. He got the shot to protect himself from the virus, but feels like he has the virus or something. The events did not require a visit to emergency room, but may go to be seen tomorrow. Events outcome of chills, muscle pain, shortness of breath, dizziness, and not been able to go to work that last 3-4 days due to feeling weak was not recovered.

22 Jan 2021-Friday-Tired,SOB 23 Jan 2021-Saturday-Tired 24th Jan 2021-Sunday-folding laundry-winded & tired 25th Jan 2021-Monday-winded, tired-climbing stairs 26th Jan 2021-tired & winded, 27th same, 28th Tired & winded 29th Today January-2021-Tired & winded-Reminded patient to GO to ER if his SOB get worse, or see his PCM Took naproxen for his tiredness

12 hours later woke up Sweating 101.5- 103, muscle ache back, joint pain finger pain, SOB fatigue. Lasted about 17hours.

Trouble breathing with chest pressure; Trouble breathing with chest pressure; Rash on face with swollen fingers; Rash on face with swollen fingers; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose of BNT162B2 (Lot number: 9264), via an unspecified route of administration on 31Jan2021 10:15 at single dose in the left arm for covid-19 immunisation. Medical history included hypertension and penicillin allergy. The patient's concomitant medications were not reported. On 03Feb2021 09:30, the patient experienced rash on face with swollen fingers and trouble breathing with chest pressure. The events result in Emergency room/department or urgent care. The patient did not receive any treatment for the events. 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 underwent lab tests and procedures which included Nasal Swab: negative on 03Feb2021. The outcome of the events was recovering. The following information on the lot/batch number has been requested.

Patients spouse reports he started to feel "funny" 5 mins post vaccination administration. Patients spouse called for assist when he he became unconscious at 7:25pm. He was found unconscious and failed to respond to a sternal rub. EMS called. Initial assessment: HR-weak pulse-not palpable, agonal, shallow breathing, and unresponsive. VS- BP 160/100 HR- 100 Wife used smelling salt to arouse the patient. He was confused after regaining consciousness. 7:37pm- EMS arrived and assumed care, transferring patient to a higher level of care.

He received first dose of Pfizer COVID vaccine 1/15. Next day, he felt right axilla and trunk numbness after that which lasted 2-3 weeks and was resolving. After the second dose early Feb 5th, he started having difficulty swallowing and SOB and felt a little better after a course of steroids and antibiotics but got a lot worse after finishing the course and presented to ED 2/16 and was found to have supraglottic edema requiring intubation and treatment with IV steroids. Was extubated on 2/19, in ICU until 2/21. He did well with treatment and was discharged 2/22. Patient received a dose of influenza vaccine (FLULAVAL - GSK lot: 7N43B) on 2/22/21 3/2 he started having burning pain in the right midthoracic area, the next day he noticed right hand weakness/numbness (4th and 5th digits), gradually progressed. 3/4 noticed right facial weakness, initially was lower face, Unable to drink without drooling. MRI brain was done 3/5 and was normal. 3/5 facial weakness progressed to upper face. Unable to close right eye for the last 24 hrs. He also reports numbness left 5th digit. Presented to the ED on 3/6. Found to have elevated transaminase in ED. Hospitalization continues at this time. Etiology of symptoms is unknow, but includes vaccine reaction, shingles or early stages of autoimmune disease.

Pt received dose 1 of PfizerBiontech COVID Vaccine AT 1318. He was observed 30min without complaint and left without incident. He returned at 1356 c/o" throat and chest tightness." Upon assessment, wheezing is noted bilaterally. Resp Rate and Work of Breathing Within Normal Limits. Denies any other complaints and exhibits no further signs or symptoms. Albuterol/Atrovent Neb as well as IV Benaryl 50mg administered on scene and patient states his tightness is improving/resolving. Continues to denye further Complaints. Responding units Fire Department and Ambulance arrive on scene and care handed over to crew. Assessments, care, and treatment continued enroute and patient transported to ED

Fever, Pain (Mostly My legs), Cough, Shortness of breath, and Phlegm. took Tylenol Severe Cold and Flue and Claritin - D 12 hrs. Lasted 24 hr. Started Saturday Night and ended Monday Morning. Feeling exhausted after the events.

Tingling in ears and extremities, heart was racing, tickle in throat, dizzy, short of breath, nauseous

The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE temporally related to Pfizer BioNTech COVID vaccine dose #2 receipt. He is a Service Member and reported high levels of baseline activity, including running 10 miles each Saturday. He received vaccine #1 25 JAN 21 (EN5318) without AE. He received dose #2 on 16 FEB 21, (EN6200). He experienced no immediate symptoms suggestive of IgE event. On day 1 he reports feeling cold, mild fatigue but no other symptoms. On day 2 he was baseline. On day 3 he noted numbness, tightness and discomfort to his right calf. On day 4 (Saturday), his usual long run day, he experienced dyspnea and lightheadedness after running 20-30 feet. He states he noted tightness in his calf and instead walked the track while his wife completed her run. He rested day 5. Day 6 he noted significant edema to his calf, which he describes as double normal in size, and iced it. Day 7, he tried to schedule with PCP and based on triage was sent to ER. ER diagnosed R DVT and bilateral PE's. He was admitted overnight, started anticoagulation therapy. He saw hematology, and the workup was negative for other causes.

3/30-Adverse events experienced and are they still occurring now: Caller c/o fatigue & generalized "feeling sick" since receiving 2nd vaccine on 3/25/2021. C/o shortness of breath beginning on Sunday 3/28/2021, called out of work yesterday and today, stayed in bed both days due to "feeling exhausted", no distress while on phone. Reports taking tylenol/ibuprofen as needed as well as using rescue inhaler for asthma as needed. Advised to follow up with PCP or Urgent Care due to SOB and asthma history. 4/1-Follow up call by Patient feeling better than yesterday, no longer feeling shortness of breath. Recommended to follow up with physician if symptoms worsen.

Finished Pfizer series on 1/8/2021. Tested + for Covid-19 on 4/4/2021. Sxs started on 4/1/21 including diarrhea, f/c, SOB/dizziness, nausea. Improved quickly.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient experienced numbness in arm a few minutes following COVID vaccine. He was instructed by the pharmacist to sit for 30 minutes for monitoring instead of the usual 15 minutes. After about 30 minutes, he said he was experiencing difficulty breathing (he was alert and orientated and was able to talk but he said he was laboring to breathe). EMS was called. No treatment was given on site by EMS and the patient elected to be brought to the hosptial.

patient felt chilled through out body immediately after receiving vaccine with full body shaking showed signs of low blood sugar but said he did eat lunch he was unsure of what medications or insulins doses that he had taken today. gave sugar and water and no improvement symptoms progressed oover 10 minutes patient developed ragged breathing 911 was called and epi pen administered. was taken to hospital by ems.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: patient felt like his throat was itchy and felt flushed and sweating. he had no other apparent symptoms, we gave him a benadryl and he appeared to be fine

Patient reported feeling clammy, lightheaded, short of breath, anxious, and nauseated after vaccination Patient seen by medical team and vitals improved after patient drank Gatorade Patient reported not having anything to eat in the morning Patient has history of anxiety Patient refused medical transport and signed medical form, patient stated symptoms improved Patient will have a family member pick him and his daughter up to drive home

Pt recieved his second dose of Pfizer vaccine at 1120am stated at 1130am that he felt like is throat was feeling itchy and swollen also stated he has a history of severe anxiety then further stated it may not be swollen but i just feel like its very itchy. Nurse evaluated the patient noted O2 sats of 97% pulse was 80 no visible signs of distress were noted on the patient. nurse was noting signs of anxiety with figiting and constant movement to the patients limbs. Benadryl 25mg liquid was administered PO patient was able to swallow the medication without any visible difficulties. Nurse frequently checked on patient with no changes at 1208pm patient stated he was feeling better. Nurse released the patient from high observation area with mother driving and patient in the passenger seat.

Symptoms: Fatigue, headache, nausea, joint pain, elevated temp 100.4F, chills, sweating, difficulty breathing. Treatment: Tylenol, water, anti-nausea, sleep. Duration: 18hrs

About 10 minutes after receiving the vaccine. I felt hot and sick to my stomach. I couldn't breathe. I took my mask off and fanned myself. I started to feel dizzy and then I fell to the floor and passed out. The paramedics did an ekg and thought I was having a heart attack. They rushed me to the Emergency Room and they performed more tests. The tests showed their was nothing wrong with my heart previously.

collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded. Case will be re-assessed upon the additional information provided. 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.

Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle fatigue and extreme tiredness

Difficulty breathing and chest pain. Elevated CRP. ON STEROIDS NOW. Suspect potential heart (or peri) inflammation.

Cough, shortness of breath fatigue, headaches, congestion or runny nose, lightheaded and sore throat, chills, fever, sinus pressure, sinus pain, diarrhea and nausea, back pain and myalgias

Patient arrived for second dose of vaccine and verified name and DOB, patient responded negative to using immunisuppressants, having COVID in the past 90 days and any other vaccinations in the past 14 days. Pt also responded negative when asked if she had ever had a severe allergic reaction to anything ever. Per nurse, in observation, pt notified staff that she started to get hives and had some shortness of breath and carries an epi-pen on her. Per nurse patient wasn't observed to be short of breath at all and was talking just fine. Regardless, patient did not want EM S attention and confirmed she felt ok before leaving facility. Patient's husband was driving her. Pharmacist notified after pt had left.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Additional Details: blueish right calf

Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 weeks

I felt faint about 20 minutes after I took the first vaccine shot on 4/1/2021. I felt like I had heart palpitations, then a tingling feeling in my left arm. After the second shot, I felt like my balance was off if I laid down or looked down and then pulled my head up. That went away after the first day. Starting the following day, I had some chest pain over my heart, and at times, I would have a burning sensation in my heart. At times, I also felt a tingling down my left arm (sometimes out of nowhere). I would be very short of breath. These symptoms were on and off for the first two weeks after I took my shot. They have since completely gone away.

Patient complained of dizziness about 5 minutes after shot. Also stated felt shortness of breath described as chest tightness but no wheezing. Offered water, Gatorade, and Benadryl. Patient took water and Gatorade. Stated was feeling better. Checked on patient minutes later and had another wave of the feeling. Spacing was further and less severe. At 9:53 am patient got another wave of dizziness/tightness and 911 was called at 9:57am. Patient reported no side effects to first dose but when EMS arrived they claimed experiencing this with the first dose but less severe. EMS took to ambulance to further evaluate.

He had his 2nd pfizer vaccine on 5/3/21 The next day he felt tired 2 days later (on 5/5) he started with fever, chills and body aches He then started with abdominal pain --hurt to take a breath in, he could not lay flat He went to Hospital and was dx with myocarditis He was started on ibuprofen (changed to naproxen for discharge), colchicine and protonix

Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, nausea. Worst I've ever felt in my adult life, like my whole body was rebelling against me. Long-term (for roughly 10 days after both shots): Serious shortness of breath, irregular and very high heartbeat, extreme fatigue. Couldn't do any physical activity without immediately becoming out of breath (normally very healthy and active). Heart would race unpredictably, reaching 120 bpm (normal resting for me is 60-70). General malaise. Felt more like 80 years old than 40. Was unable to do normal physical activity and work for weeks. Feeling better overall, but still sometimes feel like I get tired unusually easily and heart behaves strangely now and then.

Client states that 24 hrs following his 1st dose Pfizer COVID vaccine (LOT EW0173 Expiration date 08/31/2021) received on 04/29/2021 he experienced a tight throat, difficulty swallowing, headache, mild diarrhea and increase of mucus production in his throat that required frequent spitting up. He denied any chest pain, facial swelling or difficulty breathing. He stated the symptoms lasted 2 days and then resolved on their own. He reported taking 1x 300 mg Advil for the headache with little relief. Client denied reporting the symptoms to his primary care provider due to being in between insurances and in between providers. He also stated because the symptoms self resolved he figured they were normal side effects to the vaccine. Client denied any other significant medical history and medication use.

My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest. He was shocked back to life where he lay in a coma. His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.

Tachycardia, numbness in extremities, dizziness, shortness of breath. All intermittent for about 8 hours following shot. Intense for a 2 hour period 4:30-6:30.

On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gone numb and he had vomited. Patient called his mother to come help him with the baby because he wasn't feeling well. When she got there 30 minutes later he was not breathing. They were not able to revive him. He died of a blood clot in the front of his heart.

PATIENT STATED THAT HE RECEIVED THE VACCINE ON FRIDAY, AT THE END OF THE DAY ON SATURDAY, HIS CHEST STARTED TO FEEL HEAVY AND HE HAS LABOR BREATHING. HE WOKE UP SUNDAY AND DIDN'T FEEL WELL. HE TOOK A NAP AT AROUND 4PM ,THEN WOKE UP AND COULDN'T BREATH WITH HEART PALPITATIONS. HE WAS ABLE TO ARRIVE TO THE EMERGENCY ROOM AND TRIED TO WALK HIMSELF IN. HE COLLAPSED ON THEIR YARD.

After about 15 Minutes after the injection, My Hands and Feet broke into a sweat, about 1 minute after that the top of my head started to tingle ( like pins and needles) after about another minute it felt like I had to keep breathing on purpose. ( what I mean by that is I was aware of my breathing and had to knowingly take breaths it was like I had been under water and just come up for air) I don't remember the exact time maybe another minute or so, my heart started to race. This All went on for about 45 Minutes. When this first happened the Pharmacist told me that what was happening was common with vaccinations and had nothing to do with the covid 19 vaccination, I asked for the nurse that had provided the vaccine to me and was told she went to lunch. So there was no healthcare professional there to help me. The pharmacist just had me sit in a chair and told me to sit there until I felt better. This happened for both injections. I have never experienced this type of reaction with any other vaccine in my life.

Approximately seven days following second dose of Pfizer COVID vaccine, I began experiencing heart palpitations, elevated heart rate, chest pressure, difficulty breathing, shortness of breath, and dizziness. Multiple "episodes" each day would occur without warning, did not relate to physical activity, or any other stimulus - would just happen throughout the day, often multiple times per hour. Even to this day, more than 90 days following the second dose of Pfizer, there are multiple times each day when I feel chest pressure, heart palpitations, and slight shortness of breath. It is not as common, or as severe as it was early on, but some symptoms remain.

The 2nd dose of Pfizer vaccine was injected on May 3rd, 2021 at a clinic. Minor arm ache, fatigue, fever/chills felt for approx. ~1day post vaccination and then felt back to normal. Around day 3 post vaccination felt sudden, sharp, stabbing pain within chest cavity which forced me to take shallow, rapid breaths to avoid triggering pain. Lasted a few minutes before subsiding. Following day or so pain returned as a dull, diffused pain and was felt intermittently for several weeks. Generally I run fairly often for fitness, however activity level was reduced due the ongoing chest pain. Wanted to resume normal activity levels, but decided to consult a Doctor for peace of mind due to pain taking so long to resolve. Scheduled virtual appointment (06/24/21) who advised an ER visit due to it being a potentially risky chest issue, and the fact that they could run the appropriate tests to diagnose it relatively quickly. Walked over to a nearby ER that afternoon and was hospitalized for 1 night, who diagnosed an "Unprovoked VTE" with a "Pulmonary Embolism" in Right lung. Was treated with Lovenox injections at hospital and currently taking Eliquis medication. As a side note: my brother (43yrs old) who lives in another country, was administered the 1st dose of the AstraZeneca vaccine on 05/24/2021 and subsequently fell ill, went to the ER twice and was eventually diagnosed with VTE/Bilateral PE. He is also currently taking Eliquis medication.

vaccine was administered and patient lost consciousness. he began to turn red and did not breathe for several seconds at which we were about to administer an EpiPen. He then took a breath and started to convulse. he regained consciousness and was not coherent at first. He was sweaty and pale. Pt became alert and oriented and stayed in the room while we waited for the emt to arrive. He declined to be taken to the hospital. He moved to the waiting room and was monitored for 30 minutes before leaving

I experienced similar symptoms the day before the first vaccine - (Just the pain in the chest- like something sticking in my chest. More severe stuff was experienced after the second vaccine. After second vaccine, I had pain in my chest. I had a dull ache - like a broom stick stuck in chest - sometimes front and sometimes back and sometimes both. Goes up my spine into my neck sometimes. Sometimes it comes with shortness of breath. One point when it went down my left arm and into my hands. Dull pain. I have gone to medical center - Urgent Care twice and two different doctors and they haven't found anything yet. I woke up gasping for air - one time last weekend. That lasted for two hours - I was only getting 50% of breath when I breathed in. Today I woke up at 6 am (two hours earlier for me) and again had shortness of breath. The doctors have no idea what is going on. I have never had anything like this before. I'm not particularly stressed so I don't think it's anxiety like one doctor suggested. It's very physical and disturbing so I doubt it's anxiety. Muscular - Skeletal relaxant to take - and that didn't help and I stopped taking it because it didn't feel good to stay on it.

On Saturday July 3rd I noticed tightness in my chest, lightheadedness, and ringing in my ears. On Sunday, July 4th, I still had the lightheadedness, tightness in my chest, rapid heartbeat, and it was more difficult to breath unless I was sitting a certain way. On Monday, July 5th I had severe chest pain, difficulty breathing, fluttering and pounding heart, when I took a deep breath I would feel my heart pounding but at a much slower rate and then it would go back to normal beats, severe ringing in the ears, extreme tiredness. This lasted for about 1.5 hours and I went back to bed and when I awoke 4 hours later my heart seemed to beat fine. Chest pain lightened up a bit, but breathing is still difficult. I?m very healthy and have not had any health issues. The heart issue this morning was so bad that I?m not sure if I should get the second dose. If things worsen, I will contact my doctor. I?m hoping that it goes away soon and this will be alleviated on its own, but I?m really worried about getting the second dose even though I want it.

Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Passing out, Light headed and dizziness. Joint Pain and All Day Headaches. More recently Been having Sharp pain in kidney areas and back pain and Constant headaches. Tingling throughout whole body at times.

Acute on chronic congestive heart failure, unspecified heart failure type; Elevated troponin; SOB (shortness of breath)

slight fever sweatiness after 15-30 minutes throat started to close up, difficult to swallow and breath tingly and numb around nose this lasted for about an hour

In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, shortness of breath, diarrhea . Tested for Covid 27th of December and was positive. Was on steroids and antibiotics and vitamins; and still on steriods and breathing treatments and still haven't gone back to work.

About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I had a little shortness of breath and it felt like my heart was beating faster but this only lasted a few minutes. They had me wait an additional 10 minutes and the dizziness was better but not gone completely. I drove myself home and tried to work from home but was feeling confused. I took the rest of the day off. The next day (yesterday) I woke up exhausted. I took a sick day and slept until noon, which was about 14 hours in total. When I woke up, I felt okay but had no appetite and did not get out of bed for 5 hours. When I finally got up, I still felt dizzy. I ate dinner, watched some TV and went to bed. I woke up this morning without the fatigue but started to feel dizzy in the shower to the point where I almost lost by balance twice. I'm trying to work from home today but feel very dizzy and confused. I couldn't remember my office's phone number. I'm sweating but my temperature is 97.5.

Day of the shot (in the afternoon) I felt began feeling ?off?. Day after the shot I had pretty severe body aches and exhaustion that lasted for two full days and lingered for a third day although not as severe. It?s now a week since the last vaccination shot and I went for my first run since the vaccination. I regularly run about 5 miles 3x a week in the mornings. On this run,; which was at about 75% of my normal pace, my lungs felt very heavy with very labored breathing, having to stop and catch my breath periodically. I eventually had to stop at mile 3.

Complaining of feeling warm at head/chest, feeling need to take deep breaths about 5-10 minutes post vaccination. Was given an ice pack and allowed to lie down on gurney. Afterwards, individual felt significantly better with the cold therapy and resting, reported symptoms had resolved by 1611 same day.

Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild

Received 1st dose at mass clinic. After a few minutes while sitting in observation area, pat observed by Dr and med student to be very pale, dyspneic, lightheaded and complaining of nausea. BP 148/94 O2 applied at 1.5 LPN N/C. Pt able to sit in chair without problems, remained responsive. States he was fine until he saw others getting their vaccine and that made him anxious. Observed for 30 minutes, pulse ox 95%. Oxygen removed and pt was able to walk out without difficulty and go home after condition much improved. Local EMS on site with pulse and O2.

Deep itching; dry cough in lungs; chest tightness, heaviness; shortness of breath for 4 days after; This is a spontaneous report from a contactable consumer reported for himself that a 42-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 25Jan2021 12:00 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies, various surgeries. Concomitant medication included levocetirizine dihydrochloride (LEVOCETIRIZIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Deep itching dry cough in lungs and chest tightness, heaviness, shortness of breath for 4 days after, events start date provided as 07Feb2021 04:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. The patient received the second dose of BNT162 on 13Feb2021 11:30 AM via an unspecified route of administration at Right arm for covid-19 immunization. Information on the lot/batch number has been requested.

Client received vaccine at 13:50. Client immediately felt faint and presented with pallor and diaphoresis. Client lost consciousness and began to wheeze. Epi administered at 13:53 to right leg. Client then laid to floor and feet were elevated. Client soon recovered and transferred to hospital per protocol for post epinephrine injection. Client coherent, stable and able to independently ambulate.

Patient states he received 2nd Pfizer shot 3/26 at approximately 10:40am, approximately 2 hours after developed fatigue. At approximately 2:00pm on 3/29 developed chest pain and shortness of breath. Patient was referred to local emergency room for further evaluation.

30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., but no impediment to breathing or speaking. I rerouted to a plaza with a grocery store and urgent care clinic, and bought some Benadryl and took it at about 2:55PM. I waited 20 minutes in the parking lot before deciding I was safe to drive home. When I read about the possibility of a biphasic reaction, where my throat could close up again later, I went to a Clinic (5:40PM walk-in appointment with NP), and they could not treat me, and advised me to go to the Emergency Room. I initially decided to just go home, but went to the Emergency Room out of an abundance of caution at around 7PM. Dr. gave me a prescription for an epi pen and prednisone, just in case symptoms worsened. They did not, and I did not use either drug. The throat swelling started around 2:45PM and worsened for about half an hour. It remained steady (no airway constriction, no difficulty taking pills or drinking water) without getting worse, and started to subside around 5PM. By the time I woke up this morning (3/31), I don't think there is any lingering swelling. I can feel a very slight lump in my throat, but I can't tell if that is a very small amount of residual swelling or just hyper-vigilance based on yesterday's experience. Note: This swelling feeling is identical to my memory of what I felt when I was diagnosed as allergic to penicillin in 2000 or 2001. Back then, the only "treatment" was to immediately stop taking penicillin (and to never take it again), based on a phone call with my doctor's office. I did have a strong immune response after that (102° fever, chills, fatigue, muscle pain), but I don't consider that an adverse reaction. This report is focused on what appeared to be a mild anaphylactic reaction.

After receiving the vaccine he stayed in the pharmacy for 15 minutes and said he was fine. He came back after 30 minutes complaining of rash, itchiness and difficulty breathing. He stated he had a swollen throat. Patient was administered an Epipen and was fine shortly after.

Vaccine 1st dose in right arm. 2 hours after soreness in arm at site, aching throughout body. 8 hours after injection ... itchy all over body. Wheezing accompanied the inching. I took Benadryl just to be safe. Itching and wheezing went away within 1 and a half hours. Following day aching, lethargic all day and diarrhea for 2 days now.

3-5 MIN POST INJECTION, PT EXPERIENCED CHEST TIGHTTHROAT AND TONGUE TINGLING.hE DESCRIBED FEELING AS IF HE COULD NOT GET AIR. nO STRIDOR OR WHEEZING NOTED. PT.SPEAKING WITHOUT DIFFICULTY. PLACED ON STRETCHER, PALE, DIAPHOREETIC. EPI PEN INJECTED TO LEFT QUAD. BP 147/100sat 100% ON ROOM AIR HR 92. MD AT BEDSIDE AND PATIENT TRANSFERRED TO ER FOR EVALUATION.

1 minute after vaccine injection I experienced a tightening of my throat. It was very uncomfortable and made it difficult to swallow and felt like a "lump in my throat". I asked an onsite nurse if this was a common reaction, and she offered medical attention. I denied it because it was not getting worse. She gave me a bottle of water and it seemed to help it a bit while drinking. But, quickly returned after water was swallowed. I was monitored for 30 minutes as recommended. The tightness remained for 1 hour post vaccine injection and disappeared as quickly as it started. I fear the second dose may be worse.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) from urgent care (UC) reporting six days of vomiting, fatigue, shortness of breath, dizziness, constipation, and polyuria starting one day after receiving vaccination. Initial vital signs blood pressure 127/96 mmHg, heart rate 119 beats per minute, temperature 35.9 degrees Celsius, respiratory rate 18 breaths per minute, oxygen saturation 97% on room air. Patient diagnosed with new adult-onset diabetes, diabetic ketoacidosis, and acute kidney injury and admitted to the hospital. Administered intravenous fluids and insulin with improvement in symptoms and lab values. Currently hospitalized.

Experienced normal soreness the evening of 4/9/2021. At 2:30 pm on 4/10/21, started having generalized soreness. Temp at that point was 98.6. Within ten minutes, started having congestion in chest (rattles). This caused strong bouts of coughing with pain radiation through my lungs. I then started vomiting (x3). I started feeling fatigued so I went to lie down, when I had a cold chill. At 3:00 pm, my temp was 102 F. At 3:15, it was 102.5 F, and then crested at 103 F at 3:30. In the past five hours, the only symptom to subside was vomiting; all the others are still present with my current temp 102.1 F at 8:41 pm.

On 3/31/21 pt reports feeling "achy, like a wet blanket", headache, Restless and up every hour of the night. "I felt like a freight train ran over me. " Treated for a sinus infection with Z-Pak. Notified he was covid (+) on 4/2/21. Fever, chills, dyspnea.

anaphylaxis. throat closing, tongue tingling, couldn't breathe within a few minutes of injection epipen and Benadryl given on site, sent to hospital for observation, treatment with allergy medications and steroids for five days after. Observed in hospital for four hours. Advised by primary care doctor not to get second dose or any other covid vaccines due to reaction.

Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unable to get out of bed for 24 hours. He said the rest of the week he didn't feel quite right. A week after the vaccine he started with red capillary veins popping up all over his legs. By Saturday his legs were purple and swollen. He has multiple tests run at the hospital. They doctor believes it is vasculitis that has resulted from patient getting the covid vaccine.

Pt was found in severe distress in the bathroom by his wife. He couldn't walk or stand, complained of being dizzy with slurred speech and was throwing up a lot. 911 was immediately called. The EMTs during their assessment said his BP was normal but when he was asked his name, he started saying the alphabet"ABC... XYZ". He was transported by ambulance to ER. Cat scan showed he had a bleed on the brain. The doctors told us it was because he had very high blood pressure, however where the bleed was, they said he wouldn't need surgery and that the body would reabsorb it over time. He was admitted to the ICU and has been there ever since. Several days later, he started having difficulty breathing and they discovered several blood clots in his right leg that had broken off into his heart and lungs. He had emergency surgery to remove the clots in his heart (approximately 10) and was given heparin in small doses over an 8 hour period so that it wouldn't cause the bleed in his brain to increase. The doctor should fill in the rest.

Patient got vaccinated at 10:22 a.m. At 10:35 a.m., patient reported severe headache, chest tightness, difficulty breathing, feeling lightheaded. Patient noted to be diaphoretic, less responsive, and having left eye deviation. Patient assessed/examined by Dr. and Medics on site. Vital signs taken: at 10: 38 a.m., BP 177/126, HR 118; at 10:39 a.m., BP 172/120, HR 110, O2saturation 96% on room Air; at 10:41 a.m., BP 173/123, BG: 333, sinus rhythm on cardiac monitor. At 10:47 a.m., BP 158/78 (with manual cuff). Fire Metro Paramedics called; Patient transported to Hospital at 11 a.m.

About six hours after receiving my shot, my arm became extremely sore, as to be expected. Circa 9pm I began to have significant trouble breathing, experienced acute pain in my abdomen, and began to hear ringing in my ears combined with feeling like I was going to pass out. I didn?t feel dizzy, rather I started getting tunnel vision that blocked out more of my field of view as the ringing increased. Circa 11pm, I lost consciousness while trying to move and collapsed on the floor. My wife called 911 while I was unresponsive, and I regained consciousness while being attended to by EMTs who checked my vitals. Around 12am I didn?t feel like I was going to lose consciousness again, and the EMTs recommended I be taken to the hospital. Since I was feeling better I politely declined. Today I am still feeling foggy and have joint pain (in addition to some bruising from falling after losing consciousness , but I no longer have the acute abdominal pain.

Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and tingling, eye irritation, blurred vision, headaches, stomach discomfort.

initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.

On 30 Apr, 2nd day after vaccination, I an episode of heart palpitations ("ventricular premature complexes in a pattern of bigeminy"). These were captured on an EKG during a VA disability exam, and started shortly after providing a blood sample (I'm nervous with needles). Previous day (1st day after vaccination) I had a fever of 101.5 F and was fatigued. Suspect the stress of the fever, immune response, and then blood sample caused a stress event that triggered an abnormal heart rhythm. Palpitations not accompanied by light headedness or shortness of breath, so no immediate medical care directed. Episodes of palpitations continued for 4 days, but have mostly disappeared since.

metallic taste in mouth; breathing problems; This is a spontaneous report from contactable consumer as a patient. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unspecified route of administration on 04Mar2021 at 14:00 pm in the left arm as a first dose for COVID-19 vaccination. Medical history included gastro esophageal reflux disease (GERD) and asthma. Patient was allergic to Penicillin (manufacturer unknown), Doxycycline (manufacturer unknown), trees, nuts, shellfish and environment. Concomitant medications within two weeks of vaccination included Xyzal (manufacturer unknown), Omeprazole (manufacturer unknown), Vitamin D (manufacturer unknown) and Multivitamins (manufacturer unknown). Prior to the 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. Since the vaccination, the patient had not been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered was at a public health clinic. On 15Mar2021 at 02:00 am (10 Days after the shot), the patient had breathing problems and metallic taste in mouth. The adverse event resulted into Emergency room/department or urgent care. The patient reported that, he was never admitted before for asthma. Therapeutic measures for the reported events were Albuterol (manufacturer unknown) and Albuterol, Steroids intravenous injections (manufacturer unknown). The clinical outcome of breathing problems and metallic taste in mouth was reported as recovering. Information about lot/batch number cannot be obtained and no further information is expected.

Having long covid since May 2020, my lingering symptoms have been fatigue, shortness of breath, chest pain, loss of taste. All were subsiding and have come back since the first injection and have not abated for 2 weeks. Fatigue is particularly intense in the morning, loss of taste is now constant.

I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, nausea but did not vomit. My wife called 911 and I was admitted to the hospital.

- Uncomfortable feeling in chest around 8pm on 4/24, tried to sleep it off - Couldn't sleep very well, and woke up with a tightness of chest and unable to draw a full breath - Went to county ER and was advised I was suffering a heart attack (non stemi) (troponin levels were over 7,000) - transferred to hospital for further diagnosis and treatment - Had a echocardiogram, cardiac catheridisation and MRI, which found that I had inflammation of my heart muscles - treated symptoms with medication and was discharged after an overnight stay

1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm. At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce. I was unable to sleep well for the first 3 days after the vaccine. 3rd day - sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous. 4th day - fatigued and somewhat dizzy from time to time.

Pt reported "difficulty swallowing" and feeling of "tightness in throat" Was taken to Med Obs 1 for further assessment and monitoring. VS Stable and pt reported symptoms resolving by reporting "better" at 0804 and completely resolved by 0814. VS WNL and no objective s/s distress noted at any time. Vital Signs: Sitting 0802 BP 147/79 HR 57 RR 16 SpO2 100% RA Standing 0805 BP 147/89 HR 59 RR 16 SpO2 100% RA Sitting (prior to release) 0814 BP 126/82 HR 47 RR 16 SpO2 99% RA

"I feel short of breath, palpitations and I feel dizzy." RN put Client supine in gravity chair. RN provided juice and a protein bar. After 3 minutes, Client stated, "I feel better now, they symptoms are gone."

I was in the hospital I couldn't breathe and I was running a fever. I was shacking . While being in the hospital I am now on oxygen and I also got rhino virus while at the facility.

The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. without asking my permission he gave me a second dose Basically overdosing me. My tongue felt strange my lips sweated. The injection site hurt for 7 days and is still uncomfortable. My lungs have been extra congested with mucus. I missed 3 days of work due to the inability to use my left arm (sore) and general fatigue. Experienced strange twitching of the left arm muscle at injection site on the third day.

Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two days prior to ending up in hospital for heart.

Burning pain in the middle of my chest along with shortness of breath. Pain spreads from my chest to my right arm and makes the muscles in my right arm sore.

Patient returned from vacation and subsequently developed headache, cough, dyspnea. He was found to be COVID+ on 7/12. He was admitted to the hospital on 7/15 due to worsening dyspnea, where he is currently on high-flow nasal cannula.

I started with left sided chest pain, which was worse when I was laying down or taking deep breaths. I was out of the county when I experience it. We came home early. Motrin helped a little. I keep getting worse I went to my doctor, and they did an x-ray and EKG which both came back normal. Those were done on May 20th. By the 23rd I couldn't walk with chest pain. The cardiologist did a scan of my heart, and they found a small left sided pleural effusion. They still do not know why I have that pleural effusion. They check my labs which I had a small elevated inflammatory lab. Over the next few days after that it went way, and I was able to go back to my normal activities. I have not had problems since.

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/24/21). Patient was doing well until his return. Which he developed subjective fevers, sneezing, headache and cough on 7/7 and tested positive for SARS-COV-2 on 7/12. On 7/13 he presented to ED for SOB and was D/C'd home on levofloxacin. On 7/15 he returned to ED for worsening SOB and was started on remdesivir on 7/17, tocilizumab, dexamethasone, enoxaparin and antibiotics. On 7/18 respiratory requirements increased requiring NRB and transfer to Hospital with admission to ICU. In hospital, patient completed two more days of remdesivir for a total of 5 day course (ending 7/21) and was continued on dexamethasone until 7/25 to complete a 10 day course. Today patient remains intubated with improving oxygenation with proning.

New onset atrial fibrillation; Myocarditis/inflammation of the heart; pericardial effusion/he had a significant amount of inflammation and fluid around the heart; pericarditis; Tightness of chest; He went in for difficulty breathing; very tired; chest pain; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 42 years on an unspecified date (Batch/Lot number was not reported) at 14:00 as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to AEs. There were no concomitant medications. The patient experienced new onset atrial fibrillation (AFib) since 27Apr2021 and hospitalized form 29Apr2021, myocarditis/ Inflammation of heart (2021), pericarditis (2021), and pericardial effusion (2021) after receiving second dose of the Pfizer BioNTech Covid-19 Vaccine. Patient sought medical treatment and was hospitalized twice, the first time being 29Apr2021. The patient was still dealing with issues and went into hospital 27Apr2021 (as reported). Since then, he has been going back and forth to hospital and was admitted twice for the same issues. He was diagnosed with Afib and inflammation of the heart. Reporter just wanted to know who needs to talk to because it seemed to be vaccine related. Patient has had to take time off of work and reporter has had to take time off work to take care of him. Patient stayed a week for the first AFib hospitalization. He got out of the hospital (2021) and was at home for a week. That Friday, he went back and was hospitalized for another week (2021). That admission was for both AFib and inflammation of the heart. They saw the inflammation the first time, but it was not a lot and said it was probably normal because of the AFib. When he went back for follow up, he had a significant amount of inflammation and fluid around the heart (2021). He was still dealing with it. He had another issue with going to ER and this was Friday before last. He went in for difficulty breathing (2021) and was told he had more fluid around the heart. He was not admitted for that one. They gave him more medication to control the fluid. Reporter later stated it was prednisone and she did not have a dose, lot or expiration. She then said the dose was increased after he went for follow up and had more fluid. The first time patient was taken to the emergency they could not find anything and the next day, she (reporter) called 911 from her home and saw that he was experiencing some cardiac issues and saw that he was admitted and told he had AFIB. When she called 911 from her home, they transported by ambulance to (#) Hospital in (#), (#) and that was when he admitted and diagnosed with AFIB. Since # was out of their network, he was transferred to # that same evening or day to # and he was there about a week. Then he was released after a week and still had a hard time breathing and walking a few steps with trying to catch his breath and had chest pain and was very tired (2021). Then he went to a follow up that Friday after being released. Unknown doctor in (#) and then he was readmitted at the follow up appointment to #. He was in the hospital for a week that time as well. He was discharged and they prescribed him medication and then he came back home on medication and he has been on several medications. The one to reduce inflammation, starts with a P and she cannot remember name. He finished it and went to a follow up. After he finished medication, he was experiencing side effects (2021) such as chest pain, difficulty breathing and tightness of chest. She then remembered it was Prednisone that he was on, unknown dose, and it is in pharmacy vial with no lot or expiration. There was no seal, and count size is unknown. He no longer has any left. He went to the ER in (#) because he was experiencing the same symptoms. They saw more fluid collecting and put him on the same medication but a higher dosage of Prednisone. This dose is 10mg, 4 tablets by mouth daily. It was also in a pharmacy vial with no lot or expiration. This was where he was now. He has been out of work and so has reporter. The patient had MRI, XRays, Echo, Blood Test and was still doing blood test (in 2021). He has to go back this week. Everything came back as unknown for what caused this. The outcome of events myocarditis/ Inflammation of heart and AFib was recovered/resolved with sequel in 2021, of other events was unknown. Information on the lot/ batch number has been requested.

All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and leg numbness (feels like they are asleep), out of breath, can't think of simple words or statements, forgetting what I am doing in the middle of a process (simple stuff), heart arrhythmia.

swollen throat; Bad taste in mouth; sore throat; This is a spontaneous report received from a non-contactable consumer, the patient. A 42-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 28Mar2021 at 11:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021, the patient experienced throat swelling, sore throat and bad taste in the mouth. The adverse event resulted in emergency room or department or urgent care. The patient was tested for COVID-19 post-vaccination. The patient underwent a SARS-CoV-2 nasal swab test on 04Apr2021, and the result was negative. The patient received pain medicine as the treatment for the adverse events. The clinical outcome of the events throat swelling, sore throat and bad taste in mouth were not recovered at the time of the report. No follow-up attempts are possible; information about the lot number cannot be obtained.

Tired; Not wheezing but breathing fast; Heart beat was pumping; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 as dose 1, 0.3 ml single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. It was reported that the patient got some kind of side effect that's why he was calling to record. He was in bed and he could feel his heartbeat was pumping (on06May2021) after that day in the evening until Saturday night between 08May2021 and 09May2021. On 10May2021 in the morning he felt normal. . After the first dose, for two days he was so tired (on 07May2021). He saw that it was one of the side effects. The patient also experienced not wheezing but breathing fast on 07May2021 after his first dose. The patient asked if he could take the second dose or not. Someone in his family was a doctor and he said to call that number to see if anyone had the symptoms. The patient did not want medication, he wanted to know if he should move to second dose or not. On 10May2021, the events were resolved. No follow up attempts are needed. No further information is expected.

Dizziness mild shortness of breath, asthma exacerbation Narrative: used albuterol inhaler at home which did help.

Around 8pm I began having chills, body aches and SOB that lasted throughout the night. The next day I felt a little better earlier but got very fatigued, had a headache, chills and a large swollen lymph node developed under my left arm and its still there today. And my arm is sore at the injection site.

12/23 I woke up around 3am in the morning with a headache, body ache, fatigues, no fever or cough. 12/26 went to an Urgent Care for COVID-19 and got results 12/27 I was positive for COVID. On 12/27 I lost my taste and smell and started experiencing SOB which lasted for the next couple days.

Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to the anterior throat (feeling of swelling) but not having short of breath or trouble talking.

Metallic taste in mouth and unusual sensation in posterior pharynx (1st and 2nd vaccination courses)within 15 minutes post IM injection. Approximately 4.5 hours post IM injection (2nd vaccination) again unusual taste in mouth with swelling of posterior pharynx. Swelling not relieved by 20 mg prednisone X , Benadryl 50 mg and Pepcid 40 mg. Second dose of prednison 20 mg alleviated throat symptoms. Approximately 24 hour post IM injection (2nd vaccination), subject felt itchy, especially the eyes. Subsequant dose of Zyrtec and Pepcid alleviated symptoms within one hour.

Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating, and c/o throat tightening, was pale and still nauseated. Benadryl 50 mg Im given. His brother in law was called to drive him home. After he was stable, and no longer c/o any symptoms he was release to his brother-in=law. He says he went home and slept 3 hours and then slept til noon the next day which is not normal for him.

headache, nausea, fatigue, shortness of breath- started two days after vaccine and lasted about 5 days. Was tested for COVID19- results were negative

SM's reaction (SOB and pruritus) began approximately 15-20 minutes after receipt of vaccine. Patient received 50mg PO Benadryl and had improvement and eventual cessation of sx over his 60 min obs on site. Vitals remained stable (HR 60-72, SPO2 98-100). Patient was written for epi-pen and was retrieved from the site by his spouse. Instructions provided to both in regards to f/u and reasons to report to ED or call EMS.

After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.

Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off throughout every day, joint aches in fingers and ankles, bilateral calf pain, wheezing, heart burn, brain fog, cold feeling in feet. These occur throughout every day, on and off. We are now at week 5.

Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue, lasted about 15 minutes, called ems went to ed, was given prednisone, calmed down, helped with inflammation but still lethargic, chest pressure, and pain, stomach pain, feels like a weight and pressure in chest, feels like sinus infection in head, mucus in them morning was red and thick, also having night sweats

Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. Pt clampy and sweating. HR 47, Osat 97%. Pt had difficulty breathing with conversation. @1354 Lowered to the floor to lay flat. 1355 BP 101/62, HR 78, O2Sat 98%. @ 1403 BP 100/68, O2Sat 96%, HR 79, pt sitting. @ 1405 pt states "feels ok now" Sitting on the floor 1410 HR 85, O2Sat 94%, Pt remained talkative, alert & oriented sitting on the floor until 14:32. Pt standing 1433 "feels fine" alert and oriented x 3. Pt discharged 14:42. HR 82, Osat 98%

About an hour after getting my first shot i started to have back and leg pain, a headache was developing. about an two and a half hours I started feeling weak. It was hard for me to lift and carry things, I was getting winded walking across the building and the i would feel a little nauseous but that would go away after standing still for a few minutes.

Symptom onset 10 -15 minutes after receipt. Symptoms included pruritis, shortness of breath, perhaps CP. HE does not recall urticaria, oral/facial/throat or tongue swelling, red/watery eyes, wheezing, n/v/d. He was treated with 50 mgs benadryl and observed for one hour. There was no recurrence. Event documentation is very consistent with his report and documents VS R 60-75 SPO2: 98-100 with metal status of A&Ox4.

3/13/21 - 3:00 PM. LEFT EAR ACHE 5:00 PM. ARM HURT WHERE I GOT THE SHOT. TOOK 2 ADVIL 9:00 PM. HEAD AND THROAT ACHE 10:00 PM. CHILLS AND SWEATS 12:00 PM. EYES WATERING 3/14/21 THROUGHOUT THE DAY. SWEATS AND CHILLS, WATERING EYES, HEADACHE, FATIGUE TOOK 2 TYLENOL EVERY 4 HOURS 3/15/21 8:00 AM - SLIGHT WATERY EYES. 9:00 AM - UPPER LIP BEGAN TO SWELL, TOOK TWO ALEVE 10:00 AM. UPPER LIP COMPLETLY SWOLLEN AND ON FIRE. TOOK 2 BENADRYL 11:00 AM. FATIGUE 12:00 PM. CHEST BEGAN TO TIGHTEN AND SHORTNESS OF BREATHE, TOOK 2 BENADRYL 4:00 PM. TIGHTNESS OF CHEST AND BREATHING WORSENED 4:30 PM. WENT TO EMERGENCY ROOM. 3/16/21 - 3/20/21. FATIGUE, SWELLING OF UPPER LIP, TIGHTNESS OF CHEST, SHORTNESS OF BREATHE 3/22/21 - PRESENT. TIGHTNESS OF CHEST, SHORNESS OF BREATHE

Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.

3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, he experienced an adverse reaction with the following symptoms: Tingling and swelling of face and throat. Tightening sensation to the face including mouth. Sweating, with redness to the face. Mild nonproductive cough. Assessment : Time of assessment 0932am. Alert and oriented. Nurse assessed lung sounds, VS monitored for 30 minutes. Actions taken: assessment of face and mouth, no swelling seen, face is red and he has sweating forehead. Vitals sign taken at 0932 with BP- 185/131, P- 89. R-17 O2- 98% , Benadryl 12.5 mg liquid given po x 1, VS rechecked at 0937, BP - 190/134, P- 84, T- 98.4. R- 18, O2- 98%, Benadryl 12.5 liquid given PO at 0927. EMS on site due to another issue, assessed pts lung sounds and assessed for auditory stridor to neck, patient with slight cough, voices that he is feeling some better, he remains sitting in wheelchair. VS at 0947 , BP- 166/127, P- 82. O2- 98%, VS at 1002- BP_ 154/110, P- 85, O2- 96%. Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 0932 and 0937. Administered by RN. Disposition:Reports swelling to face and mouth has improved, he is advised to follow up with PCP for elevated BP AND SYMPTOMS ASSOCIATED WITH VACCINE/ Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/31/2021 9:08 AM 0.3 mL 12/11/2020 Intramuscular

skin was burning itchy and red; skin was burning itchy and red; sunburn; trouble breathing; tongue swelling and discoloring; tongue swelling and discoloring/ he saw that his tongue was dark chocolate like he had just eaten a black licorice; felt like breaking out in hives/chest was beat red was referring to hives; chest started to get broken out and got beat red; allergic reaction; got beat red; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162B2 (BNT162B2, lot number: EP6955), via an unspecified route of administration in the left arm, on 15Mar2021 3:00 PM (received at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included Attention deficit disorder, cholesterol, benign heart palpitations. He also had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED (emergency department). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unspecified date and ongoing for Attention deficit disorder; metoprolol from an unspecified date and ongoing for benign heart palpitations; simvastatin from an unspecified date and ongoing for cholesterol; vitamins and minerals; ubiquinol from an unspecified date and ongoing; fish oil from an unspecified date and ongoing. The patient previously had a flu shot in Aug2020. The patient previously took epinephrine and experienced insect bite were worse, and metoprolol and experienced reaction linger. The stated he thought he had an allergic reaction to the Pfizer covid19 vaccine on 15Mar2021. He states that his tongue was swollen (15 min after receiving the vaccine, at 03:15 PM), he broke out into hives. He was in the restroom of the facility where he received the vaccine and that he did not have hives yet after getting the vaccine, but then asked the nurse if he could take Benadryl and was told yes. He states they then let him go because he had no trouble breathing at that time. He drove home and was going to reroute to hospitals if needed. He took 50 mg fast melt Benadryl as soon as walked out of the facility. He drank water, drank two larger bottles of water. His chest started to get broken out and got beat red. He took another 25 mg of Benadryl and then drove home. He then proceeded with Benadryl 50 mg every 6 hours. At 1 AM, the next morning (16Mar2021), he woke up with trouble breathing and tongue swelling and went to ER. They gave him Prednisone 60 mg and then started on 5 days of prednisone. They told him to continue Benadryl, and water and to follow up at hospital if worsens and to follow up with his physician. He stated that he had a previous reaction to insect bites and followed up with an allergist. He went over a decade ago for the insect bite, they gave him epinephrine at the urgent care and said to call or come back if it worsened. The next morning, his symptoms from the insect bite were worse and the urgent care told caller to go to the ED. He added that this experience with the Covid19 vaccine was milder comparatively as they gave him just steroids and not epinephrine this time, and, they told him he was not having trouble breathing this time. Last night, 16Mar2021, at around 10:30 pm, a half hour before next dose of 6 hour Benadryl was due, his skin was burning itchy and red so he took Benadryl a half hour early and set alarm to wake up before next dose. He woke up 4 hours later and waited to see if he would have a reaction and he has not taken it since. He took the morning dose of Prednisone with improvement and is carrying Benadryl in his pocket just in case. He later clarified that he took his 11 o'clock dose last night and then set a 2:30 am alarm to see if it was worse again or about the same. Regarding the allergic reaction, he first noticed around 3 pm Monday 15Mar2021. Within 15 minutes after the vaccine, he was going through his phone and thought he felt strange while waiting at (Name) after the vaccine to see if he had a reaction. This feeling continued until 11 pm last night, 16Mar2021. He took 50 mg of Benadryl when this first happened on 15Mar2021 and then took another 25 mg 15 minutes after the first initial dose. At the time of call, he notices no redness or itchiness or swelling of the tongue. He feels like he is going in the right direction. He noticed tongue swollen within 15 minutes of receiving the vaccine and that it was also discolored (15Mar2021 15:15) and asked a friend who has allergic reactions if this happens and the friend told him that it sometimes happens to other people with allergic reactions. He went to the ER on Tuesday 16Mar2021 at 3 am, exactly 12 hours after he received his shot, because of the swelling of the tongue. This was his first-time experiencing difficulty breathing and gasping for air as well. States that he does not have it now. Prednisone and Benadryl have knocked it out. He was not admitted and was released from the ER about an hour and a half after he got there (discharged at 4:30 am from the ER). He did notice at 3:30 pm that his chest was beat red. He was hanging out and his body would tell him when it was close to 6 hours that he needed to take Benadryl because he would be breaking out in hives. He has to take Benedryl within 6 hours. This is ongoing but he has not had any today. He clarifies that the chest was beat red was referring to hives. He felt yesterday 16Mar2021 that he had a sunburn and that his face was kind of red but he had not been in the sun. He clarified on timeline that he went to check for swelling and hives in bathroom after receiving the vaccine on 15Mar2021. At that time, he saw that his tongue was dark chocolate like he had just eaten a black licorice. There was no redness or anything but he felt like it was going to be occurring so he asked the facility if he could take Benadryl. He is scheduled for his second dose of the vaccine on 05Apr2021 and may be possibly returning but is not sure. He also noticed on Tuesday 16Mar2021 that while sleeping on the couch at 3 am he was going to take the next dose of Benadryl and woke up gasping for air. He got up to drink more water and took a shower and made coffee. Then, he went to the ER. He was really tired. He wanted to be alert to drive. It seemed like the water helped and he drank a lot of water. He did not want to take the next dose of Benadryl. He noticed that it did get better, and he did not want to stay home so he went to the ER. Outcome of the event allergic reaction was recovered with sequel on 16Mar2021. Outcome of swollen tongue, skin was burning itchy and red, got beat red and hives was recovering. Outcome of other events was unknown.

On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almost immediately. By the time I got to the resting/observation area I felt that the site of the injection got really warm and I became dizzy/lightheaded and started to feel heavy on the chest and little problem in swallowing and breathing. I was taken to the paramedics on site, they checked my blood pressure (which a little high 150/90), oxygenation, pulse, and EKG (which were normal). It did not became too bad after and was allowed to come back home. However, the heavy chest and swallowing problem lasted for three days. The heaviness in the chested turned into a sensation of feeling like my trachea or the anything under the sternum area was behind strangled. Although I felt like this my breathing and swallowing was almost normal. Every now and then when I swallowed I felt some pain but I could withstand it.

Patient received vaccine at 1144a, left site, started feeling palpitation and drove back to site. MD assessed, O2 at 93%, O2 4L initiated by onsite Paramedics. Pt vomited and stated he feels dizzy and has SOB. Ambulance called, vitals taken: BP 159/96, HR 88, 98% 4L NC. Last taken BP was 133/66, patient stated he was feeling anxious, recommended to go to the hospital for further assessment. Patient was driven by his wife.

Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection site.Headache.

Shortness of breath, tight chest, burning sensation in the eyes, significant fatigue, and joint pain in all fingers, hands, knees, toes and neck.

PFIZER-BIONTECH COVID-19 Vaccine EUA PFizer 2nd dose taken on 4/13 12:30 PM 4/14 around 11 AM had shortness of breath / cough for 5-10 minutes 4/14 around 11:30 AM started seeing swelling on both left /right top Eye lids like a big sty.

Bilateral pulmonary embolism which was diagnosed on 4/14/21 after 2 days of severe shortness of breath. Associated with hypoxia requiring supplemental oxygen. Patient is morbidly obese which is only other risk factor for pulmonary embolism. He denies history of increased sedentary activity, denies recent travel, denies known history of a hypercoagulable disorder or family history of blood clots. No other causative factors for the pulmonary emboli have been identified.

Day 1 - diarrhea x 2, Stomach upset, Headache, fatigue, short of breath with ambulation only, rash on left hand - dorsal aspect - pink - pinpoint - non itchy. Did not work (called in sick) Day 7 - Rash is less but present - itchy on day 6 and 7. Fatigue and headache continue. Shortness of breath with ambulation - subsides with sitting. Sleep is normal. Attending work as usual - other than days 1 and 6 - went home after 4 hours of work on day 6. Eating normal - bowels and bladder normal. Denies fever and chills.

The patient received the injection, was monitored for 15minutes. He returned to his station at work. He had a sensation that he could not get an adequate breath. He says this started about fifteen minutes after the shot and observation had been done. He was assessed at 5:55pm on Friday (4/23/21). The pt had his vitals done at the area of injections. He was found to be stable. The pt walked under his own power to the medic clinic. There he was placed on a stretcher and vitals performed again. He was given a epic-pen injection in the left thigh, per author. This was a 6:35pm, approximately. He had no adverse effects from the epinephrine shot, with vitals still monitored. An ambulance arrived, report given and he was to be taken to the medical center for further observation.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypertension-Severe, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Severe, Additional Details: Patient was unconscious for few seconds after the shot administration. he then became conscious but was dizzy, weak, pale. He was given water and sat down for few minutes. we called 911 and he continued to feel weak and dizzy. EMS said he had high blood pressure, high heart rate , they thought he possibly was in cardiac arrest. Patient was taken to the hospital via ambulance

About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and faint. That passed quickly. Then had extreme burning sensation near injection site for about a minute. Did not report this at the time or before the second vaccine for fear of not being given the second injection. About 10 minutes after second dose, suddenly realized it was difficult to breathe. Removed mask. Started to feel better after a few minutes, replaced bottom, more breathable mask (did not report to observers). Was urged to leave vaccination site due to backlog of patients, so walked back to car. Began to feel pretty out of it (faint again, plus heart racing) on the way back to the car. Considered getting the shuttle back to the injection site, but instead sat in the car until it passed. About 25 minutes after the vaccine, started feeling very hot all over. 30-40 minutes after the vaccine, all reactions seemed to have passed and drove home without incident.

Right after receiving the vaccination began to develop very high resting heart rate(150bpm), along with dizziness and some mild shortness of breath, along with an out of body feeling. Some muscle tightness in neck. Took one benadryl after 15min, began feel better after 1hr. Then had more common reactions later that evening. Regular bpm is 55-60.

Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where the shot was given. Day after vaccine: lower than normal energy, but otherwise fine. Two days after vaccine: low energy, body aching, occasional cough. Three days after vaccine: similar symptoms of the previous day. Four days after vaccine: lower energy, body aches, coughing, persistent headache, eyes feeling tired and burning, and congestion starting in my chest, all worsened in the evening. Five days after vaccine: congestion in chest, regular cough, sore throat, runny nose, eyes feeling dry and burning, shortness of breath. Was tested for Covid on the fifth day after the vaccine. Six days after vaccine, chest congestion, coughing, sore throat, runny nose, shortness of breath, and still low energy. Covid test result came back as negative.

during the following 3 weeks, I'd experienced weird things like anxiety( excessive worries about anything, feeling of my heart beating fast, sometimes feeling my breathing is very fast, chest tightness or heaviness, and feeling that I'm losing control for few seconds, feeling cold that I put on the heavy jacket that I never used except in cold winter! feelings of boneaches especially in my fingers joints, some days I'd nausea and feeling that my stomach torture me! All the previous symptoms were on and off many times per day, I was using Tylenol and Ibuprofin almost every day. lately, I'd 4 days of continuous symptoms, that I feel like panic and cold with all the above symptoms.(from 29th April to May 3rd).

received the first dose of Pfizer COVID-19 (Lot#: EN6207) in the left deltoid in the early afternoon of March 24, 2021. He immediately felt left hand tingling/numbness at his left thumb and first finger that has intermittently worsened with flexing his arm. There was no local reaction. The next morning, he experienced severe fatigue, headache, muscle aches/soreness, fever and mild chest congestion that resolved after 5 days. He also developed itching and hives that occurred from his chin downward on his neck, bilateral shoulders, back, chest and abdomen with no hives below his waist. He had photo showing erythematous blotchy rash scattered over this neck, anterior shoulders, chest and upper abdomen. The hives continued daily despite Claritin 10 mg daily and have gradually subsided. There was no nausea, vomiting, diarrhea, abdominal pain, dysphagia, swelling, cough, wheeze or shortness of breath. HIs last hives was 2 days ago and no hives today. Prior to the vaccine he was well without colds or flu-like symptoms in his usual state of health. He had not taken NSAIDs or other medications or supplements.

I had an extremely sore body and couldn?t lift my left arm over my head (I have some should problems anyway, but it made it worse). I had a slight headache, but it wasn?t too bad at that point (maybe about 9:30pm). By 12:30am I was feeling pretty crummy in a general sense and decided to go back to bed (I work nights and normally stay up, even on my nights off). I ended up with severe chills and shivering and shuddering by 1:30am. My legs were so restless and I was shuddering so hard I gave myself charlie horses. By 2:30am I started to warm up but because especially nauseated as I got warmer and warmer. I tried to sleep off and on, but ended up in a chair sitting up and dozing with a bucket in case of getting sick. I was panting heavily for some reason. It felt like it was making the nausea less severe (I also sipped on an Alka-Seltzer and took a meclizine). For three hours I was panting and trying not to vomit. Then I kind of settled down and got an hour or two of sleep, still extremely sore and by this time my head was pounding severely. I got up at 6:30am to take my Mirilax in orange juice (I forgot to mention I take a magnesium supplement and senna on a semiregular basis, as well). The combination of Mg, senna, and OJ didn?t sit well. By about 7:30am I began to get the chills again, but it only lasted about a half hour. Again, an episode of nausea after, but more Alka-Seltzer. I tried to eat small amounts of plain salty tortilla chips, but it didn?t help. It?s now 8:20am and the nausea seems to have passed.

Pericarditis. Pressure in upper chest, trouble breathing, slight fever, rapid heartbeat. Given 800mg Ibuprofen 3 times a day for 5 days and doing much better.

After about 10 minutes of getting vaccine, throat started to swell. Nurses at the site administered Epi pen. Taken to ER via ambulance. Give Benadryl and other medicine that I cannot remember. kept for observation about 4 hours and released.

Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever; Chills; Chest pain; Oppression in his chest that does not allow him to breathe normally/ pressure in his chest not letting him breathe normally; Sore throat/ extremely, extremely sore and dry throat; Chest pain is like a pressure; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 43-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 09:00 as 2nd dose, single dose (at the age of 43-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient mentions that yesterday (27May2021) he got the second dose of the Pfizer covid vaccine at 9 am and since then he had fever, chills, sore throat, chest pain like a pressure in his chest, oppression in his chest that does not allow him to breathe normally. On 28Feb2021, experienced dryness in his throat (extremely sore and dry throat), headache, feeling terrible. He wants to report the situation. Patient what should he do, does he need to go to a hospital. Communication included Advising patient to seek medical attention or the care of a doctor. The outcome of the events was unknown. No further information is provided or obtained. Information on lot/Batch number has been requested.

Tachycardia, shortness of breath, right heart strain evident on EKG. Follow-up tests showed no blockages or anatomical abnormalities. Symptoms are resolving.

Patient had systolic and diastolic heart failure on 02/20/2021 possibly related to COVID-19 Vaccination given 12/30/21 & 2nd Dose on 01/20/21 (heart inflammation?); Grade III left ventricular diastolic dysfunction was observed during hospital stay; cause unknown; EF of Lt. Ventricle has increased form 21% on 02/22/21 to 33% on 04/29/21 per two echocardiograms on each date. Pt. was given meds for Heart Failure, BP and Hyperlipemia; Pt. had a Cardiac Cath of Rt. & Left Heart on 02/23/21; no signs of coronary disease. Pt. is receiving ongoing outpatient chronic care treatment for issue.

After 2nd dose following events occur deteriorating overall health. I don't have any preexisting health conditions. 1. On May 24th at around 12.15 am, I started experiencing 100 degree fever followed by chills. The blood pressure shot up to 165-95 and heart rate was around 140. Was feeling breathless and sweaty and was being rushed to ER . 2. On 30th May again experienced BP at 165-90 and pulse was at 150 and rushed to ER 3.Again on May 31st, BP shoot up to 170-90 and pulse 145 and ER visit. 4. Consulted cardiologist and on Metoprolol medicine 5. Always feeling dizzy and lightheaded with unprovoked rise in BP and pulse. 6.Unable to resume regular day to day activities including office work. 7. Daily fluctuation in BP and pulse observed till now since 2nd dose of vaccine.

Patient said he was feeling lightheaded and shaky. He was asked if he had trouble breathing and he said yes. One dose of Epipen was given and 911 was called.

Bad intermittent headache resembling a migraine; Felt a pain in chest each time patient breathed in; Felt a consistent heaviness orpressure in my lungs; Occasional shortness of breath.; Minor nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. The patient was not allergic to food, medications, or other products. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. 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. On 26Mar2021 at 10:30, the patient felt a consistent heaviness or pressure in lungs, occasional shortness of breath and minor nausea which was present at times. On the same day at 10:45, within 15 minutes of receiving the vaccine, the patient felt a pain in chest each time the patient breathed in which lasted for an hour. On 01Apr2021 and 02Apr2021, the patient had bad intermittent headache resembling a migraine. The events did not result in 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. The clinical outcome of the event felt a pain in chest each time the patient breathed in was resolved on 26Mar2021 in about one hour. The clinical outcome of the events occasional shortness of breath, minor nausea, bad intermittent headache resembling a migraine, and consistent heaviness or pressure in lungs were not resolved at the time of this report No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I start having SOB and fast heartbeat around the end of April. It got worst through May. I went to the ER They did blood work, that came back abnormal. So, they did a CT scan, it show that a had pulmonary embolism, which confirmed that I had a blood clot. The blood clot caused a strain on my right side of my heart. I am not taking blood thinners. I have never had blood clots before the vaccination.

He began to have lower extremity weakness on Sunday 7/18/21. He went to an outside hospital ER on Sunday due to LE weakness and diagnosed with a heat stroke and discharged home. On 7/20/21, he came to ED and reported the weakness had moved up into his upper extremities. Admitted to the hospital on 7/20/21. He has been unable to stand or use his upper extremities for the past 3 days. On exam he has tremor of the jaw, he reports he does not notice this. He does have sensation intact. Intubated and placed on ventilator on 7/20/21 for respiratory distress. Diagnosed with Guillan-Barre syndrome requiring a trialysis catheter placement acutely for plasmapheresis. Plan plasma exchange 6 times, with treatment every other day. As of today, 7/28/21 patient remains hospitalized.

throat swelling; This is a spontaneous report from a contactable nurse. A 44-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 09:15 at single dose in left arm for covid-19 immunization. Medical history included allergies to shellfish and bees. The patient's concomitant medications were not reported. The patient experienced throat swelling on 05Jan2021 at 09:15. The event was reported as non-serious by reporter. The event required emergency room visit. It was unknown if the patient received treatment for the event. There is no any other vaccine within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID 19 prior to vaccination, and the patient was not tested for COVID 19 since the vaccination. The outcome of the event was unknown. Information about Lot/Batch has been requested.

Pt was observed for 15 minutes after immunization and reported no immediate symptoms. That night, the patient ate salmon and mashed pototaes at 630pm. He reports arund 930pm, he developed stomach ache and one episode of diarrhea. Patient reports subsequent mild constriction in his throat and acute nasal congestion. Patient also reported acute onset of wheezing. He initially took his albuterol inhaler and took a puff of of Dulera without symptom improvement. He administered epinephrine IM at that point with immediate symptom improvement. He reports nasal congestion and wheezing resolved. Patient monitored symptoms at home. He did not seek medical attention. Unsure if reaction was related to salmon or COVID 19 vaccine. Patient will be assessed in clinci for a formal salmon oral challenge in the clinic. Patient will receive the 2nd shot COVID 19 vaccine and will bring epi pen with him to the clinic.

About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate went back down to normal about 2 or 3 minutes after it initially increased), I was short of breath, and slightly dizzy. The night of and the next morning after the injection, I have been tired, my left arm of the injection site, left shoulder, and lower back have been aching. The next day after the shot, I have been unusually tired, also.

10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side for first 30 min following vaccination Then after 30 minutes it switched to right side twitching (twitching not painful) Employee also had trouble breathing at that moment and was diaphoretic--Rapid Response Called VSS--employee returned to work Two hours later employee experienced diaphoresis, presyncope--went to Emergency Dept at this time--all labs and tests came back WNL 1/7: Fever 100, twitching continues (superficial) 1/7-14-superficial twitching throughout body 1/14-1/15?twitching seems to go deeper--in intestine, deep in LRQ 1/22 still having these twitches (not painful, just disturbing/odd)--Employee estimates these twitches happen 20x an hour

My signs and symptoms begin the next morning I had a rash on my chest neck and face and my throat was a little swollen

Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.

I developed acute right posterior pleuritic chest pain and shortness of breath. Diagnosed with multiple pulmonary emboli (see below). I was started on Eliquis initially, but then had worsening symptoms on 2/4/21 and switched to Lovenox injections. Symptoms have been slowly improving since then.

The night of the injection, I woke up with a 10/10 headache, tinnitus, and shortness of breath. I thought nothing of the shortness of breath as I am asthmatic. The next couple of days I felt completely drained, fatigued. Ten days later I have partial facial paralysis. I saw the emergency physician at the hospital who prescribed prednisone, acyclovir, over the counter eye drops, and an eye patch to wear at night.

small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.

sore throat; nasal congestion; very difficult to breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Mar2021 16:00 as SINGLE DOSE for covid-19 immunisation. There was no other vaccine in four weeks. No known allergies. The patient medical history was not reported.Concomitant medications included atorvastatin and Irbesartan, both taken for an unspecified indication, start and stop date were not reported. The patient started with sore throat that got progressively worse and nasal congestion. The 2 combined made it very difficult to breath. The events onset date were reported as 14Mar2021 05:15 PM, they resulted in Emergency room/department or urgent care. Patient received Benadryl, Pepcid and IV for treatment, and recovered in Mar2021. Patient didn't have Covid prior vaccination nor teasted Covid post vaccination. Information about lot/batch number has been requested.

Nnurse was called to assist a patient that had left the monitoring area. Upon arrival, patient was sitting in mall with back leaning on wall. Patient was AAAx3. He was pale and diaphoretic. Patient stated he waited his 15 minutes and felt fine. Patient received dose 1 of Pfizer Covid Vaccine (Lot #EN6207, Exp 5/31/21). When he was walking back to his car he "blacked out" and fell to the floor. Patient stated he hit his head on the ground. No visible injury to back of head was observed. Patient reported he did not eat or drink anything prior to coming. He stated it was warm in the mall and he was having difficulty breathing with the mask on. Patient was instructed to take his mask off. VS were assessed: 98/68, HR 82, pulse ox 98% room air. Patient was given water and some chocolate. Patient stated he started to feel better. Patient was assisted into wheelchair and continued to be observed. Patient stated he initially started to feel better, but then felt lightheaded again. VS reassessed @ 0948 BP 92/64, HR 72, pulse ox 98% room air. This nurse advised patient EMS should be called for further evaluation. Patient refused and stated he did not want to go to the hospital. Nurse again advised that his blood pressure remained low and he should be further evaluated. Patient continued to refuse. Patient was advised to call someone for a ride home as it was advised he should not drive at this time. Patient called his father for transport home. Patient was given a sprite to drink while waiting for his ride. Patient was accompanied by monitor until ride arrived. Patient was picked up and left without further incident.

He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had difficulty breathing, shortness of breath, fatigue, shakes, chills and feeling of weakness/dizziness. It lasted a few days. Then, April 9, 2021, he received his second Covid19 Pfizer shot, same lot at 12:15 pm and the next morning, Saturday, April 10th around 9 am Ira felt the same symptoms from shot 1, but more intense. He was feeling weak, had chills, shakes, profuse sweating, difficulty breathing, shortness of breath, dizziness and vomiting. He was unable to keep water down and stayed in bed. A little after 12pm, he complained of difficulty breathing and possibly not getting enough oxygen so I grabbed my equipment (since I'm a CNA) and checked his vitals. His B/P was very high ( 166/107), no fever (96.7), pulse was normal 72, and low respiration but oxygen was above 90. He said he needed to use the bathroom, I suggested using his urinal but he said he needed to have a bowel movement. Once he was in the bathroom, I went downstairs for a glass of water and then suddenly I heard a huge thump. I ran upstairs, knocked on the bathroom-no response but I could hear noises, so I opened the door and I saw he was face down on the floor, head under the bathroom sink counter, blood everywhere, and he was convulsing. I grabbed him immediately and moved him to his side (I had my fitbit on, it said it was 12:30pm), and he kept seizing. He looked discolored almost blueish color. I held him on his side, he vomited, making noises, but unable to speak, continuing to have a seizure. Seizure lasted three minutes. At 12:33pm, once he had calmed, I ran downstairs to find my phone. I was back at his side calling 911 at 12:35. Paramedics arrived 9 minutes later and took him to the hospital. My brother picked me up and took me to the hospital. Once outside his door, I noticed he was finishing taking X-Rays when he suddenly had another seizure.

Patient's physician reported this adverse event by phone to Medical Center administration on 4/13/2021. Per the physician, the patient received his 2nd Pfizer COVID19 vaccination dose on Friday 4/9/2021 at the drive through vaccination clinic. On Saturday 4/10/2021 the patient told to his wife that he felt ill, continuing through Sunday. On Sunday, 4/11/2021, at his home, the patient told his wife that he felt ill and went to sleep. The patients wife found him not breathing, called 911 and started CPR. The patient was pronounced deceased at his home and was not transported to hospital.

As soon as pt received vaccination, he said he felt tightness in his chest, heart racing, irregular heart rate, SOB, nurse noted he was ?swallowing hard?. EMS called ASAP, BP 172p (pt obese) hr 108 sao2 98%. He was soon able to get out of the drivers seat to allow is mother to drive, moved for further obs. Stated chest felt intermittently tight and burning. No rash, swelling of tongue lips or airway noted, pt admitted to h/o anxiety, next vitals similar, pt released after 30 min by EMS into the care of his,other

I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire, thirsty, Head pain, congestion, dificulties to function

With first vaccine on 3/11/21 pt. had syncope due to vagal response-has "needle phobia". Second vaccine was given 4/1/21, while supine, with no problems. Two days later he began experiencing shortness of breath which lasted about 5 days. He was about to call his doctor when it subsided. He is a runner and has no health problems (except seasonal allergies) and does not take any regular medications. He was not experiencing seasonal allergy symptoms during the episode of SOB.

pt got vaccine 4/7.. on 4/8 he said his whole body broke out in a rash. he said he has trouble breathing often and has asthma and "wasn't sure if his breathing was worse with the vaccine or not, since he has that trouble often". he reported this adverse rxn on 4/28 when he came for his 2nd dose. we told him we cannot do the vaccine today, he needs to go to the hospital for another dose if they will administer it, he needs to call

A couple minutes after patient got the first dose of Pfizer vaccine, patient complaint not feeling well, sweating, tongue feeling funny and not able to see. My technicians laid him down on the floor and contacted 911 to send medics. Patient was still alert but later complaint difficulty breathing. Pharmacist notice swelling around pt's neck area and weak pulses. Pharmacist administered an epipen and stayed with patient. A few minutes later, patient symptoms subsided , medics arrived and brought him to the hospital.

Pt felt dizzy immediately after injection, pt had a slight tremor and labored breathing, counselled pt to take deep breaths and stay seated, pt tried to stand and fell to the floor unconscious where he remained breathing but unresponsive for over 1 minute, came to on his own.

Patient experienced apprehension, flushing and numbness and tingling. Patient verbalized "Throat tightness" and elevated BP even though pt reports being on BP medications. O2 sat and pulse remained normal. Lungs CTA. Patient has a history of reactions to bee stings. Pt was given 50mg Diphenhydramine observed by staff and released

1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, felt like lungs were hurting in my back, weak, tired, couldn't catch my breath when i went upstairs and almost passed out. 2nd shot 5/04, felt pain at injection site (that was expected), that night started to get a bad headache and got worse and worse. Next morning, whole body aching, upper body, lower back, bad headache, Left underarm (lymph) swollen. 2nd day slight headache, neck ache, left underarm swollen. That night had rash on arms, chest, and stomach. 3rd day, nighttime rash arms, chest, stomach. Still red where band aid was over injection site. Over a week later still have redness shape of band aid, Seems I have sensitive skin since the 2nd covid shot. 10 days after 2nd shot I still have redness the shape of the Band Aid on my left arm. Got a red spot on my nose (looks like Rosacea). 4 weeks later, still have a red spot on my nose. I have itchiness between fingers left hand, on my face left side, neck, arms (left wrist, right arm in places) redness on chest, and rashes on back, left buttocks, and itchiness on legs. i noticed that it gets worse at night. As far as i know i did not get the Covid Virus, i did the rapid test and regular test and both were negative. But i was very sick with my stomach and had issues breathing in late 2019 and again early 2020, took medication (antibiotics) both times. I had to write on this form over and over again kept getting frozen with error from the PDF. Even if I hit OK, it keeps popping up and does not let me finish, so I can imagine that lots of people gave up, like I may. Pfizer 4/13/2021 EW0162. After 5pm Pfizer 5/04/2021 EW0170. After 2pm

Would occasionally have difficulty catching my breath while not doing anything. I occasionally felt my heart flutter or it would possibly skip a beat. Mild chest pain below above the sternum but I get that feeling from my Eosinophilic Esophagitis. I've become more concerned recently as I almost fainted once on 5/19 while working at my computer. I've had two other instances of feeling faint, most recently occurring on 5/27. I historically have had no heart issues and can ski and hike all day and feel great so this recent change has been concerning. After reading articles on the covid vaccines I realized that my symptoms are similar to the heart related issues and took ibuprofen when I felt additional chest pressure. That has helped to alleviate the pressure at least.

Headache, stomachache, tightness in chest, shortness of breath, onset at ~2:30am, approx. 14.5 hrs after first shot. Headache lasted approx. 3 hours. At time of this report, the stomachache, chest tightness, and shortness of breath are continuing.

I was driving home from my town to another town. About 15 mins I thought I had to take leak and my groin area was warming up on the inside and then it started to burn up on the inside and it was painful I was thinking what could have caused and it then I realized I had the pfizer vaccine and then I have implant all of sudden I loss use of arms and it took about 20 mins for me to get use in them and then they started to burn up on the inside. Later on that night I started to cough really bad and my lungs had a hard time keeping me breathing and then I knew I had got the covid from the shot and it was much worst than the actual covid. This was the first dose of the pfizer that I got these reactions and plus I heard about how the vaccine has been sterlizing people from having kids. I knew that the pfizer vaccine is 100% unsafe for anybody to take and that it was a bad batch or wrong vaccine. But I am letting you know that you need to keep money set aside for damages from the vaccine. But please do not be like the other states giving people money, guns, trucks for getting the vaccine. I am warning people not to get it because I almost die in the first dose of the pfizer vaccine.

I was required to stay 15 minutes and was very dizzy. I was having severs pains in kidney and lungs. 7 days after vaccine I took my medication (Fasenrapen) I had been on for a year my throat swelled up.

Heart rate increased (sitting heart rate jumped to at least 110), breathing felt slightly more labored. Visited emergency room and underwent tests, no specific treatment given. Outcome is heart rate slightly lower, but still appears to be higher than previously observed.

Throat/tongue and neck area swelling for about an hour. Anxiety and some dizziness. Problem began about half hour after injection then went away after an hour or so after it began - but my doctor recommended that I do not to get second shot because of this reaction.

Waxing/waning constellation of symptoms that include shortness of breath, chest pain, tachycardia, and fever along with recurrent eosinophilic pleural effusions.

Approximately one month after my second shot, beginning around 5/20, I began to lose the sense of taste on the right side of my tongue. I thought it would go away but by 5/23 I had partial paralysis on the right side of my face. Fearing a stroke I went to the ER and after a full battery of tests I was diagnosed with Bell's Palsy. The symptoms worsened for a few days and I was unable to close my right eye, had difficulty breathing out of my right nostril and both eating and drinking were difficult because my lips would not close fully. The symptoms stabilized and then finally began to improve after steroid and antiviral treatment for a week, then on to regular aspirin.

Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his throat; Rapid heart rate; really bad chest pains; vomit; nausea; gasping for air; Neck spasms; Blood pressure, clarified as low blood pressure; It was like he was catching pneumonia but then his nose was running,; severe congestion, like bad stuff in his chest and lungs; severe allergies; tired; he got really sick; It was like he was catching pneumonia but then his nose was running,; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and from a Pfizer sponsored program. A 44-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167, Expiry date: UNKNOWN, NDC number: Unknown), via an unspecified route of administration at the right arm on 29May2021 11:15 as a SINGLE DOSE for covid-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing, illness from Feb2020 to an unknown date, whole family was sick in February, palpitations from an unknown date and unknown if ongoing. History and investigation included "he said he had nothing to add during that time. But about a year ago he had gone to the emergency room for a heart attack scare. he thought, because this was when COVID first started happening, his whole family was sick in February and they would not test them at that time because they had not been to China and they never found out if they had it but he ended up getting tested for COVID when he was sick like 6 months later and then that went away and he started having heart palpitations and then after that he thought he would get a COVID antibody test and that came back negative, they told him by the time he got the antibody test, they told him he could have had it but it is not showing up on their antibody rapid test thing. He confirms this all occurred last year in 2020, he thinks it was almost a year ago. He would be sitting on the couch and his heart started racing like crazy. He did not know what that was all about". He said he had no discomfort at all. Concomitant medications were not reported. On an unspecified date in 2021 patient experienced it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running, on an unspecified date in 2021 severe allergies, on 29May2021 rapid heart rate, really bad chest pains, stuff in his throat/weird stuff on his throat , cough, on an unspecified date in May2021 vomit, nausea, on an unspecified date in May2021, gasping for air, on an unspecified date interrupted his sleep. Caller received his first dose and was experiencing symptoms such as rapid heart rate and neck spasms and blood pressure. He was too tired to go to the emergency room. He had the weird cough and also stated he had weird stuff on his throat and severe allergies. Regarding his second dose, he wanted to receive but he wanted to know if he could receive a half dose. He also had really bad chest pains and he was going to go to the emergency room but he was too tired to even go. The other reason for calling, he was trying to find out because he was afraid to take the second dose, he wanted to know if he could take a half dose or something, he was trying to find out what he should do. Severe allergies, caller clarified it was like severe allergies or like hay fever kind of, but it was different. Rapid heart rate: He said this began happening the same day as the dose was given, 29May2021, 4 hours after he got the shot. It was not ongoing, it lasted about a day. The rapid heart rate went away the next morning, it stopped doing the crazy things it was doing the next morning, 30May2021. He confirmed that has recovered completely. The chest pain coincided with the rapid heart rate. It went way the same time as the rapid heart rate. It seemed like they both would come and go until the next morning, He confirmed that had recovered completely. He said then the low blood pressure was going on too. It was like it interrupted his sleep, he did not know how to explain it, like he had low blood pressure or like his heart would stop beating and he would wake up gasping for air. It was kind of like a nauseous feeling, he wanted to vomit. It happened with the low blood pressure and was mostly when he was sleeping and a little through the day, the nausea he means, it lasted about a day and a half. The nausea went away on the 30May or the 31May he cannot remember for sure. The cough and stuff in his throat began at the same time the heartbeat stuff started and the cough went away after 2 days. He felt pretty good for about 3 days and then he got really sick, with severe congestion, like bad stuff in his chest and lungs. It was like he was catching pneumonia but then his nose was running, it felt weird like a sickly poison kind of feeling like after he got the shot, he could not tell but it seemed like severe allergies or like hay fever kind of but it was different, it was a weird feeling. He had taken a bunch of herbal remedies Benadryl took herbal allergy stuff and it worked really fast and after like 3 days it was gone. He does not know what that was but it was pretty intense. No further information provided. It was reported that, caller got his first dose of the Pfizer Covid-19 vaccine on 29MAY2021 and had side effects. He wanted to know if he could get only a half dose of the COVID-19 vaccine. He also wanted to know if there was any correlation to having COVID-19 and having more of a reaction. Caller wanted to know if there was a correlation between having COVID-19 and having more side effects to the vaccine. He stated that his Pharmacist said there might be a correlation to people having COVID before getting the vaccine and having more problematic side effects from the first vaccine instead of the second. Response was given as "he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he 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. He was referred to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would have known the health situation and could access to information that better help inform the decision. From the CONS document on efficacy. Two shots were generally needed to provide the best protection against COVID-19 and the shots were given several weeks apart. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Side effects after the second shot might be more intense than the ones experienced after the first shot. The side effects are normal signs that body is building protection and should go away within a few days". The patient underwent lab tests and procedures which included sars-cov-2 antibody tested negative. Therapeutic measures were taken as a result of severe allergies (drug hypersensitivity). He visited emergency room due to the event chest pain. On an unspecified date in 2021 the outcome of the events it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running was unknown, on an unspecified date in 2021, severe allergies was recovered, rapid heart rate, really bad chest pains, cough was recovered on 30May2021, on an unspecified date in May2021 vomit, nausea was recovered, gasping for air, interrupted his sleep and stuff in his throat/weird stuff on his throat was unknown. Information on the lot/batch was available, Additional information has been requested.

experience chest pain and tightness. He had some dyspnea. This occurred for the next week or so with the patient. He suspected it may be a myocarditis event. The pain is no longer present in

Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizziness, fluttering of the heart, feeling agitated.

Since getting this vaccine I?ve been experiencing random, completely unexpected shortness of breath. I could be sitting down watching tv and I?ll get a random shortness of breath. I?ve never experienced this prior to this vaccine.

Profound malaise, nausea, vomiting within 24 hours afterward. Then ongoing cardiac palpitations and a sense of skipped heart beats and vague dyspnea, still ongoing as of 7/23/2021 here in urgent care.

Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Blood pressure randomly goes high and pulse will drop as low as 36 bpm; Now having diabetes issue; Two trips to ER in June with abnormal heart beat and breathing issues; Two trips to ER in June with abnormal heart beat and breathing issues; Having reactions to anything with sodium over 50mg.; Sea salt allergy went from mild to anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12May2021(age at vaccination:44 Years) as single dose for covid-19 immunization. Patient didn't received other vaccination within 4 weeks prior to vaccination. Medical history included iodine allergy from an unknown date and unknown if ongoing, food allergy sea salt allergy from an unknown date and unknown if ongoing. Concomitant medications included testosterone (TESTOSTERONE) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested to COVID-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number EN6204) via an unspecified route of administration in Arm Right on 21APR2021 as single dose for covid-19 immunisation. It was reported that blood pressure stayed about 161/110 for 4 days until given steroid shot. Sea salt allergy went from mild to anaphylaxis. Trip to ER on 29May from Turkey with sea salt. Since then having reactions to anything with sodium over 50mg. Went on low sodium diet. Two trips to ER in June with abnormal heart beat and breathing issues. Now having diabetes issues. Doctors are puzzled that it all started with first Pfizer shot. Was given Benadryl shot with second Pfizer shot on 12May2021. No blood pressure issue at that time. Blood pressure randomly goes high and pulse will drop as low as 36 bpm. Patient went for Emergency room and physician office visits for the events. The outcome of the events anaphylactic reaction, diabetes mellitus, heart rate irregular, dyspnoea, hypertension, heart rate decreased, reaction to food additive was not recovered. Information on the lot/batch number has been requested.

About 15 minutes after vaccine was given, patient started feeling numbness and pain in right upper arm where vaccine was given. Patient has a PMH of stroke on the right side and diabetes. Patient also reported itchiness in right leg and dizziness. Vitals were taken and neuro exam performed. Patient given water and snack but started feeling stiffness in neck. Referred to ED for evaluation of symptoms.

passed out; twitching; Gasping for air on the ground for less than a minute.; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old male patient received the second dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0168), via an unspecified route of administration, administered in Arm Left on 27May2021 09:00 as a single dose, and dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 09:15 (Batch/Lot Number: Ew0171) as a single dose for COVID-19 immunization . Medical history included blood cholesterol increased from an unknown date and unknown if ongoing and High cholesterol and triglycerides , blood triglycerides increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On the third day after the second shot the patient did some yard work and then after coming inside passed out and was twitching and gasping for air on the ground for less than a minute. I then sat up took some juice and was fine. The patient experienced passed out (loss of consciousness) , twitching (muscle twitching) and gasping for air on the ground for less than a minute (dyspnoea). patient underwent lab tests and procedures which included blood cholesterol: high on High cholesterol and triglycerides , blood pressure measurement: fine and blood triglycerides. Prior and since the vaccination, patient was not tested for COVID-19. The patient didn't take any other vaccines 4 weeks before the COVID vaccine. The patient took the covid19 vaccine in hospital. Device date reported to be 11Jul2021. Follow-up actions are needed. Further information has been requested. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.

approximately 30 minutes after injection of shot, felt dizzy, confusion, face and throat swelling, rapid heart rate, feeling on the verge of passing out. Was driving home at the time and pulled over to call 911. 3 to 4 minutes of very intense reactions, had initial difficulty calling 911 and driving off the road to pull over. Paramedics arrived 10 minutes after the initial call to 911, symptoms had improved greatly after 3 to 4 minutes and after 10 was starting to feel back to normal.

large hive at injection site; scattered hives/smaller hives scattered; tightness in throat; thick feeling tongue; bubbled ulcer looking site on his lower left deltoid; left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 45-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK4176), intramuscular on 08Jan2021 at a single dose on the left arm for COVID-19 immunization in the hospital. Medical history included allergies to penicillin (PCN), sulfa and latex. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient had other vaccines in four weeks. The patient has other medications (unspecified) in two weeks. The patient previously took erythromycin (ERY) on an unspecified date and experienced allergies. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: LEK5230) on 18Dec2020 at 08:00 AM via intramuscular route of administration on the right arm at a single dose for COVID-19 immunization and experienced hives, itching and itchy feeling tongue wherein the patient took Benadryl, 20 mg Pepcid and 10 mg of Zyrtec. After the second vaccine the patient experienced scattered hives, with large hive at injection site and smaller hives scattered on an unspecified date in Jan2021. The patient also had tightness in throat and thick feeling tongue also on unspecified dates in Jan2021. The patient took 50 mg Benadryl, 20 mg Pepcid, 10 mg of Zyrtec and albuterol inhaler with spacer four puffs. The patient also has a bubbled ulcer looking site on his lower left deltoid with left arm soreness eight days later both on an unspecified date in Jan2021. The outcome of the events bubbled ulcer looking site on his lower left deltoid and left arm soreness was unknown while the outcome of the other events was recovering. The patient has not been tested for COVID-19 post vaccination.

well that night i lost all taste and smell that was Friday today is Monday and still no better - Saturday was the hardest i just tried to sleep the pain away- by Sunday i had full on covid19 symptoms and was very sick - now 4 days in i still have a headache , cant brethe these symptoms arent just mild and i worry about someone older then me taking this

Pt received vaccine on 1/22/21. On 1/31/21 he presented to urgent care with fever and morbiliform rash. He tested negative for the flu and was given empiric oseltamivir. He had persistent fever and was given doxycycline and ceftriaxone by urgent care on 2/2. On 2/4 at urgent care he was noted to be hypotensive and referred to ER. He had findings of cardiogenic shock and intra-aortic balloon pump was placed. He was treated for acute heart failure with improvement in symptoms. He was also treated for pneumonia with piperacillin/tazobactam as well as amoxicillin / clavulanic acid. He was discharged with resolved fever, resolved rash, and improvement in EF based on cardiac MRI. Workup for other viral causes of myocarditis was negative.

Patient received his first dose on 2/1/21 and was observed for 15 minutes. He reported that after returning home he has dizziness and weakness that lasted 45 minutes and then resolved without treatment. He did not seek care. On the day of his second shot (2/22/21) he said he had not taken his blood pressure medication that morning. His blood pressure was143/98 and pulse 70 prior to vaccination. At 10 minutes after the injection he reported feeling dizzy and having shortness of breath and feeling dry mouth. His O2 sat was 98%. Pulse had increased to 82 and then several minutes later was 110. He was placed on a monitor but a large size cuff was not available at the vaccination site. He continued to feel weak and more short of breath, so he was given a dose of epinephrine by autoinjector and EMS was called to transport him to the ER. At the ER, he was given diphenhydramine and his condition continued to improve. He was observed in the ER for 3 hours and discharged home.

Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath. His blood pressure and heart rate increased during the event. He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS. In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms. During the course of his stay he was treated with Benadryl, dexamethasone and albuterol. He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.

1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left arm hot 4. Throat tightening Was treated with Bendryl and EpiPen then sent to the ER

NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALLY WORSENED, PERSISTING.

Fever over 100.8, server body ache, swollen on arm, lump size of fist under my arm, vexation pain , shortness of breath

Nausea, denies chest pain, SOB, no difficulty swallowing. Initial BP 143/87 (pulse 64), 100% O2 sat. Final BP 133/89 (pulse 63), 100% O2 sat.

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

Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical AEs included daily and persistent dizziness, "brain fog", fatigue, difficulty going up the stairs without getting winded (difficulty with physical exertion). These symptoms are still present on March 31st (11 days post injection). GI / diarrhea symptoms are also present. Of note, I did have COVID in the past (January 2021) - and had similar symptoms that had resolved at the time of the vaccine. These symptoms are severe enough that it may prevent the second shot (due to concerns of worsening AEs or prolonged events). Of note, the fatigue was worse with the actual disease vs. the vaccine.

I fainted about 5 minutes after the injection. When I awoke, my fingers tingled, I was hot, and my breathing was labored.

Within 60 seconds of receiving the injection, I experienced moderate breathing difficulty. After 10-20 minutes, I noticed that my throat felt slightly swollen (slight difficulty swallowing). Due to a hyperallergic event that occurred about 12 years ago, I occasionally run into something that triggers the respiratory effect - although usually the reaction is milder than that caused by the vaccine. However, the throat swelling is new. I took a single puff of an Albuterol inhaler around 5 minutes after the injection, but it had no effect (usually the case for me when the cause is allergic in nature). About 37 minutes after the injection, medical staff advised me to take an antihistamine. I took approximately 6 mg of doxylamine succinate (orally). However, by this point, the breathing had already started to ease slightly. Approximately 30 minutes later, my breathing was back to normal and the throat inflamation was gone. It's uncertain how much of that would have occurred through time alone and how much of it was the antihistamine starting to take effect. My BP was very high when measured during treatment. Partially explained by the albuterol inhaler combined with pseudoephedrine taken earlier in the day, along with anxiety and exertion from the event itself.

throat tightening, wheezing and itchiness, provide patient with o2 via nonrebreather and administered epipen

first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pain when coughing, headache, light shortness of breath.

chills, fever, shortness of breath, headache, vomiting, nausea, chest and rib pain when coughing, sweating

patient called to report that not right after his shot but later that night when he was going to bed his throat started closing up and he couldn't swallow. Pt proceeded to the emergency room where he received treatment for anaphylactic reaction. Patient states he is better now.

Pt felt SOB, c/o hand/lip numbness Vitals: 1400, HR 82, BP 198/118, O2 99, @1406 HR 80, BP 174/111, O2 100, @1419 HR 77, BP 166/97, O2 100 Pt discharged to home with others at 1432

- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.

Prior allergy to varicella vaccine; Swelling of the back of the throat, Nausea, Itching, BP 167/88 HR 78 RR 16; Administered Epi 0.3mg to Right Thigh and provided EMS transport to hospital

Patient received his second Pfizer vaccine on Friday. Saturday he came down with symptoms that we considered were like the stereotypical second dose. Fever, cough, shortness of breath, coming and going. It lingered until Tuesday, at which time he got a Covid test- negative. Went to dr, and he said there was a possibility of blood clots. Tests showed that he had severe pulmonary embolisms in both lungs- the main and 3 secondary arteries.

passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very hot and sweating; This is a spontaneous report received from a contactable consumer (patient) . A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EP7533) as single dose (at the age of 45 years old) for covid-19 immunisation. The patient medical history was not reported. 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 magnesium citrate taken for an unspecified indication, start and stop date were not reported. It was reported that about five minutes after the shot, the patient passed out in the observation area. When he awoke, his fingers were tingling on both hands, a was very hot and sweating, and his breathing was labored. Events onset date was 27Mar2021. The patient received lactated ringers as treatment. The outcome of the reported events was recovered. Since the vaccination, the patient has not been tested for COVID-19.

3/28/21 Patient presented to ED w/SOB x 5 days, fever and cough for one day. RA pulse ox 42%. CXR showed bilateral infiltrates. Pt refused intubation and was started on BiPAP w/FiO2 of 100%. Given Remdesivir and Decadron. Was placed in ICU. Also covered with zithromax and rocephin which was stopped after procalcitonin found to be normal. 4/1 Pt was weaned off BiPAP to HFNC 4/3 Pt was weaned off HFNC to 4L per NC. From 4/3-4/5 he had significant improvement. On 4/5 did not require O2 at rest but still had desaturation to 88% with ambulation. The team wanted to keep him an additional night but he demanded D/C. He finished 5 day course of Remdesivir prior to D/C and was to finish 10 course of Decadron after discharge

SWOLLEN MOUTH, EVERY 4-6 HOUR LEFT SIDE LUNG DISCOMFORT BELOW THE RIB BUT ABOVE THE STOMACH. ULCER LIKE PAIN AND DISCOMFORT EVERY 4-6 HOURS, LESS SLEEP LIKE 5 HOURS DAILY.

2 days after my second shot I broke out in Hives and welts down my torso, Arms, and legs. I went to urgent care and they gave me a shot of prednisone and gave me a pack of the same steroid to take over the next 6 days they also prescribed some prescription Claritin and Famotidine.. The following day 4/16/21 around 1130pm I woke up to my face being swollen as well as my tongue. I was taken to the ER where the triage unit gave me epinephrine as well as another steroid to stabilize the swelling as I was having trouble breathing. Once stabilized I was released and took 50 mg of Benadryl every 6 hours as well as the Claritin, famotidine, and the prednisone. I had hives for a few days after and followed up with my primary doctor, but as of today I feel like i am back to normal.

Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dyspnea; Troponin trended to 19; This is a spontaneous report from a contactable physician. A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. Relevant medical history included chronic back pain, degenerative disc disease, and Clostridium difficile (C. Diff) colitis; the patient had no risk factors for cardiac disease other than obesity; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cyclobenzaprine and pregabalin (LYRICA) and experienced allergies. It was unknown if the patient had other vaccine in four weeks. The patient had no COVID-19 prior vaccination. On 08Apr2021, 8 hours after the 2nd Pfizer vaccine was received, the patient developed chest pain with dyspnea. It was also reported that on 08Apr2021, troponin trended to 19; electrocardiogram (EKG) showed very subtle diffuse ST elevations; and the symptoms were consistent with myocarditis. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit; an emergency room/department or urgent care; and hospitalization on an unspecified date for 3 days. The patient underwent lab tests and procedures, which included other/Xpert Xpress SARS-CoV-at assay: negative on 10Apr2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included colchicine and ibuprofen. The patient was recovering from all the events. Information on the batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship for BNT162B2 in the reported events, serious due to hospitalization. Otherwise, this patient did not show risk factors for cardiac disease, except for obesity. 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.

Fatigue, shortness of breath, thirsty, joint pain, lower left back pain, nausea and chills. All symptoms have been going on for 5 days now

12 hours after vaccination developed debilitating inability to think clearly, brain fog, shortness of breath, activity intolerance, heat intolerance , headaches, fatigue that have not subsided since.

When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had intense chills and hot flashes. Never a fever. I felt nauseated. Completely lethargic. Muscle aches all over my body, was hard to move. I couldn't stay awake. My eyes hurt. I had intense migraines. And no appetite. My right arm hurt, but not as bad as many others' reported. I took ibuprofen to help, it didn't. I drank lots of water and gatorade zero for the electrolytes. It didn't help either. On day #3, this was when it got scary. The previous symptoms carried over, minus the nausea and I was able to be mobile (less lethargic). But something new started to happen. I took my dog out for a short walk, a slow pace, I am very athletic, and I had shortness of breath. I was winded from just walking slowly. Then the brain fog started to set in. This I hated the most. I wasn't able to comprehend things. I tried to assemble an item I bought from Amazon and it was extremely hard to follow simple instructions. I wasn't able to see clearly for some reason. And even comprehending emails that I was receiving was troublesome. I kept drinking water, and was able to eat a little. Had two more bottles of Gatorade Zero. On day 3, most of all the symptoms subsided except that I still got winded from movement. On day 4, I was fine.

acute dyspnea started 4/10, 1 day after second vaccination, no other provoking factors, symptoms persisted for 3 days, CT chest 4/13 showed extensive bilateral PE

Fever Cough Fatigue Muscle or body aches Elevated BP Shortness of breath Congestion or running nose

It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by the time I awoke the following morning. No arm pain -- but nine days of brain pain, waking up feeling like my head was split, at least five days of altered vision, and most disturbed were my breathing and my heart. I felt for many days like I had a Brillo Pad in my lungs and heart, as well as lots of pressure in the chest and shortness of breath/labored breathing. Two days ago I thought I might be having a heart attack. The symptoms lightened yesterday morning (day nine) though I still have strange sensations in the head and taking a full, deep breath is not totally easy yet. .

Patient complained of shortness of breath shortly after receiving the vaccine. After 15 minutes patient complained increased shortness of breath and requested transportation to Hospital ER. Patient left the facility with consistent V/s's but feeling much worst per Dr.'s note. Patient sent to ER by ambulance stationed on site. EMS at this facility assisted the MD and transported the patient to the ER.

Patient suffered a seizure and pulmonary edema four days after receiving second Pfizer shot. He was pronounced dead several hours later. Patient had no health issues and was 45 years old.

Myopericarditis with fatigue, myalgias, joint pains, and dispnea on exertion since his second COVID 19 shot. Pt also found to have a DVT.

nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; pains in chest; catching my breath; very cold and clammy; This is a spontaneous report from a contactable consumer (the patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0169), via an unspecified route of administration, on 14Apr2021 at 11:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing, irregular heart beat and depression from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient did not have any other vaccines within four weeks prior to the vaccination. The patient stated that when he first got the shot he actually nearly fainted twice and had to lay on the floor for a while. It was very scary, he thought he was going to die. He got very cold and clammy and had pains in chest and had a hard time catching his breath. They checked his vital signs a couple times and said they looked good. But he still felt sick and they said if he did not feel better soon they may have to call for an ambulance for him. Eventually he felt better enough to where he was able to get up off the floor and on handicap cart to drive out of there. Also, he's been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. It's pain that is in spots, it feels like mini-charley-horses that lasts anywhere from 20 something to 30 something seconds. Now it's mostly continuous pains in his thigh muscles between his legs. And a pain in one spot in his left arm bicep. This has been happening for days." The patient experienced "nearly fainted twice" on 15Apr2021 with outcome of not recovered, chest pain, got very cold and clammy and had a hard time catching his breath on 15Apr2021 with outcome of not recovered. He also reported that he has been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. it's pain that is in spots, it feels starting on 15Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included unspecified investigation: myalgias on an unspecified date . Therapeutic measures (unspecified) were taken as a result of the events.

Pfizer-BioNTech COVID-19 Vaccine EUA - late afternoon of the first dose I began having major allergy symptoms - coughing, sneezing, runny nose, fatigue, and began wheezing. These continued for 48 hours despite OTC medications, and I wound up in the ER with difficulty breathing. I received a negative quad swab, negative chest xray, and was given a nebulizer treatment and sent home with an inhaler. Despite f/u with my PCP and aggressive allergy symptom treatment, one week later I returned to the ER with an 88% oxygen level.

patient was Diagnosed with Pulmonary Embolism after her second covid vaccine. patient symptoms were dyspnea and syncope . Patients treatment is to take Eliquis everyday.

Anaphylaxis with swollen lips; Anaphylaxis with swollen lips; felt like throat was closing; difficulty breathing, could not take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 at 12:00 (Lot Number: ER8B2) as SINGLE DOSE for COVID-19 immunization. Medical history included possible rheumatoid arthritis from an unknown date and allergy to poultry from an unknown date. There were no concomitant medications. No other medications were received by the patient within 2 weeks of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 23:00, the patient experienced anaphylaxis with swollen lips and reported that he felt like his throat was closing and had difficulty breathing, could not take a deep breath. The patient went to emergency room as well as the physician office for the reported events. As therapeutic measures multiple Intravenous (IVs), oral benadryl and steroids were taken by the patient for the reported events. The outcome was reported as recovered with sequel for the reported events.

By next morning arm sore injection site arm. The 21st of January, I had exposure to a patient who tested positive to COVID. Wednesday, 13th, is when I developed high fever, shortness of breath, cough, body aches. My SATS were 93/94. I had those symptoms for about a week. Treatment: Z Pak and support supplements Tylenol/ Advil/ OTC Nyquil; Tessalon Pearls for cough suppressant. In between I was due for my second vaccine I still had a fever when I had my second vaccine 1/18/2021. After that second vaccine, my fever spiked and my fever was worse. Since I've been sick I've been having weird abdominal pains that come and go and I have more irritable and down since I've been sick.

Pt received covid vaccine and reported he felt his "throat closing" and itching. Reports he has had similar reaction in past to the flu vaccine. Benadryl 50mg IM given. Patient reports his symptoms resolved immediately after IM Benadryl.

Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea episodes, upper right abdominal pain, muscle weakness, increased pain to all areas below T6, inability to breath without pain. Fatigue. Lasted acutely for over 30 days. Symptoms including breathing difficulty, nausea, and increased peripheral nerve pain continue to linger.

Started with flu like symptoms, after 3 days my left arm would swell slightly, become red/warm, and itchy at injection site. At 1 week I began feeling extremely worn down, exhausted, short of breath after moving at all, coupled with a slight fever and continuous nausea.

Eosinophilic myocarditis presenting as pleuritic chest pain, elevated troponin and cardiogenic pulmonary edema related to heart failure, ejection fraction and improved and patient successfully discharge from the hospital. Of note, patient also tested positive for rhino/entero on RVP and FIP1L1-PDGFRA rearrangement.

Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pressure, sweating, light headedness, dizziness, nasuea.

15 - 20 min post vaccine, patient complained of bilateral hand/feet tingling/numbness. Vague heaviness across chest and throat. Feels warm and anxious. Treated with diphenhydramine 25 mg po x 1, diphenhydramine 25 mg IV x 1, Diphenhydramine 50 mg IV x 1 (had developed angioedema/throat swelling). Admitted to hospital and then transferred to another facility.

significant fatigue; peculiarly sticky but productive afebrile cough; shortness of breath; hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%; Afebrile chills; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 17Apr2021 11:00 (at the age of 45-year-old) (Batch/Lot Number: EW0162) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient has not been diagnosed with covid-19 prior to vaccination and has been tested for covid-19 via nasal swab on 21May2021 which showed negative. Medical history included hypertension, depression, anxiety, attention deficit hyperactivity disorder (ADHD), and known allergies to Bactrim and Modanifil. Concomitant medications included methylphenidate hydrochloride (CONCERTA); vortioxetine hydrobromide (TRINTELLIX); bupropion; losartan; and zolpidem. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER2613) in the left arm on 23Mar2021 (at the age of 45-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. On 18Apr2021, the patient experienced afebrile chills which was resolved after about 18 hours bedrest. Furthermore, four days post-vaccination (20Apr2021), it was reported that suddenly back in bed, this time with significant fatigue and a peculiarly sticky but productive afebrile cough that responded to neither dextromethorphan nor guaifenesin, nor to liberal and frequent coadministration of these two drugs. Partial resolution by Friday, 22Apr2021. No chills that he remembers. Much more debilitating than the initial reaction (afebrile chills) described earlier. Cough has come and gone for weeks, never resolving for more than about three days at a stretch. About three weeks ago, patient began to suffer shortness of breath for the first time in his life - while making a very easy (and routine) walk from his car into CVS and back. The patient has been hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%. The onset date of shortness of breath and cardiomyopathy was 18Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which includes Lasix, milrinone, metoprolol, and carvedilol. On an unspecified date in Apr2021, the patient recovered from afebrile chills while outcome of the rest of the events was not yet recovered.

- Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth - Hard to stay asleep - Lack of energy

My stepfather on 31May2021 was diagnosed with Covid and right now has pneumonia; My stepfather on May 31 was diagnosed with Covid and right now has pneumonia; He had some trouble breathing; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (Patients Stepchild) via medical information team. A 45-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 23May2021 (at the age of 45-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing (it was a light condition. Arthritis was not getting worse he takes some medication). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient did not have any adverse events. On 31May2021, the reporter stated that patient was diagnosed with Covid and right now had pneumonia. Patient went to the hospital 2 days after that. Patient had to go back to the hospital a second time because he had some trouble breathing (unknown date in 2021). After the second time going to the hospital was when he was diagnosed with pneumonia. Patient was diagnosed with pneumonia a week ago (unknown date in May2021). Patient still had pneumonia, but it was much better with the medication. The reporter clarified that the patient had COVID-19 PCR testing and it took 2 days for the results to come back and patient went to the hospital he was referring to the Emergency Room for trouble breathing. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31May2021. Therapeutic measures were taken for the results of the event pneumonia. The events covid-19 and pneumonia assessed as serious. The clinical outcome of the event pneumonia was recovering and outcome of the other events was unknown. The patient scheduled to received second dose of Pfizer COVID Vaccine on 13Jun2021. Follow-up attempts are needed; information about lot/batch number can be obtained.

Patient experienced loss of consciousness, difficulty breathing, muscle rigidity, nausea and vomiting. 911 was called. Patient declined transport to hospital.

pt resturned several hours after injection and stated that he was feeling chest tightness, and slightly SOB Pt was taken to ER for evaluation

subject developed hives/itchy bullae over trunk and extremities. over the next few days, despite using diphenhydramine, also had swelling of lips and sensation that his throat was closing. Voice was slightly hoarse. Was seen in clinic and ER. was given steroids.

experienced significant shortness of breath, heavy wheezing, and coughing on the weekend of 2/6/2021. Slight wheezing had been ongoing for months (difficulty breathing in January of 2020 when diagnosed with influenza A and intermittent slight wheezing continued throughout the year). Symptoms became worse throughout the weekend. I did continue my normal routine (taking trash to the dump, helped move a heavy tank out of a walkout basement, and moving twelve 40 pound bags of wood pellets from store into truck then from truck into my home on day of hospitalization) Hospitalized on 2/7/2021

Got First Pfizer Covid vaccine on 06JAN2021. About 4 days after that I started noticing allergy symptoms and mild intermittent wheezing. Then on about the 5th day after, my lower back pain increased, causing significant sciatic pain worse than ever before. On 22JAN21 I ended up going to urgent care for increased breathing problems, and also had to have pain management appointment within days as sciatic pain was debilitating and also significantly interfered with my sleep. After steroid injection (In spine)on FEB 3rd for sciatica/back pain, and steroids/inhaler treatment for the breathing stuff, I would say I was pretty good to go . I didn't think too much of these unusual events for me both in timing and severity. On 12FEB2021, I got my second pfizer covid dose. I 14FEB I started noticing allergy symptoms again, and slight shortness of breath, used inhaler I had from before to help as breathing in seemed to not give me full breaths. Then, on 15FEB2021, in the evening out of nowhere while walking, my lower back/sciatica pain came back in full force, as if my leg were a lighting rod like before. So it almost seems as if the covid vaccine triggered an inflammatory reaction in my body. I am not certain, but because the series of events seem the same and in timing after my first covid vaccine, I figured I would at least report it.

Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardia; This is a spontaneous report from a contactable consumer and a contactable nurse. This 46-year-old male patient received the second dose of BNT162B2 (PFIZER BIOTHCH MRNA VACCINE, LOT: EL3302), via an unspecified route of administration on 25Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included lone atrial fibrillation, IgA nephropathy. No Covid prior vaccination. No known allergy. Concomitant medication included metoprolol, lisinopril and acetylsalicylic acid (BABY ASPIRIN). The patient did not received other vaccine in four weeks. The patient previously received the first dose of Pfizer BNT162B2 (Lot number=ZK9231) on 04Jan2021 on right arm for COVID-19 immunization. On 26Jan2021, after 2nd vaccine, the patient had mild fever, cough and short of breath. He went to urgent care, chest X-ray clear, Covid test negative. Mild fever subsided after one day, but short of breath and cough continued. Covid test again negative. PCP prescribed azithromycin (Zpack) and methylprednisolone sodium succinate (SOLUMEDROL). Short of breath and cough continue and amoxicillin / clavulanic acid (AUGMENTIN) and prednisone prescribed. Short of breath, cough, and fatigue. Reported to ER on 15Feb2021. The patient had atrial fibrillation, tachycardia, ventricular arrythmias and were treated and admitted for further evaluation. Covid test collected again-negative. Currently in the hospital at time of this report. All of the events were on 26Jan2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment included diltiazem hydrochloride (CARDIAZEM), enoxaparin sodium (LOVENOX), furosemide (LASIX). Covid test type post vaccination included nasal swab on 26Jan2021 with result negative, nasal swab on15Feb2021 with result negative, blood test on in Feb2021 with result negative. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pyrexia, cough, fatigue and short of breath. The events atrial fibrillation, ventricular arrhythmia and tachycardia are considered not related to BNT162B2, but rather due to underlying medical conditions. 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.

Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Refused transport.

Rash on neck, tingling, throat swelling. BP 148/86 (pulse 75), O2 sat 96%. Benadryl 50 mg IM x 1. Resolved. BP 137/83 (pulse 80).

On the way home, above stated person experienced a swelling of throat. He stated that that it was difficult to swallow and was painful. He considered visiting the emergency room for treatment of symptoms. Symptoms subsided around 30 minutes from time of event. He just arrived at his home.

At about 6 pm I started having stomach cramps and diarrhea. The cramps worsened and by midnight the pain was at a nine. I was vomiting with intense force but nothing was coming up. My abdomen was bloated to the point where I couldn't stand upright and breathing was very painful. I was in that condition for about 12 hours before the swelling began to lessen. Now, 2 days later, I am still unable to eat and drink as normal and have moderate gastrointestinal discomfort with bloating.

Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhea. Itching and swelling subsided with a dose of Loratadine. Nausea worsened that night and vomiting ensued with diarrhea worsening. At bedtime, itching returned, sleeplessness, vomiting and sweating profusely from the scalp and face, slight difficulty filling lungs with air. Another dose of Loratadine calmed symptoms. Wednesday (10th) through the next Thursday (18th ), nausea persisted, but eased with Benadryl and Emerton. Diarrhea persisted through Monday (15th). No fever, no soreness, no headache.

12:24PM HAS CHEST TIGHTNESS AND SOB. A/O, PINK, W/D, RESP REG WITH EASE. VITAL SIGNS STABLE. TO SQUAD PER WHEEL CHAIR TO GO TO ER. 12:26PM BP 121/74, HR 81, R 16. 12:30PM BP 121/80, HR 83, R 16. 4-2-21 10:20AM PATIENT: STATES HE IS DOING BETTER. SAW PCP AND IS TAKING PREDNISONE X5 DAYS AND WILL HAVE A STRESS TEST.

Received first Pfizer Covid-19 vaccination today and shortly thereafter with tightness in throat, itching. No generalized rash, itching, dyspnea, wheezing, swelling of lips, tongue and no dizziness. Has not seen a provider for a while. Medication name: benadryl inj Dose: 50mg/1ml Route: IM DIAGNOSIS Adverse reaction to Pfizer Covid-19 vaccine Hypertension Obesity DM type 2 PLAN: Feels better after RX. Has HTN and DM type 2. Begin Lisinopril, Metformin, follow-up with PCMC, would defer 2nd Covid vaccine unless premedicated and in monitored setting. Per Dr. Note Site: right deltoid Time of administration: 0908 Medication name: solu-medrol inj Dose: 125mg/2ml Route: IM Site: right glute maximus Time of administration: 0910

Body has been weak and shaky since I got the vaccine. I have had 2 episodes where I am short of breath and my blood pressure has gone up. The doctor has put me on anxiety medication but I still feel no difference. I have not been able to work for the past 3 weeks.

DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM THAT EVENING ON 3/15/2021 WENT TO BED WITH CHEST PAIN AND DID NOT WAKE UP THE NEXT MORNING PARAMEDICS WERE UNABLE TO REVIVE HIM, PRONOUNCED HIM DEAD AT THE SCENE.

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

headache; Shortness of breath; Chest pain; Difficulty breathing; Heart palpitations; Aches; Extreme fatigue/fatigue; This is a spontaneous report received from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch ER2613), via an unspecified route of administration in left arm on 19Mar2021 09:45 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Medical history: hodgkins lymphoma survivor (1996), splenectomy. Concomitant medication was not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The patient experienced extreme fatigue on 19Mar2021 at 07:00 PM, aches on 20Mar2021, chest pain, difficulty breathing and heart palpitations on 22Mar2021, first episode of shortness of breath and headache on 24Mar2021. The patient assessed events as non-serious. Treatment received for the adverse event was unknown. Test Name: RT-PCR. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. The patient was recovered from the event headache where not recovered from the events extreme fatigue, aches, chest pain, difficulty breathing, heart palpitations and first episode of shortness of breath.

11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left arm there is swelling and tender to the touch at that location. 22 hours after vaccination chills subsided, however fatigue, achiness, headaches, chills and swelling under left arm still remain. 38 hours after vaccination headache still persists, chills still come and go, swelling under left arm visible along with headaches

Patient reports received COVID19 Pfizer dose #1 on 4/4/2021 with persistent side effects presenting 2 hours post dose to include severe myalgia, dyspnea with activity, excessive fatigue, vomiting x 1, and loose stools.

Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of breath even with minimal physical activity , it's been 7 days since vaccine, unable to finish 8 hr shift at work

Patient presented to Hospital 5 days after second Pfizer dose with myocardial infarction involving the Left Anterior Descending artery. He had no significant risk factors for coronary artery disease. He reports feeling very fatigue and dyspneic after first dose, and started to have chest pain after second dose.

A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetfulness, and cough with chest tightness. Covid symptomatic in November. Received Covid Pfizer vaccine on 4.13.21 at 1pm. Felt fine headed into the vaccine. He completed the observation period and felt chest tightness after about 5 minutes similar to Covid in November. He felt slightly better and went to work. At work his cough and chest tightness worsened. Very tired, unable to eat with no appetite. Extreme fatigue Wednesday sleeping most of the day. Cough and chest tightness and feeling he cannot catch breath like being submerged in a pool. On 4.15.21 his feet became numb and tingling bilaterally. He felt more confusion, forgetting what he was doing, left frozen food in the sink and unable to recall why. He is also having headache posteriorly 7-8/10 which began on 4.14.21. He reports headache is not common, now 3-4/10 and feels very similar to Covid in November. Does have some mild neck stiffness associated. Chest tightness almost identical to Covid in November. Reports numbness and tingling in the feet has been ascending in nature. He felt unsteady on his feet yesterday morning. He is having tingling and cramping in the bilateral calf muscles today. His cough continues with no phlegm. Comes in coughing spells with chest tightness. He also noted cough is worse with exertion. Fever 99.8 yesterday. No diarrhea. No loss of smell or taste. In ED noted to have right LE weakness. Wife reports that he seemed unsteady while walking Kept for observation. difficulty concentrating - back to baseline 4/17/21 at 3:26 pm assessment SOB: CTA thorax 4/16/21 unremarkable CT angiogram thorax Symptoms began approximately 5 minutes after his Pfizer. Reports that his cough and shortness of breath now seems to be improving. Continues to have some mild chest tightness, intermittent cough. Robitussin significantly helped. Extensive workup including CT angiogram of the thorax reveals no evidence for pulmonary embolism or infiltrate. COVID-19 PCR testing is negative x2, severe respiratory isolation has been discontinued. Patient has a negative D-dimer, LDH, ferritin, CRP. Cardiac troponin has been negative x2. Patient does have some wheeze, after cough, suggesting some bronchospasm. Will trial albuterol inhaler q.i.d.. Patient does report a history of what sounds like an environmental triggers asthma like event in the past, though reports that he has undergone evaluation for asthma and was told that he does not carry a diagnosis of asthma. Patient is currently on room air. I have reviewed the reported adverse reactions from the Pfizer vaccine and coughing shortness of breath are not listed. Continue supportive care, with Tessalon and Robitussin, IS

Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe head ache 7 days later. Emergency call to doctor and doctor visit. Bumps moving and forming in different areas side of vaccine. Face swelling. Throat swelling...all on right side.

Started with dizziness then anaphylaxis like symptoms and lymph node symptoms of tingling lockjaw hard to swallow very difficult to breathe a little bit of chest pains, called EMS and paramedics to took blood oxygen levels, blood pressure which were all normal by then the symptoms had started to subside

Cough and diarrhea the day after receiving vaccine. The next day, had difficulty breathing and collapsed.

I received my second Pfizer COVID vaccine shot at 11:00 am. The first 12 hours after everything was normal and fine. I ate dinner and got ready for bed. But then, starting 12 hours after my shot, starting at 11:00 pm, I began to have severe chills and total body shakes. I was curled up into a ball under blanket, both freezing cold and profusely sweating. My breathing was very fast and I couldn't slow it down. My stomach was very upset and I was unable to eat anything. At 3:30 am, I got a severe Migraine which lasted until 6:00 am. I continued to feel very ill the whole rest of the day. Finally, around 9:00 am some 34 hours after syptoms began, they left me.

Patient called over standing by EMS provider EMS, vitals were obtained. Patient stated that he felt his throat was closing. Patient was awake and talking . Transported by EMS to ER.

46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.

Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Patient presented to the emergency department on 4/10 with a complaint of left leg pain. Patient reports onset of symptoms on Wednesday (4/7). He states that initially it just felt like a cramp in his calf. He states that over the past couple days, the pain has gotten significantly worse. He states the pain is now sharp and severe in nature. He states that he is having due to the severity of the pain. He states the pain is now moving up into his medial thigh. Patient states that around noon on 4/10, he began having chest pain and shortness of breath. Patient describes a tightness across his chest and states that he cannot breathe associated with this. Patient does have a history of asthma and states that he has had a couple of episodes like this in the past. Patient also reports a history of diabetes, hypertension. Patient does report a family history of coronary artery disease as well as a family history of blood clots. He received his Pfizer Covid vaccine 2nd dose on 4/9/2021 (Lot # ER8729) and 1st dose (Lot # EN6204) given on 3/12/2021 at an outside facility He does report arm soreness but is otherwise doing well. No recent travel. No recent immobilization. Upon evaluation in the ED, he was noted to have positive US for DVT in the LLE. Follow up CTA Chest was positive for bilateral lobar and segmental PE with right heart strain. CVM was consulted for possible PE intervention evaluation. Patient started on therapeutic Lovenox, but discharged home on 4/11 with Eliquis. . The next day 4/12/21 he returned to ED for SOB/Wheezing and LLE pain. On 4/15/21 he underwent EKOS, IVCF and iliac stent placement per Vascular surgery and subsequently sent home on Eliquis 4/16/21. Pt returned to the ER again 4/21/21 for recurrent SOB. CTA chest with no significant change in clot burden, no associated hypoxia.

Within 5 minutes after receiving the shot, patient started having headache & heartache on and off for about 10 minutes. Patient also complaint about his throat/mouth was dry. 15 minutes after he started to have numbness around his mouth and on tip/ middle part of his tongue. Numbness lasted for about half an hour. That night he vomited and has chills. Next day he had very mild fever, pain in the right lung when he sneezed / coughed. He didn't have much symptoms on the 3rd day except for an sore arm and tireness.

About 12 days after the vaccine, I woke up in the middle of the night with sharp pain in my chest. Since then I have had heaviness in my chest and other symptoms like difficulty breathing while walking or talking, etc. I was otherwise previously healthy -- non-smoker, drink very occasionally, mostly vegetarian, light on sugar consumption, daily exercise. I went to the doctor and then the ER at a local hospital on April 28. They found fluid and possible inflammation around the hearth along with very high blood pressure. Since then I have had medication for inflammation and high BP. They are still doing tests to figure out what is wrong with me.

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt apeared to have HTN crisis / seizure like aftivity 3 min after injection. Airway and then consiousness was lost with no breathing. EMS was called pt was assisted to floor and after opening airway and stimulation regained consiousness.

4/6/21 called PCP office stating ?Patient called stating since his first COVID 19 vaccine he has had wheezing in his lungs, short of breath on exertion and productive cough. Voice also sounds "harsh" per patient. He has used his inhaler and it is not helping.? Nurse recommended Urgent care tonight. Patient agreed. 4/6/21 went to urgent care. CXR no acute airspace process. COVID-19 PCR: neg. Given Prednisone. Sent home 4/13 allergy appointment cancelled. 2nd vaccine 4/20/21 received. Reports difficulty breathing, dizziness and weakness and headache on survey. Calls Nurse triage 4/20/21 and reports extreme fatigue, headache, nausea, vomiting, and chills. Calls Nurse triage phone on 5/6/21 reporting shortness of breath, phlegm and cough. Recommended to go to ED. Went to ED.

PATIENT WAS VERY NERVOUS ABOUT THE VACCINE. HE FELT DIZZY AND NO CONSTRICTION OF THROAT. PHARMACIST ASKED HIM TO PUT HIS HEAD BETWEEN KNEES AND PHARMACIST KEPT CHECKING HIM. AFTER 15 MIN HE WAS STILL DIZZY AND PATIENT WAS MOVED TO LYING DOWN WITH FEET ELEVATED AND FELT BETTER LATER

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Acute hypoxemic respiratory failure due to COVID-19 .

Severe allergic reaction; all his back was red; pain; felt like his throat was getting really raspy/ felt like his throat was about to close; tried to drink water and couldn't even pass (swallow) it; body rash all over the body, it was itching and itching/ itching and itching, got the rash on arm escape, inside arm, belly, penis, inside legs, body in the back everywhere; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) at the age of 46-years, via intramuscular in left arm on 17Apr2021 at single dose for COVID-19 immunisation. Medical history included enlarged prostate; gout; anxiety. Concomitant medications included medication for diet; prostate medication because his prostrated was enlarge; medication for gout and anxiety. Patient stated that he got injected with COVID-19 the Pfizer shot and they gave him like side effects, pain. He was experiencing one of the severe allergic reactions. The body rash all over the body, it was itching and itching. He didn't know what to take with it. He mean he called the health department, they told him to take diphenhydramine hydrochloride (BENADRYL) but he mean what can remove this bad rash all over the body. If he did what they need to give him because he spoke to a COVID-19 nurse and was told that no reverse on the vaccine. There was nothing you can take to reverse the effect. He stated that he took vaccine on 17Apr2021, and on 20Apr2021, after three days later, had broke down with rashes. When probed for ongoing of the side effects, patient stated that of the vaccine, yes, he was itching and itching, got the rash on his arm escape, inside his arm, belly, penis, inside legs, body in the back everywhere, all his back was red. He mentioned that his doctors told him to take diphenhydramine hydrochloride, it was over the counter for allergy. They said you have to take that but the doctor, the health department told him that didn't work, may be take the steroids shot but patient spoke to another doctor they told him that steroids shot was not recommended. As of 03May2021, patient stated that he went and got the first dose and 3 days later, he broke out in a rash. Then, on Friday, 30Apr2021, he felt like his throat was getting really raspy. He thought "well, let me get some water". He tried to drink water and couldn't even pass (swallow) it. He felt like his throat was about to close. He drove himself to the Emergency Room and was given a steroid shot. He confirmed he had rash and itchiness all over his body 3 days after receiving the first dose, clarifies starting on 20Apr2021. The patient was only seen in the ER and was not admitted into the hospital. He was given a steroid shot that was supposed to be for the feeling of his throat closing up and for any type of rashes and stuff like that. He confirmed he was also given an intravenous dose of diphenhydramine hydrochloride 50mg. However, he was still itchy. The patient underwent lab tests and procedures, which included weight was 260-270lbs. Blood work on 30Apr2021 was normal. Outcome of the events was unknown.

Flu like symptoms: Weakness, achy joints, fever of 102*F, chills, headache. Cough, and difficulty taking deep breath. Sleepiness. Dizziness. Could not stand for long periods. Fever finally broke around 9pm. Chills turned to sweats. By 10:30pm, felling better, but still weak and joint aches. Went to bed, sweat most of the night.

Almost fainting 3 minutes/Almost fainted/Really close to blacking out; Almost passed out; Nauseated/Swirling strong nausea through the body up to the chest; Rapid heart rate; Hyperventilation; Labored breathing; 5-10 minutes before able to uncramp his hands; Waves of the feelings came throughout the day; This is spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 15Apr2021 11:00 as single dose for covid-19 immunization. Medical history included sensitivities to ephedrine from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient experienced almost fainting 3 minutes/almost fainted/really close to blacking out, nauseated/swirling strong nausea through the body up to the chest, rapid heart rate, hyperventilation, labored breathing, 5-10 minutes before able to uncramp his hands, waves of the feelings came throughout the day, almost passed out/ really close to blacking out; all on 15Apr2021. The events were not required a visit to emergency room, nor physician office. Caller is a 47 years old patient who received the 1st dose of the Pfizer Covid vaccine on 15Apr2021. He complained of feeling nauseated, and rapid heart rate, with hyperventilation, and almost fainting 3 minutes after the 1st dose of the Pfizer Covid vaccine. This lasted approximately 15 minutes. 3 minutes after receiving a vaccine. He started to complaint about feeling nauseated. He started rapid heart rate which caused him to have hyperventilation and almost fainted. The episode last for 15 minutes and he just want to go and report it. Consumer confirmed it was the Pfizer Covid19 vaccine. The consumer wasn't still experiencing the side effects. They lasted to 5pm. I got my shot at 11am. The event was no longer persisting but he was wanting to understand the effect of the second shot, the consumer wasn't took any treatment for adverse event. Caller states that he is calling about the Covid Vaccine. Says with the first round of the vaccine he had an adverse event. He is looking to Pfizer and his doctor for some feedback to understand whether or not he should get the second dose. Says that about three minutes after the vaccine he felt a swirling, strong nausea throughout his body up to his chest. He had labored breathing and a really fast uncontrolled heart rate for about 5 minutes. States he was hyperventilating and almost passed out. He had to sit on the ground of the parking garage where he had gotten his vaccine. About 5-10 minutes later he was finally able to uncramp his hands. States that before the vaccine he was calm and not at all in an elevated state. States he is wondering about the second dose being stronger. He almost blacked out after the first dose. States it was close to the limit of what he could tolerate. States he needs further details. He was reading about clinical trials and some doctors. States that he did not have all the symptoms of anaphylaxis that they described. Says his symptoms lasted about 5 minutes or so. About 10-15 minutes later he was recovered. Says waves of these feelings came over him throughout the day. Says they decreased each time and ended that evening around 1700. Caller says he did not go to the Emergency Room when it happened. The nurses at the vaccination site attended him. At the end of the call the caller mentions that he has a sensitivities to ephedrine. States he does not take any Sudafed or Dayquil or anything like that. States he didn't know if that was relevant to mention or if anything like that is in the vaccine to make him have the response that he did. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No prior Vaccinations (within 4 weeks). No family medical history relevant to events. No Relevant Tests. The outcome of events was resolved on 15Apr2021.

Pt states that approximately 24 hours after receiving his first dose of the Pfizer vaccine he began having 8/10 chest pain and feels like he cannot take a deep breath.

Patient developed a fever to 103 and pleuritic positional chest pain the day after receiving dose #2. He presented to the ED 2 days later on May 21, 2021. An ECG showed acute pericarditis. His TnI was mildly elevated. An echocardiogram showed mild LV dysfunction with LVEF 40-45%. He was diagnosed with myopericarditis. Treatment included NSAIDS and colchicine and metoprolol. He was not admitted to the hospital.

It went into my lungs/lung infection/shortness of breath; pain; cough; My lungs hurt when i breathed; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08May2021 10:30 (Batch/Lot Number: E100171) as 1ST DOSE, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included gout from an unknown date and unknown if ongoing, known allergies to latex. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The day after the vaccine on 09May2021 at 06:00 AM, patient developed a cough. It went into his lungs within a couple of days and was eventually put on strong antibiotics with a lung infection. His lungs hurt when he breathed, patient had shortness of breath. It's currently 20May2021 and patient still had pain when he cough but it seems to be improving. The events resulted in Doctor or other healthcare professional office/clinic visit. Events treatments included an inhaler, antibiotics, cough pearls. Covid test post vaccination included Nasal Swab COVID 19 test on 18May2021 and the result was pending. Patient was not recovered from events.

He started having chest pain and shortness of breath. Arm was sore and felt lightheaded. Blood pressure increased. So he went to the hospital. They did chest x-rays and lab work. Monitored for about four hours for blood pressure. Gave him an IV.

Initially, fatigue, joint pain, injection location soreness, then 3 days later I started getting heart palpitations that lasted for 2+ days (Thurs, Fri and part of Sat.), continued fatigue and shortness of breath.

Compromised breathing; Tight chest; Dry cough; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199), via unspecified route of administration in left arm on 01Mar2021 03:15 PM (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. Vaccination facility type was reported as hospital. The patient's medical history was not reported. No COVID prior vaccination was reported. No concomitant medications were taken by the patient within 2 weeks. No other vaccine was administered within 4 weeks. On 03Mar2021 08:00 AM the patient experienced tight chest, dry cough, and compromised breathing. No treatment was received due to the events. Patient was not tested for COVID post vaccination. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown. Information on the lot/batch number has been requested.

fever; chills; vomiting; weakness; headache; cough; trace- pleural effusion; who received the entire vial of the undiluted Pfizer COVID vaccine; received the entire vial of the undiluted Pfizer COVID vaccine/The entire vial was administered all 6 doses in the right deltoid; This is a spontaneous report from a contactable nurse and a physician. The nurse reported similar events for two patients. This is one of the two reports. Only this case is serious. A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 46 years old, administered in right deltoid on 12May2021 (Lot Number: EW0168; Expiration Date: Aug2021) at single dose for COVID-19 immunization. Medical history included ongoing CRD on hemodialysis since 25Sep2017, ongoing Polycystic kidney, ongoing HTN, ongoing Brain aneurysm, ongoing GERD, ongoing Seizure disorder; Fever, nausea, vomiting, sepsis, Secondary hyperparathyroidism. Family history included Polycystic kidney disease- brother/father/uncles. Concomitant medications included ongoing allopurinol, ongoing paracetamol (TYLENOL), ongoing amlodipine, ongoing cholecalciferol, hydralazine, metoprolol, vitamins nos (MVI), phenytoin. Historical Vaccine included first dose of BNT162B2 on 21Apr2021 (Lot number ER8736, Expiration date Jul2021) at the age of 46 years old, administered in right deltoid for COVID-19 immunization. The nurse reported a medication error for two patients who received the entire vial of the undiluted Pfizer COVID vaccine on 12May2021. The entire vial was administered all 6 doses in the right deltoid. The reporter did not provide specific signs and symptoms. They were in their care after the vaccine was given for an hour and was sent home. They were instructed for any signs and symptoms to report to ER immediately. The patient also experienced fever/chills, vomiting, weakness, headache and cough, all on 12May2021 which were caused emergency room visit and hospitalization from 13May2021 to 15May2021 with treatment unknown. Lab data included CXR on 13May2021 with result: trace- pleural effusion. The outcome of the events were unknown. Follow-up (25May2021): new information received from a contactable physician included: new reporter-physician added, medical history and concomitant medications added, lab data added, vaccination on 12May2021 is updated as second dose and Historical Vaccine with first dose of BNT162B2 added, new events "fever/chills, vomiting, weakness, headache and cough, trace- pleural effusion" added and case upgrade to serious. No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. 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. ,Linked Report(s) : US-PFIZER INC-2021540031 Same reporter/product, similar events, different patient

Sensation of throat closing and unable to swallow; slight headache. Patient is treated with diphenhydramine 50mg orally and prednisone 60mg orally. Doctor's notes state patient had soft palate edema that started 10-15 minutes after 2nd covid vaccine. Patient is prescribed a short course of steroids to take at home.

patient received 1 dose of coronavirus vacccine in January. He was admitted to the hospital on 7/2/2001 with signs of acute hypoxic respiratory failure on 2 L of oxygen, with nasal pharyngeal swab PCR positive for coronavirus.

Approximately 10 - 15 minutes after receiving the second Pfizer covid vaccine, Patient felt like his throat was closing and unable to swallow. No difficulty breathing, no drooling, able to talk. Mild edema noted to soft palate and uvula. No wheezing. Patient is treated with diphenhydramine and prednisone.

Vertigo, Dizziness, Nausea, Headaches, Weakness, Shortness of Breath, Chills, Fever, Muscle Cramps, Joint Pain, Slurring Speech, cannot drive or work. Has been occuring since injection.

Patient was here for pfizer covid vaccine dose 1. Vaccinator administered vaccine to patient and then notified me that patient was having anxiety about needles and he placed patient on table while monitoring him for the 15 minutes as per protocol.. I went in to check on patient a few minutes later, patient was on the table, wife was present in the room. Asked patient how he was feeling, patient stated dislike and anxiety about needles. Patient was not in any distress at this time. Approximately 5 minutes later I rechecked on patient and he stated that his body felt tight. Reviewed possible cardiac signs and symptoms patient denied all but noted that his back and head felt tight, patient then stated he felt like he had to "breathe hard" . No signs of breathing difficulty at that time. Asked MD to evaluate patient. EKG was ordered, patients anxiety and pain were escalating during EKG. 911 was called. Patient care was being directed by MD while awaiting medic.pt placed on MD sechedule. See office visit note

Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling behind left knee which has resolved. Rash behind left knee resolved but right knee rash (burning/itching) has persisted but improved and using topical steroid. Severe diffuse headache, difficulty concentrating, slow performance, tachycardia to 120's mainly and some shortness of breath and left sided chest pressure for 48 hours along with fatigue. June 01, had tinnitus for a day. June 07, general intense feeling of not feeling well and headache. June 15, developed severe left leg pain and malaise. June 23, 8-9/10 pain behind left thigh and difficulty walking. Later developed exacerbation of prior mild right knee pain of recent onset to point could not walk.

46 Y male with a PMHx of HTN, HLD, DM, hypoT, stage II NLPHL with concomitant low grade B-cell lymphoma (dx 5/19/21) (5/2021, chemo scheduled later this month) presents with cough and SOB x6 days. 1) COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 7/15. COVID positive on 7/16. Pt was fully vaccinated on 4/1/21. Pt presented satting 88%. In the ED, he was put on 2L O2, solumedrol, remdesivir, and offer tocilizumab, which he refused at first. Pt took Tocilizumab at night. Pt now on 12L oxymizer. Offered tocilizumab again and increased methylprednisolone to Q6h. - 12L Oxymizer. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Methylprednisolone 125mg IV Q6h for 5 days (7/21 - 7/25) and taper down - Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (7/21 - 7/25 ) - f/u daily LFTs. Hold Remdesivir if ALT >10xULN or CrCl<30 - CRP, D-dimer, LDH, ferritin elevated. Trend QOD - Lovenox 40mg SQ BID and hold for Plt <25k, Fibrinogen <100, active bleeding - Tocilizumab 600mg IV x2 - Tessalon for cough - Encourage IS - Isolyte 500cc x1

This is a 46-year-old gentleman who states that he has had 2 doses of the Pfizer vaccine in April. States he did go to an amusement park a couple weeks ago and on 07/05, he started having symptoms of fever, chills, diarrhea, shortness of breath, so went to a local pharmacy and a couple days later was told that he was positive. EMS was called to the house and his oxygen saturation was 60% on room air. Patient was admitted on 7/12 to PCU and started on COVId treatment for pneumonia and respiratory failure. He was discharged 7/19.

extreme pain in his stomach with swelling and bloating; painful to breath because his abdomen was swollen/ extreme pain in his stomach with swelling and bloating; Dry heaves; painful to breath because his abdomen was swollen; sciatica to hurt and aggravated his lower back pain; sciatica to hurt and aggravated his lower back pain; hip pain; The pain was high up under his rib cage; Stomach discomfort; tenderness at the injection site; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6204; Expiration date: unknown), via an unspecified route of administration, administered in arm left on 13Mar2021 at 11:00 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation at hospital. Medical history included systemic herpes zoster infection (disseminated varicella zoster virus infection), ongoing HIV infection (he has been positive for HIV for 30 years) and previously had hip injury. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV infection from an unspecified start date and ongoing (taking for 3 years); aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]) taken for disseminated varicella zoster virus infection from an unspecified start date and ongoing (taking for 6 years). There was no history of any previous immunization with the Pfizer vaccine considered as suspect and no prior vaccinations within 4 weeks. The patient did not receive any additional vaccines on same date of the Pfizer suspect. There was no family history. The patient experienced tenderness at the injection site on 13Mar2021, diarrhea, stomach discomfort on 13Mar2021 at 18:00, extreme pain in his stomach with swelling and bloating, dry heaves, painful to breath because his abdomen was swollen, sciatica to hurt and aggravated his lower back pain, hip pain, the pain was high up under his rib cage on 14Mar2021. Patient stated recently had the Pfizer COVID 19 vaccine on Saturday and had some side effects that he had not read about. The patient clarified that he received the first dose of the Pfizer COVID 19 vaccine 13Mar2021 at 11:00 AM in the left arm. He reported that there was a little tenderness at the injection site, but it was no big deal. Then at 18:00 he noticed some stomach discomfort and had one episode of diarrhea. Then at midnight he woke up with extreme pain in his stomach with swelling and bloating. He couldn't stand up with the pain, it was at his limit. He added that his roommate wanted him to go to the emergency room, but he didn't want to go to a rinky dink hospital in the middle of the night, so he stayed home. Stated that he started to have dry heaves and brought up some fluid then it was just violent dry heaves then finally he was able to bring up air. It was painful to breath because his abdomen was so swollen, and he felt like he was exhaling forcefully. The pain was high up under his rib cage. This all continued until around noon on Sunday when air finally came up. He laid on his stomach on a heating pad and by afternoon he was better; by Sunday evening the swelling had mostly subsided. Patient stated that when he had the swelling and bloating it felt hard up under his rib cage. It pushed his ribcage out of position and caused his sciatica to hurt and aggravated his lower back pain. Mentioned he had a previous hip injury and the swelling that caused his back to be out and also caused hip pain. He further stated that his stomach was still irregular and making noises. And then at the time of this report, stated that he could do his usual stretches. Mentioned he got an email from the hospital and he reported his symptoms to them, but this was the first time to call Pfizer. He was scheduled to receive the second dose on 05Apr2021. He asked what to do to prepare for the second dose. The adverse events did not require a visit to physician or emergency room. The patient did not undergo relevant test. The outcome of the events tenderness at the injection site, diarrhea was resolved on 13Mar2021; events of extreme pain in his stomach with swelling and bloating, dry heaves, painful to breath because his abdomen was swollen was resolved on 14Mar2021 and outcome of rest of the events was resolving. No follow-up attempts are possible. No further information is expected.

CoughWheeze wheezing the next morning after getting vaccine Narrative: no wheezing noted on exam; pulse ox wnl. no resp distress noted

Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close throat dry throat. Tiredness fatigue.

0825 flushed, nausea , slightly SOB, O2 sat 96%, RR24 HR 77 BP 137/97. Pepcid 40mg, Benadryl 50mg 0830 Dizzy, flushed, SOB 0835 Dizzy, not flushed feeling, slightly SOB. O2 sat 95% 0840 Throat scratchy - slight difficulty to swallow O2 sat 93-94% HR 90 RR 28 0850 Epi pen injection, Throat tight and scratchy, hard to catch breath after coughing 911 called 0900 Ambulance transported to ER 0909 Ambulance arrived to ER still somewhat SOB and scratchy throat and nauseated, Dizziness improved. No stridor or wheezing, no hives or itching, no swelling of tongue or lips or facial swelling Received IV Benadryl, IV Decadron, IV Pepcid and albuterol nebulizer treatment and observed for an extended amount of time. SOB cleared, throat issue resolved and was discharged with just a slight residual tiny scratchy throat. He was discharged on Benadryl every 6hours until symptoms are completely resolved and Prednisone for 3 days starting on 1/26 if any residual symptoms are felt. Also given Albuterol inhaler if develop any recurrent SOB. Released home at 1413 on 1/25. Follow up on 1/27 and he stated he had fully recovered

After the vaccine, within about an hour after, I started feeling a headache, diarrhea, and extreme fatigue. The next day I still had a headache, fatigue and arm soreness. On the 31st, the symptoms kinda went away. I did notice some SOB when walking. I did see my Pulmonologists and was prescribed a medicine.

Pleuritic chest pain. Admitted due to acute pericariditis. Course complicated with new onset atrial fibrillation.

I 'had Covid' beginning Saturday before Thanksgiving. During that period, I had two tests, both from facility, and both tests came back negative. Symptoms included fever 102-103 for 12 days. No appetite (didn't eat for that duration). Headache. Excessive sweating. Extreme shallow breath. Hyperventilation. Body ache. No loss of smell or taste. No nausea. No mucus response. Since that time, I have experienced extreme fatigue, weakness, shortness of breath, headache. After the first shot, those three symptoms increased. With the second shot, I had fever 99.5-101 from Tuesday though Saturday. Nausea, headache, body ache, weakness, shortness of breath. It felt 85% similar in symptom and intensity as when I 'had Covid'. The greatest difference is the nausea. When I 'had Covid' there was no nausea and I did not throw up. This time, I had persistent nausea and threw up multiple times in the first three days.

Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate left arm/chest pain; Immediate left arm/chest pain; fatigue; body aches; This is a spontaneous report from a contactable physician. A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via intramuscular, on 18Jan2021 at single dose on the left arm for COVID-19 immunisation, administered at Hospital. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. The patient developed immediate left arm/chest pain, and fatigue/body aches. On 23Jan2021 (5 days later), he developed shortness of breath and palpitations/increased heart rate. Post-vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.

Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.

onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/2021), developed cough and low grade fever. Symptoms continued to progress with continued cough, fatigue, and generalized weakness with shortness of breath. Had O2 sat of 88% with activity on 2/9/2021 and went to emergency department and was diagnosed with pneumonia. Treatment started for community acquired pneumonia with Amoxicillin and Azithromycin. Patient discharge home from emergency department

As bad as flu after first dose, aches, pain all over especially knees and groin area. Hard to breath at times as I have bad cough/fluid in lungs though not bad enough to require medical attention. Headache, fatigue I am currently on day2 of feeling like this. Note: this is not life threatening I justed wanted to provide honest feedback to you on my side effects. Advil/Tylenal does help a bit

The pt received the vaccine and after approximately 5-10 minutes while waiting, informed the staff he was experiencing some anxiety and added he gets this when he only drinks coffee and not having eaten anything. His vital signs were done by the nurse and the PA spoke with him, too. He was given 6 8oz water bottles, a few pkgs of graham crackers and a banana while he waited in the rear of the pod. When he mentioned "chest" breathing the PA decided he should be brought to the E.D. The pt was going to walk but the staff requested he be wheeled down. He went to the E.D> with an RN and the Pod Mgr. ED: 47 yo m no pmhx p/w lightheadedness after receiving his covid vaccine. AFVSS, well-appearing, nad. Feeling better after eating, no cp or sob. Do not suspect acs. No signs of allergic reaction. Possible vasovagal vs anxiety related to vaccine. Reassurance provided, Plan for dc

Pfizer vaccine given IM and approximately 13 minutes after injection pt states that his throat felt tight and "funny". States he can swallow but it felt "funny". Denied shortness of breath or any other symptoms. Oxygen sat was 96%. BP 172/80 pulse 74. He was on hemodialysis treatment at the time. No other medications had been given. After initial assessment, S Standish, NP notified and Diphenhydramine 50mg was given IV and oxygen was given. Pt states he felt sleepy and after about 30 minutes his symptoms subsided altogether other than feeling anxious. Nursing staff stayed right with pt and helped to let him know that we were with him and pt verbalized that he was "fine." Vital signs remained the same and treatment continued. Pt left after his 3:30 treatment with all symptoms completely resolved.

Patient reported he had SOB and trouble breathing while sleeping and his tongue felt "heavy" while eating. Patient went to the ER at 1634 on 4/8/2021. ER report- positive for swollen tongue, weakness, negative for respiratory distress, Respirations were normal with mild scattered bronchial sounds

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose

Pleurisy of my lungs, or known as Pleuritis. I was treated but undiagnosed in the ER. I experienced sudden sharp chest pain and shortness of breath. I thought it was a cardiac event. The ER did not figure out what it was. My doctor was able to diagnose it a day or so later. Almost 3 full weeks now and I still have symptoms, mostly pain in my chest.

pt start to feel leg pain 10 days after the injection and then shortness of breath a week later pt was found with DVT and PE

Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremulousness about 15-20 mins after Pfizer COVID-19 vaccination.

11:30 Shot administered at drive thru site 11:40-50 Feeling mild tingling on lips, back of throat feels dry, getting the urge to pass stool. In the mirror I see the arches around the uvula swollen and red 11:50 Inform the nurse. Body starts shivering, talking and breathing is labored- according to my wife my voice sounded very different. Nurse checks lungs through stethoscope and SPO2+ heart rate- All normal, does not detect any constriction of lung air passages. But I am panting while talking. 11:55 I decide to wait and monitor. Shivering slowly stops, breathing slowly starts to return to normal (in about 20 mins). The urge to pass stool stopped. 12:22 No change either way- Breathing is ok, but mild tingling around lips, and feeling of tightness at back of throat. I take 5mg Cetrizine HCl. [Note: My mouth and throat felt like I have felt in the past with a reaction to shellfish.] 1:15 Redness at back of throat is less, and I feel normal. I drive off the parking lot of the vaccination site Next day Throat feels sore, but otherwise ok

Fever; Nausea; Vomiting; No appetite; Chills; body ache; Headache; Excessive sweat; Difficulty breathing; Hyperventilation; Exhaustion; This is a spontaneous report from a contactable consumer (patient, reported on himself). A 47-year-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318 and expiration date not provided), via an unspecified route of administration in left arm on 01Feb2021 04:30 PM, as a single dose for covid-19 immunization. Medical history included depression, COVID in late Nov2020, she had two tests for COVID which were found to be negative. She was allergic to Fructans. Concomitant medications in two weeks included vortioxetine (Trintellix), esketamine hydrochloride (Spravato), rosuvastatin calcium (Crestor), Saw palmetto (SERENOA REPENS) Saw Palme and Fish Oil. 02Feb2021 Tuesday 09:00 AM, the patient experienced symptoms 85 percent similar in type and intensity to when she had Covid in late Nov2020. Beginning with fever 99-101 until Saturday. She also had nausea and vomiting. She had no appetite (no food Tuesday till Saturday). She experienced chills, body ache, headache, excessive sweat, difficulty breathing, hyperventilation and exhaustion. The patient did not receive treatment for the events. He did not have any other vaccine in four weeks. The patient was not tested for covid tested post vaccination. Vaccine facility type: Public Health Clinic/Administration facility. The outcome of the events was recovering. Information on batch/lot number has been requested.

Onset of dry cough, moderate chest congestion, afternoon fatigue, and mild sore throat 1 day after receiving 2nd dose of Pfizer COVID-19 vaccination on 01-May (8 days now).

The Covid vaccine was given April 20 of 21 within eight days of having the vaccine I started to develop shortness of breath fatigue chest pain, I ended up at our local emergency room and was admitted with pulmonary embolism, blood clots in both lungs I stayed a total of three days hospitalized.

1732: Pt administered the vaccine. 1735: Pt had SOB, Dizziness, Chest tightness .1739: VS noted as BP 200/100, SPO@ 97% on RA, HR 92 1745: Pt developed hives on chest, shoulders. 1746: Epipen was administered 1749: Benadryl 50 mg IM was administered. 1751: VS noted as BP 200/130, SPO2 99% on RA, HR 89 1756: Solumedrol 125 mcg administered IM. 1758: 20G RAC IV inserted by RN. 1800: VS noted as BP 218/130, HR 72, SPO2 98% on RA. Pt complained of chest tightness again, 2 liters of oxygen via NC administered. 12 lead EKG performed, EMS arrived at the scene and Pt. transferred to Hospital

symptom: chest pain, pain in my left arm approximately 4 inches from my arm pit (injection side), shortness of breath, heart felt as though rhythm was off a bit. This happened about three days after my first dose for about 4 days. Starting to feel better now though. I didn't know what was happening and was tempted to go to the emergency room a couple of times but didn't. I'm just finding out about this from an article I'm just reading about 30 minutes ago and thought I should report this. I've only had my first dose and now I'm very concerned about the second due June 22nd.

Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; Within 20 minutes my throat felt tight and I had trouble swallowing. My voice sounded froggy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 28Feb2021 18:00 as single dose for COVID-19 immunization. Medical history included reaction to flu shot many years ago and known allergies from clams. Concomitant medications included tocopherol (VITAMIN E [TOCOPHEROL]); lisinopril; amitriptyline hydrochloride (AMITRIPTYLIN); rosuvastatin. No COVID prior to vaccination. The patient had not been tested for COVID post vaccination. On 28Feb2021 18:15, the patient experienced within 20 minutes my throat felt tight and he had trouble swallowing, his voice sounded froggy. The patient visited the emergency room/department or urgent care for the events. Treatment medications included Epipen, Benadryl and steroids. Outcome of the events were reported as recovered with sequel. No follow-up attempts are needed. No further information is expected.

i) Pain in left arm and shoulder started same evening. Lasted 3-4 days ii) High fever for next 2 days. Temperature was as high as 102 iii) Dry coughing and breathlessness iv) Ongoing asthma attacks and breathlessness. Started the day after second shot. v) General feeling of tiredness and lack of focus. (Ongoing)

Pt received 2nd COVID vaccine in May of 21, reports that 1-2 weeks later began to exhibit chest tightness with shortness of breath. Pt presented to ED at the Medical Center where an EKG showed ST elevation in V1-V2 concerning for pericarditis with negative troponin. Pt underwent left heart cath and diagnosis was confirmed.

Heart Attack. A feeling of burning in my arms and mouth of the stomach, in addition to fatigue when walking, started on June 12, 2021. I never had such pain before and thought it's just a stomach virus or so. As the pain continues, I called my primary-care Dr. early morning of June 17 and scheduled appointment for a week later. But around 9:30 pm that day, June 17, the pain became so severe, in addition to nausea and shortness of breath. I went to emergency room and have been told that there is acute heart attack in progress and was moved to the Critical Care Unit in the Heart and Vascular Center. A blockage has been removed and a stent was installed in morning of June 18, through heart catheterization procedure. As there was damage to the heart muscle due to the heart attack, I am supposed to go back later, in 4-6 weeks, to remove couple more blockages and install stents.

About 3 days after the 2nd dose, I started to feel chest pressure like a muscle pull on the chest. About 7 days after the vaccine, it started to worsen. I felt pain, chest pressure, back shoulder pain, jaw pain, and shortness of breath. I called the main local hospital number and was instructed to go to the ER. I did go to the ER and they did blood work, EKG which confirmed that I was having a heart attack. I was stabilized and was then transferred my via ambulance to A Medical Center which is bigger hospital and better equipped. I was admitted and the next day, I had surgery for a heart catheter. They also placed 2 stents in my heart. I was in the hospital for 4 days and was discharged with a prescription for Furosemide 40mg, rest, cardiac rehab, and to follow up with cardiologist. Prior to the heart attack, I only had hypertension.

difficulty breathing/had a very difficult time breathing; fast heart rate/rapid heart rate; contraction in the chest near the heart or the abdomen; some muscle tightness/tightness in the chest that was muscle tightness; This is a spontaneous report from a contactable consumer (patient's wife) reported for a patient. This is the first case out of two cases. A 47-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 19Jun2021 in the evening (age at vaccination was 47 years) as 1st dose, single for COVID-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. The reporter stated that she was calling because her husband and she went to the (Facility Address), yesterday at 1 O' Clock and got a shot for COVID and she had 2 side effects but she was okay, her husband had some side effects that were not really listed here under severe or more common side effects. On 19Jun2021 at 21:30 pm, last night the patient had tightness in the chest that was muscle tightness difficulty breathing and a rapid heart rate. They give them a paper work after getting the shot which listed some common side effects but not all possible side effects. It just listed few of the severe ones and then some common less severe side effect but it did not mention anything about some muscle tightness, contraction in the chest near the heart or the abdomen and difficulty breathing and a fast heart rate which was what her husband had been experiencing since last night had a very difficult time breathing but he was not allergic, he was not swelling, he didn't have a rash. The reporter confirmed that it was Pfizer COVID 19 Vaccine. No treatment was received for the adverse events. The reporter stated that it has not been resolved and it was still persisting the last time he had checked his heart rate because he was a runner and right now its 101 that was the resting heart which was high for him he normally had very low heart rate like 67 it was 136 about 20 minutes ago, it was raising without exercising. The reporter was informed about the Pfizer Medical Information. The reporter was also advised to visit nearby healthcare profession in the case of emergency. This case LRN W2021388441 was cross linked with LRN W2021388442. The outcome of the event fast heart rate/rapid heart rate was not resolved. The outcome of the other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Fatigue, muscle aches, bone pain, headache for 2 consecutive days (7/10 and 7/11) after COVID shot. Symptoms resolved on 7/12 w/o intervention On 7/14/21, new symptoms of chest pain and shortness of breath started. Still experiencing chest pain and shortness of breath as of 7/17/2021. I have not sought out any medical attention

weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020. The information on the Lot/batch number has been requested.

Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal saturation 97% on room air. Dyspnea with exertion with normal sinus rhythm rate in 80s. Cheat tightness.

I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I was worried my muscles would begin to sieze up and cramp. I had warm clothes and 5 blankets and could not get warm for over 2 hours. Elevated heart rate and breathing. Nothing warmed me. Eventually (and with ibuprofen) the incident subsided. I felt weak and just "off" with slight body aces and fatigue for the next day and a half.

During observation period after receiving vaccine, client became nauseous, short of breath, and itchy. Our staff moved patient to lay down on a mat, shortly after that pt was no longer oriented x2. Client quickly became oriented x3 after that but began complaining of intermittent chest pain. SP02 was 94%, HR 94-97, client still short of breath and diaphoretic. Gave Bendadryl around 5:15pm with resolution of itchiness. Patient rated chest pain as 10/10 specifically on right side and his back. Complained of metalic taste in mouth. Heart rate up to 114 and SP02 sitting around 96%. Ambulance arrived at 5:25pm and took pt to hospital.

Directly after the injection there was a tightening of my throat. It did not affect breathing and dissipated over the course of the day. I also had experienced reactive lymphadenopathy, specifically in the left clavicle area. The lymph node protrusion was large enough to been seen with t he naked eye.

hoarse voice, throat tightness Narrative: Patient received his 1st COVID shot 3/11/21. Ten minutes later he developed intense itching, a horse voice, and felt itching in his throat stating " I feel like my throat was getting tight". Spoke in full sentences without difficulty, O2 sat 98% on RA, denied chest pain or shortness of breath. Denied throat or facial swelling or n/v. Denied any prior similar reaction except for pruritus from opiates. Admitted to ER. IV Diphenhydramine and dexamethasone were administered with 1L of normal saline. Observed for 2 hours and discharged as symptoms resolved, no longer flushed, and voice returned to normal. Advised not to have second COVID vaccine administered due to concerns of increased reaction with second dose.

At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up. I had spots/hives on my body - not many - on the chest area. Then my hands/fingers and feet became itchy. throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up. I had spots/hives on my body - not many - on the chest area. Then my hands/fingers and feet became itchy. throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up. I had spots/hives on my body - not many - on the chest area. Then my hands/fingers and feet became itchy. throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up. I had spots/hives on my body - not many - on the chest area. Then my hands/fingers and feet became itchy. throat tigh; At 6:45 pm my mouth started to get tingly/numb and then eyes began to swell up. I had spots/hives on my body - not many - on the chest area. Then my hands/fingers and feet became itchy. throat tigh; throat tightened up due to swelling -; I couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration in left arm on 07Feb2021 at 03:00 PM as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included pantoprazole at 40mg taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient not had COVID-19 prior vaccination. The patient was not tested with COVID-19 post vaccination. The patient reported that his mouth started got tingly/numb and then eyes began to swell up, had spots/hives on body - not many - on the chest area, then hands/fingers and feet became itchy, throat tightened up due to swelling, but nothing serious where couldn't breathe on 07Feb2021 18:45. The outcome of events was recovered on Feb2021. Therapeutic measures were taken for the events swelling and hives with Benadryl. Follow-up activities have been completed and no further information is expected.

104 fever, dangerous tachycardia, incessant vomiting, dehydration, difficulty breathing. Urgent care immediately called ambulance and taken to ER. Admitted to step down unit to reduce fever and monitor dangerous. tachycardia. Ruled out bacterial, fungal or viral infection.

Client began complaining of shortness of breath, and feeling like his heart was racing. Vitals: 139/90, HR 83-90, 95% RA. Lung sounds were reported as being mostly clear. An ice pack was given.

At around 10:00pm person stated that he began with swelling in mouth, "delirious", slurring of speech, right arm pain, trouble breathing. These symptoms continued until 8:00am on 3/27/2021. No meds were taken at this time. Person did not go to ER for a visit and did not phone Dr.

After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. After 5 min, patient reported feeling light-headed and tried to stand up. The patient sat down on the floor and leaned against the wall. Patient was able to stand and walk to the provider room for closer observation. Patient felt hot and looked pale. The provider placed a blood pressure cuff on the patient, at which point the patient slumped forward and stopped breathing. A carotid pulse was not able to be appreciated. The patient was pulled to the floor, positioned airway open and was given oxygen. BP was 96/40. Blood sugar was checked (104) and the AED pads were placed. EMS was called. AED advised no shock, patient had a pulse and was breathing. Patient gradually became alert, though reported not feeling well. Patient was disoriented and was not aware of passing out nor the current event. Repeat BP 115/50. Patient began vomiting (~300-400 mL). Patient left with EMS to be evaluated at local Emergency Department. Of note, patient reports history of vasovagal syncope events 2/2 to various situations.

shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 06Feb2021 at 05:30 PM at single dose for COVID-19 immunisation. Medical history included allergies to macadamia and brazil nuts, and was on medication for a few health issues. Concomitant medications included unspecified medication (medications in two weeks). No other vaccine received in four weeks. Patient has not tested COVID prior vaccination. The patient experienced shortness of breath, tight chest/lungs, tingling in face, tight lips, dizziness, fatigue on 06Feb2021 at 06:15 P.M. Events resulted in visit to doctor or other healthcare professional office/clinic. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovered with sequel. No follow-up attempts are possible. No further information is expected.

4/11/21 generalized fatigue 4/14/21 shortness of breath and chest pain 4/15/21 right lower extremity Deep vein thrombosis and bilateral Pulmonary emboli 4/16/21 mechanical thrombectomy of pulmonary emboli 4/15/21 - 4/18/21 treatment with heparin infusion which was transitioned to eliquis

Chest pain; Palpitations; Shortness of breath; Cant Sleep; This is a spontaneous report from a contactable consumer reporting for himself. A 48-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 17:00 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation (Age at vaccination 48 years) . Medical history included anxiety,Post traumatic stress disorder , hypertension , blood cholesterol increased. On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medication included clonazepam (CLONAZEPAM) taken for anxiety, start and stop date were not reported. The patient previously took penicillin b. The patient experienced chest pain , palpitations , shortness of breath , cant sleep all on 23Mar2021 with outcome of not recovered. Course of events. This past Sunday would be 3 weeks post receiving his vaccine. Since he got the vaccine, about 3 days later he experienced chest pain, palpitations, Shortness of breath. He checked his own Blood pressure and its not high and his pulse is normal also. He's not a doctor and he doesn't know if its anxiety, but he also cant sleep, he's been getting like 4 hours of sleep every night since this started. No follow-up attempts are needed. No further information is expected. Lot information already received.

Within 10 minutes of COVID #2 Pfizer vaccine at about 10:18am, patient developed lightheadedness, cold sweats, and throat swelling sensation. Patient's temperature was low at 95.8 to 96.2.

Please note that I am the patient in question here, but also an physician, so I will write this in technical terms as best as I understand what happened. For background, my cardiac history is important. I had a work-up for palpitations performed more than a year ago that revealed normal cardiac function (EF > 65% by NM myocardial perfusion study), normal coronary arteries, and significant exercise tolerance (I maxed out the treadmill test). Usuallly I have to engage in vigorous exercise to raise my heart rate > 160 bpm. My resting heart rate is typically in the 50s or less. On Jan 15, 2021 I had an elective cerebral angiography and embolization procedure performed. I was asymptomatic prior to this procedure. The procedure requires general anesthesia for several hours. I have had the procedure conducted a few months previously and it typically has an unremarkable recovery, one night required in the hospital. After the procedure and following extubation, I had hypoxia on room air, tachycardia, wheezing and fatigue. The working cause for this was suspected atelectasis due to general anesthesia and I was given bronchodilators. While my breathing improved overnight, I was very tachycardic even while sleeping ? pulse greater than 130. Overnight telemetry noted arrhythmias with sinus tachycardia. The tachycardia persisted long after prior albuterol use so I had CTA chest on 1/16. No PTE was noted, though some basilar atelectasis and mild upper lobe ground glass opacities. I was discharged but due to continued mild hypoxia overnight, low grade fever (< 101F), and persistent tachycardia with any movement, I went to the ED on 1/17 for additional evaluation. In the ED, I had tachycardia with arrhythmias noted (rate up to 160). Sinoatrial exit block noted on EKG and telemetry. COVID-19 testing was negative by nasopharyngeal PCR and antigen testing. Resting heart rate was > 90 even when sleeping. Follow-up echocardiogram on 1/21/21 revealed depressed ejection fraction (40-45%). Cardia MRI on 2/1 was performed to evaluate for cardiomyopathy. Symptoms at this point were fatigue, dyspnea with even mild activity (e.g. walking), and tachycardia > 140 bpm with even just walking. My resting heart rate improved to 40s-50s. It showed normal wall motion and ventricle size with slightly reduced ejection fraction. Cardiology recommended cardiac event monitoring which I wore for 28 days. It only revealed sinus tachycardia and bradycardia. I still don?t feel great but able to do more physically than a couple of months ago. I await further f/u cardiac imaging to see if there has been improvement in the heart function.

Choking; Coughing out foamy mucus from his mouth and throat; soreness at the injection side; Neck stiffness; slight fever; sore throat; slightly bloody, foamy mucus from his nose; slight cough; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 48-year-old via an unspecified route of administration, administered in Arm Right on 13Apr2021 14:00 (Lot Number: Ew0153) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, and post-traumatic stress disorder (Adhd and ptsd). There was no covid prior vaccination, and no covid tested post vaccination. No other vaccine in four weeks. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); marijuana; calcium; acetylsalicylic acid (ASPRIN); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE); acetaminophen; MULTIVITAMINS [VITAMINS NOS] all in two weeks. The patient experienced choking, coughing out foamy mucus from his mouth and throat on 14Apr2021 02:00, he said it took him several hours to cough out the foamy mucus and also cleared out a significant about of slightly bloody, foamy mucus from his nose. He said all of the foamy mucus felt like it was in his throat and nose but not in his lungs. He fell back asleep, after clearing the mucus and slept another 6 hours and the foamy mucus did not return during the second sleep session. Other symptoms he experienced were soreness at the injection side, neck stiffness, slight fever, sore throat and slight cough on 14Apr2021 02:00. No treatment was received. The events outcome was recovered in Apr2021.

the patient complained of feeling a quick twinge and shortness of breath that lasted seconds. He was observed for 30 minutes and evaluated by the doctor. No medical intervention was required and the patient was discharged to home.

48-year-old male healthy presented with increased shortness of breath. He mentioned he had COVID-19 vaccine first dose almost 3 weeks ago then symptoms started of having shortness of breath with swollen upper and lower extremity not improving since it started. One week after vaccine developed generalized swelling in hands and feet up to thighs with firey red rash now on arms and inner thighs, felt warm. No itching. Reports some shortness of breath and chest pain. Treated outpatient with lasix without improvement, therefore required hospitalization for generalized anasarca. CT- pulmonary edema. Urine Protien/Cr ratio 0.16 - nephrotic syndrome unlikely, B/L lower extremity duplex negative for DVT, 2D echo showing normal EF of 60%

Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exhaustion and extremely tired; His stomach was hurting a lot; lungs felt like someone reach inside inside and punched him in the lungs; Achiness in joint in any place he had problems in the past in his body; nauseated; came right up on Pulmonary oil micro embolism or POEM; This is a spontaneous report from a contactable consumer, reporting for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the left arm on 15Apr2021 at 12:00 (Batch/Lot Number: EN6204) as 2ND DOSE, SINGLE (at the age of 48 years old) for covid-19 immunisation; and testosterone cipionate (Perrigio manufacturer), via an unspecified route of administration from 2018 (Batch/Lot Number: 2005126.1; Expiration Date: Jul2023), at 200mg/ml. 100mg injected weekly for secondary hypogonadism . Medical history included hypogonadism from 2018, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic /chromosomal abnormalities from an unknown date, endocrine abnormalities from an unknown date, diabetes from an unknown date, and obesity from an unknown date. The patient's concomitant medications were not reported. Historical vaccine included flu vaccine over a year ago, and the first dose of BNT162B2 on 24Mar2021 at 12:30 injected intramuscularly in left arm for which he had a mild sore left arm. The patient experienced came right up on pulmonary oil micro embolism or poem on 16Apr2021 with outcome of unknown, left arm sore improved after first shot as well as after second shot on 16Apr2021 at 13:30 with outcome of unknown, exhaustion and extremely tired on 16Apr2021 at 00:30 with outcome of recovering, his stomach was hurting a lot on 16Apr2021 with outcome of recovering, lungs felt like someone reach inside inside and punched him in the lungs on 16Apr2021 with outcome of recovering, he had 101.1 degree fever on 16Apr2021 at 01:00 with outcome of recovering, achiness in joint in any place he had problems in the past in his body on 16Apr2021 with outcome of recovering, and nauseated on 16Apr2021 with outcome of recovered on 18Apr2021. Details were reported as follows: 16Apr2021 at 8-9 am he gave himself the testosterone injection and he felt that tickling, rough feeling in his wind pipe like he just had to cough hard. Caller states, "yesterday, 22Apr21, I gave myself the testosterone injection like I have always done, my wind pipe started feeling like I had to cough, it tickled and felt just like it did on 16Apr21 following the 2nd vaccine dose. I looked my symptoms up on line and found pome-(pulmonary oil micro embolism)." The patient underwent lab tests and procedures which included pyrexia: 101.1 fahrenheit on 16Apr2021. The action taken in response to the event(s) for bnt162b2 was not applicable, and for testosterone cipionate was unknown.

Hot and cold flash fever off and on Cough Muscle or body aches Headache Acute hypoxemic respiratory failure Pneumonia due to COVID-19 virus Received plasma therapy remdesivir dexamethasone?changed to oral Decadron upon discharge

Patient is a 48-year-old male with patient history significant for CAD, CHF, ICD, HTN, hyperlipidemia, and smoking who presented to the ED yesterday morning with 1 day history of chest pain. Patient described the CP as moderate aching in the substernal area that did not radiate. The pain was intermittent, with each episode lasting 1-2 minutes. The CP was associated with LUE numbness and SOB on exertion. The chest pain and LUE numbness have now resolved. Patient also reports a three week history of RUE swelling. The swelling gradually worsened and is now associated with pain and proximal RUE bruising. RUE pain is rated 5/10. In the ED, patient was found to have NSTEMI and small right lower lobe segmental pulmonary artery embolus. Venous Doppler was positive for occlusive thrombosis in the R subclavian, basilic, and cephalic veins. Patient was started on IV heparin. Patient is scheduled for cardiac cath today. Hematology is consulted regarding PE and RUE DVT. Patient denies personal or family history of blood clots or recent travel. Reports receiving COVID vaccine in LUE approximately three weeks ago. Also admits to being more sedentary recently due to being unemployed. Denies nausea, vomiting, bleeding, bowel changes, fever, or chills. Significant PE findings: RUE edema, firm and tender to palpation, ecchymosis on proximal RUE, distal sensation and active ROM intact

I felt fine after the shot, but two hours later, my throat felt like it was closing and it hurt in a way I've never felt before. I had a bad migraine and my whole body was sore. My blood pressure was high for me at 143/94 with a heart rate of 94. I trend at 120/80 with a heart rate around 90. I take my blood pressure regularly to help manage Type II Diabetes. I was concerned with my throat, as the other symptoms seemed normal for the vaccine. It was very uncomfortable. I phoned the nurse line and was told to have someone bring me to the ER to check me out and take a Benadryl. I took the Benadryl and packed for the ER with meds and ID and my friend drove me. I was still uncomfortable enough to warrant wanting to go and had become very dizzy. When we got to the ER there was a wait and I went to my friend's car until called. After about 30 minutes (about 45 minutes after the Benadryl) my throat released and felt much better. My vitals were taken and seemed normal. The normal aches of the vaccine didn't concern me enough to stay, so I returned home. My symptoms remain what seem to be normal reactions to the vaccine: sore joints, slight headache, slightly sore throat, Charlie horse feeling at the injection site. Nothing of major concern. My largest worry was with the throat feeling closed, but it appears the Benadryl took care of it.

On May 9th I began to experience severe pain in my back extending down my left side. The pain was severe enough to prevent sleeping that night. The pain continued throughout May 10th becoming worse with deep breaths or any type of internal strain (cough, sneeze, etc). That evening, I took two Tylenol and later two Ibuprofen and was able to sleep. The pain persisted for the next week, slowly improving but not fully going away. On May 15th I conducted a telemedicine appointment and was advised to go to either Urgent Care or the ER. I chose the ER at Hospital. A D-Dimer test showed elevated results and a CT scan was ordered. The CT revealed blood clots in my right lung, specifically "Subpleural conslidation in the posterior basilar segment the right lower lobe is present, compatible with pulmonary infarct. Question additional pulmonary infarct in the lateral basilar segment the lower right lobe. Probable atelectasis in the left lung base." MD prescribed Eliquis @ 10mg 2x daily and I was discharged with a referral to .

This is a Healthcare employee working at a facility, divested this center and it is under new management. Previously on 12/1/2020 PT was diagnosed as COVID-19 positive, remained asymptomatic and returned to work on 12/11/2020. On 12/28 administered the vaccine at a workplace clinic . 4 days post-immunization on 12/31/2020 PT reported feeling "unwell' to his direct supervisor and was sent home. On 1/4/2021 PT reported to his supervisor that he had gone to the hospital due to having a fever and shortness of breath, he was tested for COVID at that time and was negative. PT returned home. On 1/13/2021 the center received a call from PT mother reporting that her son had returned to the hospital on the evening of 1/12/2021. Per his mother, PT was attempting to drink from a straw, but was unable to and had noted a facial droop. When he arrived at the hospital he was diagnosed with "suspected Bell's Palsy". Due to the immunization being administered on 12/28/2020 and suspected diagnosis of Bell's Palsy on 1/13/2021 it is unclear if the two events are related.

Shortness of Breath when doing aerobic exercises. Chest tenderness around heart. Going to ER on 5/23.

Patient was admitted 5/24/21 ~2-3 weeks after his 2nd dose of pfizer vaccine. Stated that he had had shortness of breath and chest pain that started a few days after vaccine that never really got better. He was found to have pericardial effusion and pleural effusion of unclear etiology. Did not have evidence of myocarditis on EKG or imaging, but findings suspicious for pericarditis.

Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for about 45 minutes. Then irregular heart beat and significantly high blood pressure (over 190). Stent put in.

I was playing ice hockey on April 10, 2021 when I started to experience shortness of breath. Coming to the bench between shifts is part of the game and that time on the bench is used to recover (both for your muscles and for your cardiovascular system). However, towards the latter part of the game, I continued to be short of breath even while sitting on the bench. Then in the last 10 minutes or so of the game, I fell to the ice for no reason. It was as if my muscles had just totally failed. I thought the shortness of breath may have been a sign of a Covid infection since I had not reached the 14 day period after my second shot. So I went to urgent care to get a Covid test. My test came back negative, but the doctor was concerned with my symptoms, so he took an x-ray of my heart and an ECG. He said that he noticed a blur around my heart, but didn't have any explanation. He thought I was in very good health, so he gave me a list of heart specialists to contact if I had another 'episode'. Fortunately, I did not have another episode. The only reason that I am submitting this incident is because I understand the administration is having an emergency meeting to review cases of an inflamed heart. I am not sure my situation was an inflamed, but I wanted to have my episode documented in case my situation was a temporary adverse reaction to the vaccine.

Patient had no reaction at time of vaccination; was monitored for 15 minutes prior to leaving clinic. This nurse was notified today by ER Physician that the patient came into the ER around 8pm (on the night of the same day that he received his vaccine in the early morning hours) with c/o shortness of breath. It was reported that the patient had taken nebulizer treatments at home with no relief. Symptoms began around 5:30pm. Patient ambulated into ER at time of visit but during the visit became unresponsive. Patient was intubated and coded with time of death called at 9:52pm. Patient has history of asthma.

Facial numbness, hot flash, Sweating, increased heart rate, palpitations, shortness of breath, Dizziness, faintness, nausea, headache, fullness in the ears, lightheadedness, stomach pain.

Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart area. Racing heart, Intensity of beat, Severe tinnitus left ear only, adrenaline, Can?t sleep; Symptoms worst when I get into bed Phase 2. (10 APR) Urgent Care Visit: Chest very weak, each day gets worse; inflammation left side of body (chest, hand, face), felt like hole in heart, shortness of breath, numb hand, easy to excite, pain when lean forward; heart out of rhythm; Phase 3: (13 APR) Nighttime rushed by wife to ER due to symptoms of a heart attack couldn?t breathe, numb hands, shivering, heart going berserk, dizzy, aggressive, heart out of rhythm. Did EKG and diagnosed with Arrhythmia and Palpitations Phase 4: 14 APR Condition Stabilizes with bed rest; heart speed and intensity reduces slightly, heart still out of rhythm; ringing in left ear continues; noticed left hand, face, chest all swollen, out of breath walking to mailbox; can?t breathe deeply; Chest begins to bubble, gargle, fizzle when I lay down. Palpitations in throat, legs, need to drink a lot water; can?t sleep due to heart racing then sore and breast bone enlarged; chest tenses up often. Phase 5: Visit to Cardiologist (26 APR) He mentions potential Nerve damage with injection and prescribes Ultrasound. Days later I have second ?ER like? Scare and confirm in my mind this also nerve related. Phase 6: Mid May Start Recovery: Chest still tenses up doing emails, phone, late at work; easily excited; Each night total relaxation; start to feel nerves twitching like electric pulses in left chest; Feels like Electric Pulses/Pain from injection site to location of original twitch in heart area. Lean forward pain/discomfort; Still very weak chest muscles that get painful and sore easily Phase 7: Early June: Ultrasound at Heart Dr. (2 JUN) looks better /normal size. Heartbeat steadier and quiet but palpitations persist (extra heart beats felt in my throat); Overall body feeling stronger but chest muscles still weak and sore after ultrasound experience. Ringing in the left ear is better and milder twitches in chest at night. Teeth sensitive to cold liquids and Numb hands while walking esp 4 June; tense chest at work/home and need to step away and breath; Heart faster; long time to calm after warm/hot bath Currently late June still suffer from muscle weakness especially left chest, left arm where shot went in. Hands are still numb and Heart races when in bed.. Chest also still freezes up during work. Have to focus on breathing calmly. Overall though my condition continues to improve.

Stated that he had shot on May 15, 2021 and had flu like symptoms for 48 hours afterward (fever, belly aches, very tired-and slept for 14 hr.) Seven days later he noticed feeling dizzy, having chest pain described as very heavy feeling in chest, light-headed and exhausted. Had biometric screening done at work on 6/29/21 and began to "feel faint". BP 73/42. He layed supine on floor, took deep breaths and drank apple juice and felt better. He said he had gone to the ER on 6/28/21 with shortness of breath and chest pains. BP went up to 98/66 and he was sent home from work. He went to his family doctor who did x-rays and referred him to cardiologist. Has an appt. with Dr., cardiologist, on July 12, 2021.

@1045 Nurse was called to the hallway because pt was feeling tachycardic. C/O dizziness, SOB, tachycardia with rate of 100s+ Upon seeing pt, he reported that the HR is better. C/O feeling hot, dizzy, numbness and weakness to bilat hands, SOB. Resp even and unlabored. RR22. VS 170/95 (110) 59 98%. Team alert was initially called but pt refused to go to the ED. Team alert cancelled. Pt wants to rest and wait it out. Assisted back to room. Pt ambulated with supervision and support of RN. Pt refused to use the wheelchair. Water provided. Pt was able to ambulate towards to room without any difficulties. Able to speak in full sentences. @VS 1117 VS 150/89 59. Pt's symptoms are starting to get better. Dizziness is really mild. Denies SOB. Slightly better numbness and weakness to hands. Instructed to increase fluid intake. @1125 VS 140/92 (107) 60 97%RA. Pt is feeling better. Denies dizziness, tingling to hands. C/O mild weakness to hands but able to move it better than initial encounter. Pt stated that he wishes to leave, go to cafeteria and eat. Pt is confident of going home. Pt has a ride home, mother will drive him home. Checked with the Dr. Per MD, okay to go home. Encourage pt to follow up with PMD and to go to the ED for new symptoms or worsening symptoms. Pt verbalized understanding. @1142 VS 151/82 (109) 61 Pt stood up. Feeling better. Gait stable. Denies any dizziness. Mild weakness to bilat hands. No sob noted. No s/sx of distress noted. Resp even and unlabored.

48 year-old man referred for admission from outpatient echo appointment after finding of large pericardial effusion. Patient's history includes iron-deficiency anemia from hiatal hernia and season allergies. Was in usual state of health until received second Pfizer mRNA Covid-19 vaccine 5/18/21. A few days later developed cough, 'brain fog,' dyspnea. Had remote outpt visit and treated with abx for sinusitis. Covid test was negative 5/28/21. Symptoms worsened and developed swelling of legs and abdomen, worse exertional dyspnea and had to sleep sitting up due to orthopnea. Began on lasix 20 PO BID as outpt with significant improvement in swelling and other symptoms over past week - thinks he lost 20 lbs. Still feels more bloated than usual. Had outpt echo as part of eval and sent to ED. Denies chest pain, palpitations, dizziness. Brain fog is improving. Mildly constipated. No black or bloody stools. No abd pain. PERICARDIAL EFFUSION (6/15/2021) Assessment: echo Large pericardial effusion noted mostly post and no echo evidence of tamponade. Smaller in size. no need for pericardiocentesis Discharge home on lasix 20 mg daily Net neg 5.4 L chest xray looks improved unbale to get thoracentesis due to not enough fluid Vitals stable

After receiving the vaccine I had the occasional sore arm and pain at the vaccination site. The second day after I started to feel my chest started to burn, which was accompanied by trouble breathing. It was a pain that I have never experienced before in my chest it felt tight and was burning very bad. I started to feel light headed as if I was going to faint while doing my normal daily activities. I decided to stop doing anything that caused my heart to beat too fast. So later on that night i decided to go to the ER, where they did an ekg and some blood work. They also did a scan of my chest where the doctor said everything came back and looked normal. Over time the pain and everything I was experiencing started to get better. I still have a hard time breathing every now and then. Also after the vaccine I experienced a slight cough and runny nose.

I felt like a hey fever attack, congestion in the head, over the next day nothing really changed. By Wednesday, I could not breathe through my nose at all, and I had a slight head ache. By Thursday, I had upper chest congestion with the head ache. On Friday, I lost my taste and smell and I went to urgent care and that is where they told me I had Covid after having a Covid test done.

On December 23, 2020 she had the Pfizer COVID-19 vaccination at 7:30 p.m. She then worked her shift as a dialysis nurse and went home the following morning. She did not have any symptoms until 5:00 p.m. the following afternoon when she woke up. She developed itching of her back and a mild erythematous rash across her chest. That evening around 7:00 p.m. she noticed a rash on her arms that was itching. At 7:30 p.m. she had tightness in her chest and a nonproductive cough. She attributed the symptoms to her asthma. Her symptoms improved throughout the night. She went home on Christmas morning and went to bed. She woke up at around 5:00 p.m. She had swelling of her eyelids and an urticarial rash across her face and chest. She did have some mild throat itching. She reported to work at 7:00 p.m. but continued to have symptoms with increasing shortness of breath. She reported to the emergency department and was evaluated. She was given famotidine, Methylprednisolone, and hydroxyzine. She was also given ipratropium/albuterol nebulized. Her respiratory symptoms did improve, and she was discharged around midnight. She continued to have a slight erythematous rash that was present until she went to bed the following morning. When she woke up it had resolved.

after 5 minutes states her fingers felt weird -numb and felt like her hear was racing, very anxious started to hyperventilate. Took her to ER via WC . During transfer stated her fingers were twisting (noticed definite contractures in both hands. States her heart was beating very fast. Denies any allergies but did states she has history of low potassium and has had issues with medications nad vaccines in the past. However no sx like this but does get "a little loopy" even when taking motrin. Instructed her to notify any provider prior to any vaccinations of the above sx. If I would have know any off this I would have highly recommended her to get authorization from her PCP prior

Confusion, Headache, Myalgia, Arthralgia, SkinRash, CoughWheeze, Rash, UrticariaPruritus, NauseaVomiting Narrative: Employee reports he was so ill he thought he was going to die. He is very fearful of getting second vaccination. He currently is refusing to get it.

Received the vaccine on 01/20/21.Patient reports on 01/21/21 started having myalgia throughout his body and fatigue. He had difficulty sleeping due to discomfort. Reports vomited x1 on 01/20/21. He reports that he noticed DOE on 01/21/21 and SOB with in one block of walking. Asthma wise: takes ventolin/combivent with no relief of symptoms. Reports he is specifically having pain in his lungs/pleuritic in nature worse with coughing/sneezing, went to the ER on 01/22/21.Chest xray,EKG and blood work were done. Xray and,EkG were normal with blood work showing anemia. Treated with IV pain medication with relief and D/C home with advise to take Nebulizer at home.

oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) . A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30 at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day. I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask. I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems. I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering. Information on lot/batch number has been requested.

Fatigue then sudden onset dyspnea with exercise in previously well and athletic physician/ health care worker

Difficulty breathing, sharp pains in the center of the chest, and tingling in the throat. Patient was offered ambulance transport and denied due to no insurance, his daughter took him immediately to the ER net door to be seen.

Injection site pain-minimal Tiredness- 3days, low energy Headache-severe for over 3 days Nausea- mild, 2 days Difficulty breathing- on two separate occasions after minimal activity

Pt received 2nd dose on 2/27/2021. 3/1/2021 reports onset of fever, headaches, loss of taste, fatigue, nausea and vomiting, body aches and shortness of breath.

Post vaccination, patient sitting in waiting area for observation. Staff informed nurse that patient appeared was not feeling well and appeared to have difficulty breathing. Attempt to move patient to assessment area, unable to ambulate and laid down flat. Appeared weak and pale, diaphoretic and labored breathing. Administered epinephrine per protocol and transported to nearest Emergency Department via EMS.

joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeling cold and shaking to hot and sweating. I was positive for COVID-19 in April of 2020, the reaction to the first shot of the vaccine was worse than the virus itself (with the exception of chest congestion and cough). it is nearly 48 hours from receiving the vaccine and I feel slight improvement, but still have body and muscle aches, slight fever, chills.

3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later, heart rate elevated north of 190 bpm and blood pressure went up to approx 180/100. Developed dry mouth (was very thirsty) and shaking/chills. Took about 60 minutes to stabilize. Went to ER for evaluation and tests around 2:30P. Received a liter of fluid. Both EKG and Bloodwork was indicated as normal. Released from hospital around 6P. Slept through most of the night. 3/26: heart rate was erratic all day. Would race and then stabilize throughout the day/night. Extremely lethargic. No trouble breathing (was able to breathe and take deep breathes) but took effort to breathe. 3/27: 1:40A woke up heart began racing at close to 200 bpm. Dry mouth, shakes. Similar to what I experienced immediately following the vaccine shot. Went to ER out of precaution. Symptoms stabilized after about an hour. Hospital did EKG, blood work and chest X-ray. all were normal, lungs were clear. However, glucose and bilirubin were both slightly elevated. 3/29: Still feeling lethargic. Heart rate has stabilized some but is still erratic. It easily increases from simply walking around the house (much more than usual). 3/30: Scheduled appointment with primary care physician 3/31: Scheduled appointment with cardialogist

BP 150/98. HR 96. Chest tight Throat felt tight at first now continues with chest tightness. Pt felt like chest is getting better after few minutes History of possible vasovagal reaction after getting shot

Shortness of breath when exercising or active. Slight fluid in lungs...lungs feel heavy. Must stop and catch breath, cough and rest. Has happened 7-10 times since vaccine. No fever. Some fatigue

Lost consciousness, awoke with vomiting and nausea, low blood pressure, and shortness of breath. Never had previous issues with any vaccines or injections, and never previously had vasovagal response. Since injection, I was constipated for 3 days and suffering extreme muscular/skeletal pain and headaches.

Within 10 minutes patient with complaints of shortness of breath, tongue discomfort and roof of mouth discomfort. Patient states that he also had a weird taste in his mouth. NP and paramedics at patient side. Patient appeared anxious. Lungs clear, posterior pharynx normal, uvula with no inflammation noted. Legs elevated. Patient placed on O2 and initial vitals normal. Patient then became hypertensive with SOB. Patient states that he can not take Benadryl because his doctor advised him not to ever take it. Patient is unsure if allergy. Initial EKG patient with inverted Twaves on 4 lead, then patient with normal EKG with 12 lead. Patient given 0.3mg of Epi and fire rescue notified. Fire Rescue arrived at 1256 and patient transported to ER at 1pm. Patient remained with weird feeling to tongue and roof of mouth on transport, shortness of breath was improving.

First feeling of throat closing up/narrowing, not the same feeling as a sore throat though. Then chills and fever for the rest of the evening and into the night.

Began experiencing chills and had difficulty breathing. Pulse oximeter was between 90 to 95%. Pulse as high as 106. Could not breath adequately laying down until after 4:00 am. So I had to sit up or dtand that time. Due to chills needed to have blanket wrapped around me.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Mild

trouble breathing/shortness of breath; terrible headache; I had chest pains; This is spontaneous report from contactable consumer (patient). A 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW6H02, expiry date not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 17:00 as single dose for covid-19 immunization. The patient medical history included allergies to IVP dye (reported as "die"). Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medication included insulin 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. The patient previously took penicillin, codeine, and atorvastatin (LIPITOR) and experienced allergies to them. On 26Feb2021, the patient had chest pains, and on an unspecified date in 2021, had trouble breathing, terrible headache, and shortness of breath which lead to surgery. The events were reported as serious life-threatening and had caused hospitalization on unknown dates. It was reported that for the event chest pains the patient was hospitalized for 5 days, while for the other events it was not provided how many days the patient was hospitalized. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 on 20Mar2021 which was negative nasal swab. Therapeutic measures were taken as a result of the event shortness of breath which included surgery, and chest pains. The outcome of the event chest pains was recovering while the outcome of the other reported events was unknown.

The evening of the shot my body basically turned on itself and began an all out mission to rid the vaccine. Of course, that couldn't happen, but my body was going to proceed until I was dead or recovering. I began having severe chills, roasting heat flashes, headache, and body ache. Every sweat gland turned on full blast and did not turn off. I began to vomit in outrageous fashion. As violent as I've ever experienced. I had "sessions" of vomiting at least thirty times from Thurs night to Monday afternoon. When I could get out of the bathroom, I would collapse back into my sweat soaked bed. I would have an awful time trying to catch my breath. It would be up to ten minutes of hyperventilating and racing pulse, until it would suddenly normalize. And then I'd be utterly exhausted and slip into some kind of semi-sleep coma. This would not last even an hour before I'd be racing to the bathroom again. This was the first sixty hours. Vomit. Hyperventilate. Wish for death. Sleep coma. Repeat. About 24 hrs in I added severe diarrhea that was a part of every bathroom journey from then on. Ate nothing. Couldn't take normal meds. Sipped some pedialite. Late Sunday I turned a corner and felt like I wouldn't die. Took a full seven days for me to get any energy back and feel human again.- Every single symptom besides headache, was the worst I've ever experienced.

low grade fever; felt pressure on chest; slight difficulty breathing; This is spontaneous report received from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:45 (Lot Number: EP6955) (Age at vaccination: 49 Years) as single dose for covid-19 immunisation. Medical history included Psoriasis; psoriatic arthritis; No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included rosuvastatin; valacyclovir [valaciclovir]; finasteride; vitamin d [vitamin d nos]; cetirizine hydrochloride (ALLERTEC, OTC allergy medication)). The patient previously received the first dose of bnt162b2 (lot number: EP6955) in Left arm on 17Mar2021 10:00 for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr2021 14: 00 (also reported as 13 minutes post injection), the patient felt pressure on chest/slight difficulty breathing for 15-20 minutes. On 08Apr2021 20:00 (one day post injection) had a low grade fever. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of events felt pressure on chest/slight difficulty breathing was recovered on 07Apr2021, of low grade fever was recovered on 08Apr2021. No follow-up attempts are needed. No further information is expected.

Chest congestion, weight in center of chest, little coughing, breathing ok Pfizer-BioNTech COVID-19 Vaccine EUA

moderate fatigue lasting 7 days, mild nauseous especially post eating lasting a few days, heavy chest pressure (still experiencing this after 30 days) with mild labored respiratory breathing and increased blood pressure to clinical high. Low grade headache (everyday for past 30-days).

Hypertension spike since 1st dose of vaccine (averaging 150/100) since getting vaccine. Lightheaded, shortness of breath. No history of Hypertension (though always on the borderline (averaging 120/80).

2 days after receiving vaccine pt developed sudden onset of difficulty breathing. He could not take a breath in. Denies cough, wheezing, fever or URI sx. Went to ER and diagnosed with bronchitis and pleurisy. Given albuterol, medrol and toradol.

Pt was vaccinated and was found to be complaining of swelling in his throat and was feeling lightheaded. He was given 50 mg of Benadryl. Patient was assessed after and his vitals were within normal range. He was fine and was picked up by his son to go home.

Second vaccine was on 04/15/2021. Lost my breath and could not breathe for a moment, I went to the ground , almost blacking out. Paramedics came and my vitals were very high. I don't know if it was because of the vaccine, but wanted to report it.

Experience two large heart palpitations and what seemed stopped beating for a second, this was followed by tremendous pressure in my head, I thought I was experiencing a stroke. I felt like I was going to black out and was having tightness in my chest , my wife took me to the E.R. I had an EKG done and it not show any arrhythmia and CT scan of my head did not show any abnormality. They scheduled me to follow up with cardiologist. The whole week I experienced the following symptoms: Tightness and sharp pains in chest; Difficulty breathing, especially at night (had to sleep sitting up on couch one night and another night woke up with difficulty breathing , appeared to be the biggest problem when laying flat). Would get out of breath walking up stairs; Moments I would get really light headed with a feeling like I could pass out; Symptoms last until the 4/16 , when they finally went away. Follow up with Cardiologist, who scheduled an electrocardiogram and stress tests on 5/7. The tests results showed that I had a healthy heart and no underlying conditions. I'm 49 and never have experienced any cardiac events. before or have a family history of cardiac disease. I have no known allergies either.

He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.

Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, SOB, lymphadenopathy, diffuse maculopapular rash. He had his first dose of COVID vaccine (Pfizer) on 4/23, and his symptoms began on 4/29. He was itchy all over, but when he developed fever and SOB he came to the ER on 5/2 and was discharged on prednisone. His symptoms continued and so he came back to the ER and was admitted. He had a lymph node biopsy to rule out lymphoma (pathology returned negative for lymphoma). He was treated empirically with ceftriaxone and doxycycline. He tested + for EBV IGG but not IGM. EBV PCR was pending upon discharge. He had a borderline positive lyme serology. He was discharged on doxycycline and steroids with improved symptoms. He returned to the ER with again worsening SOB, night sweats, worsening rash, recurrence of fever. He denies sore throat or any sick contacts. He reports a normal appetite. He was found to be hypotensive and in AKI.

Post vaccine #2 on 5/18 he developed hives, shortness of breath and reportedly did not feel with fatigue. Symptoms worsened and he was admitted to ICU on May 21st via the ED for multiorgan failure including respiratory failure with R pneumonia, Shock, Renal failure, Disseminated intravascular coagulation, shock liver failure requiring invasive vent support and treatment for septic shock including vasopressor support and antibiotic therapy. He was started on CRRT on the 22nd. His INR continues to rise and Hb dropping consistent with worsening DIC. Blood cultures are positive for MRSA. He will likely die from progressive septic shock and MSOF.

Pt presented with complaint of mild SOB. Pt denied CP. Full assessment performed and V/S obtained. Pt denied any significant PMH. (+)breath sounds and equal bilaterally, (-)stridor noted. Pt stated that he felt as though it may have been an anxiety reaction. Pt rested in observation area x10 mins. At conclusion of time, pt noted relief of symptoms. Pt stated that he did not want to go to the hospital. Pt informed of risks of refusing, up to and including death. Pt accepted risks and stated he would follow-up with his PCP. Pt signed AMA and released without incident.

By the second day of ?second shot all of my symptoms from being sick (previously cured by 1st vaccination shot) returned with a vengeance. fatigue, shortness of breath, cough, sinus infection, ear infection, swollen lymph nodes, dizzy spells, fever off and on, muscle and joint pain.

Pt presented with complaint of mild SOB. Pt denied CP. Full assessment performed and V/S obtained. Pt denied any significant PMH. (+)breath sounds and equal bilaterally, (-)stridor noted. Pt stated that he felt as though it may have been an anxiety reaction. Pt rested in observation area x10 mins. At conclusion of time, pt noted relief of symptoms. Pt stated that he did not want to go to the hospital. Pt informed of risks of refusing, up to and including death. Pt accepted risks and stated he would follow-up with his PCP. Pt signed AMA and released without incident.

Pt presented with complaint of mild SOB. Pt denied CP. Full assessment performed and V/S obtained. Pt denied any significant PMH. (+)breath sounds and equal bilaterally, (-)stridor noted. Pt stated that he felt as though it may have been an anxiety reaction. Pt rested in observation area x10 mins. At conclusion of time, pt noted relief of symptoms. Pt stated that he did not want to go to the hospital. Pt informed of risks of refusing, up to and including death. Pt accepted risks and stated he would follow-up with his PCP. Pt signed AMA and released without incident.

Patient received first dose COVID vaccine (Pfizer, lot#EW0185) in the left arm on 05/22/21 at 11am from vaccinator, RN. During the client's second dose appointment on 06/12/2021, client reported to vaccinator RN that he experienced intermittent chest pain with mild SOB approximately 2.5 weeks after receiving the first dose and persisting for 5 days. RN reported information to, Lead RN. RN completed a medical consult. Client reported pain level 3/10, denied radiating pain, denied lightheadedness, dizziness, difficulty swallowing, slurred speech, and numbness or tingling to the extremities. RN received clearance by MD to vaccinate for second dose Pfizer on 06/12/2021.

MYOCARDITIS shortness of breath, brain Fog, chest Pain pain left shoulder and Arm i gave blood and alot of chest pain has decreased.

50-year-old male status post heart transplant on 02/08/2017. He developed antibody mediated rejection in June, 2020. He received multiple sessions of plasmapheresis and IVIG. Last echocardiogram in March 2021 revealed normal LV systolic function with an EF of 60%. He presented to the ED on 6/10 with cough and dyspnea. Labs revealed lymphopenia, neutropenia, and leukopenia and tested positive for COVID. He is s/p Pfizer vaccination on 2/22 and 3/15. He received casirivimab, imdevimab on admission. Before this admission, he was taking tacrolimus 4/3.5 mg twice daily, Rapamune 1.5 mg daily, MMF 1000 mg twice daily, and prednisone 5 mg daily.

Pleuritic pain in left portion of chest and back. Pain is located in the lower anterior chest and left back. Pain is worse with deep breaths. Patient is treated with ketorolac, morphine, and ondansetron.

Shortness of breath, Dizziness, Sharp pain on the chest, Lasts 30min to 1hr. Been in ambulance 5 times with same symptoms,

Nausea; Fever; Fatigue; Chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: Er2613) via an unspecified route of administration administered in Arm Right on 24Mar2021 and second dose (#lot: Er8629) via an unspecified route of administration administered in Arm Right on 14Apr2021 as single dose (at the age of 49-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea, fever, fatigue, chest pain and difficulty breathing on an unspecified date. The patient did not report this because he didn't think it was relevant until recent media about myocarditis. He was close 3x to dialing 911 thought was having heart attack. The outcome of all the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aortic dissection, pericarditis, myocarditis. On arrival, patient appeared critically ill with cool, clammy skin, diaphoretic, complaining of chest pain. Patient initially able to answer simple questions, however quickly became unconscious, witnessed having tonic colonic seizure activity. Patient given 2 mg of lorazepam which aborted the seizure, however he remained unresponsive. IV fluids were started, and patient remained hypotensive after 3 L of fluids. Bedside cardiac ultrasound was performed which showed a large pericardial effusion with tamponade physiology. We continued fluid resuscitation and patient was intubated, while stat Cardiology consult was called. Patient suffered a cardiac arrest shortly after intubation. Cardiology performed emergent pericardiocentesis at the bedside which showed hemopericardium with output of greater than 500 mL of blood. ROSC was achieved following pericardiocentesis, and we continued resuscitative measures. Emergent arterial line and central venous lines were placed. Patient began to have profuse bleeding from all orifices, and massive transfusion protocol was initiated. Patient was stabilized enough to be taken to CT scanner which showed an extensive aortic dissection extending into the RCA, abdominal aorta, brachiocephalic artery, common carotids, and into the abdominopelvic vasculature. Cardiac and vascular surgery were consulted stat, and the decision was made to take the patient emergently to the OR. We were informed shortly after that the patient had expired en route to the operating room and they were unable to obtain ROSC. Final impression: type A aortic dissection, cardiac tamponade. Second dose of mRNA vaccine (unknown if Pfizer or Moderna) received two days prior to event.

AFTER 2-3 WEEKS AFTER THE SECOND DOSE, STARTED FATIGUE, SOB, COUGHING CAME TO SEE ME, HAD CHF , REFERRED TO A CARDIOLOGIST DR, MD, WHERE HE HAD ECHO DONE WITH NML CHF AND SEVERE LVH. HE HAD A COVID TEST NEGATIVE.

severe allergic reaction within 10 minutes of the shot being administered. severe itchiness, some shortness of breath. Was able to be calmed down by Benadryl

headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, red patches spread over cheeks, neck and body (which started on the 5th day and most visible on the 8th day). Up to today (July 11th), still experiencing shortness of breath, fatigue, lack of focus, and mild coughing

pneumonia; valley fever; diabetes; shortness of breath/difficulty breathing; body aches; headache; got sick; hadn't been well enough; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-years, via an unspecified route of administration, administered in right arm on 23Apr2021 at 02:11 at single dose for COVID-19 immunisation. Medical history included he and his family did have the COVID-19 virus in Nov2020 (with the COVID-19 virus in Nov2020 his fever had reached 103 degrees Fahrenheit). Concomitant medications were not reported. He was calling about the vaccine. He was scheduled for his second dose on 14May2021 but between his first and second dose, he developed pneumonia. He reported he and his family did have the COVID-19 virus in Nov2020. He was the only one that got sick after receiving the vaccine. He didn't know if it was coincidental or happenstance. He had been taking medication and hadn't been well enough to get his second dose. His primary care doctor and the doctor he saw at the urgent care both told him not to get the second dose until he was well. Now several weeks had passed and he wanted to know if he was ok to get the second one or will he have to restart and get the first vaccine again. The type of pneumonia that he had was called Valley Fever. He had been told it was because of the dry climate. He did have a chest x-ray and that was who the doctor knew he had pneumonia. He also had a blood test to confirm that he had the Valley Fever. He also had a COVID-19 virus test and that was negative. He actually thought he had the COVID-19 virus for a second time. The symptoms were exactly like the COVID-19 virus. He had a low grade fever, body chills, body aches, a cough developed and a really intense headache. He went to the urgent care with those symptoms and tested him and found out he did have the Valley Fever, a type of pneumonia. The doctor ordered the blood test to confirm the Valley Fever. His fever didn't get as high this time like it did when he had the COVID-19 virus. This time with the Valley Fever his fever was about 100 degrees Fahrenheit. He definitely had body aches, chills, shortness of breath and difficulty breathing. Since Nov2020 when he had COVID-19 he can say his lung capacity wasn't what it used to be pre COVID-19 virus. He was just able to go out and walk his dog and felt like he was breathing normally. Then he received the first dose and a week and a half later he got sick with the Valley Fever. He would like to get the second COVID-19 vaccine but wanted to know if he had to start the process over. He didn't take any medications and considers himself healthy. He would like to add that when he went for his follow up for the Valley Fever he had a complete blood work and urinalysis and interestingly enough his numbers came back that now he was in the diabetic range. He didn't know if it was related to the COVID-19 vaccine or not but thought that he should add it. He wasn't prescribed any medications for the diabetes he was told to change his diet. His blood sugar came back normally and his doctor told him when people have diabetes their blood sugar gets out of whack. He was going to change his diet for the next couple months. He went to the urgent care on 14May2021 with his symptoms, that was the same day he was supposed to get the second COVID-19 vaccine. He was asking if he was outside the window and need to start over or just need to get another shot. He said that he wants to get the vaccine. The events shortness of breath, difficulty breathing result in physician office. Outcome of the events was unknown. Information about lot/batch number has been requested.

redness; feeling very weak; he couldn't, his speech was because he was shivering so much that he couldn't fully speak; dry cough; his pupils dilate; gets bit of a blurred vision; Fever; sweats; chills; throbbing headaches; rash that looks like bruising spread over the body; fatigue; shortness of breath, he wasn't breathing fully; kind of look like bruises; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 15Jun2021 17:30 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for covid-19 immunisation. The patient's Medical history was not reported. The patient's Concomitant medication included collagen (COLLAGEN) taken for an unspecified indication, start and stop date were not reported. On 16Jun2021 17:30 patient experienced fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises and On an unknown date patient experienced redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision. The patient underwent lab tests and procedures which included blood test: unknown result on 23Jun2021 "He underwent taking blood test on June 23". Patient was treated with "Antibiotics, tylenol, motrin" for the events fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises, redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision. Patient experienced Fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, difficulty breathing for 8 days, and some of the symptoms still ongoing past 8 days. Currently on 10th day. Symptoms started day after vaccine. Reporter stated, "If you are asking, is he suffering from medical condition, he did after taking the vaccine but before that he did not have any other medical condition". Reporter stated, "A week later, on June 23rd (not clarified) he went to see a doctor and he prescribed him antibiotics and before that he was taking Ibuprofen, he was taking Advil and then they told him not to take Ibuprofen but to take Tylenol and Motrin. So, since June 23 (not clarified) he has been taking Antibiotics, Tylenol and Motrin." (later clarified that patient was taking Antibiotics, Tylenol and Motrin as treatment). Reporter stated, "He underwent taking blood test on 23Jun." (not clarified further). Reporter stated, "So, he was taking Advil and then since 23Jun, he has been taking Antibiotics, Tylenol and Motrin". Reporter further stated, "He had severe headache and even when he took Advil sometimes it would not go away and it would get worse when he was just lying down and he would get headache that would come and go. He would wake up in the middle of the night sweating. He would have to (voice breaking) many times and then after that he would get chills and get very cold and he would shake, he was very cold. He had shortness of breath, he wasn't breathing fully and then on June 23rd (not clarified) which was a week later, he started having this rash all over the body and on his face specifically, they kind of look like bruises. So, when it was like pressed too long like when he had contact and it was pressed too long, it did developed redness and the redness is starting to go away, now it has gone away and he was feeling very weak and then he couldn't, his speech was because he was shivering so much that he couldn't fully speak and he was getting a little bit of dry cough. But mostly, it was the headache that would not stop and then yesterday, he is getting better and now, he is now able to breathe fully, he is able to walk around with more energy, he has less of a temperature fluctuations and but he still sweats at night but not as much and then sometimes he gets like his pupils dilate and he gets bit of a blurred vision but the shivers have gone away now". The outcome for the events "fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises" was recovering and outcome for the events "redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision" was Unknown. No follow up attempts are possible. No further information is expected.

Shortness of breath; Upper and lower GI side effects; Slowed mentation; Daily severe headaches/Massive headache; This is a spontaneous report from a contactable physician. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175), dose 2 intramuscular, administered in Arm Left on 05Jun2021 12:00 (age at the vaccination 49-year-old) as DOSE 2, SINGLE for covid-19 immunisation at Doctor's office/urgent care. Medical history included prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0185), via an intramuscular, administered in Arm Left on 15May2021 12:00 PM date as 1st dose, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath on 05Jun2021 12:45, daily severe headaches /massive headache on 05Jun2021 12:45, upper and lower gi side effects on 05Jun2021 12:45, slowed mentation on 05Jun2021 12:45. Every afternoon patient had massive headache which patient had never before, shortness of breath and had digestive problems every night, digestive problem like patient can have days of digestive problems upper GI and Lower GI. Adverse event (AE) required visit to the Physician Office. It was getting worst. Therapeutic measures were taken as a result of daily severe headaches/massive headache. Patient took Motrin for headache. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event Dyspnea cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Fever; Injection site swelling; Feeling unwell; Difficulty breathing; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the arm left on an unknown date in 2021 (at the age of 49-year-old) and the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the arm left on 26Apr2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and 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 05Apr2021 at 12:00, the patient experienced dizziness, difficulty breathing, injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, fever, injection site swelling (vaccination site swelling) and feeling unwell. The clinical outcome of the events dizziness, difficulty breathing, injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, fever, injection site swelling (vaccination site swelling) and feeling unwell were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Sharp piercing left sided chest pain that radiated to left shoulder and back 7-8/10 on pain scale. Taking a deep breath made pain worse but no associated shortness of breath. Pain worsened with attempting to eat food. Severe symptoms lasted 2-3 hours and then subsided. Troponin and other cardiac markers negative. No history of GI, cardiac, or pulmonary disorders. Mildly present the first half of the next day (1-2/10) until afternoon then completely resolved

Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that continues on; This is a spontaneous report from a contactable healthcare professional, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular on 21Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included neuropathy. Concomitant medication included gabapentin. Past drug history included known allergies: TOPAMAX. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020, the patient experienced fatigue, chills, tingling sensation of extremities that continues on. Treatment for the events fatigue, chills, tingling sensation of extremities included ibuprofen (MOTRIN) and acetaminophen (TYLENOL) taken with minimal or short temporary relief. On 30Dec2020, the patient experienced shortness of breath on exertion and weakness and tried to go to Urgent care clinic for Covid test but no available test so the doctor prescribed ZITHROMAX in case it was Covid. On 30Dec2020, MRI, XRAY, LABS were taken and all came back negative and normal except having all these symptoms. On 02Jan2021, Covid test done and result was negative, tested for antibody and it was positive. The outcome of the event fatigue was unknown. The outcome of the events chills and tingling sensation of extremities was recovered in Jan2021. The outcome of the events shortness of breath on exertion and weakness was not recovered. The events fatigue, chills, tingling sensation of extremities that continues on, shortness of breath on exertion and weakness required a physician office visit.

1:28: BP: 168/99, HR: 117, O2:98%, felt different 1:30: Complaint of throat tightning, BP: 169/99; HR: 110, O2:98%, Med team alerted 1:34: Benadryl 25 mg, IM to right thigh 1:35: BP: 150/88, HR: 100, O2: 97% 1:40: MD report symptoms throat tighning after vaccine, no rash, no hives, talking fine, no change in voice, symptoms mild, no swelling of tongue, lips, or pharynx, pt refused epinephrine, improved over a few mins. Plan send to ED for continued observation; transferred at 1:43

Date these symptoms started was 1/27/2021: About 12 hours after injection, developed fatigue and slight nausea as expected. Oral temperature 98.0. Commuted to work without issue. ~ 1400: As day progressed, nausea subsided, but fatigue grew more profound and developed pain in the right subscapular area with exertional shortness of breath walking any length of time. (Injection of initial and second doses were both in right deltoid). 1540 - 1800: Fatigue increased, developed a burning/tearing pain with every yawn and deep breath from the top of my trachea into both left and right mainstem bronchi and radiated to right arm. It literally felt like someone was trying to tear out my bronchial tree with each breath. 1800: Arrived home and medicated self-medicated with Motrin 400mg. 1800 -2030: rested at home with still some breathing pain, no shortness of breath, but incredibly tired. 2045: Went to bed and slept for the next 12.5 hours without any issued during the night. 0800: Woke up nearly all symptoms were gone, only some minor residual fatigue. No breathing pain, no nausea, no subscapular pain. I did not seek medical attention for symptoms, nor did I contact my provider. I experienced fatigue and a headache with the first dose, but no other symptoms. I never experienced fever or chills

allergies; allergy induced asthma; This is a spontaneous report from a contactable physician (patient). This physician reported similar events for 2 patients. This is the first of two reports. A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension, Asthma, Allergies and allergy to penicillin. Concomitant medication included varicella zoster vaccine rge (SHINGRIX), olmesartan (OLMESARTAN), nebivolol hydrochloride (BYSTOLIC), hydrochlorothiazide and triamterene (MAXZIDE). It started several days after the vaccine. Patient have allergies and allergy induced asthma on 25Jan2021. It started slowly and became worse. Patient had to take allergy pills and double his steroid inhalent. Its the middle of winter and this never happens. No treatment was received. Outcome of the events was not recovered. The reporter considered the events non-serious. Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021125841 Same reporter/product/event, different patient

At 09:21 am Stated tightness in throat, diaphoresis, and nausea. At 09:24 am was given; 1 ml Benedryl IM left deltoid. Started feeling relief at 09:30 am, then approximately 14 minutes later had tightness in throat again, stated having no difficulty breathing or swallowing. Called 911 at 09:45 am. O2 sat and heart rate were within normal range, elevated BP 153/93 lying and 163/103 sitting left arm. Agreed to go to ED with medical team at 09:55 am. walked out with paramedic.

Tingling up left shoulder, neck and head approximately 1 minute post injection. Followed by flushing, nausea and trembling. Approximately 5-7 minutes post injection experienced onset of difficulty swallowing and rapid heartbeat. 10-12 minutes post injection sensation of throat closing with some difficulty breathing, difficulty swallowing increased. 15-17 minutes post injection, paramedics arrived. Blood pressure was 169/113. Dizzy upon standing. 20 minutes post injection paramedics administered 50mg Benadryl due to difficulty swallowing and sensation of throat closing however it wasn?t worsening. Paramedic asked me to rate the swallowing difficulty (1-10) which was a 5-6 but never exceeded that. Transported to Emergency Room.

I got my first Pfizer covid shot around 3:30 PM on March 16, 2021. Around 10:00 PM, my arm started to get some soreness. I also noticed that I started feeling really sluggish with some muscle pains. Approximately 11:30 PM, I attempted to go to sleep and noticed that I started having a minor respiratory distress where I could hear myself wheezing. The wheezing only lasted about one hour. All the symptoms disappeared after 36 hours without any treatments or medications. At this point, I'm not sure If I should get my second vaccine shot.

Immediately following vaccine administration patient claimed had throat closing but upon further questioning, patient had a tickly throat and patient claimed tongue felt enlarged. Gave patient 10ml of children's benadryl (25mg) and patient felt better. Waited in store 45 minutes following vaccine but symptoms disappeared 10 minutes following shot. Patient left pharmacy feeling fine with wife who was home with him all day to monitor symptoms. Told patient to use benadryl throughout day.

Got first pfizer vaccine 3-12-21. Developed SOB after about 10 minutes which resolved with albuterol when got to car. 1/5. to 2 hours later developed dry mouth. Water couldn't produce saliva. Had external cheek paresthesia about 4-5 times on the way home from work that same day. Resolved by time he got home. Over next 2--3 days would get the numbness and tingling on his cheeks. Still had dry mouth. 3-4 days later developed upper/lower lip numbness on the outside for 5-6 episodes. No lip swelling. 5 days after vaccine developed a metallic taste in his mouth. Was still able to eat/smell/taste food. That lasted a day. The following day the metallic taste went just to the right side for a day. Since then occasionally gets a paresthesia around his lip/cheek area.11 days still getting metallic taste sensation for 5-15 minutes at a time

Every since getting my vaccine I have been having these symptoms. I received my first dose of phizer on 1/22/21 and a second dose 21 days later but was given Moderna not phizer. I continue to have headaches on and off all day, they are short but intense lasting about 5-10 minutes, sometimes hour or two between. Also shortness of breath and increased heart rate with just slight activity. Going up a flight of stairs my heart rate will quickly increase to 130-140 BPM which has never happened before. I have a fitness tracker on my watch so I watch it closely every day and it was never that high. My heart rate will recover fairly quick if I sit and it will come down to 80-90 BPM, at night when relaxed for a while the lowest I see it is about 70-75 BPM, sleeping it will be around 65 bpm.

Pt received vaccine on Friday, March 19th. On Monday, March 23rd, t was hiking with boy scout troop, became short of breath, collapsed and went into full arrest. BLS done on scene, transported to local ER where pt was pronounced dead.

Patient received vaccination at 1:45 PM on 3/16/21. Woke up at 3:00 AM on 3/17/21 with difficulty breathing. Went to ER where he was diagnosed and treated for angioedema secondary to a vaccination. Given IV steroids and benadryl. Discharged home with oral prednisone, hydroxyzine and epi pen. ECG, cardiac enzymes, CT neck negative for any acute process. Patient has a history of stephens johnsons syndrome secondary to taking Bactrim. Followed up with PCP on 3/25/21. All symptoms had fully resolved.

2 days after 1st shot I felt extreme fatigue and shortness of breath for several days. Got tested for COVID with negative results. Went to hospital on 16th of February and was admitted due to heart condition and recent heart attack. I told them my next vaccine was due on the 18th and they gave it to me while I was admitted. Within 24 hours I had another heart attack. I was sent to another hospital for an Angiogram where they expected to find blockage and prepared to install a stint. They found no blockage. There is no medical explination.

A perfectly healthy guy, who did not change anything else in his life, got the first vaccination, and 12 days later had a blood clot in his right lung. Went to ER, was diagnosed, and spent 3 days in the hospital. Serious. Doctors so far has no explanation for why this happened.

Weakness, headache, nausea, exhausted, wanting to sleep constantly, trouble breathing when sleeping(wife noticed this). These symptoms although getting better have lasted six days.

About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy feeling and I felt two spots on the front of my neck itching. I looked in mirror and saw two pimple size type spots itchy. over the neck 30 mins another itchy pimple grew and neck got a bit red and under an ear got red and itchy. over the next hour my breathing felt a little more difficult, though oxygen level oximeter reading still good. 8.5 hours after vaccination both sides of my upper back/shoulders were covered in hives. I felt a bit foggy also. I administered epinephrine pen to my thigh. Over next few minutes the hives disappeared (except for a few pimple size spots though they basically disappeared)and the itch was gone. My breathing felt fine. I monitored signs and symptoms with no noticeable issues for the next day+. This was the 1st time I ever used an epi pen.

developed chest pain and shortness of breath 12 hours after vaccination and went to ED and hospitalized with PE and DVT and now on xarelto

Breakthrough COVID-19 + . Known unprotected exposure at home, developed sore throat, congestion and cough. Pfizer COVID-19 vaccine received 1/6/21 and 1/29/21.

Shortness of Breath with cough , generalized weakness, left rib pain radiating to upper back pain (sharp in nature)

pulmonary embolism; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ep7534), via an unspecified route of administration, administered in right arm on 16Mar2021 15:00 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included verapamil. The patient previously took lisinopril and experienced allergies. The patient received first dose of bnt162b2 on 23Feb2021, 13:00 for Covid-19 immunization. On 19Mar2021, the patient started having challenges with shortness of breath. On 31Mar2021, after the challenge continued to grow he was checked into the hospital and was diagnosed with pulmonary embolism. Despite no travel nor history of family blood clots, nor was he was genetically dispositioned. The events resulted in emergency room/department or urgent care. Therapy for the events included Blood thinner. The patient had no other vaccine in 4 weeks, and no Covid prior vaccination. The patient was Covid tested post vaccination. The patient underwent lab tests and procedures which included nasal swab was negative on 31Mar2021. Outcome of events was recovering.

Patient presented to ED for c/o SOB 4/17/21. He was diagnosed with PE. Also for completion, patient did have shoulder surgery 6 weeks ago without complication.

Pt received his first dose of Pfizer COVID vaccine on 4/10/21 and started having myalgias and cough on 4/14. He was tested for COVID on 4/16 and received the positive result on 4/19. He then developed fever, loss of taste, nausea, and shortness of breath which prompted him to present to urgent care, and they told him to go to ED on 4/22/21. Patient was found to be hypoxic and was admitted to the hospital for COVID treatment.

Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappearing in various places, occasional itching sensation, numbness, brain fog, double-vision, extreme tiredness. Symptoms tapered off over 3-5 days. Similar experience with 2nd vaccine but less pronounced with a shorter timeframe, tapering off after 2-3 days. Strongest side effects after first vaccine, symptoms did not become noticeable until a couple of hours after it was administered, increasing next 24 hours before lessening over time. Basically identical to long covid symptoms but lasting only for a few days after vaccinations and not before.

Patient came in with diffuse urticaria and some difficulty breathing which resolved after a few hours spontaneously

1st Pos. COVID-19 test, resulted on 7 Dec 21 Symptomatic. Second COVID -19 pos. resulted on 29 APR 21, s/s: fatigue, difficulty breathing , SOB w/ exertion Onset 29 APR 21. fullness in the trhroat, COPD Chronic Glaucoma, GERD. 1st COVID vac,14 Jan 21, 2nd 6 Feb 21. Since the second onset of symptoms was more than 90 days from the first infection and more than 14 days after the second COVID vaccination. This is considered a new case.

Pt says that he has had "fuzzy thinking," having trouble recalling words and was off balance. He had slurred speech. He also had left side chest pain and trouble breathing.

One week after receiving the vaccine I started experiencing shortness of breath. Symptoms peaked 6 days after they started, approximately 2 weeks after receiving the vaccine, then subsided.

Upon return from the vaccination I experienced no ill effects until that night. The symptoms were then similar to when I had Covid in December of 2020. Chills, headache and body aches. This lasted overnight and the next day I only felt the aches and fatigue, which have lingered, slowly improving for the past several days. Three days after the shot, I experienced some respiratory issues, shortness of breath during certain activities and occasional coughing. This lasted about two days. Now, six days after the vaccination, the remaining symptoms are minor aches and fatigue, these seem to be waning.

Presented to ED today with complaint of right-sided CP onset yesterday. Patient has history of renal cell carcinoma with metastatic disease to the liver. He has had recurrent pleural effusions involving the right lung. Has worsened pain with breathing. Had a R tube placed due to pleural effusion and last week when the tape was taken off it pulled and caused pain. Endorses SOB. No significant cardiac history. No h/o DVT, PE. Has renal CA and had L kidney removed. Patient admitted. Pulmonary/critical care was consulted regarding Pleurx catheter. It is felt that his pleural effusion had decreased in size, and the catheter was likely contributing to his right-sided pleuritic chest pain. Catheter is removed with good results of his pain. Patient however did have recurrent fevers. Empirically placed on Rocephin. With this, he did improve. He was discharged in stable condition.

Patient with Hodking's lymphoma (bendamustine and brentuximab since 4/28/21), admitted for subacute onset of SOB and hypoxia w/ CT showing bilateral pulmonary opacities concerning for pneumonitis or infection.

COVID infection 2/2021. Resolution of symptoms. dyspnea on exertion since 1st COVID vaccination that started a few hours after the vaccination and has continued since that time.

PT RECD 2ND DOSE PFIZER VACCINE ON 5/4/21, HAS BEEN HAVING SWOLLEN LYMPH NODES AND DIFFICULTY BREATHING WHICH CONITNUED FOR THE PAST 2 WEEKS. PT DID NOT SEE MEDICAL CARE, BUT RETURNED BACK TO OC FAIR POD TO RECEIVE MEDICAL CARE. PARAMEDICS ASSESSED PT, VSS, LUNGS CLEAR, WAS OFFERED TRANSPORT TO HOSPITAL BUT REFUSED. HE WILL GO TO HOSPITLA BY HIMSELF.

Flu like symptoms for two days once those subsided then shortness of breath and heart palpitations began and have not subsided.

BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM, Lot no. EW8730, anatomical location: Left arm. 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. On 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night. The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG). Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo. The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.

Pt developed dizziness, lightheadedness, sob after receiving vaccine. Then reported mild chest pain, headache, neck pain, weakness in lower extremities. BP 220/112, HR 86, O2sat 99 RA. Pt escorted to ER via wheelchair.

Transient memory loss--unable to find way to daughter's school or back home. Doesn't know what time school starts. Mild headache, occasional shortness of breath, cough, fatigue, generalized malaise. Neurology consult and examination--- normal. Patient treated with diazepam. Patient discharged home

ABOUT TWO WEEKS AFTER THE 2ND PFIZER COVID VACCINE I DEVELOPED DYSPNEA ON EXERTION AFTER WALKING FOR N + MILE (I WALK DAILY APPROX 3 MILES.. NEVER HAD ANY PROBLEMS). IT WAS STRANGE -TAKING DEEP BREATHS DID NOT HELP. INITIALLY I THOUGHT I MAY HAVE THROMBOTIC COMPLICATION, OR A CARDIOMYOPATHY RELATED TO SOME VIRUS. SINCE I WAS ABLE TO WALK DAILY 1-3 MILES I DID NOT SEEK MEDICAL HELP, ALSO, THESE SYMPTOMS OF DAILY DYSPNEA ON EXERTION (N + MILE) LASTED N 2 WKS - AND COMPLETELY RESOLVED IN ADDITIONAL 2 WKS. NOW I THINK THAT THESE SYMPTOMS MIGHT HAVE BEEN RELATED TO THE COVID VACCINE (AND WANT TO INFORM POTENTIAL GUIDANCE FOR THE USE OF MRNA FOR REVACCI- NATIONS FOR INDIVIDUALS WITH SIMILAR COMPLICATIONS. ALSO, I FILED A PREVIOUS REPORT - I DEVELPOED MULTIPLE JOINT EFFUSIONS AFTER THE 1ST AND 2ND DOSE COVID VACCINE - IT TOOK A COUPLE OF MONTHS BUT BY NOW THESE SYMPTOMS ARE RESOLVED.

Shortness of breathe, heart palpitations.; Shortness of breathe, heart palpitations.; This is a spontaneous report. A contactable male consumer (patient) reported a 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for COVID-19 immunization on 20May2021 11:00, at 50-year-old. No medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications received within 2 weeks of vaccination. The patient previously first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm for COVID-19 immunization on 30Apr2021 11:30, at 50-year-old. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced shortness of breathe, heart palpitations; both were on 23May2021 15:00 with outcome of not resolved. Information lot/batch number has been requested.

Reports onset of "return of Covid symptoms" almost immediately (fever, chills, diarrhea, shortness of breath, loss of taste and smell, jaundice). Followed by extreme symptoms as of May 7th including fever above 104 degrees Fahrenheit. Pt first seen by medical professional on May 11. Patient was hospitalized May 15 and remained hospitalized until June 1 and was treated for multiple infections and sepsis during hospital stay.

swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swelling of face; slurry words; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Feb2021 at 09:00 am (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to iodine, shrimp and iodide (like the CATSCAN contrast fluid). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) and One-A-Day Mens over 50 vitamin. The patient previously received first dose of flu shot in upper right arm on 12Jan2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. On 10Feb2021 at 15:00 pm, the patient experienced swelling of tongue, face, confusion, slurry words, difficulty breathing, no pains though, headache (bad one) and numbness in right side. The patient received treatment with DECADRON (steroid) and Diphenhydramine (Benadryl). Since the vaccination, the patient has been tested for COVID-19. The patient underwent Nasal Swab COVID test (COVID Nasal/Nasopharynx COVID test) on 28Feb2021 and the result was negative. The outcome of the events was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

1) Asthma exacerbation started 2 days after shot. Persisted beyond 2 weeks. Developed some secondary infection treated with Steroid inhaler and antibiotic. 2) Severe tinnitus exacerbation also started 2 days after shot. Both ears. Still persisting at 2 weeks. Gradually improving but not back to baseline.

Extreme Convulsions (uncontrollable shaking); Fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours; extreme pain in the hips to where he could not move; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 10Jun2021 17:00 (Batch/Lot Number: EW0187) (at age 50 years old) as dose 2, single for COVID-19 immunization. The patient's medical history. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient previously received the first dose BNT162B2 on 19May2021 16:00 (lot number: EW167) (at age 50 years old) in left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 11Jun2021 21:30, the patient experienced extreme convulsions (uncontrollable shaking), fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours, extreme pain in the hips to where he could not move, and shortness of breath. The events were reported as non-serious. Treatment was not given. The patient was recovering from the events.

Pt.'s friend stating 06/11/2021 after receiving vaccination difficulty breathing, swelling of the face, dizziness/weakness, on/off fever, chills. Edema of both legs (Left more swollen), no seeping. No physician seen.

Having a minor respiratory issue where I could hear myself wheezing; Soreness around the site of the shot; Feeling tired; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: 6205), via an unknown route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included allergies. The patient did not have any allergies to medications, food, or other products. 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 ZYRTEC. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 16Mar2021 at 22:00, the patient experienced some soreness around the vaccination site of the shot, felt really tired along with muscle soreness. At 23:30, the patient experienced a minor respiratory issue, where patient could hear wheezing. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the vaccination site pain, tiredness and muscle soreness was resolved on 18Mar2021 (All the symptoms disappeared after 36 hours); while that of the wheezing was resolved on 17Mar2021 (this lasted about 1 hour). No follow-up attempts are possible. No further information is expected.

Difficulty Breathing (Labored Breathing) Chest Pain June 26, 2021 *Pleurisy treatment with Prednisone, Ibuprofen, Pantoprazole Not better after steroid, Went back to dr. Sent to do a CT Angiogram Chest Pulmonary Embolism with and without contrast July 2, 2021 Results showed Pleurisy and Calcification on left lungs. Referred to do a Full PFT pre and post bronchodilation / to a pulmonologist.

Chest pain; Shortness of breath/could not breathe while sweating profusely; Shortness of breath/could not breathe while sweating profusely; He turned white as a ghost; The patient all of the sudden didn't feel right; troponin was elevated; The patient's blood pressure has never been high but it was high when he got to the hospital; The doctors are leaning more toward myocardiopathy; This is a spontaneous report from a contactable consumer (wife of the patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8737; Expiration Date: 31Jul2021), via intramuscular route of administration, administered in left arm on 31Mar2021, as dose 2, single (age at vaccination: 50 years), for covid-19 immunization. Medical history included type 2 diabetes mellitus which was diagnosed about 3-4 years ago and sleep apnoea which was diagnosed about 10 years ago and the patient sees a lung doctor for this yearly and uses CPAP machine (both are unknown whether ongoing or not) and the patient has never smoked or done drugs. The patient did not administer any vaccinations within four weeks prior or on same date of the Pfizer Suspect. There was no family medical history relevant to adverse events. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, expiration date 30Jun2021) on 10Mar2021, administered on right arm muscle as dose 1 single, (age at vaccination: 50 years), for covid-19 immunization and had no adverse effect. Patient's wife said that nothing like this has happened in the past. The patient was sitting at the kitchen table at about 5:30 pm and it was about an hour since they ate. The patient all of the sudden didn't feel right, couldn't breathe, was having chest pains, and was white as a ghost, started sweating profusely. The reporter and the patient got in the car and went to the hospital and they did a cardiac work up on him, they gave him nitro paste on his chest and was hospitalized or admitted because of the events. All the symptoms started at the same time. On 26Jun2021, they did an electrocardiogram/EKG which was fine (normal) but the patient's troponin was elevated. They transferred the patient to another hospital. The patient had a stress test on 27Jun2021, which was normal (They took pictures of the patient's heart during the stress test). Reportedly, the patient's blood pressure had never been high but it was high when he got to the hospital. The patient is not back to normal but was not complaining of anything. They put the patient on a heparin drip at the hospital for the troponin levels. The doctors are leaning more toward myocardiopathy and think it was related to the vaccine. The hospitalization duration was of 2 days, i.e., from 26Jun2021 to 27Jun2021. The patient was going to see a cardiologist on Tuesday. The outcome of the events: The doctors are leaning more toward myocardiopathy, blood pressure has never been high but it was high when he got to the hospital and troponin was elevated reported as unknown and the outcome was assessed as resolving for rest of the events. Information on Lot/Batch number was available. Additional information has been requested.

Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration, administered in left arm on 17Mar2021 at 15:45 (at 50 years old) as Single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There were no medical history and concomitant medications. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath which continued from 19Mar2021 to 30Mar2021. Start date of the events was reported as on 17Mar2021 at 18:00. No treatment received for the events. Outcome of the events was not recovered. Information about Lot/Batch number was requested.

Immediately after receiving the injection, I felt pain/sore that traveled from the injection site, went through and across my left pectoral and ended at center of my chest/heart area. I waited 15 minutes in the observation area to see if symptoms would get worse, but they did not; and so I left the facility and drove home. On my way home, about 45 minutes after receiving the shot, I felt my throat tightening up a bit, and my left hand and eyelids began to cramp up. I stopped at a pharmacy and bought some Benadryl. After 30 minutes, the pain in my chest began to feel better, and the cramping had disappeared. At about 6 pm that same day, my chest pain returned; and so I took one more Benadryl. The pain/soreness began to disappear after about 30 minutes. I felt fine for exactly two weeks. On Thursday, April 1st, I woke up with severe abdominal pain, diarrhea, and constant vomiting for about 12 hours. Went to urgent care and received an anti-nausea shot. The vomiting stopped, but the abdominal pain continued until the next morning. The weekend of April 10th, I experienced the chest pain again. This time it was very concerning because I felt very lightheaded, short of breath and faint. I checked myself into ER two days after.

Dizziness, shortness of breath, swollen hands and fingers, shaky blurred vision. all occurred 2 hours after giving the shot. Patient was given benadryl and felt better in about 1 hour, he went home and the next day came back to work normal

11 minutes after vaccine administration I began experiencing prickling sensation of mouth lips followed by prickling sensation of my tongue, increased heart rate and for a few seconds felt my throat tightening. Symptoms lasted a few minutes. By the time I was evaluated at the emergency department a few minutes later I was feeling much better. I did not need to take any medications. 7 hours later I began experiencing itching all over my body however, I never developed a rash. My heart rate slightly increased. Simply did not feel well. Symptoms lasted a few minutes and again resolved without having to take any medications.

Very hot, flush, stomach upset, sweating, increased respiratory rate, slouched in chair, chills over face/neck

Dose 1 -Muscle twitched on injection into R deltoid. Immediately after injection experienced warm and cold sensations through right arm, intermittent pains along arm. Was asked to be observed 30 mins post injection. Sent home. Paresthesias (intermittent warm, cold, tingling sensations) continued with radiation into right axillary, and into neck. Experienced intermittent facial tingling. On day 3 post injection, started with burning eye discomfort in right eye. Went to eye doctor to rule out eye infection. No eye infection, Instructed to use Refresh drops. In 4 days subsided. Day 7 experienced ear flushing and warmth that last 3 days and subsided. Saw a neurologist to rule out nerve damage. EMG was normal. ANA titer was 1:40 with speckled and cytoplasma pattern. My last ANA was negative when tested for inflammation due to back pain few years prior. Neurologist did not think this was an allergic reaction and since symptoms were gradually improving recommended second dose. Symptoms fully resolved after 2 weeks Dose 2 - Jan 19 , 2021 (21 days post) - Decided to inject left deltoid to avoid trauma to right arm. Was observed 30 mins and released. No symptoms. Moderate arm soreness x 4 days. Day 3 post injection developed burning eye discomfort, intermittent tingling sensation in arm, warm/cold sensations. Pain radiating to shoulder and neck. Day 6 started very mild tingling and warm sensations in in cheek and chin area. Also experienced intermittent prickly sensations in throat and sensation of throat tightness predominantly on left side. (but no actual swelling). Today (Jan 26, 2021) is Day 7 and these intermittent sensations are persisting. Arm soreness has resolved. Right eye burning discomfort improving.

Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left facility with a 7 of 10 headache. Then I had a weird taste in my mouth (metallic like). My tongue started to tingle and was a bit numb. Eventually after Doctor at facility took me in, I was given benedryl 50 mg and an antacid. After a few minutes the right side of my mouth became itchy but the tingling stopped. The itch was not unbearable but it was getting there. I was already having a slight difficulty breathing but that was from the morning even with inhalers. As an instrument player a doctor said I have super lungs so my results would be skewed due to how much air I take in. But any loss of air, although in the safe range for others, is like breathing through a straw for me. My blood pressure was 139/90 at the time. My normal blood pressure is 117/70. I went home feeling cold and just not feeling well, relatable to flu symptoms. This is the next day after taking benedryl every 6 hours at 50mg/dose. My breathing is slightly labored. I feel ok but my arm hurts, I have been moving it around a lot just to get it mobile. My chest feels like there is a slight weight on it which is weird for me. At the moment my pulse is 81bpm and my oxygen is at around 96. My norm is around 70bpm and oxygen at 99. No temperature is consistent at 97.3. I feel a little weird today. I am stiff all over as well. Little aches here and there but that is a norm. Doing my stretches and exercise is not a go today. Can't breathe as normal.

Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.

The night after receiving the second dose of the Pfizer Covid , the patient developed severe headache, who body myalgias, severe fatigue, and fevers. The next day he also developed pleuritic chest pain and shortness of breath. He described the chest pain as like a heart burning sensation, worse lying down and better sitting up. He documented a fever to 100.8 deg F. By the thord day the fever had resolved but the chest pain persisted, leading him to present to the emergency department. On exam he had BP 113/84, HR 95, RR 18, O2Sat 95% on RA, Temp 97.5 F. His lungs were clear to auscultation. Heart was RRR, S1, S2 WNL without MGR. ABD was soft, without tenderness, masses or HSM.

Pt c/o difficulty breathing, esophageal spasms, severe coughing for hours during the night; resolved by 1400 on 3/15/21. 98% sat on ra; increased RHR of 86 bpm (normal is 48-52bpm) -

Progress Notes 3/24/2021 Date: 3/24/2021 Subjective Patient is a 51 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience "funny feeling in his face" and difficulties breathing. He denied rash, difficulty swallowing, wheezing, throat tightness, dizziness and facial swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches Previous Reactions: Denies. Objective Vitals Vitals: 03/24/21 0825 BP: (!) 132/90 Pulse: 89 SpO2: 100% Physical Exam Vitals reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Systemic reaction (hypoglycemia, hypotension, generalized rash) 3/24/2021 9:12 AM

shortness of breath; high blood pressure; This is a spontaneous report from a contactable consumer (patient's friend). A 51-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 17Mar2021 (at the age of 51-years old) as SINGLE DOSE for COVID-19 immunisation. Medical history included cardiac event and stent placement in Jan2021. The patient's concomitant medications were not reported. On 18Mar2021 at 10:30am, patient was admitted to the ER (Emergency Room) due to shortness of breath and high blood pressure. He had cardiac event and a stent placed in Jan2021. Patient was admitted due to not knowing if the issues were due to the COVID shot or the recent heart issues. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room or urgent care and hospitalization on 18Mar2021. The patient was not tested for COVID prior to vaccination. Patient was tested for COVID (Nasal swab) post-vaccination on 18Mar2021, results pending. The outcome for both events was unknown. Information about Batch/Lot number has been requested.

The patient is a 51 yo old reservist with a history of hypercholesterolemia with an onset of illness 10 days after Pfizer vaccine (lot #2 ELI283) on 6 JAN 2021, where he was on 87 day active duty orders with Medical Task Force - COVID mission. He denies any AE after dose #1 (Dec 17 lot #ELD140). He denies any immediate symptoms suggesting IgE event(pruritis, urticaria, SOB, wheezing, oral, facial throat, tongue swelling etc.) and denies any local site reaction. He reports about 10 days later he experienced severe nausea vomiting and diarrhea, CP and SOB. He was seen in ER 3 times where he was found to have Acute Kidney injury, and treated with IVF, odansetron meclizine dicyclimine. After the third ER visit he was admitted where he subsequently developed GI pain. He has continued to have significant health issues, but no unifying diagnosis has been identified. He would like to know if this was related to his Covid vaccine receipt. He reports no one else in his group will ill and they were otherwise isolated for travel related Covid quarantine. Per review of records he presented to ER 17 JAN 2021 (day 11) with complaints of nausea global weakness, watery diarrhea, and shortness of breath . He had a acute kidney injury with cr 1.4. A non contrast ABD CT was normal. He was diagnosed with viral gastroenteritis, treated with hydration, Zofran and Bentyl. He returned to ER 19 JAN (day 13) with a complaint of same with severe dizziness. A noncontrast head CT was normal He had a positive Dix-Hallpike and he was diagnosed with benign positional vertigo. On 1/20/21 (day 23) he continued symptoms with tachypnea on minimal exertion noted in ER. CXR demonstrated lateral RLL opacity and he was treated with Rocephin and azithromycin. He developed vague abdominal pain and was transferred to MTF. 26 JAN 21 GASTROENTEROLOGY: EGD - 'marked chronic active gastritis' - blood, stool sample and gastric biopsies are negative for H pylori infection - Protonix 40mg BID CT of kidney showed cyst on the left and nonobstructive 3mm stone and creatinine on is 0.9 (0.7-1.2).

C/O dizzy, blurred vision, SOB, Right arm severe pain and tremors with Rt sided neck pain/spasms. Brought to Medical Tent by W/C. Verbalized had a Rt sides stroke 10 years ago, hx of pain/spasms in Rt arm if irritated. Had not eaten or drank fluids. Given OJ and Gatorade. Ice applied to neck & upper arm. No redness, rash/hives at injection site. Vitals stable. Home with wife after observation of 30 minutes. Advised to f/u with primary care physician if further adverse reactions. Advised not to have vaccinations in Rt arm.

Pain in left arm . Tension in arms and shoulders. Shortness of breath. On 3/19/2021 I was diagnosed with pulmonary embolisms in both lungs and right leg

Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BPM; Shortness of breath; This is a spontaneous report from a contactable other health care professional. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 02Mar2021 16:00 (at the age of 51-years-old) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took tylenol and experienced allergies. The patient did not receive other vaccines in four weeks, and other medications in two weeks. On 12Mar2021 16:00, the patient experienced Elevated heart rate resting rate of 100. My normal is 74 BPM. Shortness of breath. Extreme night sweats. Unusual impotence. All started 10 day after injection. The outcome of the events was not recovered.; Sender's Comments: The company does not attribute the unusual impotence (PT: Erectile dysfunction) to BNT162b2, considering the event being an intercurrent disorder. 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.

About 2 and a half hours after the vaccination, I started to have pain in the body, I was shaking, headache, tired, chills. During the course of about 4-5 hours after the vaccination, I had other symptoms such as an urge to urinate, accompanied by pain and burning. Pain in the ribs, back, left arm, diarrhea, felt like inflamed lungs and shortness of breath. Today and 3 days later I still have diarrhea, headache, fatigue and pain when urinating.

It started feeling current in the posterior part of the body, then it started pain in the whole body that continued to increase and burning sensation in the skin, chills, felt like was burning, marked respiratory difficulty, sensation of asphyxia, pain in the ribs, urinary retention, hematuria, liquid diarrheas, trembles, pain in the ribs and pain in the left arm (contrary to the one injected). Took Tylenol 500 mg 2 tabs q 4 hrs

Patient reported red bumps "breaking out" over both his lower arms. He states that he is experiencing itching along these areas. He also stated he was having slightly worse breathing due to his COPD. Pt states he is also allergic to benadryl. I advised the patient to reach out to his PCP if his condition worsens.

Pt received dose of vaccine on Sunday. Had business trip on Thursday. After flight became short of breath and had discomfort in the chest. Worsening on trip back

Chest pain Acute kidney failure, unspecified DOE (dyspnea on exertion) Hypoxia Bilateral pleural effusion Chronic obstructive pulmonary disease, unspecified COPD type Chronic kidney disease, unspecified CKD stage Acute on chronic heart failure with preserved ejection fraction

Blood Clot/The Blood clot was in the legs and went to his lungs; Blood Clot/The Blood clot was in the legs and went to his lungs; fell; Leg pain; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thrombosis from 2020 to an unknown date, it was Months ago in 2020, He was prescribed a medicine for blood clots, but since then he has had no issues, anxiety from an unknown date and unknown if ongoing. Her brother in law had anxiety about even getting the vaccine. The patient experienced leg pain on Mar2021 , pulmonary thrombosis, leg thrombosis and fall on an unspecified date. The patient died on 02Apr2021. An autopsy was not performed. The clinical course was the following: The Blood clot was in the legs and went to his lungs, his leg never got red or anything and it was a blood clot. He was having such bad leg pain, it's too bad, had there been some sort of warning, he would have thought to wait till next year. There was nothing the day he got vaccine, but that night his leg started hurting, his girlfriend said let me go get a cold wrap and she wrapped it, he's a farmer. He wakes up the next day and his leg is still hurting, the 3rd day it goes on, his leg still hurting and no one is thinking it a blood clot, he calls the doctor and tells the doctor his leg is hurting, they suggest ibuprofen for inflammation, the next day thought maybe it's better, by Friday he was making breakfast, fell and died. With his girlfriend she said what's going on, and he went straight to hospital, they said the clot in his leg went to the lung. The Blood clot when it was in the leg it never got hot, red, or anything like that. He had the vaccine in the morning and on that same day the leg pain started later that night. It Started out with Leg Pain, she does not know if it was right or left but it was just one leg.; Reported Cause(s) of Death: Thrombosis pulmonary; Thrombosis leg; Fall; Leg pain

Week after vaccine developed shortness of breath and pain breathing. Trip to ER and admitted to hospital. Diagnosed with Pulmonary Embolism. Blood clots both lungs.

patient having reaction to pfizer shot given on april 11th. patient states symptoms from numbness to extremities, shortness of breath, sores on lip, headache, yellow eyes, weakness. on 4/25 Overnight he felt very "hot", like he was breaking a fever, but was not febrile per vital signs. He sweated and then noticed bubbling of his skin on both hands and feet and then those bubbles popped and his skin is peeling now.

Pt. reports shortness of breath and aching 2 hours after receiving vaccine. 25mg Benadryl given Pt. states he went to Urgent care 4-27-21 4-28-21 Pt. reports aching, feeling better overall. Has no follow up appointments at this time

BRIEF OVERVIEW: Bilateral PE Discharge Provider: MD Primary Care Provider at Discharge: NP Admission Date: 4/26/2021 Discharge Date: 4/26/2021 Active Hospital Problems (Diagnosis Date Noted) ? Pulmonary embolism without acute cor pulmonale, unspecified chronicity, unspecified pulmonary embolism type (HCC) 04/26/2021 Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: Patient is a 51 y.o. male with a past medical history of psoriasis, environmental allergies who presents today with sudden shortness of breath, left side pleuritic chest pain 7/10, worsened with deep inspiration. No recent travel, no family history, no history of malignancies, no immobilization or surgeries. He had his 2nd dose of Pfizer COVID vaccine on April 1. He does not have a history of COVID-19 infection, and COVID-19 PCR test was negative in ER. His blood pressure is a little high at 170 6/83 mm, pulse 76 per minute saturating 96% on room air, troponin less than 6, BNP 16, WBC 12.3,, EKG without any significant ST T-wave changes. CT angiogram of the chest shows nonocclusive thrombi in almost all the lobes, there is no saddle embolus noted. There is no evidence of right heart strain. Echo: The technical quality of the exam was limited due to suboptimal acoustic windows. The left ventricle is normal in size. There is normal left ventricular wall thickness. The left ventricular ejection fraction is 60%. Regional wall motion abnormalities cannot be excluded due to limited visualization. The right ventricular size, thickness, and function are normal. No significant valvular pathology identified with Doppler examination. There was insufficient tricuspid regurgitation envelope detected to calculate right ventricular systolic pressure. Injection of contrast documented no interatrial shunt. There is no comparison study available. He was started on Heparin gtt. And admitted for observation. He required no supplemental oxygen. He was discharged later pm on Eliquis 10 mg bid for 7 days, than 5 mg bid for 3 months. I am questioning did he had COVID-19 vaccine related bilateral PE. His hypercoagulable profile is pending. He has no sign of malignancy, no new symptoms, no weight loss. He had normal colonoscopy 2 yrs ago. He should follow up with his PCP. He was given work excuse from 4/26-5/3/21. She shouldn't take non steroidal anti-inflammatory (Ibuprofen (Motrin), Naproxen, Naprosyn, Voltaren, Relafen ... meds because of blood thinner Eliquis. He can take Tylenol 500 mg 1-2 tabs 3-4x a day as needed. He was also prescribed Lidoderm patch. For HTN he was started on DASH diet and Norvasc 5 mg daily. He should follow up with PCP next week. Also he was instructed to quit smoking.

Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; Peeling & itching hands, feet; faceSweats; lung pain with deep breaths; abdominal pain; lower back pain; disoriented; This is a spontaneous report from a Contactable Consumer. A 51-Year-old male patient received BNT162B2 (Pfizer Covid-19, Formulation: Solution for injection, Batch/Lot no: EW0153) first dose via unspecified route of administration, administered in left arm on 11Apr2021, as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient not had COVID prior vaccination. Patient not tested for COVID post vaccination. On unspecified date Bilirubin level of 12 (jaundice) Peeling & itching hands, feet, & face Sweats, lung pain with deep breaths, abdominal pain, lower back pain, disoriented. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) hospitalized up to six days. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat anything; Wheezing; migraine; Light, hacking cough; Fever/ 103.9 degrees; Chills; No more than 2-3 hours of sleep per night for 5 nights; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered on left arm on 14Apr2021 10:45 (Batch/Lot number was not reported) at age of 51 years as single dose. The patient medical history and concomitant medications was reported as none. Historical v for covid-19 immunisation accine included the first dose of BNT162B2 administered on left arm on 24Mar2021 at age of 51 years for covid-19 immunisation and experienced no issues. Patient reported that after the second dose of the Covid-19 vaccine, he had a fever for 8 days and was diagnosed with pneumonia on 21Apr2021. Patient reported that he was tested for both Covid-19, Influenza A, and Influenza B twice on 19Apr2021 and 21Apr2021 and tested negative for Covid-19 and influenza both times. Patient reported that he had no pre-conditions and that he was feeling great the night before he received the second dose of the Covid-19 vaccine, 13Apr2021. Patient reported that he was planning to go to work following the second dose of the Covid-19 vaccine on 14Apr2021. He began running a low-grade fever (102 degrees) on 14Apr2021 after receiving the Covid-19 vaccine and then his temperature flared up to 103.5 degrees on 15Apr2021. Fever: He received the second dose of the Covid-19 vaccine at 10:45 on 14Apr2021 and about 2:00 in afternoon on 14Apr2021 was the first fever that was significant. The last fever he had on 21Apr2021, his temperature was 103.9. He was put on antibiotics for pneumonia. He contacted the on-call nurse for his company. The on-call nurse advised him to see a doctor on Saturday, 17Apr2021.He went to the doctor on Monday, 19Apr2021. The doctor only ran a Covid-19 swab for testing and a flu swab. His doctor did not do blood work and stated that the patientwas experiencing an ill effect of the Covid-19 vaccine and sent the patient home. He went back to the doctor on Wednesday, 21Apr2021. When he went back to the doctor, the staff performed a chest X-ray and ran 4 different blood works to see what the patient had. The second Covid-19 test that he received on 22Apr2021 was performed with both the rapid test and the test that was sent off. Both Covid-19 tests came back negative. SARS test on 22Apr2021 was negative. 508-3 High Sensitivity CRP: One of his numbers that was parts per liter, 3 is considered to be high risk and he had 300 (300+) of whatever it was on 21Apr2021. He went back to the physician and was given another steroid shot an additional prescription. He had been back to the doctor 3 times since then. Fever: His fever was 103 consistently after 15Apr2021. 508-3 High sensitivity CRP: This value showed abnormal. The results said that relative risk was greater than 1 mg/liter and high was greater than 3. 1000 CBC with auto differential on 21Apr2021: The abnormal results were red blood cells measured at 4.38; hematocrit measured at 13.82; MCHC measured at 36.4; Neutrophils measured at 84; Lymphocytes measured at 12; and absolute Lymphocytes measured at 0.57. He wore a Garmin and that it recorded that he received no more than 2-3 hours of sleep per night for 5 nights. He didn't know anything about pneumonia previously and that he had specifically told his physician's office everything about what he was experiencing. He told his physician about the wheezing in his chest (on 17Apr2021), cough (on 16Apr2021), fever, and chills (on 14Apr2021). His physician told him it was a normal reaction to the Covid-19 vaccine and sent him home on 19Apr2021. He then consulted Google and started to realize that his side effect were very atypical. Wheezing: When he breathed really light, the crackling would continue. If he breathed shallow, the wheezing was audible but if he breathed deeply, it was not. The pneumonia was in the left side of his chest. He was still being treated for the pneumonia. He has his last dose of medication tomorrow, 27Apr2021, and that he was also being released to go back to work tomorrow. Cough: He had a little cough that would then go away. The cough began late Friday, 16Apr2021. It was interesting because it wasn't a main part of the illness. The cough was just kind of a hacking cough every once in awhile. The cough was not continuous like go and go and go and stop. The cough came, went away for awhile, then came again.The cough being worse was relative. He was coughing more than he did on Wednesday 21Apr2021, Thursday 22Apr2021, and Friday 23Apr2021. The cough was consistent more so at night when he laid down. He would probably say that it was a different feel towards the cough but it was still a cough. The cough was still the same volume but not the same effect. Headache (on 18Apr2021): He had been waking up with headaches in the morning and going to bed with them at night. On Wednesday, 21Apr2021, the headache was due to dehydration from the fever and night sweats. Once he got away from the dehydration headaches, the headache got better but he had woken up with a headache the last few days and had a headache at bedtime a few nights in a row. The headache was usually a frontal headache and this morning, 26Apr2021, the headache was toward the back of his head. The headaches last a few hours until he started moving around. On Saturday, 17Apr2021 he experienced a migraine that would not go away. He didn't usually get migraines. The migraine lasted hours if not for a day and that the headache was something furious. Sunday 18Apr2021 was pretty much the same thing with the headache. Because of the massive fever, he couldn't eat anything at all (17Apr2021). The headache was mostly due to low blood sugar and dehydration. Appetite: His appetite improved after his second doctor's appointment on 21Apr2021. The second provider was a lot more straightforward and advised the patient that he needed to start taking care of himself and trying to force himself to eat. He forced himself to eat on 21Apr2021 and by Thursday 22Apr2021, he had a full appetite and was craving food again. Shortness of breath (Apr2021): Patient reported that the shortness of breath was just from being fatigued. Patient reported that he got out of breath from going up and down the stairs. He was unsure when the shortness of breath began because he was moving very little, but that he noticed the shortness of breath on Monday, 19Apr2021 when he got up to go to the doctor.On Friday 16Apr2021 and Saturday 17Apr2021, he had a really good break.On Friday 16Apr2021 from 9 AM to 1 PM, he had no fever and it was like the sun was coming out, then the fever hit really hard. The same thing happened on Saturday, 17Apr2021, but the fever free period lasted maybe a little longer. His fever returned and that the afternoon of Saturday 17Apr2021 was the worst he had been the entire time. On 13Apr2021 to get away from arm soreness, he did a few laps in the pool. On 13Apr2021 he had a new best time on the 100 in freestyle in the pool and that he felt really strong going into 14Apr2021 to get his second dose of the Covid-19 vaccine. There was nothing that would have indicated that he had anything going on before getting the second dose of the Covid-19 vaccine. Up until Saturday, 17Apr2021, he had only been taking Motrin and just taking 2 tablets. He had no break in between fevers and chills and was not able to get ahead of the fever with the Motrin. There was a long stretch where the Motrin wasn't working and his temperature didn't get below 100 for several days. He tried to cycle acetaminophen in beginning Saturday 17Apr2021 to try to get the acetaminophen in between the Motrin doses. When he went back to the doctor on 21Apr2021, the provider told him that he could take 3 to 4 Motrin tablets at a time but not to exceed 4 doses per day. He never took more than 3 tablets. Motrin was generic ibuprofen. Night sweats (on 21Apr2021): The last couple of nights have been the same. He had a fan on to keep a little cooler and that it was 61 degrees outside and he felt the night sweats. He had a buckwheat mat that was cool that he put on the floor to stay cooler with the night sweats. Come Thursday, 22Apr2021, he said we're done with this and he couldn't sleep from it (Apr2021). Last night, 25Apr2021, he knew that he had night sweats because he was sweating at night and the temperature in the room was 64 degrees. AEs did not require a visit to Emergency Room. AEs required a visit to Physician Office for fever, wheezing, cough, shortness of breath, chills. Outcome of events was unknown.

ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Principal problem Discharge Summary (Physician Assistant) ? ? Internal Medicine Cosigned by: MD at 2/27/2021 4:06 PM Discharge Summary Hospitalist Medicine Admission Date: 2/23/2021 Length of Stay: 0 Days Discharge Date: 2/25/2021 Admission Diagnosis Hospital Problems POA * (Principal) Costochondritis Yes COVID-19 Yes Problem List Resolved POA Resolved Problems Atypical chest pain 2/25/2021 Yes SIRS (systemic inflammatory response syndrome) (CMS/HCC) 2/25/2021 Yes Hyponatremia 2/25/2021 Yes Dehydration 2/25/2021 Yes Home Or Self Care CODE STATUS: Full Code Active Issues Requiring Follow-up Test Results Pending at Discharge Pending Labs Order Current Status Blood culture x 2 SETS Preliminary result Blood culture x 2 SETS Preliminary result Hospital Course Hospital Course: Please refer to the admitting providers H&P for full history. Patient is a 51-year-old male with a PMHx significant for hemochromatosis, sarcoidosis and morbid obesity who initially presented to the ED for evaluation of chest pain, cough and shortness of breath. On presentation, vitals were mostly unremarkable other than some mild tachycardia and tachypnea. Patient was able to maintain adequate oxygenation on room air but was placed on supplemental oxygen for comfort. Blood work was mostly unremarkable. ABG was not particularly concerning. Troponin was negative x3. Patient underwent chest CTA which showed basilar atelectasis bilaterally and scattered groundglass opacities and scattered borderline size hilar and mediastinal lymph nodes consistent with patient's known sarcoidosis. Patient was treated with supportive care and monitored overnight. He was able to maintain sufficient oxygen levels. On the time my evaluation, patient continues to complain of bilateral rib pain worse with deep breaths consistent with costochondritis. I discussed with the patient that he will need to continue to take NSAIDs on a scheduled basis to help with his discomfort. Additionally I offered to prescribe cough medicine. I discussed possibly discharging the patient on steroids however he states that he makes a point to avoid taking steroids due to his history of hemochromatosis. At this point, patient no longer requires care in the hospital and can be discharged home. Patient is agreeable with the plan and all questions have been answered appropriately.

Having adult onset severe asthma I am prone to lung inflammation from a number of sources including some foods and allergens as well as viruses and smoke of any kind. I had been doing fine that week until the day after the second shot. I had severe shortness of breath, bad enough to keep me home and using my rescue inhaler several times that next day. This also occured when I had Covid in November 2020. It took me longer to test negative, 3 weeks. I believe that the shot caused an immune reaction, like it should, but also triggered an asthma attack that lasted several days but progressively reduced as time went on. Last week I had dizziness and heart palpitations. I have no idea if it was the shot still or the meds for my asthma, but I thought I should include it.

pain in left arm (side of injection) but also pain in left neck, left ear, sore throat, pain and throat congestion continues 3 days later

On 5/20/21 the patient was at home with his mother when he had acute nausea, light-headedness, and abdominal pain. He presented to the ED by ambulance. Excerpt from ED notes od MD follows: "Initial ED interventions: iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by her presence, but she is unable to direct him, and describes his behavior as irregular, and events acute this evening at her home. Patient rests, and then HR decrease to 50s on monitior and patient found to be pulseless - I immediately start chest compressions, and achieve ROSC after PEA arrest with administration of EPI/compressions. Patient intubated per procedure note without complication. L femoral central attained per procedure note without complication. CPR performed over ED course intermittently (always PEA arrest) with ROSC achieved with administration of EPI, EPI drip started in addition to sedation meds, and iv fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees with admininstration of alteplase. I disucss risks with mother who consents verbally. Patient without response to alteplase, and with continued pattern of PEA arrest following bradycardia. I discuss etiology of presentation with mother,and that patient is with very poor prognosis of survival, and likely poorer prognosis of neurological status, and patient is made comfort care, and fentanyl drip increased, patient is taken off of ventilation and drips. Pronounced deceased at 22:00. MDM: Initial concern for but not limited to appendicitis, AAA, diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis, toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis, intra-abdominal infection), AAA, dissection, PE - as ED course progresses, differential narrows and consider more likely PEA arrest secondary to ACS, PE, dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place, no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC, and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE, with subsequent cardiac arrest, despite heoric efforts including thrombolysis. Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition: deceased."

Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; soreness in arm and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration: not reported), via an unspecified route of administration, administered in arm right on 06Mar2021 10:45 as single dose for covid-19 immunisation (at the age of 51-year-old). The patient's medical history was none. Concomitant medication(s) included nortriptyline (as other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks, no covid tested post vaccination, no covid prior vaccination and no known allergies. Previously, the patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration, administered in arm right on 13Feb2021 10:45 as single dose for Covid-19 immunisation (at the age of 51-year-old). On 06Mar2021 11:30, the patient experienced slight dizziness, a slight breathing difference and heart palpitations, and soreness in arm and shoulders, with tiredness. Not major issues but the patient thought should report them. No treatment taken. The outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

All over body rashes; Shortness of breath; Dizzy; Foggy head; Nausea; Tired/ Fatigue; horrible excruciating migratory arthritic pain; Have variety of symptoms very painful; Areas of my body have been in serious pain; I couldn't walk for days and it affected my right foot and right hip; Really been destroying my health; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 51-years, and administered in left arm on 02Apr2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was completely heathy before this vaccine. There were no concomitant medications. Historical Vaccine included the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient stated that she was having really horrible excruciating migratory arthritic pain and all over body rashes on 07Apr2021 since she took the Pfizer vaccine. it was reported that she had went emergency twice and she had been to the doctors going back to the doctors again and she was going to ask him can she see rheumatologist, they're taking blood test and urine test and she had variety of symptoms very painful. Areas of her body have been in serious pain like it felt like a migratory arthritis kind of pain that just moved area to area every three to four days and twice it got her unable to walk. The patient couldn't walk for days and it affected her right foot and right hip and she was unable to walk since in two instances she was left unable to walk for a few days and it was very painful but she also had like all over body rash, shortness of breath from time to time, dizzy, foggy head, nausea, tired, fatigue. The patient was completely heathy before this vaccine. It had really been destroying her health basically. The patient had been taking pain pills and Benadryl(Treatment) because of the rash and stuff, pain pills for pain but it had not really helping a lot it was just she had been taking like generic Tylenol(Further not clarified). And patient stated above symptoms still happening. The patient underwent lab tests and procedures which included blood test and urine test: normal on Apr2021 (They couldn't find anything wrong with patient). No follow-up attempts needed. No further information expected.

patient complained of dizziness, patient became lethargic, diaphoretic, patient complained of nausea vomit, chest pain, shortness of breath. PATIENT TAKEN TO HOSPITAL .

Onset 1-2 days after second vaccine (on 4/27/2021), has felt ill, has difficulty breathing, cough - deep and strangling, N/V, no fever, but is sweating, out-of-breath with little exertion. No history of heart or lung problems. Has not seen a doctor. Referred to the ER today (6/18/2021).

Symptoms: rapid, pounding heartbeat when lying down; occasional cough at night; shortness of breath when trying to sleep.

Sharp chest pains, shortness of breath.; Sharp chest pains, shortness of breath.; This is a spontaneous report from a contactable consumer (patient reported on himself). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN0199, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00, as 1st dose, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: RE8734, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00 (at the age of 51-years-old), as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the hospital. Medical history included abdominal discomfort from an unknown date. Concomitant medication(s) included omeprazole (PROTONIX [OMEPRAZOLE]), pseudoephedrine hydrochloride (SUDAFED 12 HOUR), glucosamine (GLUCOSAMINE), l-arginine (arginine), ascorbic acid (VITAMIN C ACID) and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took PCN (penicillin nos). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Mar2021, the patient experienced sharp chest pains and shortness of breath. The patient did not receive any treatment. The clinical outcome for the events was not recovered.

June 15 - Right side lower rear rib cage pain. June 17 - Lightheaded. June 20 - shortness of breath and weakness. Symptoms progressively get worse and increase in intensity. June 26 - go to Emergency Room. CT scan with contrast revealed a blood clot in each lung of moderate size and several small clots. Diagnosis was pulmonary embolism. Put on Heparin and admitted to hospital. Administered Heparin for 2 and 1/2 days. Upon discharge (June 29) was prescribed Eliquis.

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additional Details: Fully recovered

"funny feeling in his face"; difficulties breathing; This is a spontaneous report received from a non-contactable other healthcare professional. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration on 24Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had experienced funny feeling in his face and difficulties in breathing during his 15 minutes waiting period after vaccination on 24Mar2021. The patient denied rash, difficulty swallowing, wheezing, throat tightness, dizziness and facial swelling. The patient received treatment with antihistamines and had taken water and snacks. The follow up response after treatment was good. The patient was stable to go home and follow up with primary care physician (PCP). The clinical outcome of the events funny feeling in his face and difficulties breathing was resolved on 24Mar2021. No follow-up attempts are needed. No further information is expected.

On 7/3/21 in early morning, case was hospitalized due to Covid symptoms including Shortness of Breath, Fever, Cough, Nausea, Vomiting, Diarrhea, Headache, Fatigue.

51yo Male, received 2nd COVID pfizer vaccination 6/17, since then has had chills, fatigue, DOE, headaches, body aches, dry cough, random easy bruising. Had been ruled out for ACS 6/18 in ED, CXR neg. Many of symptoms typical post-vaccination symptoms, but cough/DOE atypical. Patient also tested neg for COVID 6/22/21. Afebrile (fevers only lasted first 2 days after vaccination). 1 month later, symptoms are unchanged. I am repeating a D-dimer, CXR, CBC, INR. Patient has been unable to keep his job due to his ongoing symptoms. Patient has been very worried about symptoms, likely strong anxiety component contributing as well, but etiology of symptoms still unclear. consulted ID, recommended further labs. Repeat CXR 7/26 clear, repeat D-dimer neg.

Trouble swallowing, sensation of throat swelling approximately 45 min to 1 hour after receiving dose #2. Pt received one dose of Benadryl 25 orally. Symptoms improved completely.

Headache, diarrhea, fatigue, Pounding Heart, Muscle/joint pains, stomach cramps, sore/swollen throat, difficulty swallowing, trouble staying awake, gassy

trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ when trying to return to bed, passed out a second time; This is a spontaneous report from a non-contactable physician. A 52-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 07:30 at a single dose for COVID-19 immunization at the workplace clinic. The patient's medical history was not reported. Patient has no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR). Patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. On 15Jan2021 04:00, patient had severe body aches, followed very quickly by fevers and chills. At 4:45am started to have trouble breathing. Patient was concerned about respiratory symptoms, and woke his spouse, then stood up to try and breathe better, took a couple steps, and passed out. When the patient woke, when trying to return to bed, passed out a second time. Over the next few hours respiratory symptoms improved. Remainder of day characterized by extreme fatigue, body aches and headaches. Patient had an unspecified over the counter anti-inflammatory medication. The patient has a negative COVID 19 test via a nasal swab on an unknown date. Patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported passed out and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

At first I started to feel tired and achy. A couple days later a cough came and fatigue got worse. It was mostly body aches, chills, sore throat, stuffy nose/congestion and a cough. I got released to go back to work on Jan 26 and I worked all day and that night I woke up with serve shortness of breathe and a temp a 103. I went to the ER and had pneumonia. I tested positive on Jan.11 for Covid, I tested on Jan. 4 and it was negative. I still have not went back to work.

*Please note it is not known if event was related to vaccine* On 2/10/2021, at approximately 5:30 AM, patient began to experience dizziness and shortness of breath. Per witnesses, he then began to have seizure activity followed by cardiac arrest. He was treated with CPR and 1 shock from the AED, which resulted in spontaneous return of circulation. He was awake and confused after return of pulse and sent to Hospital Emergency Room. This event occurred 19 days post first vaccine. He was scheduled to get his second dose on 2/12/2021, but did not receive it due to event.

Patient is allergic to cats, had tightness in chest, unable to breathe. Took a benadryl- it went away, eyelids was swollen. Sx did improve- eyelids are still swollen. Received #2 COVID 1/19/21 at 8am. Had a dental appt that afternoon for extraction, given Lidocaine w/out Epi, took Ibuprofen after visit. Reports acute onset chest tightness, SOB, audible wheezing at 5pm (approx 9 hrs post vaccine), then felt anxious. Took Benadryl 25mg and started feeling better in 20 min with resolution of wheezing and chest tightness after 1 hour. Also reports left eye swelling the same evening that has gradually decreased, now only mild with itching. Had similar eye swelling, however bilateral, after first vaccine dose. No SOB or wheezing noted since eve of 1/19/21. Denies hx asthma. NKDA. Allergic to cats. Denies swelling of lips, tongue, throat or rash. Reports feeling well today. Denies Covid-like sxs.

Within 5 minutes of shot had rapid heart beat and trouble breathing. Removed face mask and heart rate and breathing returned to normal within 5 minutes

35 Minutes after receiving vaccine, itching on head, then body and face, including welt on chest, hives. 50 minutes later eye itchiness and swelling in left eye, throat felt weird (swelling), dizziness, change in voice, wheezing (not severe, but could tell breathing was more restricted than before shot). Almost went to ER, but symptoms subsided without any medication in 2 hours. Did not go to hospital or ER.

After the injection, local soreness but not noticeable unless moving my arm. Day 1 after the shot had no symptoms. Woke on Day 2 around 5am, with chills, nausea, dizziness, vomiting, shortness of breath, severe headache. Symptoms persisted until approximately 2pm the same day. Headache was persistent, as was dizziness, but nausea and chills were intermittent. 4 incidents of dry heave vomiting.

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Additional Details: Patient had shortness of breath, chest tightness and throat swelling (uncomfortable feeling described by patient). Paramedics took the patient with them. Patient came to the pharmacy 3 hrs later and informed us that he was doing okay and his breathing was better.

anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at me in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. went unconscious, - after recovery I had tremors for a few hours such that I could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired.

tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority. Information on the lot/batch number has been requested.

Patient received his second vaccination 2 days prior to presentation. States he woke yesterday feeling tired with associated chills, nausea, decreased appetite and hoarse voice. He was able to go to work as usual. He came home and ate some fish and clam chowder for dinner. Around 7pm that evening, his voice became muffled. Symptoms progressed to difficulty swallowing and sensation of throat swelling so he came to the emergency department for evaluation. On arrival to the ED, he was noted to have water bag edema of the uvula. O2 sats 98% on room air, no respiratory distress. He was treated with diphenhydramine, famotidine, and methylprednisolone and observed. No progression of symptoms noted.

Received a Janssen product 3 weeks earlier. His wife had received the Pfizer and she had a 2nd appt and he thought he needed one as well. Cough, generalized soreness, lethargy, shortness of breath, joint pain, watery diarrhea, night sweats.

Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Eyes swollen; some wheezing; tired; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; minor tightness in breathing; Sever chills; fever; extreme fatigue; headache; eye ache; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318), via an unspecified route of administration on arm right on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history included Chronic Kidney Disease Stage III, High Blood Pressure, Asthma from an unspecified date and allergies to Penicillin, Levoquin, Erythromycin, Clindamycin from an unspecified date. 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 Concomitant medications were not reported. Historical vaccines included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), via an unspecified route of administration on arm right on 06Jan2021 at single dose for COVID-19 immunization. On 28Jan2021, the patient experienced Sever chills, fever, extreme fatigue, headache, eye ache and got cleared on the same day. On 03Feb Lymph Node under left arm starts to itch/hurt. On 07Feb Eyes swollen (right almost swollen shut); left arm pit Lymph Node swollen/itchy, achy; some wheezing; and tired. Since then: i) swelling in eyes reduces and then swells again, ii) lymph node under left arm still itchy/achy/swollen, iii) at times minor tightness in breathing; and iv) tired.The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken, and treatment included prednisone and EpiPen. The outcome of the events was reported as Not recovered. Follow up (15Feb2021): This follow up report contains no new medically significant safety information. Follow up (17Feb2021): This follow up report contains no new medically significant safety information.

Ringing of ears intensified; Face was numb; Slurred speech; Slight swelling of tongue; Slight trouble breathing; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Er8735), via an unspecified route of administration, administered in left arm on 12Apr2021 as single dose for COVID-19 immunisation. Medical history included known allergies on certain beta blockers and macadamia nuts from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number= Er6204) on 22Mar2021 11:30 AM, on left arm, for COVID-19 immunisation, and experienced ringing in both ears. Upon receipt of the second shot, ringing of ears intensified and has continued to present. Additionally, approximately 25 minutes after the second shot on 12Apr2021, the patient's face was numb, had slurred speech and slight swelling of tongue, slight trouble breathing with wheezing. Face numbness subsided after 10 hours. The events resulted in disability or permanent damage. No treatment for the events was received. The patient has not recovered from the reported events.

The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have developed a cough left side chest pain at times twitching in left shoulder area headaches and now have a difficult time doing anything physical like simple walking feel out of breath.

Patient presented for first dose Pfizer COVID vaccine; vaccine administered at 1315. At approximately 1330, patient reported 7/10 chest pain associated with shortness of breath, stated symptoms unlike previous chest pain episodes. Patient transported from vaccine clinic to private room via wheelchair, EMS called at 1335. Upon EMS arrival at 1342, patient reported chest pain had decreased to 1/10, still reported shortness of breath. Patient transferred from wheelchair to EMS stretcher, transferred to ED via EMS.

Virtually no symptoms from first vaccine or in first 72 hours after 2nd injection. Approximately 74 hours after 2nd injection I noticed some slight nausea and body aches. Within a few hours I was severely tired, weak stomach, had short, shallow breathing, tight chest and body aches. This has gone on continuously until this morning, 5 days after vaccine.

Patient stated he didn't feel well 2 days after receiving the vaccine and he went to hospital next day. He was diagnosed for blood clot in lung, treated in the hospital and discharged home. Patient stated the doctor was not sure what has caused the blood clot in lung.

body aches, loss of taste and smell, tired, congested, shortness of breath, fatigue, cough, chills, fever, chest pain

New onset peripheral edema, found to have pericarditis and bilateral pleural effusions without apparent underlying cardiac pathology, infection, or malignancy. Inflammatory markers also elevated.

On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir of 85%, respiratory rate 22, development of hypotension with BP 85/55 bpm with weakness, drowsiness, chills, flushed skin, bilateral edema both lower extremities with wheezing and rhonchi throughout both lungs and was sent to a local medical hospital for treatment where he tested positive for COVID and was returned to the psychiatric hospital after a 3 day stay and 2 administrations of remdesivir on 11/09/20 and 11/10/20 improved. The client subsequently received the Pfizer COVID19 vaccinations on 12/29/20 and 01/19/21 from different lot numbers noted above. On 5/16/21 the client began to have respiratory symptoms including temp of 99.5, pulse 103 O2 Sat of 85% with rhonchi responsive to albuterol inhalation and subsequently albuterol nebulizer treatment; however the following day symptoms progressed with weakness, wheezing, cough, shortness of breath, pallor and O2 saturation 77% unresponsive to albuterol nebulizer treatment. He was was transferred to a local medical hospital for treatment of severe respiratory symptoms and tested positive for COVID a second time and after the complete Pfizer COVID19 vaccination series approximately 4 months prior. He is still hospitalized at the medical hospital at the time of this report (2 days).

Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason for Visit ED Discharged 4/30/2021 (2 hours) Treatment team. Providers COVID-19 Clinical impression, Fever, Generalized Body, Aches, Chills. Chief Complaint Patient presents with Fever, Generalized Body Aches, Chills. HPI: 52-year-old male with history of diabetes, hypertension, obesity presents the emergency department with gradual onset of moderately severe generalized nasal congestion with associated cough unproductive of sputum and fever, T-max 103.8 at home the patient states began approximately 1 week prior to arrival. The fever worsened today and he decided to be seen at that time. He states he had his first dose of Pfizer COVID-19 vaccine 3 weeks ago. Denies sick contacts, chest pain, shortness of breath, syncope, dizziness, lightheadedness, numbness, focal weakness, abdominal pain, nausea, vomiting or diarrhea, changes in bowel or bladder habits or other complaint. No other signs or symptoms and no treatment prior to arrival. ED Discharged 5/1/2021 - 5/2/2021 (5 hours). Last attending Treatment team COVID-19 +1 more. Clinical impression, Chest Discomfort, Chief complaint. ED Provider Notes. Expand AllCollapse All. HPI. Chief Complaint Patient presents with. Chest Discomfort. Patient History. 52-year-old male with history of asthma, diabetes, heart murmur, hypertension, obesity, sleep apnea and was seen in the emergency department yesterday complaining of generalized nasal congestion, fever and cough and was discharge with a diagnoses of COVID-19 4/30/2021 presents to the emergency department with complaint of chest tightness. The patient states that tonight he developed chest pain which woke him from sleep. He describes the pain as burning. He states the pain is similar to the pain he had when he had a gallbladder attack. He also states the pain is well localized and does not radiate. Initially the pain was 10/10 initially and is currently a 4/10. He took his temperature and states he had a fever of 101.6 and took 1,000 mg of tylenol just prior to arrival. His O2 saturation today has not gone under 90%. Medical History. Past Medical History: Diagnosis Date Asthma 5/29/2017, Diabetes mellitus, Heart murmur, Hypertension, Obesity, Sleep apnea, obstructive. APAP 8-20CM WME AIRVIEW. Surgical History. Past Surgical History: Procedure Laterality Date CARDIAC CATHETERIZATION 03/2004. OTHER SURGICAL HISTORY ear surgery as a baby. STRABISMUS SURGERY repair of congenital strabismus-childhood. Family History. Problem Relation Age of Onset. Hypertension Mother. Diabetes Father. Hypertension Father. Hearing loss Other. Kidney disease Other. Social History. Tobacco Use. Smoking status: Never Smoker. Smokeless tobacco: Never Used Vaping Use. Vaping Use: Never used. Substance Use Topics. Alcohol use: No. Drug use: No. Review of Systems. Constitutional: Positive for fever. Respiratory: Positive for chest tightness. Cardiovascular: Positive for chest pain. All other systems reviewed and are negative. ED to Hosp-Admission. Discharged 5/4/2021 - 5/6/2021 (2 days) Hospital. Last attending Treatment team Acute hypoxemic respiratory failure due to COVID-19. Principal problem. Presenting Problem/History of Present Illness/Reason for Admission. Acute hypoxemic respiratory failure due to COVID-19. Hospital Course. Patient is 52 yo BMI around 40, presents to the hospital with severe sepsis secondary to COVID-19 pneumonia. He was first positive on 04/30, had progressive shortness of breath with weakness and worsening cough. He presented to the hospital originally on 05/04, and desaturated to 85% on room air. He admitted to the medicine service, pulmonology was consulted. Severe sepsis (tachycardia, tachypnea, and fevers with acute hypoxemic respiratory failure) secondary to COVID-19 pneumonia. He was started on dexamethasone IV, and transition to oral dexamethasone. He will continue 7 more days at home to complete 10-day therapy. He was started on remdesivir therapy and received 3-day treatment. Pulmonary consulted, as he was a possible candidate for Actemra, however his inflammatory markers including D-dimer, ferritin, CRP improved, and his oxygen requirements also improved. On discharge, he will continue with oxygen supplementation 2 L with rest, 4 L with activity, 2 L with sleep to be infused into his CPAP therapy. Hyperlipidemia. Continue rosuvastatin 10 mg Monday, Wednesday Friday. Benign essential hypertension. Holding hydrochlorothiazide Continue lisinopril and metoprolol.

Within one day of receiving the 2nd shot started having heart palpitations in the middle of the night, Went to Urgent care, not help. Went back to hospital and a got a heartmonitor and wore that for a week. Thenon Friday, May 7th went to the emergency with sweats and almost passed out. They kept him there for over a day, ran tests, etc. Blood work came out fine. He was released the following day. No answers. One doctor there admitted that he believed it's related to the vaccine. Now here we are, May 20th, no answers and feeling the same, but now chest pain, shortness and breath. Never had ANY HEART PROBLEMS BEFORE THIS!

The patient had Covid 19 from approximately January 28, 2021 through early February 2021. He received the first dose of the Pfizer Vaccine on March 26, 2021. On March 27, 2021 at approximately 7:30 PM, the patient suddenly became unable to speak clearly and walk normally. The ambulance was called at approximately 7:45 PM. The patient was evaluated and placed in the ambulance by approximately 8:15 PM. He stopped breathing in the ambulance. He was resuscitated and placed on a ventilator at some point. After evaluation at the hospital, it was found that he had suffered a pontine hemorrhage. He was kept alive until his heart stopped on March 29, 2021.

Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, shortness of breath associated with it 20MAY, continued chest pain with relief when leaning forward- concern for pericarditis

? 5/21/21: Pulmonary Embolism o Presented with chest pain, abdominal pain, breathing problems o CT showed pulmonary embolism o Stable for outpatient anticoagulation. Started on 10 mg Eliquis BID x 7 days and then 5 mg BID thereafter.

The day after receiving the shot i was very tired. Slept part of the day. I am a runner and was unable to run that day but could tell i was very winded even going up and down stairs. The rest of the week was unable to run from being winded. Then after a week was able to slowly get back to my normal routine. I had a calcium score scheduled for 7:00 am on May 19th. I was called into my doctors office to be given the results the next week because my calcium scan came back fine...but doing the scan they found a 3mm nodule on my lung. I have never had any type of lung issues. I do not know that this is related to the shot. But because of how my lungs felt for a week after the shot, i feel this could be related. I am not a smoker and never have been. They say the majority of these type nodules are formed from inflamation or infection. At the time they told me about the nodule they also did my yearly physical. Since i know some are getting inflamation around the heart...i'm curious if there can also be inflamation around the lungs which would have given me the nodule. At this point..the doctor plans to do a ct scan in one year to see if the nodule has grown. I felt like i should report this since this may not be discovered by many others unless they just happen to go from some type of scan of the lungs.

feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eyes swollen and his vision was diminished; Eyes swollen and his vision was diminished; On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball/A huge lump appeared a few inches from injection site; Numbness from his ankle to his feet and from his knees to his feet/numbness in legs and feet; feels like it's cold and tingly; feels like it's cold and tingly; ringing ears; pressure in his neck to his injection site; back pain/pain in back; vision is blurry; throat was swollen.; Toes locking up; Really dizzy and really lightheaded; Mind has been foggy; Glands were swollen; Arm soreness; Nose is bone dry; tiredness/tired; injection site pain/injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08May2021 at 02:38 PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included Bug bite (happened 5 days prior to 30Apr2021 and regimen of an antibiotic). He was completely done with the rotation for a least 8 days before he got the vaccine. It might have something to do with this. concomitant medication included dicloxacillin (started it on 30Apr2021 and it was for 5 days. He did not know what it did was). The patient reported that on 08May2021, day one, he experienced, tiredness and injection site pain. On day 2, until now side effects which had not gone away. It hadn't gotten worse, but it was not any better. The patient felt like congestion, but his nose was bone dry, like crusty dry. It hurts a little bit because it was so dry and he had arm soreness, nothing out of the ordinary. The arm soreness was just normal injection stuff. At first it was a little tender on the injection spot. It went away after about a day. On 10May2021, the patient felt like there were little, tiny baby hands pinching his internal organs randomly throughout his abdomen. It was not a sharp pain, more like a little squeeze all through his abdomen. It felt like his whole throat was swollen. It was not visually swollen, it more felt like a football in his neck. Stretching it was helping. His toes have been locking up like a pre-clamping. He had numbness from his ankles to his feet for 8 days, and now he has numbness from his knees to his feet. It was not completely numb, but it was not normal. The feeling of baby hands pinching his internal organs started the second day after the vaccine and has stayed consistent. The patient's eyes swollen, and his vision was diminished. Day 2 through today, it felt like his eyes were swollen, his vision was seriously diminished, he had a golf ball sized welt on his arm not at the injection site but 2 inches from it, and he was really dizzy and really lightheaded and almost fainted at the corner store. The feeling like his eyes were swollen started on day 3 after the vaccine. The crease of his eye be-low the eyebrow and on top of the socket got red and puffy and looked like sunburnt skin does. It was at the point that now it feels swollen all the time almost like he had pink eye and his vision has been diminished about 30%. He had a test done yesterday and his vision was 20/25. Some-times he could not even read a text and had to stare at his phone for 10 minutes to make out words. He did not have these issues before. The feeling of his eyes being swollen was a little better in the mornings and about 1300 it gets worse when he gets lightheaded to where was when it started. His vision became diminished about day 3 after the vaccine. It was a little better in the morning, but in the afternoon, it goes to exactly the same as when it started. He noticed the golf ball sized welt on his arm about 3 days ago. The doctor seemed to think a drop of the injection might had travelled from the injection site and his body was creating a defense to it. It was scary to take a shower and then see that. It didn't hurt. It was not painful, but it was a weird foreign entity. The cramping in his toes started probably day 3 and was consistent. The numbness started on day 2 after the vaccine, and up until 3 days ago it was just his ankles and feet. 3 days ago, it got to the point where it was from his knees to his feet. It has gotten worse since it was now travelling up his legs. On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball - when asked with his doctor he said that he thinks that a drop of the vaccine travelled and his body building a reaction to it and it was very abnormal. The patient also had numbness from his ankle to his feet worsened and from his knees to his feet- almost feels like it was cold and tingly. The patient also had dizziness and lightheaded about day 2 after the vaccine and it was the same. It came in waves but was consistent throughout the day. He would be fine then had a wave of dizziness. He has been laying down so much because he was so tired, ringing ears, felt like his glands were swollen, pressure in his neck to his injection site, and back pains. The patient stated that his doctor was only form urgent care. The patient Felt like whole throat was swollen, toes locking up, really lightheaded, mind has been foggy, and arm soreness. The patient had bizarre side effects from the Covid Vaccine for 11 days now. He thought it was the smart thing to report them to Pfizer. He didn't like to give personal information. He declined to give his mailing address or his email address. He hated when asked for race, but he guessed it might be important. He did not have a mailing address, phone number, or email address handy for his physician. He went to Urgent Care yesterday to have it checked and they did an EKG and said he had to be sent by ambulance to the ER. The doctor did bloodwork, and she said everything looked alright and to rest a few more days and keep hydrated. The patient underwent the lab work and procedures which included chest X-ray with unspecified result. He thinks it was on 18May2021. His mind has been foggy with all of that. It was yesterday or the day before. He could not be sure. He has been sleeping so much and was in a complete daze. The fogginess he had the whole time as his other symptoms, and it was the same. He has been eating well and hydrating and taking a multivitamin and Gatorade, all the things' people say to do. He asked if Pfizer has heard of this before. He was panicked it might be chronic, and he worries about the safety of the second shot for him. He was sure many people haven't reacted, but these are freaky side effects. He asked for advice and if Pfizer had heard of this before or if he was some weird anomaly. On his way to get the vaccine he asked 2 people at the city health line if they had taken it and they both said no. He asked 3 other patients and they said they took the Pfizer. One woman said she will take it when they make her. The guy who gave him the shot lied and said he wasn't eligible. It might have been his way of not having to discuss it. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not diagnosed with Covid prior vaccination. The patient was tested for Covid post vaccination with Nasal Swab on 18May2021. The outcome of the events was not recovered. Device Date: 23May2021,Additional information has been requested.

Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a hot room like 78 degrees with the window open he can not take the heat like he used to; Hot flashes; rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing; Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging; felt like he was drugged; pulse rate has been a little elevated; Palpitations: Caller stated this started the same day 10 to 12 hours after getting the first shot. Caller stated it was getting somewhat better but after the second shot it got worse.; getting out of breath was reported as worsened; felt like there was pressure in his skull; he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall ove; Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiry date: 31Aug2021) via unspecified route of administration in left arm on 01Jun2021 as single dose of COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0173; expiry date: 31Aug2021) via unspecified route of administration in left arm on 11May2021 as single dose of COVID-19 immunization and experienced palpitations, felt like he was drugged, felt like there was pressure in his skull, getting out of breath, rash got bright pink, respiratory rate was somewhere around 16, blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle. On an unspecified date in Jun2021, after second dose of vaccination, the patient experienced palpitations, getting out of breath like when he was walking up and down the stairs especially when carrying laundry or a garbage can and he never had this problem doing that unless he had an upper respiratory infection and prior to the vaccine he was perfectly fine, palpitations was reported as worsened, getting out of breath was reported as worsened, rash on his left side where he got the shot on his hand, specifically the top of hand and on his first, second, third, fourth, and fifth finger was reported as worsened, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle was reported as worsened, crack in the knuckle area on the second finger was reported as worsened, rash got bright pink was reported as worsened, felt like he was drugged, Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, felt like there was pressure in his skull, felt like he was going sideways, and on 01Jun2021 experienced hot flashes. On 02Jun2021, he was in a hot room like 78 degrees with the window open he cannot take the heat like he used to. On an unspecified date in Jun2021, patient stated that palpitations got worse after the second shot it was started on the same day of first shot of vaccination, 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse. On 03Jun2021, that next day of vaccination, patient had a rash and explained that on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle, this stopped a week to ten days after the first dose and then it came back after the second. Patient had a crack in the knuckle area on the second finger: patient stated he was scheduled for the dose around 12:20 and they had to get more vaccines and so he had to get it around 3:00pm. The patient stated this started to feel bad in the first two hours. For the event of rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing. Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging. For the event "felt like he was drugged" patient stated this started within 4 hours of first dose, he started to feel better in 5 days and then 10 days after he was completely better and stated he got this again from the second shot and it was getting better but the more he exerts himself the slower he feels but he does not feel like he is on anesthesia. The patient stated that his pulse rate has been a little elevated, stated on the following day after first dose his pulse rate was 114 and 120 was the highest. He stated after the first dose it was between 116 to 120 and after the second dose it was slightly elevated like 90 or something. The patient stated but his pulse rate has been 86, 87, 90 so the pulse rate has been a little elevated. The patient reported he also had hot flashes. He felt like there was pressure in his skull, 10 to 12 day after the first vaccine and this got better, then within 7 to 10 days after the second shot he got it again and he anticipates that for 7 to 10 days he will have to deal with the same crap. The patient felt like he was going sideways, this stopped within two days after the first dose and then it happened within one day or a day in half after the second shot. The patient stated that hot flashes lasted a day or day in a half. The other problem he had noticed is when he is in a hot room like 78 degrees with the window open, he cannot take the heat like he used to. Reportedly, after the second shot they had the patient sit for 15 minutes and so he went to the hospital main area after to get a pass to eat and he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over. He stated the first hour or so after the vaccine he felt like he was drug and he even had caffeine and got his car cleaned, but he felt like his body was behind him like woozy to stomach like in slow motion with exertion and it felt like he was drugged. The patient stated he just wished the vaccine dosage had a high of like if it was 0.3 maybe should be 0.2. The patient stated there should be a different regimen based on height and weight. The outcome of the event "hot flush" was resolved on 01Jun2021, for the event "Palpitations: The patient stated this started the same day 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse", "getting out of breath was reported as worsened", "The patient stated he got the second shot two days ago and that next day he had a rash", "he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over", "felt like there was pressure in his skull", "Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine", "felt like he was drugged", "pulse rate has been a little elevated", "when he is in a hot room like 78 degrees with the window open he cannot take the heat like he used to" was not resolved and for the event "Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging" was unknown, for the event "rash got bright pink, the patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing" was recovering.

Had clots in his lungs / blood clots; Stroke; He received his first dose on 27Feb2021 and second dose on 26Apr2021; This is a spontaneous report from a contactable consumer(patient). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 at his 52-year-old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He previously received his first dose BNT162B2 for Covid-19 immunization on 27Feb2021 at his 52-year-old. The patient experienced stroke on 07May2021 with outcome of unknown , had clots in his lungs/blood clots on an unspecified date with outcome of unknown. The clinical course was reported as follows: After her received his second dose of the Pfizer COVID-19 vaccine he ended up with a stroke. He had clots in his lungs and one broke off and gave him the stroke. He was just looking to see if there have any information about long term events occurring with blood clots, like is this a one time event or is there a potential for it to keep happening now that he had the vaccine in his system. He received his first dose on 27Feb2021 and second dose on 26Apr2021 and had stoke on 07May2021. He had a stroke after Pfizer shot, now coincidentally he had no other health issues. He did not know if it was related to vaccine COVID may not have been. He was healthy 52 year old male, no medicines no nothing headed with the stroke, they developed a blood clot in his lung ended up with the stroke. Information about batch/ lot number has been requested.

Pt had shot on 6/10/21 , pt developed chest pain/lung pain on 6/28 and also tachycardia rate into the 120s at times, pt's chest pain/lung pain improved with sitting upright and bending forward. Pt came to primary care office on 6/29 and had evaluation by chest x-ray, and ekg done in office. pts symptoms and ekg were confirmatory for pericarditis.

That night I got night threats, no fever. The next day I started coughing, wheezing, short of breath. The next day I saw my Dr., she listened to my chest, and checked my blood pressure and it was 160/100. I have never had high blood pressure before. She prescribed losartan potassium 60 mg tablet. I take 1 every morning now. And cough medication: benzonatate 200 mg tablets 1 every 8 hour now. The cough and the blood pressure is still ongoing. There is no pneumonia. I had a Bilateral hip replacement, total hip replacement on both legs, it has become very sensitive and painful after the vaccine. I take the 4 Advils for the pain in my hips. The doctor is trying to determine if I'm a long-hauler of COVID related. I have never had Covid-19 virus, not to my knowledge.

Vaccinated with Pfizer on 1/13/21 and 2/3/21. Symptom onset 7/10/21 with cough, runny nose, shortness of breath, chills, nasal congestion, fever. Tested positive for Covid-19 on 7./13/21.

Vaccinated with Pfizer on 1/23/21 and 2/3/21. Symptom onset on 7/10/21 with cough, runny nose, shortness of breath, chills, fever, nasal congestion. Tested positive for Covid 19 on 7/13/21

1. Woke up at 2am with sweats and chills (Fever). An hour later had pain on my left flank (seemed like pain from the same area that I had previously had a Diverticulitis event. Previous Diverticulitis event the pain gradually increased in that area. This time it was immediate. Chills and Sweats (Fever) lasted until 7-8AM. Started Antibiotics and diet Monday afternoon (2/15/21). Pain on my left flank lasted until I completed my Antibiotics Treatment 8-9 days later. 2. At some point within about 3 weeks of the 2nd Vaccination I noticed I was wheezing at night while I slept (it would wake me up). I was not really short of breath, but while laying down would wheeze. I had asthma as a child, but since I was a teenager, I have not had any Asthma or Wheezing issues. Doctor gave me a course of Steroids and Albuterol which I am still using daily. It has gotten better but I still need the inhaler daily.

Approximately 12 hours after the vaccine, experienced wheezing and difficulty breathing. Had to use an inhaler to regain normal breathing. Happened with first dose but patient did not report.

Started developing breathlessness/Breathlessness while sleeping, running and biking (active athelete).; chest pain; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Apr2021 at 15:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0150) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient started developing breathlessness, chest pain around 10Apr2021 (10 days after 1st dose). Breathlessness while sleeping, running and biking (active athelete). The patient went to ER on 26Apr2021 unable to breathe. Stress test/EKG, CT Scan of lung, Covid all normal. Breathless still exists during physical activity & sometimes while sleeping. The event onset date was reported as 10Apr2021 at 13:00 PM. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with inhaler for breathlessness. The outcome of the events was not resolved. COVID was not tested post vaccination. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08May2021 at 13:00 PM, at patient age of 52-year-old, as single dose (Lot number EW0173) for COVID-19 immunization.

Starting at about 14:00 on the day of receiving the first dose of the Pfizer-BioNTech COVID-19 I began to feel soreness at the vaccine injection point. After about another hour, I started to feel fatigue; about another hour or two later, headache; about another hour later numbness in my head; and about another hour later achiness in other parts of my body. I am submitting this report on July 24, 2021 at 06:53, about 23 hours after receiving the vaccine, and the numbness in my head has subsided, the headache and body aches have mostly subsided but are still present; and the soreness at the injection point has not yet subsided. I am noticing a little shortness of breath that I did not notice yesterday.

I had headache, body ache, serve fatigue, low grade fever, nausea, and difficulty breathing. I went to the Urgent care. They did a Covid-19 test, which came back negative. I did have a repeat of the same symptoms two weeks later.

This is a late entry note regarding adverse reaction status post Pfizer COVID-19 vaccine which was given to the patient yesterday at 9:45. Secondary to the patient's past medical history he was advised that he would wait and observance for approximately 1/2-hour instead of 15 minutes. At approximately 10:15, 30 minutes after receiving his vaccine, the patient did report tingling and numbness in his lips and mouth, this progressed to tightness in his throat at 10:45, the patient denied any shortness of breath or wheezing and was constantly monitored by emergency medical services as a vaccine clinic to take place at our local fire hall. Secondary to throat tightness, and chills, and ongoing tingling numbness in his lips and mouth. #18 IV was started in the right AC, normal saline 1000 cc was up open, the patient received 25 mg of IV Benadryl per protocol, as well as 125 mg of IV Solu-Medrol at 1055. Vital signs at that time 168/95, pulse was 73, and O2 saturation was 100%. Physical exam did not reveal any indication of blockage within the throat, there was no shortness of breath or wheezing. Lung sounds are clear but diminished to auscultation bilaterally, heart rate regular. Temp 98.2. Approximately 10 minutes after receiving medication blood pressure 161/100, pulse-73, sat remained 100. Assessment of patient's symptoms patient does report that the throat feels slightly thicker, he denied any shortness of breath or wheezing, there was no oral or facial edema throughout the entire episode. The patient received 1000 mg of IV Tylenol at 1125. Continued observation for the next hour, the patient did report improvement in his symptoms, lip tingling and numbness dissipated, along with throat tightness. Vital signs at 1236 122/74, pulse 79 oxygen saturation 100%. The patient was placed on a cardiac monitor the entire time of this incident. Follow-up phone call to patient on 01/06/2021 at 8:00 patient reportedam that he did have 1 further episode of tingling in the tip of his tongue and around his lips yesterday afternoon at 16:00 he did take Benadryl as instructed and this dissipated, he reports throughout the night he has had no further episodes of tongue or lip tingling, throat tightening shortness of breath or wheezing difficulty swallowing. He was instructed prior to leaving the vaccine administration site to continue with Benadryl 25 mg every 6 hours, along with Tylenol alternating with ibuprofen per box instructions to aid with chills and rigors for the next 24 hours. He reports that he is had an improvement in his symptoms, We will follow-up again in 1 day.

mild SOB, facial tingling/numbness, flush, light headed all while eating lunch. Pt sats 100%. No resp distress noted. LS CTA. VSS. Denies chest pain or other symptoms

Extreme chills, shaking, shivering x 1 day, loss of appetite, diarrhea x 2 days, weakness, lightheaded x 3 days, shortness of breath x 4 days

Headache the next morning after receiving vaccine that hasn?t gone away, fluid in left lung, blood clots in right lung and leg.

Diaphoretic, syncope for approximately 2 minutes, panic attack, rapid breathing. Transported to nearest ER by EMS.

Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores that won?t heal and debilitating malaise fatigue A few days later: Joint pain and air hunger A few days later: Numb extremities Two weeks to date: Body temp regulation issues , heart pounding, face flush. Sleep disturbance entire time. Extreme fatigue.

tingling in lips and sinuses 10 min. after vaccine -dizziness /lower lip slightly swollen /bp 124/84 pulse 82 -c/o tightness in throat -swallowing -no respiratory issues

The evening of the vaccine I had minor tongue swelling. The next night after eating Tuna I had the tongue swelling again with some Tachycardia and a severe headache with red welts all over my body. I also had tightness in my throat. I went to the Urgent Care where they gave me Antihistamine, Prednisone, something for headache and IV Fluids. I was discharged after three hours and felt better within a few hours. I took Prednisone for five days.

Shortness of Breath, fever-ish, muscle aches throughout body. Took ibuprofen, but didn't seem to help. Ice packs on forehead and neck. Sleep

In observation area, patient reported feeling dizzy, short of breath and confused. He was brought to the observation area where he reporting that he was not able to take his morning insulin. He reported he felt confused and this was typical when he was not able to take his insulin. He did not know the date or the day of the week. He reported having took anti-viral medications this morning, but not diabetes meds, including Lantus He denied chest pain. He had a history of open heart surgery/valve replacement in December 2020. Recommended transfer to Medical Center ED via ambulance for further evaluation.

Side effects: Mild chills, headache, joint pain, nausea, feeling unwell, rash and itching, muscle pain, and difficulty breathing.

Shot arount 4pm. Couple hours later, a little bit of coughing. Around 8pm, more cough from chest. Close to midnite, wheezing and more cough. Took Xyzal and benadryil. Today (20 hours after the shot), lot of coughing, and weird feeling in chest. May need to goto urgent care today , lets see.

Pfizer COVID-19 Vaccine EUA Approximately 5-10 minutes post vaccination patient experienced chest tightness, shortness of breath, and tongue swelling. Initially treated with epinephrine by EMS with some resolution, but symptoms returned. Patient transferred to emergency department and treated with epinephrine 0.3 mg, famotidine 20 mg, diphenhydramine 25 mg, and methylprednisonole 125 mg. Observed patient for over 2 hours, symptoms resolved with treatment, and discharged home.

On April 6th, after 30 hours of receiving the first dose of the vaccine. Approximately at 5:00PM , there was a little bit of heart racing, shortness of breath and dizziness. It lasted only 3 minutes or so. It didn't need any medical attention. The anxiety continued till 7:00PM. With this event, do I still have to obtain the second dose after 21 days?

Slight pain in shoulder several hours after injection. By 7:00 am it felt like I had Covid again. I had a fever of 102.8 cold sweats, muscle aches throughout my body and bad headache. I took recommended dose of Tylenol drank tons of fluids and laid in bed the entire next day. what was mild discomfort in shoulder turned into large pain. after about 12 + hours of Tylenol and fluids the fever broke and was down to about 100.6. As of today (Friday) I am up and about with shortness of breath but no fever and minor aches.

Fever (+2 degrees above normal); very strong headache, body aches, chills, fatigue, hot flashes, some chest congestion, could not sleep due to aforementioned. Symptoms began about 12 hours after second dose. Symptoms subsided about 24 hours after second dose.

4/1/2021: SEVERE LEG PAIN, PRESENTED TO HOSPITAL ER AND WAS FOUND TO HAVE ACUTE DEEP VENOUS THROMBOSIS LEFT LOWER EXTREMITY. 4/4/2021: SEVERE SHORTNESS OF BREATH, SQUEAD WAS CALLED AND HE WAS TAKEN TO HOSPITAL ER WHERE HE WAS FOUND TO HAVE BILATERAL PULMONARY EMBOLISM

Patient received 1st COVID vaccine on 3/17. On 3/24, he experience pleuritic chest pain and was admitted to the hospital for pericarditis confirmed by EKG. During this hospitalization, he was incidentally found to have left main stenosis 60-70% on the LHC, requiring PCI. Patient did not have an acute MI - hence Dressler Syndrome was thought to be less likely. He was discharged after a week on 3/30/21 with colchicine and other cardioprotective medications. He received his 2nd vaccine on 4/7/21. On 4/14/21, patient was readmitted for pleuritic chest pain attributed to recurrent pericarditis.

A week later I am driving on the highway and I started to feel shortness of breath, within 2-3 minutes I got out via an exit and park at a gas station, I palpated my chest and felt a weak but rapid heart beat. I ingested the carvedilol 6.25mg, I felt dizzy but walked in the gas station to got a granola bar and chocolate milk drink went back to the car. Twenty five minutes after taking the first carvedilol, I felt no changes in heart rate & shortness of breath and took an additional 6.25mg of carvedilol. I then called my wife and talk to her (and my children) about what was happening and where I was. I asked to call 911 if I loose consciousness. At about fity five-Sixty minutes went by and symptoms were unchanged and I took third dose of 6.25 mg of cavedilol. At approximately 75-80 minutes after onset of symptoms my hear rate went down and shortness of breath improved to normal. I contacted my doctor the next day

Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower breathing and respiratory response; Extreme fatigue; very low energy; Loss of appetite; loss of weight; Abnormally wide fluctuation of blood pressure while not exerting myself; Difficulty relaxing and sleeping; Nausea; dizziness; Stomach pain; diarrhea; Headaches; low grade fever; shortness of breath; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; sudden increased heart rates and high blood pressures reading; spikes his heart rate/sudden increased heart rates; intestinal discomfort/strong stomach discomfort; intense chest pressure and some pain; This is a spontaneous report received from a contactable consumer (the patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in right arm on 09Apr2021 12:30 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included high cholesterol, anxiety disorder, known allergies: Clonazepam (KLONOPIN), food allergies: sea bass and orange roughy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date; lovastatin taken for an unspecified indication from an unspecified date; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified date; ibuprofen taken for an unspecified indication from an unspecified date; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (Pfizer Covid-19 Vaccine, lot number EP7534) via an unspecified route of administration in right arm on 18Mar2021 11:00 AM at age of 53-year-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was currently 11 days out from receiving his second COVID vaccine and he was still having very strong side effects. This included an emergency room visit on 16Apr2021. He was generally very good health and he exercised regularly including running so these were very abnormal effects for him. Beginning one day after receiving his second dose of the Pfizer vaccine for COVID-19: 1. Strong chest pressure and fluctuating heartbeat. 2. Slower breathing and respiratory response. 3. Extreme fatigue & very low energy (for example, walking up two flights of stairs made him very tired and spikes his heart rate, abnormal for him). 4. Loss of appetite and loss of weight. 5. Abnormally wide fluctuation of blood pressure while not exerting himself. For example, higher blood pressure readings (155/95) with a slower pulse (60) or the opposite scenario, (110/89) elevated pulse 98. 6. Difficulty relaxing and sleeping. 7. Nausea and some dizziness. 8. Stomach pain and diarrhea. 9. Headaches. 10. Low grade fever. As of 26Apr2021, it stated the day after the patient received his 2nd dose of the Pfizer Covid-19 vaccination (10Apr2021 12:00 PM), he began to have side effects which he expected to some extent. However, as of today, he has 17 days straight of side effects or perhaps an adverse event. His symptoms began mildly the day after but suddenly increased greatly within the next couple days and he had been dealing with this ever since. He had made two emergency room visits, seen his general practitioner, and as of today (26Apr2021) a cardiologist who ordered imaging. His symptoms range from, extreme fatigue, nausea, strong stomach and intestinal discomfort, weight loss, shortness of breath, sudden increased heart rates and high blood pressure readings, intense chest pressure and some pain, powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of his head at the cerebellum. His life was basically come to a screeching halt and he was searching for answers! The doctors he had spoken to were unclear as to what was wrong with him and why. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the events. COVID tested post vaccination on 17Apr2021 included PCR and Nasal Swab, both showed negative result. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (COVID-19 VACCINE, lot number: EN6203; expiration date: Jun2021), dose 1 via an unspecified route of administration on 27Feb2021 18:00 as single dose for covid-19 immunisation. Medical history included ongoing lyme disease. There were no concomitant medications. The patient went through post- vaccination especially because he has Lyme disease. He has had this pre-existing autoimmune disease for 8, almost 9 years, he wants to add this information to the database. Caller states the first shot he would say was kind of catastrophic, the second shot, he will go into. Caller states the second shot, he showed up at the military vaccination place locally and they actually declined his ability to get it with them because of his first reaction even though he had the go ahead from his Lyme specialist and primary doctors. Caller states because of this, he went after four weeks instead of three and he went to a high risk clinic to protect him from anaphylaxis. He has received both doses, the first dose was horrendous and the second was quite easy. Caller states no reaction whatsoever with the second, though he still has remaining symptoms. Reporter Details: Caller states his legal name is (Name), he goes by (Name). Caller states he would prefer if company contacted him and also so that maybe they can warn people with autoimmune or Lyme that the first one is going to be kind of rough. Caller states he works with the public. Prescribing Healthcare Professional: Caller states unsure of email address. Caller states the only thing missing off the initial story is that all in all, the second shot was really good. Caller states he does have some very lingering issues still that he is going to be seeing the Lyme specialist about. Caller states the first dose, it's pretty intense. Caller states the second one, he had fatigue and neuropathy from the stupid autoimmune stuff. Caller states there is residual symptoms, but nothing like the initial ones. Caller states what he did was he just jotted some notes down about every third or fourth day up until the second shot just to detail each symptom. Caller states he only wrote about 5 days worth of little sentences. Caller states 27Feb2021, the first dose, it was a Saturday so by Monday 29Feb2021, it started with itching, burning rashes, so like a visible rash on his chest with raised bumps, neuropathy- shooting pains in his fingers and toes that feels like bugs are crawling all over him, headache, fatigue, and dizziness. Caller verifies all of these symptoms actually began on 01Mar2021. Itching, burning rashes: Caller states he would say they lasted about 2-3 weeks because he went to the walk-in to have them check and called his primary doctor and went into his primary and had him check. Caller states it ended sometime in Mar2021 and he has recovered completely. Neuropathy: Shooting pains in his fingers and toes: Caller verifies it began 01Mar2021. Caller states he would say he still has about 20% left. Caller states it is hard to sleep at night because he still gets itching and burning and stuff. Caller states it is persisting, but certainly not as bad. Headache: Caller verifies it started 01Mar2021. Caller states it ended Mar2021 and has recovered completely. Fatigue: Caller states began 01Mar2021. Caller states this is one of the bad ones he would say. Caller states he still, he would like to go for a walk or work out and he barely has the amount of energy to work let alone the others. Caller states he can't workout or walk. Caller states if he goes up and down stairs, he's exhausted. Caller states that's definitely a lasting one. Caller verifies it is ongoing, persisting. Dizziness: Caller verifies it began on 01Mar2021 and is ongoing. Caller states when he walks he literally cannot turn his head quickly or he feels like he's going to throw up or pass out. Caller verifies it is persisting. Caller states he would say about 4 or 5 days later from getting the first shot, this was really interestingly weird, he had mouth sores that wouldn't heal and debilitating malaise and fatigue. Caller states malaise so bad he couldn't get through work, he could barely work. Caller states the mouth sores were so weird. Caller states everything he is telling company he has read about online. Caller states he has had canker sores from low immunity, but this was on the tip of his tongue, either side of the tongue tip, it came and went three or four times through the entire month. Caller states it was like his immune system was on the edge of crashing, then he would sleep a lot more. Caller states he would do whatever he could do to make it come back. Caller verifies this debilitating fatigue is different than overall fatigue that began 01Mar2021. Caller states the debilitating malaise began 04Mar2021 or 05Mar2021. Debilitating Fatigue; Debilitating Malaise: Caller states the debilitating fatigue also began 04Mar2021 or 05Mar2021. Caller states it is acute. Caller states ended sometime in Mar2021. Caller states recovered completely but is still left with some fatigue. Caller states recovered with lasting effects maybe. Caller says the other one, he could barely get up, he could barely work, he literally couldn't function. Caller states the overall fatigue has not left, it's ongoing. Mouth sores that won't heal: Caller states began around 004Mar2021 or 05Mar2021 and stopped sometime in Apr2021, it took about a month. Caller states he recovered completely. Caller states he just wrote what happened down about every 2 days up until 14Mar2021. Joint Pain: Caller states literally every single joint in his body was killing him and felt inflamed. Caller states it began around 03Mar2021 or 04Mar2021. Caller states joint pain is ongoing, but has improved. Air Hunger, shortness of breath upon exertion: Caller states if he went up and down a few stairs, he would breathe almost as if he was having an asthma attack, it was shortness of breath upon exertion and started about four days after. Caller states it began around 05Mar2021. Caller states he actually had it this morning, felt like he just walked up a flight of stairs. Caller states he is very physically fit, so that should not happen. Caller states it's ongoing and has improved. Numb Extremities: Caller states a week later from 01Mar2021 he had numb extremities. Caller states he started being very aware of the fact that his fingers and toes were starting to lose feelings on 08Mar2021. Caller states it resolved within a week on 15Mar2021. Caller states it was a weird sensation that happened for a while but is completely resolved now. Body Temperature Regulation Issues: Caller states two days later, he had body temperature regulation issues. Caller states he was cold when he should have been hot and hot when he should have been cold. Caller states began around 03Mar2021/04Mar2021 and is ongoing, but not terrible, it's probably the least of the issues and has improved. Heart was pounding out of his chest; face was flushed: Caller states a day or two later, his heart was pounding out of his chest and his face was flushed to the point where people were asking if he was okay. Caller states he felt like he got a quick burst of a run and then stood still. His face was visibly red and very aware of his heart beating out of his chest and this is with no exertion. Caller states he was laying on the couch and he could feel his face flush while doing nothing basically. Caller states began 02 or 03Mar2021 and just stopped a week ago around 12Apr2021. He recovered completely, for now, it seems. Caller states he went to (Clinic name) on (Address), he doesn't have the doctors name, it was a walk-in. Caller states they literally said no big deal, it's all side effects of the vaccine, they just said he's fine. Caller states they simply recommended anti-inflammatories, Tylenol, which was smart and he wishes he thought about it. They also recommended Benadryl to stop the reaction. Caller states it was very helpful, the Benadryl really helped a lot. Caller states there was also a good amount of insomnia because of all the symptoms, it would be close to impossible to sleep. Insomnia: Caller states it seemed to get worse, started a week later because it was getting disconcerting to him so he couldn't sleep. Caller states it started 08Mar2021 and have had that on and off with Lyme. Caller states has struggled for years, is ongoing and is persisting. Caller states on 14Mar2021, he couldn't sleep, couldn't get out of bed, completely weak and dizzy, his left leg and quad was spasming like when he had Lyme's, left knee itches, tingles, and burns and that's where he got bit by the tick and that's when he had his symptoms when he was acute. Caller states it resolved within 3 weeks after the initial onset of the shot. Caller states when he had Lyme initially, that's what he experienced, his left knee swelled, burned and itched, his left knee cap. Caller states ended 17Apr2021. Caller states its a situation where some of those are still there because of Lyme and some are gone. Caller states the knee cap stuff and can't get out of bed was gone on 17Apr2021. Caller states he has recovered completely. Caller states he still is weak and dizzy and his left leg and quad are still spasming, but it's better and is improved. Caller states on 20Mar2021, his left knee cap hurt, was twitching and tight, his left toe was numb, felt like something is chewing on his toe with a sensation of worms under the skin and sleep disturbances. Caller verifies the sensation of worms under the skin and something chewing on his toe is all related to neuropathy, which is still there. Caller states he had written down that on 20Mar2021, he was supposed to get his second shot at 1800, but was denied due to side effects he was experiencing and was rescheduled for 31Mar2021 at a local high-risk clinic. Caller states on 22Mar2021, he slept good, but was fairly weak all day. caller states he took a shower mid-afternoon, and couldn't get off the couch. Caller states basically all he did was take a shower and threw himself on the cough the whole day. Caller states he has written that he has the sensation of ants crawling over the top of his back, no desires to go outside, and light sensitivity. Caller verifies the ants crawling over the top of his back was also neuropathy, and he recovered completely within 3 weeks. Light Sensitivity: Caller states throughout the whole thing, had it today and is still ongoing and persisting. Caller states began sometime in Mar2021, its been the whole time. Caller states 28Mar2021, he only slept 6 hours and woke up completely fatigued, could not get out of bed until 2:00 in the afternoon, has a complete loss of appetite, had a drink and 2 eggs and laid down, couldn't move until 1930. Caller states got up, had a nutrition shake, he wasn't desiring solid foods whatsoever, had 100% malaise, fatigue, no appetite, and was dizzy. Loss of appetite: Caller states he has lost 7 pounds since the first shot. Caller states he wasn't really interested in eating. Caller states he has a natural desire to eat and nothing sounded good. Caller states started Mar2021, is ongoing, and has improved. Caller states 31Mar2021, he got the second shot, he had a little bit of irritation, tingling and burning at site and definitely a flushed face throughout the day, almost like a sunburn. Caller states he was joking with clients and said the first shot killed him and the second shot cured him. caller states after the second shot, he is 80% better but can list the remaining symptoms. Caller states what he is left with is fatigue, he does not have any energy to do anything other than work, sleep issues, neuropathy, and dizziness. Dizziness: Caller states the dizziness has been consistent and goes with the sleeplessness, ongoing since Mar2021 and is persisting. Irritation, tingling, and burning at injection site: Caller verifies the irritation, tingling, and burning is at the injection site of the second dose. Caller states it happened within a few hours on 31Mar2021 and resolved within a week on or around 07Apr2021. Covid Vaccine: First Dose: Caller verifies he received the injection in his left arm around 1800. Caller unsure of NDC. Covid Vaccine: Second Dose: Caller verifies he received the second dose on 31 Mar2021. LOT: ER8730, Expiry Date: They didn't write that down so caller unsure. NDC: Caller unsure of NDC. Caller unsure of dosage given. Caller states was given via injection in his right arm around 1300 or 1330. Covid Vaccine: Indication: Caller states first off he owns a business, he did it to be responsible to the public. Caller states he wants his business to appear as safe and compliant as possible. Caller states he definitely was afraid because of the Lyme disease. Concomitant Products: Caller states he made sure he did nothing before purposefully. Test Results: Caller states after the first shot, he went to (Name) family physician, they did a lot of blood work trying to make sure his inflammatory markers weren't going up, to make sure he wouldn't have issues. Caller states the good news was he was great, everything looked normal, there was nothing crazy in the blood work. Caller states they though the shots would have triggered an autoimmune response of Lyme. Muscle/Joint: He reports a bit of muscular/joint pain in the area where the shot is, if he goes to reach The outcome of the event "itching, burning rashes, like a visible rash on his chest with raised bumps", "headache", "can't workout or walk", "exhausted", "immune system was on the edge of crashing", "immune system was on the edge of crashing", "face was visibly red" was resolved in Mar2021; the outcome of the event "debilitating malaise" was resolved with Sequel in Mar2021; the outcome of the event "Numb Extremities" was resolved in 15Mar2021; the outcome of the event "mouth sores" was resolved in Apr2021, the outcome of the event "face was flushed" was resolved in 12Apr2021; the outcome of the event "couldn't get out of bed" "left knee itches, tingles, and burns" was resolved in 17Apr2021, the outcome of the event Back disorder was unknown, the outcome of the event "complete loss of appetite", "Joint Pain", "Body Temperature Regulation Issues", "barely has the amount of energy to work let alone the others/Weak" was resolving, the outcome of the other events was not resolved.

Shortness of breath; pericardial effusion requiring drainage/fluid around the heart that made the heart beat super fast to pump up blood; inflammation of the heart sac; fluid overload on the lung; fluid around the heart that made the heart beat super fast to pump up blood; This is spontaneous report from a contactable consumer (patient) reported for himself. A 53-year-old male patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in left upper arm at 53 years old on 20Mar2021 08:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure from 2018, he says he has had this for roughly 3 years. Concomitant medication included amlodipine at 5mg once a day for high blood pressure from an unspecified start date in 2018 and ongoing, he says he has been taking this for a few years, maybe 3 years. No additional vaccines were administered on Same Date of the Pfizer Suspect or within 4 weeks. He was not sick at the time of vaccination previously. The patient was calling about the Pfizer COVID vaccine. He says he is just trying to get answers because what he experienced was very alarming to him. He got the vaccine at 8:00 in the morning. He says a student did it, she took a long time, she was very timid. He says she was being supervised by an RN. He experienced shortness of breath on 07Apr2021, he says it was in the morning that the shortness of breath started, because he did make an appointment to go the the COVID test, he got the COVID test around noon that same day. He says he was diagnosed with pericardial effusion requiring drainage and inflammation of the heart sac. He says he had fluid overload on the lungs that required IV diuretics. He says the symptoms started after the vaccine, and these symptoms were what was causing the shortness of breath. He says the fluid around the heart made the heart beat super fast to pump up blood. He says the fluid triggered the shortness of breath. He says when they removed fluid the breathing got easier but then it settled into the lungs. He says Tuesday he dropped off the cliff, Tuesday or Wednesday night, one of them, for two nights he was on oxygen, they gave him a diuretic for the lungs, after 12 hours he started feeling better, continued to get better and better after they moved the fluid from the lungs with Lasix through the IV. He says he doesn't fit the profile of someone who would develop these issues, he has no history, no cancer, no autoimmune disorders. He says they say well maybe it is the virus but the doctors currently have no specific answers for the caller. He says they told him that someone having this would be the profile of an IV drug user. He says he never uses drugs, he does not fit a profile like this. He says he wants to be fully vaccinated. He says the timing is suspicious with the vaccine shot. He says it is 50/50 on the doctor's opinions, half say to get the shot, the other half say don't do it. He says they say the second shot is worse. He says he is confused as to what to do, that he understands this is a big experiment, he wants the vaccine but not at the cost of another visit to the hospital. He says he was at the hospital on oxygen, he couldn't get out of bed for a day. He says the doctor said there was a study in (Withheld), the caller says he did a lot of research in the hospital for 6 days, that says the demographic is younger but it is heart issues with men for the heart with the Pfizer vaccine. He says they are studying it. He says a couple of doctors referred to that, the ones that say don't get the shot, not yet. He says he can't pinpoint it exactly. He says it could have been a fluke but the timing is very suspicious. He says that because of some of the side effects, his week in hospital, he was concerned for his life, he wants to be fully vaccinated but not at the cost of going though this or cost of killing him. He says he does not want to go through this again, he will not get vaccinated unless he is comfortable. He asks should he switch to (Withheld), is that a safer bet, (Withheld), should he just skip it all together or not. He says he knows they are a different type of vaccine. He says they had to remove fluid form his pericardial sac, he had 2 days of draining, they drained a liter from around the heart so it could beat normal again. He says apparently some of the fluid went to the lungs so he needed oxygen. He says this all happened Tuesday morning, he came back home yesterday, he looks pretty good. He says he just wants to do the vaccine and asks should he take the second one or not. He would like to get any information. He says the fluid in his heart was starting to build up on 05Apr2021 or 06Apr2021, he started getting symptoms that come and go. He says he was admitted to the hospital on 19Apr2021 and his procedure was on 20Apr2021 so his shortness of breath resolved the day after the procedure. He says he was hospitalized from 19Apr2021 to 25Apr2021. After reporting shortness of breath he says that was it, basically. He says he went to the nurse treatment center on 19Apr2021 because he thought it might be COVID but this event landed him in the hospital. The events required a visit to emergency room, he said he went to the emergency room on 19Apr2021 and a doctor told him he might not make it. The patient said he was scared and he didn't know why the doctor would have said that to him. He said he did not have an appointment date to physician office yet, he was waiting to get a call back. Relevant Tests included: Rapid COVID test, Date 07Apr2021 Result negative, Date 15Apr2021 Result negative, Date 19Apr2021 at Patient First Result negative, Date 19Apr2021 at the hospital on admittance, Result negative. Standard COVID test, Date 19Apr2021 Result negative, Date 15Apr2021 Result negative. He says at the hospital there was a lot of tests done on his heart and lungs, nothing was coming back scary, they were coming back as perhaps viral markers. The outcome of shortness of breath was recovered on 21Apr2021, of other events was unknown.

8 hours after shot I became nauseous. Was shaking, major chills, 2 large hives on face, accelerated heart beat and had little bit issue breathing. Took benadryl. Started feel good after 20 minutes

Slight fever, fatigue, breathlessness, body aches, headache started approximately 24 hours after injection and lasted for approximately 24 hours

6 hours after receiving 2nd dose, develped a fever (99.8), dizziness, chest tightness (lungs felt constricted), trouble breathing, coughing, and very fast heartbeat. Took Tylenol, the next day fever was gone but chest tightness and cough persisted. On 5/11/21 checked into Urgent Care facility because fast heartbeat and chest tightness did not subside. Dr. checked my pulse (at 99 beats) and gave me a PCR test for Covid. Coved test came back negative. On 5/16/21 at 1:00am, chest tightness felt like it was getting worse. Checked into Urgent Care ficility again. Dr. took a check x-ray and EKG. Both came back normal with nothing unusual found. Dr. prescribed Zithromax and Prednisone in case of bacterial infection and the Sterol to help with my breathing.

chills; shortness breath; hives on face; dizziness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0177), via an unspecified route of administration, administered in arm left on 15May2021 at 11:15 (at the age of 53-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included known allergies: seafood shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the 1st dose of the Pfizer vaccine, was fine for 8 hours, then had chills, shortness breath, hives on face and dizziness on 15May2021 at 20:00. The patient had shellfish seafood allergies. Last time he had one, that also happened after 8 hours. Therapeutic measures were taken as a result of all events [50mg diphenhydramine (BENADRYL)]. The outcome of the events was recovering.

Swelling of nasal passage and throat. Then swelling of feet, ankles, calves, thighs, genitals, and shortness of breath.

Consistent pain in the chest area around two days after 2nd shot- light shortness of breath . Pain became severe May 10th - Saw my doctor and was sent to the emergency room. Diagnosis was Pericarditis

Started experiencing shortness of breath and coughing on May 27, 2021. Noticed shortness of breath as walking up hill. Breathing issues continues to get worse over time. Went to urgent care doctor on June 4th. They said my oxygen level was low and could hear wheezing in chest. They did a chest x-ray and thought I might have pneumonia. Gave me antibiotics. Recommended to see primary care doctor. Went to HCF on 6/7/2021. Saw FNP. She did blood work. Scheduled me for a cat scan on 6/8. Blood tests indicated d-dimer level was high. Cat scan showed pulmonary embolisms in both lungs. Went to hospital.

Breathing Issues, shortness of breath, fatigue, that has gotten progressively worse. I was an active and healthy person and have been unable to do normal activity and exercise since receiving my second vaccine.

Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; difficulty sleeping; Extreme fatigue; headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6208), via an unspecified route in left arm on 11Mar2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had past drug allergy with ibuprofen. The patient received other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure. No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent nasal swab test on 22Mar2021 and test the result was negative. The clinical outcome of extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure was not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.

dizziness,facial redness, wheezing and c/o of throat swellimng and ot cant breathe. Treated with Epinephrine 0.3mg admin to left Vastus lateralis through jeans pants.

unable to breathe, bed ridden with bouts of unconsciousness and severe chronic fatigue for over two weeks along with heart pains and heart palpitations. The inability to breathe and bouts of unconsciousness have subsided with chronic fatigue and heart palpitations still present. I haven't sought medical treatment because I have no insurance and I can't afford it.

The Second shot the next day my lymph nodes swole up as big a baseballs under my arms, hot flashes, uncontrollable shakes on lefts side. But now I am shaking on both sides, short of breath, and headache

2 week after 2nd shot I started having heart palpitations, headaches, shortness of breath, dizzyness. I did not associated these symtoms with the vaccine. These symptoms have continued for 2.5 months. Some days they are stronger, somedays less, but have not gone away. Monitoring show PVCs, but stress test and echocardiagram were unremarkable I have not discussed the vaccine as possible cause with any healthcare provider but did not on V-Safe responses.

Cough; Minor breath problems; No energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the right arm on 14Mar2021 at 09:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included montelukast sodium (SINGULAIR) from unknown date for unspecified indication. The patient previously received acetylsalicylic acid (ASPIRIN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced cough, minor breath problems, no energy. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events cough, breathing difficult, loss of energy was recovered with sequelae. No follow-up attempts are needed. No further information is expected.

Dizziness, difficulty breathing, body aches and pains, fluctuating heartbeat ,anxiety, loss of taste and appetite, confusion, Symptoms have been lasting almost a month,

He got chills; problems breathing; Got Covid after receiving the Covid vaccine; felt bad; missed second vaccine dose; Asthma; Cough; felt crappy; This is a spontaneous report from a contactable consumer (patient), from Pfizer sponsored program. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0150, Expiration Date: 31Jul2021), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 53-year-old) as dose 1, single for covid-19 immunisation. Time of the vaccination given was 12 or 1:00 PM. The patient's medical history included diagnosed allergies, obese, hand was beginning hurt, carpal tunnel. Concomitant medications include allergy shots started on an unspecified date of 2019 for allergies. No additional vaccines administered on same date of the pfizer suspect. No prior vaccinations received within 4 weeks. 3 days later after receiving the Covid vaccine he got Covid on the 10Apr2021 and was diagnosed positive on the 11Apr2021. HCP advised to wait 2 months and start over with the first vaccine. No clinics want to do that. He went to two locations and they don't want to give him the first vaccine. They only want to give him the second dose. He went to the clinic and they were going to give him a second dose, but he was wanting to know if that was ok or if he would have to start all over. Patient wants Pfizers recommendation. He was way past 21 days. The patient stated he would want to start over if they don't know how good the second vaccine was if given that late. Patient was asking that this Pfizers recommendation. According to the CDC they are not allowed to give him three vaccines. He was not asking for three. He had to start over because this happened. They said they don't care, and they would just give him the second. He said he told them no and that his doctor told him that he needs to start again. They told him they don't care what his doctor says and that they know more than him. He figures he would go directly to the manufacturer and see what Pfizer says. Pfizer will know the vaccine better than anyone else, his doctor or the pharmacist. Whatever Pfizer tells him to do, he will do. He had been taking for allergy shots two years or a year and a half because they closed the offices for Covid and then his serum expired so he was going to have to restart again this year, name of shots unknown. Patient was taking Covid 19 vaccine to protect self and family, he doesn't want to die. End date of adverse event lasted until the 20Apr2021 according to the state. But he felt crappy for still another week and gives you ten days quarantine. For another week he was still coughing and having problems breathing which kind of still lingers, he still had it. He had asthma he guesses now. Asthma was diagnosed, but now they are saying it may be cardio. The patient stated he had recovered with lasting effects. He had never had asthma in his life until after the vaccine. Now they are saying it may not be asthma, it could be cardio. So, he was going through tests right now. With physical activity he gets out of breath and the only thing that does help was his inhaler. His inhaler does help him for now. He thinks he missed his second dose in Apr2021. He got chills. Everything happened in Apr2021. Cough Came on the second week. It was the week of 12Apr2021. It was three weeks after his first one. Maybe the 21Apr2021 or 28Apr2021. The patient stated it was still ongoing, but he had recovered with lasting effects. The patient stated he was definitely not recovered. It was not everything so he ok with the rest of the stuff. It was just the breathing that was still there breathing issue began on Mother's Day. It was the first time he noticed it. He went for a bike ride and he felt it again maybe two weeks after and since then he hadn't done any physical activity. He was trying to avoid it. Patient The patient stated he does tech support and for a living and was really thorough. It was good, but his hand was beginning hurt and he had carpal tunnel. He started feeling bad on the 10Apr2021. It started then, a week after his first effect. It was 15Apr2021 or 17Apr2021. He was feeling bad until 24Apr2021 or 25Apr2021. Maybe even 01May2021. He was feeling crappy for about a week and then he started to walk around his backyard, and he was having trouble breathing, but he knew he had Covid. They are possible cardio issue, and they are testing but there was nothing concrete. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 11Apr2021. Description of product complaint of Pfizer Covid Vaccine includes patient clarifies he got Covid three days after the vaccine dose 1. He got the vaccine 07Apr2021. He needs to take a picture with his phone because the sticker was so small. Then 10Apr2021 was when he got Covid. The outcome of the event COVID-19 was resolved with Sequel on 20Apr2021, outcome of events asthma, problems breathing, cough was not resolved, event felt crappy was resolved with Sequel on an unspecified date and unknown for other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021814814 similar report from same reporter

Breathing Issue/problems breathing; Felt bad/crappy; Got Covid after receiving the Covid vaccine; Asthma; Cough; He got chills; hand is beginning hurt; Height shrank he thinks; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0150 and expiration date was 31Jul2021) via an unspecified route of administration, administered in arm left on 07Apr2021 at 12:00 or 13:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation. Patient did not receive other vaccinations within 4 weeks prior to vaccination. Medical history included diagnosed allergies (allergy shots from 2019 to unknown date), according to the thing he was obese, and carpal tunnel. No family medical history reported. Concomitant medications included unspecified allergy shots for allergies (he had been taking for two years or a year and a half because they closed the offices for Covid and then his serum expired so he was going to have to restart again this year). The patient did not receive any vaccine prior vaccinations (within 4 weeks). The clinical course of the events was reported as: he got his first dose on 07Apr2021 and six days later he ended up getting Covid. His healthcare provider advised him to wait two months. He went to the clinic and they were going to give him a second dose, but he was wanting to know if that was ok or if he would have to start all over. He went to two locations and they did not want to give him the first vaccine. According to the CDC they were not allowed to give him three vaccines. He was not asking for three. He had to start over because this happened. They said they did not care and they would just give him the second. He said he told them no and that his doctor told him that he needs to start again. They told him they did not care what his doctor says and that they know more than him. He figured he would go directly to the manufacturer and see what Pfizer says. Pfizer would know the vaccine better than anyone else, his doctor or the pharmacist. Whatever Pfizer tells him to do, he would do. He clarified that he got Covid three days after the vaccine dose 1. He needed to take a picture with his phone because the sticker was so small. Then 10Apr2021 was when he got Covid. Height shrank he thought. But he felt crappy for still another week. For another week he was still coughing and having problems breathing which kind of still lingers, he still has it. He had asthma he guessed now. Asthma was what was diagnosed, but now they were saying it might be cardio. Stated he had recovered with lasting effects. He had never had asthma in his life until after the vaccine. Now they were saying it might not be asthma, it could be cardio. So he was going through tests right now (as reported). With physical activity he got out of breath and the only thing that did help was his inhaler. His inhaler did help him for now (as reported). He thought he missed his second dose in Apr2021. It was three weeks after his first one. Might be the 21Apr2021 or 28Apr2021. Cough came on the second week. It was the week of 12Apr2021. States it was still ongoing, but he had recovered with lasting effects: He stated he was definitely not recovered. It was not everything so he ok with the rest of the stuff. It was just the breathing that was still there. Breathing issue began on unspecified date (as reported). It was the first time he noticed it. He went for a bike ride and he felt it again maybe two weeks after and since then he had not done any physical activity. He was trying to avoid it. He stated he did tech support and R and D for a living and Pfizer was really thorough. It was good, but his hand was beginning hurt. He started feeling bad on the 10th. He got chills. Everything happened in April. He was feeling bad until 24Apr2021 or 25Apr2021. Might be even 01May2021. Asthma: He was feeling crappy for about a week and then he started to walk around his backyard and he was having trouble breathing, but he knew he had Covid. It started then, a week after his first effect. It was 15Apr2021 or 17aApr2021. They were possible cardio issue and they were testing but there was nothing concrete. The events were not resulted into emergency room visit and physician office visit, but he did have a tele visit. He did go get tested as well. The outcome of the events asthma, cough was recovered with sequel and the outcome of dyspnoea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021807432 similar report from same reporter

Within several weeks, I started noticing what felt like heart palpitations that caused me to lose my breath and wheeze/cough. I had called my primary care physician and saw them and said I wanted a visit with a cardiologist. Just one week later, during a work call, it the event happened so severely that I started passing out. Thus, I went immediately to the ER and checked myself in. It was not until mid-July that I got to see a cardiologist, and my symptoms were much less frequent or severe by that time. For several weeks though, it was very uncomfortable and unnerving.

fast heart beat; difficulty in breathing; dizziness; confusion; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other medications within 2 weeks of 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 did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:00 the patient had experienced fast heartbeat, difficulty in breathing, dizziness and confusion after one hour of vaccine administration which was lasted for about 3 minutes or less. The reaction repeated again after 30 hours and lasted for about 2 minutes. But he reported only the effect that happened after 30 hours and not the initial experience. The clinical outcome of the events fast heartbeat, difficulty in breathing, dizziness and confusion was resolved on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.

Strong headache; Feeling like throat was closing; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an Intramuscular route of administration in the right arm on 30Apr2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications were not reported. The patient's past drug history included DK (MANUFACTURER UNKNOWN), since unknown date for an unknown indication. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021, the patient initially experienced a strong headache but then progressed to feeling like the throat was closing. It was reported that the patient went to urgent care for tx. The events resulted in emergency room or department or urgent care. The clinical outcome of the events strong headache and feeling like the throat was closing was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Slight swollen/sore throat; Slight swollen/sore throat; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included slight high blood pressure and medicated for hypothyroidism, under control. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. 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 04May2021 at 06:45, morning after second dose, the patient experienced slight swollen/sore throat that started getting better after couple hours. The clinical outcome of the events slight swollen/sore throat was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Patient developed dyspnea on exertion noted 7 days after his vaccine; Note that he had fully recovered from COVID infection one month prior with cardio on bicycle without drop off of performance metrics. DOE was noticeable on bike rides - almost had a syncopal episode on a bike hill climb at post injection day 10; medrol dose pack started - symptoms resolved in one week. No sign of desaturation noted on pulse oximetry; patient elected NOT to pursue the second vaccination shot given the side effects.

I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later in the day it seemed as though I had COVID again. Winded very easily, no strength, body aches.

RespDepression, Rash, paresthesia extremtiies (>24 hours post vaccine) Narrative: employee developed rash/hives 24 hours after vaccine; which progressed over time (initially arms, waist, then torso, face). She also began having shortness of breath. She took otc bendaryl day after vaccine but due to worsening of symptoms, she went to a community ER where she was treated with several doses of IV bendary, steroids, Pepcid, and zyrtec. Her symptoms have improved but she is still taking benadryl and steroid taper.

he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away

At time of injection slight chest pain under the arm pit, side of chest, hot flushed feeling shortness of breath. Hours after injection moderate pain at injection site. Days after injection growing pain at injection site. Weeks after injection a blob of pain and discomfort rising up my left arm into my left shoulder joint and lower neck.

Pt seen in ED on 1/20 with increasing chest pain - pain in the mid chest, worse with breathing and limited ability to bend over and lay flat.. Troponin negative x2, ProBNP 42.4. Slightly elevated WBC at 11.96 and PTT at 36.7. PT/INR ok at 11 and 1. CT of the chest demonstrates no PE or pericardial effusion. ECG with no significant changes. Pt given ASA 324 mg and Norco 7.25/325 x1 in ED. D/C with Ibuprofen 800 mg TID for pericarditis. Covid test on 1/21 was negative. Pain improved as of 1/26. Per cardiologist review on 1/22 patient with elevated CRP (1.522) suggestive of pericarditis as cause.

9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache requiring taking Tylenol alternate with Advil every three hours. I tested for COVID-19 (PCR) and it was negative. Fever continued. On day 6, I went to urgent care center and was tested again with PCR for SAR-CoV-2 virus. The result was again negative. On day 7, I started coughing so I went to Hospital ER and was admitted. Chest X-ray and CT scan of chests showed pneumonia. The COVID-19 PCR test was again done and was negative. Respiratory panel PCR was negative. Mycoplasma titer was negative. I was given steroid and fever improved. I continued to cough until now (1/30/2021)

Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; strong head pressure sensation; depression symptoms; This is a spontaneous report from a contactable Other HCP reporting for self. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient received first dose of bnt162b2 on 17Dec2020 09:00. The patient's concomitant medications were not reported. The patient experienced Uncontrolled short rhythmic breathing, brief electric shock sensation and little sporadic back spasms, strong head pressure sensation, depression symptoms currently persistent and decreasing gradually on 09Jan2021. Patient had Nasal Swab on 12Jan2021 with negative result. Outcome of events was recovering. Patient received treatment for all events.

3 days after the vaccination, started with shortness of breath, and dysphony. The shortness of breath gets worse walking on stairs and the dysphony worsens when talk. I also noted a hotness sensation, but when used the thermometer the temperature was normal. When checked both lungs didn't have any abnormal sounds. On the absence of these symptoms, I started using Fluticasone with Salmeterol, that improved the shortness of breath, but it came back after 12-14 hours, requiring use of 2 inhalations mornings and nights, the dysphony was related to the hotness and light tiredness. I used the medicines from January the 16th to February 6, when noticed that the shortness of breath improved and didn't required the dose for the night, then stopped the dose for the morning. Regarding the hotness sensation, is still present but the dysphony disappeared.

heart palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration at the left arm on 14Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home/Senior Living Facility. The patient had no medical history. The patient had not received other vaccine in four weeks. Concomitant medication included erythromycin eye ointment. On the 17Jan2021 4PM, 3 days after being vaccinated the patient got heart palpitations and shortness of breath. This continued until the 23Jan2021 when he stopped having the heart palpitations. However, the shortness of breath has continued. It started out as light shortness of breath and has evolved into moderate. He was not gasping for air but it was uncomfortable enough where he has had to take time off of work. He was seen by a doctor on 27Jan2021. The patient did not receive any treatment for the event. The patient had Nasal swab/ SARs CoV-2 RNA Real time RT PCR on 25Jan2021, and the result was negative. The outcome of the event heart palpitations was recovered on 23Jan2021 and shortness of breath was not recovered. Information on lot number/batch number has been requested.

Itching and the sensation of throat swelling. Did not get severe. I took 2 Benadryl with no change. NO RACING PULSE . NO SWELLING OF LIPS OR FACE. Symptoms disappeared after roughly 8 hours.

Patient was nervous prior to the vaccination. Once he received the vaccine he asked to use the bathroom and while he was in there he felt nauseous and came out of the bathroom. He then felt extremely light headed and nauseous that he almost collapsed to the floor. The pharmacist and myself (an immunizing pharmacy intern) rushed to check on him. He reported a little difficulty breathing but was still conscious. We proceeded to call 911 and gave one dose of 0.3 mg Epi-pen. After about 5 minutes he felt much better and was able to sit up. He reported that he never lost complete consciousness but was extremely nauseous and lightheaded. Patient handed over to EMS.

Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec after ) I started to feel an slight painful tingling in the corner of my mouth on my lips I thought it was like a chapped lip it progressed to my full set of lips and it was tingling and slight painful to touch maybe slight swollen but not a lot I then started to clear my throat and felt like my mouth was very dry like a lump in the back of my throat i was slightly having little difficulty in feeling could not catch my breath and considered going to the closest hospital i was getting a little worried so that may have been the cause of resp issue It started to improve and i drove home and in about 10 to 15 mins all the symptoms were gone and i am symptom free now about 24 hours later

Difficulty bre-athing; Swelling of face and throat; A fast heartbeat. Pt went to the ED where he was treated with solu-medrol, pepcid & benadryl and monitored over 2 hrs. He continued to report fever, chills, sore throat, mild to moderate difficulty breathing over the next 2-3 days. He refused further recommendations to return to ED and on 3/20/21 admitted to feeling better

Starting the following day after the vaccine a rash appeared on the whole body, arms legs feet. Rash was treated with some medication throat started swelling, mild headache and burning sensation all over body.

Pain on the side of the injection, chills, difficulty breathing, palpitations and severe dizziness almost like fainting. Tremors in the hands and arms, these lasted approximately one hour and thirty minutes.

Report coughing, chest congestion, nasal congestion, HA, chills and fatigue began day 4 post vaccination. Treatment: PCP tested for COVID-19, Tylenol. Outcome: Waiting on results of PCR test, no improvement of symptoms. Does not interfere with ADLs.

started 1pm on 4/7 patient experienced dizziness, shortness of breath, tightness of chest and throat, lethargic, and sweat profusely. PT woke up and bed was soaked. Anxiety and confusion lingers to today 4/8 - today patient still feel lethargic but not nearly as bad - Recommended patient to keep monitoring and proceed to ER if needed

Left vaccination facility at 1:10PM, March 7th, 2021. About 2 hours later, hives and rash appeared on my upper torso and top of both thighs. When I woke up the next day, the hives and rash covered everywhere except my head. I took a shower and it became hard to breath, my eyes were very light sensitive, nauseous, and very dizzy. I tried to make it back to my bed, but fell twice. The second time I fell I stayed on the ground for about 5 minutes. When I got up, everything was back to normal. I left soon after to the Hospital emergency room to get checked.

Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vaccine is awful. Worse than my covid. At least I know my body is doing what it is supposed to be doing. But it is just miserable. Massive headache, soreness, weird shooting pains in my leg, sweats and chills and nausea, and now the racing heart and shortness of breath.

Chills, shake, fever, headache. Shaking stopped by 6 AM. Fever was low stopped by 8 AM. Took Advil once. Constipation 48 hours. Cramps on day 2. Headache continues after 48 hours. Shortness of breath on day 2. Advil taken morning of day 2. Dizziness at times.

This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male patient (height: 193cm, weight: 99.79kg) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6207) via an unspecified route of administration at right upper arm on 18Mar2021 18:00 (54-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included blood pressure, teeth cleaned (Shortly before the shot, went to the dentist to have teeth cleaned. Directly from Dentist went to pharmacy. Went to pharmacy's Drive Thru to pick up a little antibiotic from the dentist. It was 4 capsules of Amoxicillin. He was supposed to take the Amoxicillin before the dentist office visit, but he forgot to do that. Therefore, soon as he left the dentist office he went to pharmacy to pick it up so he could take it. While he was there, was offered the COVID 19 vaccine and that it was the last shot). Concomitant medications included atenolol tablet from 2016 (been taking for 5 years) and ongoing for blood pressure, and ascorbic acid/ cyanocobalamin/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine mononitrate (ONE-A-DAY). No additional vaccines administered on same date. No history of all previously immunizations. No prior vaccincations wtihin 4 weeks. He got the shot Thursday and by Sunday, many different side effects were coming in. He has had side effects from the COVID VACCINE, but initially he does not want to file report, just thinks that everyone needs to get the shot. He does not have complaints. He is wondering how long the side effects will last, and when they go away. States that he is being treated as he has gone to the doctor's. Also states that he made an appointment with the doctor and almost went to the emergency room a couple of times. Right after the shot, he was getting in the car and his right leg started hurting (on 18Mar2021). It didn't go away for a couple of days. It went away but then noticed his shoes started feeling funny. He wasn't looking at his feet, put his shoes on they felt tight. Then he started to look at feet more. Below his knees, his legs are swollen. Swelling started within 2 to 3 days after the vaccine. The swelling is really severe when standing. Everybody at work has seen how sick he is and his legs. Swelling in the legs has him concerned, thinking maybe it's a blood clot. He was given medicine and would like to see it go away. He keeps his legs up. He has other side effects (all in Mar2021) and is having flu like symptoms. He basically has the flu. He has never had the flu shot. This is the first flu shot (He referred to the COVID vaccine as the flu shot as documented. However, confirmed suspect product as Pfizer covid vaccine) he has had that he knows of. He is questioning if he should get the second shot. He feels a little dizzy. Quick questions get him confused and that it comes and goes. Lungs felt full, gasping for air: not now but, since the doctor gave him antibiotics (unspecified injections, he was given 2 shots at the doctor's office, one in each arm), his lungs felt full. At times he was gasping for air. It went away but thought he was going to die. Now when he gets winded, it feels like he has a dry cough. Gets winded easily. The doctor ordered him an inhaler, Symbicort, but it was very expensive, so he did not get it at that time. He never picked it up because it was too much money. The fluid is not there anymore and he does not feel like he needs this as does not feel like it needs to be cleared. He is having wheezing. He can now take deeper breaths. Fatigue: initially, that he was feeling tired within 1 or 2 days, but he did not recall the next day feeling that way (later stated it was within 2-3 days he started to feel tired). He is still tired. Unable to clarify time frame of fatigue further. He feels bloated and full. Hasn't really eaten but feels real full and bloated. Hot and cold flashes started occurring about the same time as the other symptoms. He had these last evening. He does not get the flu very often and doesn't take the Flu shot. This is the closest thing he can remember having a pretty good episode with the flu. He was also given prescriptions for 2 new medications: Triamterene 37.5mg daily, for leg swelling; Clindamycin, 300mg, twice a day, an antibiotic. The odd thing is that it seems like his eyes are big, like really, really big, like they are really open. It is like big eye balls. States that he is just sick and his body is reacting to getting better. He has not been to work in the last 3 days. States that he is fine, just worried about work. Patient asked for personal advice about going back to work. The outcome of "his right leg started hurting" was recovered; outcome of "below his knees, his legs are swollen/ swelling in the legs/ put his shoes on they felt tight" and Fatigue/feeling tired was not recovered; outcome of other events was unknown.

The pain that is felt is like many needle punctures on primarily the right lung, but has been felt on the left lung at times. The pain is not constant but rather at random times throughout the day. This sudden, sharp, needle-like pain was felt mostly on the following dates: Tuesday, 04/13/2021 (both lungs felt pain twice early in the morning around 1:00 AM and a few more times in the afternoon), Sunday, 04/18/2021 (pain felt twice only on right lung around 2:00 PM), Monday, 04/19/2021 (pain felt on right lung around 10:00 AM and again around 4:00 PM), and on Tuesday, 04/20/2021 (pain felt on right lung around 1:30 PM). Since Monday, 04/19/2021, a constant feeling of discomfort, tenderness, and slight burning has been felt on the right lung.

I recently was recovered from Benzodiazepin withdrawals and got the 1st shot of Pfizer and started having headache and nausea and then started having the withdrawal symptoms come back. Insomnia, air hunger, back and shoulder pain after eating and fatigue, burning feet and Tinnitus.

Patient is a lovely 54 year old- year old male initially seen 4/5/2021, kindly referred by Dr. History of COVID pneumonia in 4/2020 which was complicated by ARF and shingles, Ramsay Hunt Syndrome, with subsequent post-herpetic pain on right side of scalp.He recently received his COVID-19 Pfizer vaccine 3/20/2021 11 days prior to presentation to the hospital with shortness of breath, worsening dypnea on exertion which started 2 days after vaccine. Before this he was biking twice a week, and swimming nearly daily. He did report any medical problems before COVID, was on no meds. 3/31/2021-CT PE protocol showed multiple bilateral PEs without right heart strain. Pulmonary Vasculature: Bilateral filling defects consistent with pulmonary emboli are visualized involving the following: Distal right main pulmonary artery extending to the right lower lobar, segmental, and subsegmental branches, right middle lobar, segmental, and subsegmental branches and proximal right upper lobe artery. Left lower lobar, segmental, and subsegmental arteries. The right heart is not dilated.COVID/flu swab neg, trop x2 neg, BNP wnl. - Started on therapeutic lovenox then plan to transition on discharge to PO xarelto 15 mg bid x21 days then continue with xarelto 20 mg daily. He was seen by Dr. and referred to me for follow up. He had US 4/5/2021- which showed Right Lower Extremity: There is acute thrombus of the femoral proximal vein.Right Lower Extremity: There is no evidence of deep or superficial venous thrombosis in the common femoral, popliteal, posterior tibial, peroneal, GSV and SSV veins. Left Lower Extremity: There is no evidence of deep or superficial venous thrombosis.' 4/5/2021: Initial hematology visit Currently does not have any pain in legs, swelling. Reports that he still is not back to 100%, he got on peloton yesterday and was only able to go 5-6 miles at a slower pace. Denies fevers, chills, sweats. He has some intermittent pain where his previous zoster scalp lesions were. He has been undergoing facial PT. Thrombophilia workup sent which was grossly negative.

I went to ER with extreme chest pain and difficulty in breathing. I was diagnosed with pericarditis.

Strong throat irritation and wheezing began 5 minutes after administration. Breathing not severely impacted. Pulse and oxygen saturation remained normal. Throat irritation continued for the rest of the day, wheezing subsided quickly.

Acute respiratory failure with hypoxia Pneumonia due to COVID-19 virus Patient was treated with Covid medications including convalescent plasma, remdesivir and dexamethasone. Patient is able to wean off oxygen, currently requiring a minimal amount of oxygen support with exertion. Patient will complete antibiotic course

Fatigue and lymph node pain for several days and s(wollen lymph nodes on left side by chest) I had an episode of lightheadedness and labored breathing for 2 minutes and was unable to think clearly or speak in a sentence for 45 seconds. I had chills and needed to be covered with blankets to feel comfortable again. 2.5 hrs later was feeling better with a mild headache.

Patient began to feel short of breath on May 7th. May 10th seen by doctor and diagnosed with new onset atrial fibrillation.

Patient arrived to post vaccine area after first dose of Pfizer COVID 19 vaccine. Patient reported feeling some throat "fullness". No rash/hives/redness/swelling, airway clear and patent. Vital signs 144/91 hr 66 O2 100%. Patient reports taking 50mg PO Benadryl 3 hours prior to arrival. Patient seen by MD on site, given additional 25mg PO Benadryl by physician. MD discussed plan of care with primary care provider. Prescription for PO prednisone arraigned with PCP. Patient monitored for one hour post Benadryl by post vaccine nurse. Reported improvement of symptoms, refused EMS/emergency care/911 services. Confirmed he will be picking up prednisone prescription and will call 911/ seek emergency care if symptoms worsen. Reported to VAERS by supervisor

Fever and chills Myalgia Viral syndrome ED to Hosp-Admission Discharged 4/18/2021 - 4/22/2021 (4 days) Hospital MD Last attending ? Treatment team Acute respiratory failure with hypoxia (CMS/HCC) Principal problem Presenting Problem/History of Present Illness/Reason for Admission Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course This pleasant 54-year-old gentleman with history of hypertension came in with increasing shortness of breath and hypoxia secondary to Covid pneumonia resulting in hypoxic respiratory failure and diffuse pulmonary infiltrates. Patient was hospitalized for management of severe sepsis secondary to Covid pneumonia resulting in acute hypoxic respiratory failure. Patient was also treated for possible secondary bacterial pneumonia given duration of Covid symptoms prior to coming into hospital. Patient made nice recovery and was able to wean off from high flow oxygen down to 2 L with exertion. Patient overall made nice recovery hence he was discharged home. Patient was noted to have rising D-dimers despite clinical improvement in Covid infection. He is at high risk for developing DVTs hence he was recommended to use Xarelto 10 mg daily for 1 month to prevent any risk of DVTs. Patient voiced understanding of this. In he was discharged home with home health care. His readmission potential is low to moderate.

Shortness of breath; Unable to pass stool; Extreme water retention; Excessive mucus drainage; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; This is a spontaneous report from contactable consumer (patient) reported for himself. A 54-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization, at the age of vaccination of 54 years old. Medical history included sleep apnoea syndrome, irritable bowel syndrome, high blood pressure, congestive heart failure, diabetes. Patient known allergies included Sulfa drugs and Lisinopril. Concomitant medications included metformin; hydrochlorothiazide, omeprazole, Blood the (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient experienced shortness of breath after 2 min walk, unable to pass stool, extreme water retention, excessive mucus drainage, swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved, all on an unspecified date with outcome of not recovered. The patient was hospitalized for events for 4 days. The patient underwent lab tests which included computerised tomogram Cat scan): unknown result magnetic resonance imaging (MRI): unknown result, x-ray: unknown result, all on unknown date. No other vaccine in four weeks. The events resulted in: Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment received for events. No Covid prior vaccination. No Covid tested post vaccination. Information about the Lot/batch number has been requested.

Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Fever on days 3,4, and 6. No treatments. Severe coughing with lung pain from day 7- Present. Treatment is cough drops/Dextromethorphan HBr on Day 26. No male penis erections from Day 10-30. No treatments. Extreme Nausea from Day 14-Present. Feelings of vomiting but never did. 4-6 hours each day.

Patient reported feeling "flushed" in the face, lightheadedness, and shortness of breath during 15 minute post-vaccination observation period. States this felt like when he received contrast for imagining which resolved without intervention. Patient was given diphenhydramine 25 mg oral suspension. Patient reported that symptom were improving by time of discharge. MD discussed with patient that additional dose of diphenhydramine could be administered if symptoms persisted. Patient felt well enough to go home. Wife accompanied the patient.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient admitted for another diagnosis and found to have COVID-19 infection two days after vaccination. Vital signs on admission stable except blood pressure slightly elevated. Patient reported shortness of breath with exertion, dry cough, and mild dyspnea at rest. Received cough suppressants and supportive care. Patient discharged medically stable two days later.

Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel a bit achy; Mild headache; vision is hard to focus; Not feeling right on and off; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0150, expiry date: unknown), via an unspecified route of administration, administered in right arm on 02Apr2021 as 1st dose, single for covid-19 immunization. The patient's medical history included Type 2 Diabetes mellitus, patient reported that it was diagnosed at least 10 years ago, and his sugar levels had been in very good control, Covid-19 from unknown date in Nov2020 to unknown date in Dec2020. The patient's concomitant medications were not reported. On 03 Apr 2021maybe started Saturday after the vaccination the patient experienced with mild Headache and not feeling right on and off for 6 days. Patient reported that his head feels worse since he got the slight fever, he took Tylenol to deal with the fever in morning, like 11:00 AM then he did not feel quite right, probably feels worse to next day, sometimes his vision was Hard to focus he was to struggle a bit to focus or just worse because of the fever. since he got the vaccine, in the first couple days, he might have just felt like things were a little blurry and again it was very mild, but it seems worse than it had. on 08Apr2021 the patient feels little achy, and he took the Tylenol and only felt worse because of the fever and later felt better and had general body aches the patient did have COVID back in the end of November, then he recovered in the beginning of December, he got an asthma episode still that he believes was triggered by the COVID. The patient reported that he had a blood work on 03 MAR 2021, he saw his doctor on 10 MAR 2021 and his blood work was pretty normal. His blood sugar was very good, and he also has been very active, he walks every day. The patient enquired second dose was scheduled for 23 APR 2021, was it fine to have a second dose. The patient did not visit Emergency Room or No Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient took TYLENOL 500 mg for the treatment to the events (LOT: SJA014, scan code:30044439; NDC: 50580-449-36EXP: 06/2024). The outcome of the events headache, vision is hard to focus was not recovered, fever was recovering, feeling unwell, general body aches, feel a bit achy asthma episode and was unknown. No follow-up attempts are needed. No further information is expected.

I began to feel the onset of the AE the next morning at around 3:00 AM after the vaccination. Generalize pain throughout my body, muscle aches, slight fever, muscular skeletal pain and general feeling of being extremely tired, and I feel like I have brain fog . Asthma and fibro maylagia are worse since I had the vaccination, sinuses I'm constantly congested. I feel more tired now than I did previously. I will never take this Pfizer vaccination again. My symptoms are not as bad as the week after the vaccination but I have not felt normal or as I did prior to the vaccination.

Heart palpatations started roughly 1 week after second dose, followed by shortness of breath and sweating. Overall lethargic until 2 weeks after second dosage.

The first night I had itching down my left arm and palm of my hands, my wrist. Then my hands swelled up quite large. It lasted about 3-4 hours and then completely went away. The following day, the same thing happened but this time it was both hands around midday. I had some pain, but it was not severe. This lasted 3-4 hours again and went away. The next day, both my armpits swelled up profusely and itched. I had light itching on both arms and swelling again. On my back, the pain shot down my back and in my left hip. The pain was not extreme, it was just uncomfortable. This lasted a few hours and went away as usual. About 24 hours and nothing happened. Then my left hand and palm started itching lightly. My tongue and mouth began itching and swelling profusely to a point where i couldn't eat anything. The next day, my heels started itching on both feet and my toes swelled up. I saw my doctor who provided me steroids. They lasted 5 days and I had no symptoms while on the steroids. When the steroids ended, my throat started to swell and my mouth as well. It got a little difficult to breathe but by the time I got ready to go to the ER it had subsided. This was accompanied by lite swelling and itching in my left hand. The same symptoms keep occurring. I went to an allergist/immunization specialist. I am now on my 3rd run of steroids. As soon I am off the steroids, my symptoms return. I have also been on antihistamines which seemed to help a little in conjunction with the steroids. Without the steroids, they do not help.

Came to ED due to progressively worsening intermittent pleuritic chest pain, fatigue, subjective fevers and chills of x6 days duration. At ED patient found to have elevated troponins and non-specific ST and T wave changes on ECG. cardiology consulted who recommended continuing colchicine + ibuprofen therapy.

Chest pain, shortness of breath, wheezing, fatigue. Sx severe for several days, then waned, completely recovered as of 6/22/2021

Patient stated he received reaction after the first shot. The first shot was given 3-14-21. The lot number for the first Vaccine EN6200. He just thought that they were normal side effects. Patient stated that he was very athletic and now he can not exercise or walk to the car without becoming shortness of breathe.

About two weeks after the second Pfizer covid shot I started to develop chest pains, shortness of breath and arrhythmia. I didn't connect the dots to the shot until i read about the cases in another cou ntry. I am an avid cyclist who rides over 100 miles a month and I noticed my athletic performance was suffering greatly and I would wake up most nights from a sound sleep with chest pain.

Pleuritic chest pain & dyspnea onset 6/19/2021 (approx 2 months post vaccination). Negative troponins, negative chest CTA. Diagnosed as pericarditis and improved with colchicine + aspirin.

fever 101-100 (which resolved now) but having headache; Chills; fever 101-100 (which resolved now) but having headache; joint pain; fatigue; Shortness of breath; bruising at the injection site on right upper arm; swelling at injection site right upper arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL3249, expiration date unknown) 2nd dose, via an unspecified route of administration administered in right upper arm on 02Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, as single dose for COVID-19 immunization. Caller stated that he had his second shot of vaccine on 02Feb2021 in last week and after that he had having side effects from 03Feb2021 as he was having fever 101-100, chills, joint pain, bruising and swelling at injection site and shortness of breath. He stated that that his fever was 101 for the first two days and the third fourth days that it was 100.5. Caller wanted to know if this was normal, and should he go to ER and also mentioned that the fever was resolved now but he still has some joint pain and headache. He also mentioned that due to side effects he has missed four days of work. Therapeutic measures were taken with Tylenol and aspirin to treat the events. On feb2021, the patient underwent lab tests and procedures which included body temperature which result showed fever was 101 for the first two days and the third fourth days that it was 100.5. The outcome of the event Pyrexia was recovered on 05Feb2021 and patient was recovering from the events of chills, dyspnoea and vaccination site swelling and was not recovered from the events of headache joint pain, fatigue, arthralgia and vaccination site bruising. Follow-up attempts completed. No further information expected.

The first thing that happened was I got a stomach virus that lasted for 24 hours. I did end up vomiting 4 times, I had an upset stomach the whole time and had to stay in bed as a result. I could tell my voice was going. I ended up with laryngitis, I had no voice for 3 days. My throat was sore and then I began having upper respiratory pain. By Friday, I went to an urgent care. They gave me an antibiotic and said I should be significantly better in 72 hours. I went back on Monday because I was not a whole lot better. They did a COVID test that came back negative. By Wednesday of that week I was quite a bit better but I still had some congestion. By that weekend I was better. It lasted about a week and a half. The most important part to me is that I never get sick. I got two illnesses quite close to each other and the only varying factor was receiving the vaccine.

cough; I have problems with breathing after only 5 or 10 minutes of exercise which I did not have before I took the first shot; This is a spontaneous report from a contactable consumer. This 54-years-old male consumer (patient) reported that: A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 19:15 (at the age of 54 year) as single dose for covid-19 immunisation. Medical history included Allergy to penicillin from an unknown date and unknown if ongoing Maybe penicillin but I'm clear on this point. Patient other medical history reported as none and in good health. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Patient have problems with breathing after only 5 or 10 minutes of exercise on 14Mar2021 at 20:30 which did not have before he took the first shot, also have a small cough which started after the first shot on 14Mar2021 at 20:30 and it seems to have not gone away. Since vaccination patient not tested for covid-19. Patient visited to physician's office for the events. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as not recovered.

Patient noticed Bilateral Lower Extremity (BLE) swelling approximately 1 week after receiving the first dose of the vaccine—at the time patient was not sure whether the swelling was attributed to accidentally stepping in a hole while work or due to an adverse effect of the vaccine. Patient was prescribed diuretics. During this encounter, the patient also experienced one episode of shortness of breath that lasted for about 30 minutes. At the time of this encounter, patient diagnosed with Essential Hypertension

For the first week, he had fever, body aches, and chills. After that, he had chest pain on both sides. The pain was also between shoulder blades, stabbing in the chest in the middle of night. He had severe shortness of breath. His feet were cold and he could not sleep most of the nights. Today he said his breathing is okay, slowly getting back to normal.

No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11. This continued for two weeks with increasing symptoms of loss of appetite, nausea, abdominal pain, tingling sensation on scalp before going to ER. Visited urgent care on June 16 and bloodwork results indicated elevated white blood cell count and eosinophil count. There was a question as to whether patient had been subjected to a tick bite, so doxycycline was prescribed. After several days, patient returned to urgent care for follow-up bloodwork (June 20th). Results showed WBC and eosinophil count continued to escalate. He went to ER on June 25th and was admitted to the hospital for 5 days. During his visit at Hospital, he was seen by a team of specialists: cardiologist, pulmonologist, hematologist, infectious disease doctor. Multiple tests were run, as the doctors started broad to eliminate certain diagnoses - i.e., bone marrow biopsy, heart cath, CT scans, x-rays, thoracentesis, etc. Patient had fluid around his heart and lungs and was diagnosed with myocarditis. He had no previous heart issues nor family history of heart issues. Test results indicated no abnormal blockage or other issues, other than inflammation and his heart strength was at 27%. I am unable to access his account, as it was disabled after his death. An autopsy is being performed and results are pending; however, the question(s) at large: what was the condition of his heart at the time of his death and was this vaccine-related? Did his myocarditis get worse? Did his heart muscle weaken further and rupture? Please let me know if the autopsy results are needed and where to send them.

I am not feeling well; I am having the fever; there is a mess with my breathing; I am keep sweating up under the fan. I keep sweating. I am breaking in sweat.; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: FA6780, Expiry date: unknown, at the age of 54-year-old), dose 1 via an unspecified route of administration on 29Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she was having some side effects. She was not feeling well. There is a mess with her breathing, little bit. She was having fever and kept sweating up under the fan. She was breaking in sweat all on 30Jun2021. Outcome of the events was unknown.

shortness of breath, chest pain, erratic heart rate. Lasted for one month. I am an endurance amateur athlete so have data in cycling tracker showing the impact this had on my cycling...

About 1 hour after the first vaccine shot, I started to have typical symptoms -- achy body, tightness of breath, basic flu like symptoms. About 3 hours after the vaccine I started having sharp pain (like 8 or 9 on a scale of 1-10) running down the insides of my legs. It felt like lightning was running through my body. I tried to sleep Friday as well as the weekend, and the pain was intense. I had to limit and stop all exercise, and to-date, I can only walk for limited times before I feel pain in my legs again. I have also long-term lethargy and tireness, and find I am sleeping 12-16 hours a day. Prior to Covid vaccine, I would only sleep 4-6 hours a night.

Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue. Was sleeping 12 plus hours a day without feeling rested in the least. No problems with sleep. Also had heaviness of chest - felt like rib cage made of iron- this dissipated by the 28-29th. No excessive cough or fever, did have dyspnea with any exertion and this continues but seems to be lessening. Was not able to work due to fatigue. Yesterday remained tired but felt noticeably different-felt lighter-and today seems promising.

"EE reviewed contraindications and verbalized ""non"" to all contraindications. Vaccine administrd at 1045. 1100 EE stated ""I feel weid"". EE complained of SOB and dizziness. RN and LVN assisted EE to floor and elevated lower extremities. EE was taking deep breaths, pulse normal. RN, Called ED to notify them of EE situation. 1110 EE breathing normal and EE verbalized, "" no feeling of dizziness"" and was assisted to sit in chair. 1113 RN escorted EE wo security golf cart and was transported to ED by Manager of security. EE was stable. ED Note 55-year-old male presenting with dizziness and anxiety after vaccination. This is a potentially seriously ill patient with significant medical complexity and risk who was assessed emergently on arrival given their concerning story. Differential includes but is not limited to orthostatic hypotension, cardiac dysrhythmia, atypical presentation of myocardial infarction, allergic reaction, adverse effect of medication. Fortunately, the patient denies any chest pain his troponin is not elevated with no ischemic findings on his EKG. He is nonfocal neurologically make me doubt stroke. He has no findings at this time to suggest an anaphylactic reaction and his vital signs are within normal limits. Orthostats were checked and negative. He has no anemia, leukocytosis or emergent electrolyte derangements that could be participating in his symptoms. Patient is tolerating oral intake and asymptomatic at this time. He was monitored and on serial reassessment developed no no recurrence of symptoms. He is safe for discharge at this time but ED read precautions were given and the patient was discharged from the emergency department in good condition. Impression: Acute dizziness anxiety, suspect adverse medication reaction"

1st day after chills, minor. 2nd day fatigue all day, swelling of face noticed by wife in the evening, moderate. Can not hear out of one ear. 3rd day, 4am get up to go to work. Still can't hear from one ear and my eyes are swollen almost shut face swollen. By 1100am it had gone down just a bit. Went see family doctor for assistance. He prescribed, Prednisone 20mg twice a day for three days. Benadryl 25mg every 6 hrs until swelling comes down. There may be some breathing difficulty but it is so far very minor unless exertion happens, then it's noticable.

angio edema of lips and periorbital area; Nasal and sinus congestion; rash on chest and face; wheezing; This is a spontaneous report from a contactable physician. A 55-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 17Jan2021 at a single dose for COVID-19 immunization. Medical history included mixed hyperlipidemia. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on Jan2021 via intramuscular. On 17Jan2021, the patient experienced nasal and sinus congestion, rash on chest and face, angioedema of lips and periorbital area and wheezing. The outcome of the events was not recovered. The patient received an OTC antihistamine and monitored the condition. Information on the batch/lot number has been requested.; Sender's Comments: Based on a chronological association and known product safety profile, a causal relationship between event angioedema and BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through

This was my 2nd shot. (1st shot was 3 weeks prior). Four days after 2nd shot, I developed wheezing and congestion. On my 6th day, I had an asthma attack. I obtain an albuterol inhaler and used it occasionally for the next 3 days. Today, after 11 days, I still have a slight cough but feel like I'm getting my energy back.

Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite. Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin, d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city.

Patient had the first dose of the Pfizer COVID vaccine (LOT# EL9264) on 1/29/21 at the vaccination center at Medical Center (set up in Hotel). He had the second dose on 2/19/21 (LOT# EN6201) at 12:30pm, and reported leg pain and difficulty breathing on 2/26/21 as he was going to bed. He presented to the ER at Hospital that day, and was diagnosed with a deep venous thrombosis and pulmonary embolism. He is currently taking Xarelto, and will schedule an appointment with Hematology, as he has no family or personal history of clotting disorder.

Itching, rashes, redness of skin and difficulty of breathing. They would be gone after a few minutes of taking Benadryl one tablet 25 mg.

Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vaccine, the pain started the second day and the injection site got swollen. But this second dose was within 2 hours of my vaccine even more and overwhelming fatigue. - aches, chills, muscle cramps, coughing, sweating - those lasted three days; headache - ever present and felt like head was in a vice; breathing was an issue - asthma was triggered on Sunday - I started prednisone - informal dr consultation with a friend - on Tuesday because of the asthma and by Friday I was feeling halfway better again and by the following Sunday about 75% better. 9 days later I was back at work. It took that week back at work though to get back out of the funk and by the following weekend I was close to 90%. Pain in the shoulder lasted about two weeks - it was quite tender for that long.

injection site pain, minor, 36 hours duration, resolved no treatment tiredness, 10 hours duration, resolved - sleep swollen lymph nodes, start within 30 minutes, duration 8 hours, resolved no treatment throat swelling, start within 1 hour, duration 6-8 hours, resolved no treatment dizziness and weakness, start within 2 hours, duration 6 hours, resolved - sleep

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: note: pt stated no allergies on form and when asked verbally by immunizer. at the 7 minute mark he began to exhibit weakness and started falling off his chair. seemed like he was going to pass out. his breathing seemed labored. we position pt on floor, rph admin epipen to left outer thigh. 911 called. ems responded. pt felt better after epipen. bp, hr normal. pt taken to er by ems

Sore throat. Extreme Fatigue, fever, nasal and head congestion, chest congestion (coughing up phlegm)

11:10 PT STARTED TO FEEL TIGHTENING IN THROAT, PT BROUGHT OVE TO VACCINATION STATION FOR FURTHER ASSESSMENT. AIRWAY PATENT, NO STRIDOR OR S/S OF RESPIRATORYDISTRES NOTED AT THIS TIME. VSS B/P 152/90, HR 90, RR 18, SPO2 99%. BENADRYL 50 MG PO GIVEN X 1. PA OVER TO ASSESS PATIENT. PT STATES HE HAD A SIMILAR MORE MILD EXPRERIENCE WITH FIRST PFIZER DOSE. 11:30: PT STATES EVERYTHING STILL FEELS THE SAME, NO CHANGE OR WORSENING OF SYMPTOMS AT THIS TIME. 11:45 PT STATS LEFT SIDED CHEST PAIN 7/10 STABBING. MEDICAL PROVIDER NOTIFIED. PT BROUGHT BACK TO OBSERVATION ROOM. ASSESSED BY EMTS. 12 LEAD EKG PERFORMED. PT SR WITH 1ST DEGREE BLOCK. HR 70. B/P 149/94, SPO2 99% 11:50 PROVIDER IN TO SEE PT. PT TO BE TRANSFERED TO FACILITY FOR FURTHER TESTING AND TREATMENT.

High fever , extreme sweeting , throat closed up but not completely. Still running low grade fever and have swelling and soreness still in throat. 4 days and counting. Two days of almost closed throat and soreness still continues.

Little tingling in throat within 10 minutes of vaccine administration . Which subsided within 20 minutes. I took 20mg of reactine as prophylaxis before injection Cough and serious wheezing started night of Saturday Jan 16th ; had Covid tests done negative Ended up in urgent care Jan 29th , 2021

No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as typical vax reaction 4 me. But that 2nd day after, G.I. issues began middle of nite. So fatigued & short-of-breath, barely made it to dialysis, where they put me on oxygen. All during treatment, BP fluctuated 90-170, temp 96-101, chills (shivering!), continued fatigue & weakness, even after leaving - they wanted to give me antibiotics & send me to e.r.!!! Staff did collect blood sample for culture (result in 24 hrs + neg). I refused antibiotics and e.r., convinced it was vax reaction, and I was right, all normal another day later. Anxious bout 2nd shot ??

On the night after my vaccination in bed I was very dizzy. Next morning dizzy and weak, and now whenever I put my head back I get dizzy and still when I go to bed dizzy when I?m laying down and when I move on my side. The dizziness does not stop. I?m also experiencing shortness of breath as a result from my daily walks, this never happened before.

55-year-old male with no diagnosed past medical history presents emergency department after cardiac arrest. Per patient's daughter, patient was feeling at baseline today. He got his COVID vaccine at 5 PM this evening. He was running some errands and called his daughter at 8:40 PM. He told his daughter he was not feeling well. She reports he sounded out of breath and sounded as if he was slurring his words. Daughter told him to pull over and she called 911. She met him on the side of the road and he was gasping for air. She arrived at the same time as EMS. Upon arrival of EMS patient was in ventricular fibrillation. He was defibrillated 3 times. He also had one episode of ventricular tachycardia. He was given 300 mg of amiodarone and 3 rounds of epinephrine with had return of spontaneous circulation. King airway was placed and patient was brought to the emergency department.

Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest, lungs hurt, body aches earlier in week, had to stay in bed on and off all week, no energy, forced myself to eat, severe coughing by Wednesday 4/7/21 which has only stopped on 4/10/21. was most severe Thursday 4/8-Firday 4/9 Could not concentrate all week, even watching tv.

I was at the Neuroscience center and in the auditorium shorty after. Where I started to sweat, blurred vision, very difficult to breath and losing some motor skills. Luckily I got up in time and went to one of the nurses up front that got me to a waiting area to cool down, some water and to breathe without the mask. Probably stayed about 30 minutes as my vitals were pretty low before returning to normal. I will say it was pretty hot and a little crowded in there and the nurses all said it's been happening a bit with the heat in there. And it was about 11:40am so I only had crackers in the morning.

Felt tired and worn out and had a fever of 99. Also coughing and congestion going down my throat. all this started Sunday after noon and continue through the present time, although feeling more strength today

fatigue mild headache shortness of breath chills low grade fever diagnosed with ACUTE PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONATE had two hospital doctors two hematologist two pa-c specialist all suspect pfizer shot . taking eloquis for 90 days

Swollen left testicle, and on 04/16/2021 headache and sinus pain and slight breathing issues and chest pain

Patient was diagnosed with deep venous thrombosis 11 days after receiving Pfizer Covid-19 vaccine. Patient developed L leg pain and swelling 3 days after vaccine. First notice pain with swimming when he felt a cramp. Over next few days leg became painful while walking on it. He had no shortness of breath or trouble breathing except for a brief time while he was swimming and felt as if he was slightly shorter of air than normal. He has had no injury to the leg that he can remember. He has not been immobilized or gone on long trips lately. Patient was diagnosed with DVT on 4/13. Patient was started on Xarelto

30 to 45 minutes after getting vaccine, pt began to experience: itching all over body, throat closing, lips swelling. Pt went to ER and was given IV benadryl and steroid. Pt has to continue to take benadryl every 4 hours due to itching

feeling dizzy when he went to bed/dizziness occasionally throughout the day; feeling weak; a little bit out of breath; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 55 years old on 02Apr2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feeling dizzy when he went to bed/dizziness occasionally throughout the day on 02Apr2021, feeling weak in Apr2021, a little bit out of breath in Apr2021. The patient was calling on behalf of her husband, the patient had first dose on 02Apr2021 and started feeling dizzy when he went to bed that night, he's dizzy when laying down in bed sometimes it woke him up, he had dizziness occasionally throughout the day and he was also feeling weak and a little bit out of breath. The patient was concerned on getting second. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Date of service was 4/2/21 and patient is still currently hospitalized. Diagnosis is acute hypoxemic respiratory failure due to COVID 19.

Pt. stated experienced SOB, dizziness after first Pfizer vaccine. Pt. had taken methotrexate prior to vaccination. Juice and water provided to pt. Pt. states feeling better after ingestion. Pt. offered to lay down, pt refused. Vitals signs taken, all stable. Pt. educated on food and hydration before and after future vaccinations.

Skin rashes on chest, arms, abdomen, legs, backs, and difficulty of breathing. These symptoms would disappear 5 or 10 minutes after taking Allergy Relief.

Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/2. He had expected post-vaccine side effects including headaches, muscle aches, fever/chills, which lasted 2 days. On 4/19, he presented to the ED with 2 days of R sided pleuritic chest pain, dyspnea, and was diagnosed with PE based on CTA. He was started on treatment with apixaban and his symptoms of pleuritic pain and dyspnea have resolved.

Right ear itchy after getting vaccine. Around 3 pm Right ear itchy, throat tight , sore under jaw like when you swallow clearing throat .No problem eating dinner.7 pm Trouble swallowing feels stuck when swallows food, esophagus tight. 10 pm took Benadryl . Panicky at 12 midnight. Benadryl helped still feels tight did not want to take second benadryl . Watched until 1:30 am felt tightness under chin but esophagus relaxed. Ringing in ears Saturday all day and still has it. Started Friday but has gotten worse. was told to inform patient to go to PCP.

Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could see all of his veins; Head rush; Felt like he was going to spazz out; Sweating; Diarrhea; Headache and pressure at his temples; His ears were ringing; Left arm pain from injection site; Drop foot; Legs went to sleep; Arms were roided out or supercharged/Forearms did not feel like his blood was right; Difficulty/pain breathing in the upper chest; Difficulty/pain breathing in the upper chest; Pretty big at the base of his left index finger, red spot; Pain in the right thumb base/Pain in base of right foot; He felt like he was going to die 5 times; Thought he was having a stroke; Heart rate would go up or be faint; Lost four pounds during this, and gained one back; Stiff right arm/Left thigh was stiff; Thrashing event; Heart rate went up; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, expiration date: 28Mar2021) via an unspecified route of administration on left arm 24Mar2021 10:00 at single dose for covid-19 immunization. Medical history included cytomegalovirus from on an unspecified date 2010 and Palpitations. The concomitant medications were not reported. The patient reported, he has gained back a pound and that he is starting on the road to recovery in the last week. Stiff right arm lasted the first and second week. It started the first day of when he got the shot. The next morning, he calls a thrashing event where he felt like his limbs would not work. They did work, but it felt like he needed to move them around. He was thrashing in bed and making the motion with his big joints, then getting into the small joints. It was his arms and legs. Over the course of like an hour, his heart rate went up to like 120. He does not qualify this as racing, but his heartrate is normally 60. This was several times over the course of the first week so it would have been around 04Apr2021 or 03Apr2021. Events occurred 9 days later, which is what he is considering this first week. His left arm was where he got the vaccine, but his right arm was stiff. He felt like he was going to die 5 times. He also had extreme fatigue. He never went to the emergency room. At this time, his glucose was high and his zinc was low. The doctor thinks the extreme fatigue was the antibodies reacted to the cytomegalovirus. He adds that the back of his knees was cramping in the first and second week. In the right arm, he had some small very small bruises. His forearms did not feel like his blood was right. He does not know how to describe it, but he has had metal slivers in his arm in the past and it felt like that, like an infection. He does not know how to describe it. He adds that in his upper right arm inside, he could see all of his veins, like a roadmap. He also had some other things, like his left side of his head rush, like it felt like blood was rushing from the top to left side of his brain. At dinner and meals he had several instances he could barely sit there, he felt like he was going to pass out or spazz out. His limbs felt like they were going to spazz out. In second week, he had several nights where he sweated a lot overnight. The second week into the third week, he did not have the thrashing stuff anymore but for pretty long his heart would go up a notch and/or the heart would be faint. He had diarrhea when he got up. It did not go up to 120, but maybe 80, Headache and pressure at his temples, ears ringing. Left arm pain from injection site. It started with a bang and really hurt. It was really sore and kind of spread into cramping. It was stiff and the source was the injection site. At work, he thought he was having a stroke. His left leg and thigh were stiff and spreading feeling. About 20 minutes after sitting, his legs did not work, and he collapsed. He had Drop foot when his legs got stiff. It took like a week to retrain his arm and leg, like he had a mini stroke. He did therapy for himself and retrained his arm to play guitar. He had a little bit of stiffness in his left arm that comes and goes, stiffness in his left thigh that comes and goes, and his ears are ringing a little bit and it comes and goes. He is not getting second vaccine. He took zinc per his doctor recommendation, but it did not go well. He felt like his arms were roided out or supercharged. He had difficulty/pain breathing in the upper chest, a pretty big at the base of his left index finger red spot like blood collection, and pain in the right thumb base. He had pain in the base of his right foot. Blood tests were in the second week. Glucose was high and he is hypoglycemic. Glucose 117 mg/dl (79-115 normal range), zinc 54 mcg/dl (60-120 normal range), CMV IGG AB >10 u/mL (positive is > or = 0.7 range). The outcome of the events was unknown.

Patient reported palpitation and rash on the opposite arm after receiving the shot. Blood pressure was 164/89 and he was alert and able to communicate. He took 50 mg of Benadryl and 911 was called. Patent then reported shortness of breath but he was able to talk. 911 operator advised against epipen shot and recommended to wait for paramedics. Patient was asked by paramedics if he wants to be taken to hospital and he said yes and was taken to hospital

Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI. On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.

2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; Received First dose on 03Apr2021, Second dose on 17Apr2021; Received First dose on 03Apr2021, Second dose on 17Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Apr2021 17:00 (at age of 55 years old) (Lot Number: EW0172) as single dose for covid-19 immunisation. The patient other medical history was none. No known allergies. The patient's concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on 03Apr2021 17:00 (Lot Number: EW0150), also at age of 55 years old for covid-19 immunization. The patient reported that 2 hours after 2nd dose, he started to cough and wheeze and felt his throat was closing. He didn't want to go to the hospital and it felt better after his wife gave him diphenhydramine (BENADRYL). Adverse event start date was reported as on 24Apr2021 19:00 (CLARIFICATION PENDING). Events were reported as non-serious. AE treatment was reported as "no" (CLARIFICATION PENDING). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event outcome was recovered in Apr2021.

tested positive for COVID; Disorientated; Difficulty breathing; Fever; cough; This is a spontaneous report from a contactable consumer (the patient's wife) received from a Pfizer-sponsored program. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 02Apr2021 (also reported as 03Apr2021) around 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no adverse events following prior vaccinations. The patient tested positive for COVID on 10Apr2021 and went to the hospital. The patient also experienced fever, disorientated, and difficulty breathing. The patient's wife clarified that the patient went to the emergency room and was hospitalized for four days, from 16Apr2021 to 20Apr2021, for all three symptoms of fever, disorientated, and difficulty breathing. The patient was hospitalized for COVID. It was also reported that fever was from 11Apr2021 to 18Apr2021, disorientated from 16Apr2021 to 17Apr2021, difficulty breathing from 14Apr2021 to 24Apr2021, cough from an unspecified date. On 10Apr2021, COVID test results were positive. On 24Apr21, COVID test results were negative. For treatment at home, the patient took acetaminophen (TYLENOL), ibuprofen (ADVIL), and an albuterol inhaler. When he was admitted to the hospital, he was given IV fluids, TYLENOL, dexamethasone, a blood thinner (did not know the name). He also took cough medicine called guaifenesin at the hospital. When the patient was released from the hospital, he was given 6 days of prednisone to take. The patient did not have an appointment yet for the second dose. All events were considered medically significant. The outcome of cough was unknown. The other events recovered on the following dates: tested positive for COVID- on 24Apr2021, fever- on 18Apr2021, disorientated- on 17Apr2021, difficulty breathing- on 24Apr2021. Information on lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498996 same drug/similar event, different patients;US-PFIZER INC-2021502035 same drug/similar event, different patients;US-PFIZER INC-2021502065 same drug/similar event, different patients