Pfizer

In December 24th late in the evening I experienced sweats followed by extreme chills for a few hours. I also had upset stomach and diarrhea throughout the day. All symptoms only lasted the day after injection.

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.

Severe nausea x 2 days, body aches x 1 day, fatigue, tiredness, moderate soreness at injection site. All symptoms started the day after the vaccination. Was administered

Administration at 2:00pm; At 2:15, patient complained of nausea and became diaphoretic. He was placed in a supine position and provided a moist cloth for his forehead; vital signs and blood pressure remained stable. He was provided a snack and dishcarge d to home at 2:50pm

Pfizer-BioNTech COVID-19 Vaccine EUA Starting two days after injection: headache, sore throat, cough, exhaustion, some intestinal cramping

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.

general ache/pains, headache woke me up ~3:30am. movement hurt, pain progressed, headaches got worse, never went away. nausea, fever throughout the day, general tiredness and increased join point all day. swollen glands in arm pits. headache pain completely impaired daily activity. Tylenol in the afternoon for fever, dramamine for nausea Effects lasted 24 hours... headaches persisted 5+days

Right lower quadrant pain over 24 hours. Diagnosed with appendicitis via CT scan and underwent lap appendectomy. Symptoms resolved post-op

Had COVID test/positive test result/Tested positive for COVID-19 after getting the initial dose of the vaccine; I am sick with COVID 19; This is a spontaneous report from a contactable other HCP. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in left deltoid/left arm on 05Jan2021 at a single dose for covid-19 immunization. Medical history included ongoing high blood pressure diagnosed about 7 years ago and ongoing GERD that he had his entire life. There were no concomitant medications. The patient got the first vaccine on 05Jan2021, then tested positive for COVID-19. The patient added that he experienced fever of 103, body aches, headache, cough, fatigue, nausea and vomiting and diarrhea times one week.Had COVID test Friday, 08Jan2021 and positive test result received on Saturday, 09Jan2021. The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.

Inmate seen in health services with complaint of left ear pain extending into left cheek and around his mouth. He has some drooping of the left side of his mouth and he is not able to blink or close his left eye. He noticed symptoms on 1-23-2021, the Saturday after getting the COVID 19 vaccine on 1-21-2021 (Thursday). Had some trouble swallowing liquids without having them dribble out the left side of his mouth and he says that he is not able to chew on the left side without biting his tongue. Says that his left ear is causing him a great deal of pain.

STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA, FEVER, LEFT ARM AND AXILLARY PAIN ,

Fever; chills; nausea; vomiting; diarrhea; sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included COVID prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, chills, nausea, vomiting, diarrhea, and sore arm on 16Jan2021. No treatment was received for the events. The patient was not tested for COVID post vaccination. The patient was recovering from the events.

Fatigue/chills/nausea later that day, (Saturday) runny nose on Monday, nasal congestion on Wednesday, tested positive for COVID-19 (PCR) on 1/15/2021

Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest congestion, cough. Loss of taste and smell (this began on 01/31). All side effects symptoms are still present on 02/01.

About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said my eyes were open but glazed over. I also started shaking. When I woke up I was confused and felt nauseated. A few minutes after I woke up the EMTs ran my vitals. My heart rate was in the 40s and my blood pressure was in the 90s. I have never had a reaction like this to any other shot/vaccines.

First day - Cold sweats, Fever, Chills, Headache, Nausea, Diarrhea, Body aches, Extreme back pain. Second day - Back pain, Nausea, No fever

Patient had dizziness, extreme headache and muscle and join pain as well as diarrhea on the second dose of the vaccine. The symptoms about a day and half.

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.

Saturday evening experienced headache and nausea. Both symptoms continued and left upper arm began to feel hot and very painful and sore to touch which started later in the evening. Sunday all day nausea, headache and sore arm continued with chills and whole body feeling hot. I may have had a fever but did not confirm with thermometer. Treatment included increase hydration with water and rest. I felt like my normal self on Monday morning.

Symptoms began at 6pm. Fever, headache, runny nose, chills, pain in left arm, nausea. Took 1 Advil at 7pm. Advil is cutting the pain.

My parents live with my family of four. My father was exposed to COVID when he was in the hospital from 1/19-1/21 getting his hip replaced. My mother and wife lost their sense of smell on Sunday 1/24. They got rapid and differential PCR tests on Tuesday 2/2. The rapid test came back positive for both of them. I served as primary care provider for all four of them during their illness. I started to experience mild symptoms on 2/13. Symptoms included: reduction in sense of taste and smell (could not smell cinnamon or taste spicy foods), headaches, runny nose, waves of nausea. I went to an medical center on 2/16 to receive the Rapid, PCR, and flu differential tests. My Rapid test came back negative but my PCR test came back positive on 2/17.

Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision. patients wife called 911 and patient was taken to Hospital ER for emergency evaluation. CT scan revealed a brain bleed. patient was rushed to Hospital Neuro ICU for immediate care. patient was at Hospital from Sunday Feb. 14th - Tuesday Feb. 16th. patient blood pressure (which is usually well controlled) had spiked up to dangerous level and caused a rupture to an AVM in the tegmentum region of his brain. hospital treated patient and got his blood pressure regulated. Patient discharged on Tuesday Feb. 16th 2021 with the expectation of making a full recovery after several weeks of rest.

Diarrhea appeared fairly quickly and lasted about 18 hours. Used Pepto Bismol and generic Immodium roughly 6 hours apart. Second symptom is exhaustion. Still ongoing. I just want to sleep.

Headache and nausea - they got a little worse after the second shot; headaches got a little more intense . I still get headaches now. I still get nausea but not as much as before. January 25th, 2021 and another one on January 26, 2021 at the medical center.

Chills; no fever; real bad headache; nausea. Headache and nausea it lasted all the way until the second vaccine - January 19, 2021. I was taking Tylenol which didn't really help. The headache and nausea was pretty steady throughout the day and night - rough during the entire day and at night. Doctor's visit on January 25th, 2021 and another one on January 26, 2021.

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.

After receiving the vaccine, patient started to feel dizzy, nausea, headaches, and neck pain. @1213: diphenhydramine 50 mg po x1; lot#202906 exp 9/2023 @1216: HR 69 bpm, SO2 99%, BP 120/98 mmHg. @1227: HR 54, SO2 98%, BP 150/90 mmHg @1238: patient discharged to home. @1349: Called patient at home, arrived safely.

Feverish, nausea, body aches, pain/swelling and bruising at injection site, hurts from left side of face and ears down to wrist and back to shoulder blade on left side, hurts under left arm pit, tired, soreness in whole body

began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week - diagnosed with diabetes on March 1

Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Additional Details: Patient warned immunizer that he was anxious about receiving vaccine because he is scared of needles. Once he received the vaccine, he became nauseous, sweaty, clammy, dizzy and lightheaded. Pt explained to immunizer that he was switched to night shift and had taken his diabetic meds without food soon before his shift at 5:30pm. An EMT was on scene and she proceeded to call more medics. I checked on the pt and he was vomiting and very pale. Medics checked pt vitals and okayed him for work.

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.

Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired and sluggish and slow". Soreness in arm is painful and radiating to neck on left side Narrative: Advised to seek treatment from PCP or Emergency services if symptoms do not improve, worsen, or become severe Other Relevant History:

8 hours after shot extreme nausea. In one instant, extreme feeling of an instant blow to the head, extreme ringing in ears, unable to hear, disoriented, unable to speak, incoherent, rapid fever that quickly reduced. Symptoms disappeared quickly and were gone within an hour. Afterwards mild headache, fatigue, nausea persisted for 2-3 days.

Patient stated he might of passed out for a few seconds. He also stated he felt dizzy and nauseated . Onsite EMS was called vitals HR 56 BP 105/68. Patient was released to go home.

Systemic: Fainting / Unresponsive-Medium, Systemic: Pale, aware of surroundings-Medium, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Pt was sitting with wife about 10 minutes after vaccine became unresponsive. Wife got my attention. Had weak pulse, cold to touch, but was responsive to me. Knew his surroundings but said didnt feel 100%. Had NP from minute clinic look at him and called EMS for extra evaluation. Pt was transported to hospital

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.

1.5 days after vaccination, patient started uncontrollably vomiting dark green liquids, seen in EC and discharged.

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

Dizziness; upset stomach; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 at 07:30 (at the age of 40-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications included losartan, metoprolol, omeprazole (PROTONIX) and citalopram. The patient previously received Keflex and experienced allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced dizziness and upset stomach on 24Mar2021 at 06:00. No treatment was given for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

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.

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.

1100 Pt reports increased in nausea and "feels like is going to throw up". Pale and diaphoretic. Pt reports name and states has hx of vagal with injections/vaccinations and sutures-which occurred 2 years ago. EMS activated. Pt increase with diaphoretic and vomited x 2. EMS assessed and controlled situation. Pt appeared to recover without difficulty after 10-15 minutes. Drank 16.9 oz. bottle water. Ambulated independently without asst to exit. Pt reports he is not driving and he has a ride. Pt instructed to inform medical to lay down prior to 2nd/next injection/vaccination in 3 weeks. Pt verbalized understanding.

Dizziness starting the second night after the vaccine. Dizziness was worse at night for the first three nights. on the fourth day after the vaccine, dizziness persisted throughout the day and persists currently. Mild to medium dizziness resulting in mild nausea, light headedness, loss of balance when changing directions while walking, some stumbling.

4/10/21, Swollen/ sore lymph nodes left arm pit. 4/12/21, Trouble swallowing food. Flare up of EoE 4/13/21, Dizziness, low grade headache, tingling of skin on face and hands. Elevated response to seasonal and food allergies . Ongoing 4/15/21, Swollen/ sore lymph nodes right arm pit.

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

note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was worrisome in case of side effects. dizzy first day, chills, fast heart. Everyday so far feel off and on tired, dry mouth off and on, dehydrated? Felt tired within an hour of injection on Tuesday. I don't remember if my stomach was growling on the first night on the day I got injected and I just went to bed. The next morning I woke up really thirsty/hungry and tired. I slowly made myself breakfast. Sat down to eat on a stool and felt dizzy. My heart raced for 30 sec as I carefully made my way to the flow to be safe. I had the chills, a bit shaky for a short period. I called my doc who told me to stay hydrated. The clinic where I got injected DID NOT inform me about dehydration. As of today, I still have off and on a dry mouth, feel more of an empty stomach at meal time, tired off and on, and maybe dehydrated. I work from home so I am not pushing myself. I have not felt dizzy again and am decent at taking in water now.

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

4/10-1945 Caller states patient had flu like symptoms post vaccine. headache fatigue fever diarrhea Cramps. Cramps and Diarrhea has continued and is still every 15 minutes . Advised to seek medically attention diarrhea every 15 minutes for days needs medical attention . 4/11-Patient's spouse returned call, patient continues with diarrhea, not as many bouts as yesterday, started taking Immodium as directed today. Will follow up tomorrow. 4/12-Follow Up: He stated he didn't go to the urgent care he just took Pepto Bismol and Loperimide to help with diarhea (which help tremendously). As of 4/11/21 he stated all his symptoms have subsided (diarrhea, headache, etc) and feels a lot better.

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

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

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.

Fever - Unverified by Medical Treatment Facility Dizziness Sitting & Standing Vomiting Psychosis - Inability to Communicate Properly Major Anxiety Allergic Reaction - Unverified by Hospital CT - Scan Not Performed Psychological Evaluation Not Performed

Hit by a train (figuratively), Sore Arm, High Fever (102.1), Vomiting, Diarrhea, Headache, Close to fainting, Shake, Chills, Loss of Appetite (didn't eat for 10 days), Fatigue. Symptoms were intense for 2 days, then were mild for 2 days.

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

Pt was vaccinated with Pfizer brand of covid vaccine given intramuscular at his left deltiod administered by LVN today 04/29/21 at 3:36 pm. At 03:48 pm I, RN (EOA) noticed pt was pale and diaphoretic, came near to pt and asked how he is doing pt verbalized he is okay, when I was about to move out he eventually stated that he is dizzy and nauseous. I took initial set of vitals at 03:49 pm BP 100/60mmhg, PR 60 bpm, RR20 cpm, Temp 96.1F, Spo2 98% at room air. I called for admin assistance from admin assisted me in monitoring the patient together with another RN. Pt was given water and felt relieved. Ice packs was placed on pt's nape and made him relaxed. Pt had no complaints of chest pain and SOB. Pt had no history of DM, no HTN, no known allergies and had not gotten any flu shot for long time. Pt also verbalized that he hadnt slept well for the past 2 days related to job adjustment and hadnt eaten since yesterday that might have contributed to his complaints of dizziness Reapeat set of vitals were taken at 3:58 pm BP 100/80, PR 64 bpm, RR 18 cpm, SPO2 99% at room air. Pt stated he is back to normal and no more complaints of dizziness or nausea. Pt refused to call 911 as well. at 4:06 pm latest BP 126/88 mmhg. At 4:20 pm pt was assisted by me RN to his car with resolved dizziness and nausea. Pt was advised to have an appointment with primary physician for wellness check and health teaching was given related to side effects of vaccine and when to contact 911. Pt verbalized understanding and is appreciative of the care provided.

early appendicitis; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (at the age of 40 years) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient began to have severe abdominal pain so he went to the emergency room and was evaluated and then about 8 am it was confirmed that he had early appendicitis. The event was considered serious for hospitalization. Patient would like to know if his appendicitis diagnosis is related to the COVID vaccine or if it is completely irrelevant. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Swollen lymph nodes under injection arm, injection site swelling and redness, fatigue, dizziness, lightheadedness, nausea, joint pains

Hit quickly and strongly. Dizziness, nausea, waves of hot and cold, with profuse sweating. This was followed a couple of hours later by body aches, alternate hot and cold spells and headache. Injection site was sore, which started the previous day. Massive headaches from 4/9 to 4/11. NSAIDs somewhat helped symptoms. Began feeling human on 4/12. Was like a bad influenza, but no one else in household had any symptoms subsequently, so assume it was the vaccination.

patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diarrhea/abd pain, with 2 ED visits ultimately admitted to hospital and diagnosed with MIS-A with elevated bnp, troponin, and inflammatory markers, and treated with dex 6mg x 10 days with complete resolution on follow-up.

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.

Onset of severe LLQ abdominal pain 10am 5/1/21. By 5pm same day, decided to seek emergency services. Went to ER. Diagnosed with kidney infarction

Developed severe abdominal cramps on my left side around 7 p.m. on Wednesday, April 28. Cramps were intermittent and in varying degrees of intensity. Cramps continued through Friday, April 30 with varying intensity. Attempted to treat with Tylenol and GasX. Starting around 10:30 a.m. on Saturday May, 1, the pain in my left side increased in intensity and was not waning. After consulting with a telehealth practitioner, I went to the emergency room and was quickly admitted. My blood and urine were tested, along with CT scans of my body. The CT scan revealed that blood was no longer reaching two parts of my left kidney and I was diagnosed with a arterial thrombosis. I was fully admitted to the hospital and a heparin drip was immediately started.

Presented to hospital emergency department with complaints of flank and abdominal pain. CT imaging showed two areas of attenuation within kidney that were determined to be a renal infarct. Patient was anticoagulated, hematology was consulted, hypercoagulable work-up ordered, other etiologies for thrombotic even ordered. Transitioned to apixaban and prednisone with plan for outpatient follow-up after 3-day hospital admission.

Severe cramping, diarrhea, vomiting, fatigue like I have never experienced before. This should not be injected into humans

Severe Diarrhea at 36 hrs after 1st dose, continuing for 48 hrs Severe Diarrhea and muscle aches 20 hrs after second dose.

Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: vivid dreams-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: general feeling of increased inflammation of joint pain

worried it's appendicitis; have abdominal pain on the right side; This is a spontaneous report from a contactable consumer reporting for himself. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 05Apr2021 (at the age of 40 years old) as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. 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. On an unspecified date in Apr2021, the patient started to have abdominal pain on the right side, 1 week after his second dose. The patient was worried it's appendicitis. The events resulted in a physician's office visit. The patient did not receive any treatment for these events. The outcome of the events abdominal pain and suspected appendicitis was not recovered. Since the vaccination, the patient had not been tested for COVID-19. Information about Batch/Lot number has been requested.

I developed sudden-onset, severe, crushing pain in my left shoulder, radiating down my left arm. This is the location where I received my vaccine one month prior. The pain was 8/10 and lasted approximately 7 hours. It woke me from sleep. I also experienced nausea. I tried Tylenol 1000mg, ice, and heat. Nothing helped. I went to the Urgent Care. They did multiple EKGs and lab tests. They ruled out a heart attack and pulmonary embolism. There was no injury. They were unable to find any cause for the pain. They administered aspirin, protonix, and nitroglycerin. The pain resolved after the third dose of nitroglycerin. (I was told by the cardiology PA that this was probably a coincidence.)

Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a concussion

part of my left kidney was no longer receiving blood; blood clot; placed on stroke protocols.; I developed severe abdominal pain in my left side during the evening; lack of appetite; bouts of severe discomfort; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0167) via an unspecified route of administration, administered in Arm Left on 28Apr2021 12:15 (40-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Vaccination Facility Type was clinic. Concomitant medications included ibuprofen (ADVIL); desloratadine (CLARINEX). The patient previously took first dose of BNT162B2 (lot number=EN6208) on 07Apr2021 01:15 PM (40-years-old) on Left arm for COVID-19 immunization. It was reported that the patient developed severe abdominal pain in my left side during the evening of Wednesday, 28Apr2021 19:00. The pain appeared sporadically throughout the evening and continued through Friday, April 30. During this time, he experienced a lack of appetite and bouts of severe discomfort. Tried treating with GasX and Tylenol. Duration of Hospitalization reported as 3 days. On Saturday, 01May2021, starting around 10:30 a.m., the pain in his left-side abdominal area intensified and did not diminish. After 6 hours, he visited the ER at hospital. After being admitted to the ER, a series of blood, urine and imaging tests were performed on me. The doctor on duty reported that a CT scan showed that part of my left kidney was no longer receiving blood (disability). He was placed on Heparin and admitted to the hospital. He was diagnosed with a blood clot and placed on stroke protocols. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse events was Heparin, fluids, blood work, urine analysis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events abdominal pain, lack of appetite, and bouts of severe discomfort was recovering; while other events was unknown. Events reported as serious due to hospitalization and life threatening.

Severe nausea and vomiting. Headaches. Fever, chills. Widespread body aches (extremely tenderness and soreness).

Severe Chills; Mild nausea; achy muscles; Severe headache; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 10Feb2021 11:30, at 40 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID after vaccination. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 20Jan2021 at 11:30 AM in left arm. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 21:15 the patient experienced sever chills, mild nausea, achy muscles and severe headache. No treatment was administered. The reported events were resolving at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Nausea, vomiting, severe fatigue, fever, chills, weakness ongoing for over 2 weeks. Have not reported to doctor because I felt ok before I got the vaccine and I can?t miss work. The first dose didn?t make me feel sick.

Developed appendicitis approximately 2 weeks after first dose. Had emergency surgery to remove appendix.

40 Y/O M 15 mins post vaccine- A/Ox0, presented disoriented with a confused daze followed by complaint of dizziness and general feeling of "not right". v/s within normal limits. PT given emesis bag for episode of nausea. PT A/Ox3 w/in 2 minutes post-episode. W/in 10 minutes still feels "cloudy". EMS called for evaluation.

Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Nausea-Severe, Systemic: Unable to Sleep-Severe, Additional Details: He was covered in red spots, terrible itching. Couldn't sleep or eat for 3-4 weeks. He has taken mostly steroids to treat. Finally cleared on about May 14th. He said the itching was intense, could not eat or sleep. Ready to jump out of his skin. Just wanted to call someone to let them know and document.

Severe nausea and vomiting for an entire day. Could not keep any fluids down. Severe burning pain in muscles all throughout the body for 3 days. Severe muscle spasms and cramps all throughout the body. Could not stand or walk for 12 hours. Severe burning sensation on the skin all over the body, felt like a sunburn. Severe headache for 3 days. Minor muscle spasms for an additional 5 days after the severe ones diminished. Moderate fatigue for 10 days. Had tested positive for COVID 4 months prior to being vaccinated, but only had minor symptoms for 2 days.

Allergic reaction; Allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis); itching; Heavy fatigue; vomiting; diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03May2021 at 08:45 AM (Batch/Lot Number: EW0173) at the age of 40-years-old as 2nd dose, single for COVID-19 immunization at a pharmacy or drug store. The patient had no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included complex regional pain syndrome (CRPS) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lamotrigine (LAMICTAL); both taken for unspecified indications, start and stop dates were not reported (received within 2 weeks of vaccination). The patient previously received the first dose of BNT162B2 (Lot number: ER8729) on 15Apr2021 at 02:15 PM in the left arm for COVID-19 immunization. On 03May2021 at 11:00 AM, the patient experienced allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis). There was extreme pain and burning in addition to itching, and the patient also experienced heavy fatigue, vomiting, diarrhea, and headache. The events resulted in doctor or other healthcare professional office/clinic visit and also emergency room/department or urgent care. The patient was treated with antibiotics for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Eleven (11) days after 2nd dose, nearly fainted on driveway after standing in sun too long and discussing medical issues. Called advise nurse and was advised to visit emergency department. Past medical history pertinent for hypertryglyceridemia, elevated BMI presenting to the ED with complaint of SYNCOPE (Pt. was talking with his parents about 'medical' stuff, and felt a little queezy, had brief near syncope episode, no full LOC. Scraped arm on a brick wall during episode as fell to ground)

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).

Stomach cramps; Diarrhea; Cold sweats; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Ep6955) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced Diarrhea, cold sweats and stomach cramps. The patient was not treated for the adverse events. The clinical outcome of the events Diarrhea, cold sweats, and stomach cramps was resolved on an unknown date at the time of the report. No follow-up attempts are needed. No further information is expected.

Hives covered both lower arms; Extreme malaise; headaches; chills; body aches; Vomiting; diarrhea; Klein-Levin Syndrome episode was triggered; Klein-Levin Syndrome episode was triggered; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 24Feb2021 at 16:00 (at the age of 40-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included common variable immune deficiency, mannose binding lection deficiency, ongoing klein-levin syndrome, peptic ulcer, arthritis and was allergic to Keflex, Reglan and Prilosec. The patient did not receive any other vaccines within 4 weeks. Concomitant medications included pharmacy brand 50+ year old multivitamin (within two weeks). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: PAA156051) via an unspecified route of administration, administered in right arm on 27Jan2021 at 15:00 at a single dose for Covid-19 immunization. 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 24Feb2021 at 22:00, the patient experienced hives covered both lower arms and on an unspecified date in Feb2021, the patient experienced extreme malaise, headaches, chills, and body aches began within 12 hours, vomiting and diarrhea occurred within 36 hours and persisted for approx 18 hours and A Klein- Levin Syndrome episode was triggered 72 hours later and persisted for 17 days. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

experience excruciating stomach pain that feels like a knot. He says it radiates to his back; experience excruciating stomach pain that feels like a knot. He says it radiates to his back; "a little bit" of nausea; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported) via an unspecified route of administration on 22May2021, as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22May2021, that evening patient experienced excruciating stomach pain that feels like a knot, it radiated to his back and had a little bit of nausea. Asking that this was normal. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Same restricted mobility as first dose on left arm near vaccination location lasted 24-48h after second dose. Persistent fatigue (not after first dose), specially arms and legs. No other side effects until 06/1@8:00am blood in stool, foul-smelling. Usual shape/color.

Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.

Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left started the night of the shot around 2 am. The pain kept getting worse and worse each day. I finally had to drive myself to the emergency room (5/4/201) to get it checked out. It felt like something was squeezing my heart. i was super light headed and felt like i was going to drop on the floor dead. They gave me a chest x ray and took blood work. Everything cam back good and the doctor said if i kept getting those chest pain i should return. so they let me go. i still kept getting my chest pain for another week. however i didnt go back to the ER, because i was scared of getting a second bill as im not insured.

Diarrhea, vomiting, back pain, muscle weakness. Started about 3 hours after vaccine. It?s 10:51 pm on Sunday, June 13, 2021 and still have symptoms.

Starting the next day after the vaccine 1st dose, I notice a throbbing pain right below my stomach. I did not take any medications. I went to the doctor after 2 weeks of having this pain. They did blood test and urine sample and was referred to the ER for a CT scan. Everything came back normal. I was still having abdominal pain and was referred to a GI specialist. The GI performed sigmoidscopy (normal) and nothing was prescribed and to follow up in a few months. I am still having abdominal pain, but it is very mild and has not effected my quality of life.

On or around 6/4/2021, I started feeling mild/moderate abdominal pain. It would come and go. The abdominal pain increased in duration & intensity over the next few days. It became severe by 6/9/2021. I saw my primary care physician the morning of 6/9/2021. He sent me home with pain meds and made an appointment for an ultrasound the next day. The pain became so severe later that day that I went to the local ER, around 3:30 pm on 6/9/2021. Around 10:30 pm on 6/9/2021, I was diagnosed with appendicitis. I had an emergency appendectomy on the morning of 6/10/2021.

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.

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.

diagnosed with appendicitis; abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in right arm on 17May2021 at 14:15 (at age of 40 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included Penicillin allergy as a child. Concomitant medications included Daily Immunity Vitamin and fish oil. Prior to vaccination, the patient was not diagnosed with COVID-19. Starting around 04Jun2021, the patient started feeling abdominal pain. The pain slowly increased over the next few days. It became severe by 09Jun2021. He saw the primary care Dr in the morning of 09Jun2021. Dr sent he home with pain meds & ultrasound apt for the next day. The pain got so bad he went to ER 3:00 pm afternoon of 09Jun2021. At 10:30 pm on 09Jun2021, the patient was diagnosed with appendicitis. He had emergency appendectomy on morning of 10Jun2021. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Seriousness criteria reported as Life-threatening. The patient was hospitalized 2 days in Jun2021. The patient underwent lab tests and procedures which included covid-19 test: negative on 09Jun2021. The outcome of the events was recovering. Information about batch/lot number has been requested.

Extremely High Fever, Chills, Urination burning, Nausea, Headache, Sore Throat, Extreme Fatigue, Mental fog and unusual thoughts.

Chest pains, left rib area won't stop hurting, a few days after shot felt like my abs were having a charley horse. Back pain, nausea dizziness and confusion on a daily basis. Doctors have no idea what's wrong with me suggesting upset stomach, ulcer, heartburn, spinal issues., anxiety, depression. They are just guessing.

Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-Year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in right arm on 23Mar2021 at 12:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6198) via an unspecified route of administration in right arm on 02Mar2021 at 12:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Mar2021 at 15:45, the patient experienced diarrhea which began after he got the vaccine, before he ate anything. It was mostly liquid. The patient did not receive any treatment for events. The clinical outcome of event diarrhea was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

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.

Client reported feeling dizzy and nauseous after vaccination. On assessment client appeared pale, and his skin was cold and moist. Client blood pressure was 98/54. Client responded appropriately to all questions. Client was given ammonia ampule, water and a lollipop. Client reported having eaten a sandwich earlier in the day. Client reported increased dizziness. Client was instructed to lie down and his legs were elevated. Client was monitored. Client's coloring improved and client reported feeling "better". Client's Blood pressure was taken again 140/80, Pulse 67.

Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where he has "recent" injuries (vasectomy, back issues). No control over bowel movements. Disoriented/ motor skills severely lacking; couldn't walk down steps or down the hallway. had to call for help to family to do normal tasks. mild hallucinations. mental anguish; things were true in his head but not true in reality; mental dysphoria. Thinking this was the end; was able to recognize it but also very concerning. 3:30 am saturday this started; not all gone yet (7/14). Tension headaches (not prior). Extremely cold, clammy, sweaty; had to change clothes based on the amount of sweat. Not drug user, not alcohol, active military, not 48 hrs prior till recent. no pre workout. no medications. ibuprofen later saturday morning. First vaccine he just had local pain at shot site, some pain to the older issue sites and tiredness but nothing more than 24 hours. No mental illness dx at this time; possible ptsd but never diagnosed, not something he suffers from on a daily basis.

Chest pain persisted for ~3 day. Chest congestion for ~7 days with occassional heartburn-like pain. On 3/31/21, sharp pain in left arm and back.

He felt like throwing up; After the first shot, he got sick; He reported that after getting both doses he experienced CHILLS; arm was a little sore; 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, formulation: Solution for injection, lot number was not reported, patient was 40-year-old at the time of vaccination), via an unspecified route of administration on 25May2021 at 09:30 as single dose for COVID-19 immunisation. It was reported that patient works at withheld Center and they get stuff from all over the country, out of the country, and they distribute to all withheld. He touches a lot of stuff and is diabetic. He was not wanting to get it but his sister and girlfriend and son told him he should to be safe. He just kind of listened to them. Medical history included diabetes; he has had since he was 22 he thinks, Smoker; he has been smoking since he was 17 he guesses, Occasionally drink on the weekend, ketoacidosis, He had high blood pressure. Family history included his dad had cancer and passed away when he was 58. Concomitant medication(s) included insulin human injection, isophane (NOVOLIN N, patient had been on since he was 23); insulin human (NOVOLIN R, patient had been on since he was 23); insulin (INSULIN) all taken for diabetes mellitus. Reported that he is diabetic and uses insulin and the same medication he has taken for years. He has been fine. His doctor a year ago gave him some heart medication because he had high blood pressure. The time before he saw him he said it was too low and stop taking it. He walks a lot and exercises or swims and uses insulins. One is long and one is short acting, he thinks he is a type 1 diabetic but he is not sure, he takes insulin. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. On an unspecified date in May2021, the patient experienced he felt like throwing up, after the first shot, he got sick, he reported that after getting both doses he experienced chills, arm was a little sore. Reported that Arm was a little sore because he just thinks the pharmacist who gave the shot gave it rough. Also, his job is to walk a lot and lift stuff so that could be contributing to that part. Reporter seriousness for After the first shot, he got sick and it made him throw up, arm was a little sore was unspecified. On an unspecified date in 2020, the patient underwent lab tests and procedures which included blood test and CAT ketoacidosis, Reported that patient had ketoacidosis last year and they did do everything, CAT scans and all the blood work and everything. This was this past year but states it was prior to receiving the vaccine. No treatment received because his doctor did not know what to do and just referred him to a neurologist. The outcome of events (He felt like throwing up, After the first shot, he got sick, He reported that after getting both doses he experienced CHILLS) was recovered on an unspecified date in 2021 and the outcome of event (arm was a little sore) was recovered on an unspecified date in May2021. Information about lot/batch number is requested.

He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he went from 180 to, when he was at the doctor, they said 175; Nausea; After getting both doses he experienced Chills; Vomiting; Arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, NDC number, Expiry Date of Pfizer Covid-19 Vaccine: Unknown), via an unspecified route of administration on 15Jun2021 at 10:00 AM (vaccinated at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes and reported as patient has had since he was 22 he thinks. He went with his ex-wife on vacation and came back, so probably 22, Caller clarifies that he thinks he is a type 1 diabetic but he is not sure, he takes insulin. Ongoing smoker and reported as I smoke and occasionally drink on the weekend maybe but nothing crazy. He has been smoking since he was 17 he guesses. Ketoacidosis and reported as caller adds that he did have ketoacidosis last year and they did do everything, CAT scans and all the blood work and everything. This was this past year. Caller does not know additional information but states it was prior to receiving the vaccine. The patient doctor a year ago gave some heart medication because patient had high blood pressure. The time before he saw him, he said it was too low and stop taking it. Family medical history reported as nobody has diabetes in his family, and he is the first. His dad had cancer and passed away when he was 58. Concomitant medications included insulin human injection, isophane (NOVOLIN N) and insulin human (NOVOLIN R) both were taken since he was 23 years for diabetes from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown) on 25May2021 for Covid-19 immunization and he got sick, it made him throw up, experienced chills. The first dose appointment was at 9:30 am. The patient states he got the second shot last Wednesday. Then, he went to work on Thursday. Friday on 18Jun2021, his legs started shaking and Friday it got worse. Saturday it got worse. Sunday, they felt a little better. Monday, or actually yesterday, he went to the doctor and the doctor said he has to go see a neurologist because the doctor kept him there for 3 hours looking at his legs and feeling them. They were moving out of control. Caller added as, considering his job, he walks 20-30,000 steps a day and he has never had trouble with his legs but he was diabetic. Caller adds that right now he kind of walks, like his girlfriend and son explained it, like a gimp and when he walks his legs pop. The patient cannot sleep. He slept maybe 6 or 7 hours since last Friday 18Jun2021. On an unspecified date the patient went from 180 to, when he was at the doctor, they said 175. Caller confirms this was new since receiving the vaccine. He has been 180 my whole life. He has not been able to work in a couple of day because he cannot walk. He guesses the weight loss is because of the vaccines. But, he is diabetic too, and was in pretty good health before this. Caller adds he has to pay for doctor appointments, his doctor kept him there for close to 4 hours and he looked at his legs for 45 minutes. He did not understand what was going on, and he sees him all the time for his diabetes. The doctor said that he has to see a neurologist, but none of these symptoms happened in his life until he got the shot. The patient arm of course was a little sore like when you get a shot and it hurts. Caller went to work and was fine, went to work the next day and was fine. This past Friday, his legs started shaking and he does not know. He could not sleep, they would not stop moving. He can control them if he uses muscle and really tries to control them. caller adds this is not going on still, he just thinks the pharmacist who gave the shot gave it rough. Also, his job is to walk a lot and lift stuff so that could be contributing to that part. Legs shaking, The patient spoke as per attached document in terms of nausea and vomiting. Treatment; cannot not sleep: caller adds he has a pool and when he goes swimming it feels better. If he walks around too much, how can he explain it, it gest worse but he can control it. If he flexes his muscles he can stop it, like flexing his legs that is how he stops it. If he does not, they just shake. He cannot not sleep because they shake so much they wake him up. The patient was diabetic and uses insulin and the same medication he has taken for years. The patient has been fine. His doctor a year ago gave him some heart medication because he had high blood pressure. The time before he saw him he said it was too low and stop taking it. The patient walks a lot and exercises or swims and uses insulins. One was long and one was short acting. Investigations were none, the patient saw a doctor yesterday who was trying to get him into a neurologist. He thinks it has to do with his nerves. He is trying everything he can. Adverse events do not require a visit to emergency room, but the doctor said if he cannot get him in to a neurologist in the next day or two, that he wants him to go to the emergency room. Needs visit to physician office. The patient doctor did not know what to do and just referred him to a neurologist. Caller just wanted to report this because none of these symptoms occurred until the second shot, or, well, it was the first shot that made him throw up and the other things with the second shot. his doctor did not know what to do and just referred him to a neurologist. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. Adverse events following prior vaccinations was none, he has not had a vaccine since he was a kid or teenager he guesses. The patient underwent lab tests and procedures which included weight loss: went from 180 to 175 lbs on an unknown date and reported as He went from 180 pounds to 175 pounds. Outcome of the event cannot sleep and his legs started shaking and Friday it got worse were not resolved and event arm was a little sore was resolved on an unspecified date, and remaining events were unknown. Information about lot/batch number has been requested.

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.

Vomiting; Massive headache; Incredibly tired; Sore right arm; 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: EN6206) via an unspecified route of administration in the right arm on 31Mar2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have 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 31Mar2021, after about 3 hours from the first dose of vaccine, the patient was incredibly tired and slept. The event of incredibly tired was not that bad. The patient woke up for a little while and then went back to sleep again. On 01Apr2021 at around 06:15, the patient woke up with a massive headache. He took a couple of ibuprofen and tried to relax. About fifteen minutes later, at 06:30, the patient could tell he was about to vomit and did. He kept vomiting for about the next 20 minutes or so till there was nothing left. He slowly sipped water for the next hour. After that he had no adverse reactions. The patient stated that, he had not vomited in at least the past 7 years and that episode of vomiting was violent and also stated he could not control that. On the same day, in the evening, the patient only had a slight sore right arm and episode of tiredness. On 02Apr2021, after vomiting the patient slept for the next five or so hours. His arm was still slightly sore but really did not bother him. After around 2 PM (about 24 hours later), he had felt totally fine. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events of tiredness, vomiting and sore right arm. The clinical outcome of the event tiredness, headache, vomiting and sore right arm were resolved in 02Apr2021. No follow-up attempts are needed. No further information is expected.

Severe dizziness, headache, loss of balance, heart palpitations, upset stomach, blurry vision and nausea.

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.

Patient had a fever (T100), severe body aches, and diarrhea one day post immunization. [note; COVID recovered April 2020]

headache/ his head was really pounding; nausea; chills; he had no appetite; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration in the right arm on 31Dec2020 at 14:00 at single dose for COVID-19 immunization as front line health care worker. There were no medical history and no concomitant medications. The patient received the Pfizer COVID 19 vaccine first dose 31Dec2020 at 14:00 in the right arm and then experienced a headache, nausea, and chills on 02Jan2021. He took two days off from work and now felt better, had no more symptoms. He noticed the symptoms on Saturday 02Jan2021, then Sunday he was able to go to work then he took off on Monday because the symptoms got worse. He had no appetite on 02Jan2021. Today he felt great. He was supposed to get the second dose 21Jan2021. He did take Ibuprofen with strength 600 mg oral once on 02Jan2021, because his head was really pounding and then he went to sleep and it was better the next day. He had no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations -within 4 weeks. There was no family medical history. He had the COVID 19 test 3 months ago in 2020 and it was negative. The outcome of the events was recovered on 04Jan2021.

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.

patient started to feel very nauseous and had stomach cramps, went home early and took some OTC related medications to relieve symptoms

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.

99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue; felt like he was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PFI302), via an unspecified route of administration in left arm on 05Jan2021 11:00 at single dose for ''front line worker''. Medical history included Crohn's disease from 2012. Concomitant medications included adalimumab (HUMIRA, injection, Lot: R22-03-A-01, Expiry: Feb2021) from Feb2019 and ongoing at 40 ml twice monthly for Crohn's disease (When providing weight he adds that he has had some weight gain due to medication side effects with Humira), ibuprofen (He took Ibuprofen on Tuesday night and 1 last night. He has not taken any today). Caller received the Pfizer covid-19 vaccine two days ago (05Jan2021). He has mild side effects to report. He is a Clinic Social Worker. Following the vaccine he experienced muscle aches and pains on 05Jan2021. He was tired and fatigued on 05Jan2021. His temperature was 97.5 yesterday (06Jan2021). It now 99 degrees (07Jan2021). His temperature went up 1.5 degrees. He felt like he was going to throw up in Jan2021. He received the vaccine at 11:00 am. At 05Jan2021 4:00 pm he felt really bad. He feels like a 3 or 4 out of 10. He is scheduled to get his second dose on 26Jan2021. The outcome of the events muscle aches and pains and tired and fatigue was recovering. The outcome of other events was unknown.

severe headaches, nausea, a few days after, vomiting, diarrhea, and body aches. improved with Tylenol, Advil, and Imodium.

1/16/21, Covid vaccine injection at 12:09 PM Minute 1: dizzy and light headed (like drinking a beer on an empty stomach) Minute 10: Nausea Minutes 23-25: Neck tightness (like doing unsupported crunches and holding my head up) Minute 27: Inability to swallow and inability to speak EMS on site administered EpiPen auto-injection to left thigh, immediate improvement in symptoms Transport to hospital via ambulance Hospital monitored me for several hours and discharged same day

Beginning 5 days later, and persisting for the last 3-4 weeks (on and off): GI issues, headaches, lightheadedness, dizziness, palpitations, high blood pressure.

On 12/26 (Sat), heart rate increased to 170 and then calmed down. On Sun and Mon - vomiting, nausea and HA on and off. On Mon heart rate increased again. Went to Urgent Care and tested covid negative. On Wed 12/30, BP at 180/105. Went to ED and BP eventually went down to 145/95. Dr is speculating that since patient had high antibodies from covid infection in August and still high antibodies in October that all of this is a wild immune reaction triggered by the vaccine.

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.

About 4 hours after receiving the vaccine, began with headache and nausea/upset stomach. Symptoms progressively worsened to create low grade temperature body / joint achiness. Notable extreme fatigue. Prevented from going to work.

join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints; Within first hour of injection slight nausea that lasted a few hours; pain in hands; This is a spontaneous report from a contactable healthcare professional. A 41-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 28Dec2020 10:15 at a single dose for covid-19 immunisation. Medical history included food allergies to dairy and nuts. Concomitant medication was not reported. On 28Dec2020 11:00, the patient experienced slight nausea that lasted for few hours, along with join pain initially in bilateral shoulders then within a few hours hurt all different areas around body especially in joints. By end of day the patient could not type on phone due to pain in hands. Ongoing joint pain for almost three weeks now. The patient did not receive treatment for the events. The outcome of event nausea was recovered in Dec2020; all other events was not recovered.

17h post the second dose of vaccination I have experience fever 38.1 C (100.6 F), persistent headaches, chills, muscle pain, low energy and lost of appetite. Fever does not respond well with Tylenol (1000mg) and is persistent.

Headache; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received second dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer), batch/lot no. and expiration date not provided, via an unspecified route of administration (vaccination location: left arm) on 21Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included sinus tachycardia and Pvc (premature ventricular contractions). He had no allergies to medications, food, or other products. Concomitant medication included atenolol. Historical vaccine included first dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer) for covid-19 immunization on 31Dec2020 09:15 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered at a hospital. The patient experienced headache 24-36 hours, fever at 36 hours, fatigue, and nausea on 21Jan2021 05:00 PM. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was very hot similar to being in a sauna. Removing for changing the blanket to a thinner one resulted in extreme chills within one minute. Covering with blanket resulted in extreme hot within 10 minutes. Repeated this cycle for several hours until fall asleep. High discomfort throughout body. Woke up at 10:00 a.m. with mild grade fever of 99.5° (average resting temperature is 96.5). Felt extreme cold and chills shivering body aches headache until 6:00 p.m. felt hungry and okay enough to eat. Main concern is the extreme hot to extreme cold cycle in early morning. It felt as though the body was not in sync. During fever throughout day/afternoon body's reaction was normal - fever meant chills and shivering, putting on a blanket meant comfortable warmth (after long periods of time). But in early morning no no fever yet body burning hot almost suffocating sauna heat insider body, and removing the blanket a immediate and severe chills with uncontrollable shaking, instead of relief from heat... Concerned if vaccine affects body's heart regulation system (hypothalamus, thyroid, etc). General malaise during this period is an understatement... It was not a single spot or feeling pain it was the whole body wanting to twist itself and feeling 'deprssed' and very 'ill' all over all at once.

Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.

Intense vertigo with nausea and nystagmus started 3 days after injection (1/30). Couldn't walk or stand so went to Emergency Room on 1/31. MRI of head & neck done to rule out stroke. Meclizine 25mg & ondansetron 4mg ODT prescribed. Meclizine 25mg x 2-3 doses per day was needed for the next 7 days to perform daily activity. Was able to resume walking slowly with medication on 2/1, but could not look at a computer screen to work without meclizine due to nystagmus until 2/6. Symptoms did not improve enough to be cleared to drive until 2/9. Full symptom resolution by 2/11.

The initial symptoms exp stomach cramping. Then on 12/31 I started exp pain in lower back felt like muscle spasm. I went to ER got Chest Xray,Flu (results negative)and Covid test (result positive).

95.4 body temp, grogginess, confusion, fatigue, headaches, confusion, irritation, lack of appetite, lethargic

Mid-grade fever (topped out at 102 F), severe body aches, joint pain, headache and nausea. Symptoms lasted for roughly 36 hours; they were very intense for the first 24 hours from the time of onset.

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.

High fever (102 Fahrenheit); body aches; chills; severe headache; nausea; This is a spontaneous report from a contactable consumer (patient himself). A 41-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (at age of 41-year-old) (Lot number: EL3247, expiry: May2021), at single dose in Left arm for COVID-19 immunization. The patient medical history reported as none and no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Feb2021 10:15 AM (at age of 41-year-old) (Lot number: EL3247, expiry: May2021), at single dose in Left arm for COVID-19 immunization and experienced Body aches, joint pain, and intermittent nausea. These symptoms started approximately 8 hours after the shot and persisted for 48 hours. The patient experienced high fever (102 fahrenheit), body aches, chills, severe headache, nausea on 25Feb2021 22:00. These intense symptoms began approximately 12 hours after the 2nd shot and are currently on-going. These events did not result in emergency room visit or physician office visit. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 25Feb2021. No treatment received for the adverse events. The outcome of the events was not resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021213613 same reporter/patient/drug, different time/event

Mild headache; mild upset stomach; tiredness; This is a spontaneous report from a contactable consumer(patient). The 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Feb2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced mild headache, mild upset stomach, and tiredness, all on an unspecified date(Feb2021) with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Body aches; joint pain; intermittent nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration on Left arm on 04Feb2021 10:15 at single dose for covid-19 immunisation administered at workplace clinic. Medical history included none. The patient's concomitant medications were not reported in two weeks. On 04Feb2021 07:30, patient had Body aches, joint pain, and intermittent nausea. These symptoms started approximately 8 hours after the shot and persisted for 48 hours. The patient not received treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events resolved. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021232169 same reporter/patient/drug, different time/event

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: LEFT ARM TREMERS-Mild, Systemic: Nausea-Mild

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

Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination with headache, body aches, chills, followed by abdominal pain, vomiting and diarrhea over the next 3 days, then became confused per wife so he came to ED for evaluation on 3/16/2021 and evaluated by me. Also had black stools and vomiting blood. Diagnoses: Septic shock, Gastrointestinal Bleeding with severe blood loss, Hepatitis with Hepatic Encephalopathy, Liver cirrhosis. Admitted to hospital 2/16/2021-discharged 2/21/2021. Since symptoms developed day after vaccination, I am compelled to report.

For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debilitating headaches, which led to nausea (because they were so severe). Elevated blood pressure also coupled with headaches. I initially took Ibuprofen (which helped somewhat), whereas Tylenol did nothing. I also have a flexible ice pack that I placed over my head. That also helped a little. I went to the doctor on March 17th, but he was dismissive of the headaches being related to the vaccine. I have since been referred to a neurologist (April 1st appointment).

Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptoms ongoing as of 9:45am 03/23/2021

Fever with chills that didn't come down easily even under the administration of Acetaminophen 500mg every 4 hours (strangely temperature was only 37 C), throbbing head ache, body ache, drowsiness and fatigue, loss of apetite, nausea, heartburn, constipation.

Sudden dizziness and then vomiting. Specifically within hours of food being eaten. Nausea the following 2 days, March 28, 29, specifically after eating. March 30th, woke up with chills, sore throat, headache, body aches lasting all day. Diarrhea. No longer nauseated. March 31st, all symptoms subsiding except for a minor headache and sore throat with mild cough and phlegm.

NAUSEATED, BLACKED OUT, COLD SWEAT. CAME TO FINE WITHIN A FEW SECONDS EPISODE RESOLVED QUICKLY CLIENT MONITORED FOR 30 MINUTES AND LEFT WITHOUT FURTHER INCIDENT.

Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the same day, I had vertigo and had to vomit. Since then there has been nausea and headache, and I have trouble sleeping in. I feel some more discomfort after eating food. I have intermittent fever also. It has been about 10 days today since I got my COVID Pfizer shot and I still don't feel physically well. I just wanted to report this, as the impression from documentation I read is that symptoms should go away in 3-4 days.

6pm April 2 - began feeling nauseous and chilled, began shivering. 8pm April 2 - began vomiting...bouts of vomiting every 1.5 hours from 8 pm April 2 until 12 noon on April 3. An acute stomach ache followed and continued until the morning of April 4th. After vomiting stopped, I laid in bed from about 3pm on April 3 until 9 am on the 4th...I would sleep for 45 minutes at a time and wake in a cold sweat...I physically felt very cold, but was drenched in sweat. The chills and cold sweats stopped on the morning of the 4th and gave way to a lingering but persistent headache and dull stomach ache which are continuing now (3pm on April 4), but seem to be slowly fading.

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.

Headache - 4 days and still comes and goes sometimes being very extreme. Fatigue - Started feeling tired around 5:00pm the day of the vaccine and I have continued to feel tired after 4 days. Muscle/Joint pain - Started getting sore arm first a couple hours after shot then progressively getting worse on my entire body for 3 days. On day two is was almost unbearable with my lower back being the most painful. I could not sleep because of the pain with no position that would relief it. Chills - Started getting chills on the evening of the vaccine. They came and went for 3 days. On the second day it was uncontrollable shakes no matter how many blankets I used. Fever - Started the night of my vaccine increasing to 102.4 and reaching the highest on the second day at 103.5. I took ibuprofen every 6 hours for two days straight with it staying steady at above 100. Nausea - Started the evening of the vaccine and got very severe. It has continued for 4 days. Fast Heartbeat - It has stayed consistently above 110 and sometime getting up to 130 while laying in bed shivering.

Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea legs and feet turned purple Constant frontal headache Lack of appetite/ nausea Some foods taste metallic

Patient reported he started feeling hot, dizzy, nauseous, lightheaded and faint within a few minutes of receiving the vaccine. We sat him down and grabbed our nurse practitioner. She monitored his pulse. He began to feel so faint that he asked to lay on the floor. We called 911. When paramedics arrived he was starting to feel much better. By the time it was over he left the store (was not transported to the hospital).

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

Presyncope (lightheadedness, nausea, blurry vision). Normal vitals. Symptoms improved with supine rest and oral rehydration.

Extreme Nausea and runner vision within 30 seconds of vaccine administration. Symptoms went away on their own

Headache, diarehhia, fatigue, muscle and joint pain, swollen lymph nodes (arm pit on side of injection), chest pain

Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightening. 7th. Dizzy , tight muscles, sore arm, that late afternoon i sneezed. My back went out. Severe spasms and pain from The 7th-16th. Late night on the 16th. Chest neck and shoulder pain. Heart flutters, tachycardia, oxygen levels dropping to 89. Hovering around 95. Severe nausea. Abdomen pain. Tight painful muscles in legs Same and worse today on the 17th , had ER visit Been taking Valium and Tylenol for pain and spasms per my PCP since April 15

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

Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic violation." He was told "to get out of the car and had a field sobriety test, and I looked intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

Anaphylaxis treated with EpiPen, Steroids & Benadryl It began as a hives on 04/16 around 8 PM, the morning of 04/17 I had swelling in my eyes, lips and tongue, Along with difficulty swallowing. I was treated with epinephrine on 04/17 around 1 pm and then again on 0/18 around 11 am.

complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6207), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 08:30 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient started throwing up, fever, complete body went paralyzed and lost vision all it the ER on 05Apr2021 13:00. The events were resulted in emergency room /department or urgent care. There is some treatment (saline and ondansetron) for the events. The patient did not have covid prior vaccination, did not test covid post vaccination. The patient received Covid test post vaccination via Nasal Swab on 05Apr2021, covid test result was negative. There is no known allergies, no other medical history, no other vaccine in four week, no other medications in two weeks. The outcome of the events was resloving.

Starting after leaving pharmacy (receiving second vaccination), sunlight sensitivity causing migraine like headaches and nausea. Symptoms are lessened with sunglasses. Onset is within minutes of being in direct or overcast sunlight. Symptoms have persisted for 8 consecutive days since vaccine.

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.

Day 1 after vaccination: Fever, chills, aches, headache, nausea; all day Day 2 after vaccination: None Day 3 after vaccination: Woke up in the middle of the night with dizziness, or head "swimming" sensation, and body aches. Managed to get back to sleep after about an hour, but woke up at normal time still feeling a "swimming" sensation in the head where it's not dizzy, but similar, and still minor body aches. Submitting this report while I'm still in Day 3

Patient states he was sitting when he got very hot and nauseated before fainting. Staff saw patient fall to carpeted floor face first and ran to his side. Patient briefly non-responsive but almost immediately regained consciousness and turned over onto his back. Legs elevated to chair and patient instructed to remain supine. Vitals at 1:35pm 120/80, HR 91%, O2 level 97%. Patient states he tends to get very hot and nauseated with shots. 1:37 pm: c/o tingling in both hands and requested an ice pack. Obtained his wife's phone number and contacted her using his phone. Attempted to cleanse abrasions to (L) forehead and bridge of nose but he was not able to tolerate the smell. Drinking bottled water provided by staff. EMS enroute. 1:40 EMS arrived; BP 112/72, HR 89, O2 98%. Patient remains alert and oriented. Kept supine. Using his ice packs to hands. 1:57pm: Still has tingling and slightly nauseated. EMS requested privacy with patient.

irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Day 1: Symptom a) Severe Abdominal and Back Muscle pain for two to three hours before taking acetaminophen. Pain consisted of sharp pain wrapped around my torso. Symptom b) Nausea. Symptom c) Tiredness Day 2: Mild chills in the evening and night sweats Day 3: Mild chills in the evening and night sweats Day 4: Abdominal and Back pain for approximately one hour (pain reduced after taking acetaminophen. Pain continued overnight. Day 5: Tiredness Day 6: Felt great Day 7: Severe Abdominal and back pain wrapped around my torso and burning sensation in my back

He tested positive for Covid on 30Mar2021; bad cough; severe fatigue; lost his sense of taste; loss of appetite; everything tasted like metal; Lost 15 pounds in 2 weeks; feeling sick; inflammation; This is a spontaneous report from contactable consumer (patient's mother) via Pfizer sponsored program. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (age at vaccination 41 years), Solution for injection) via unknown route of administration, in the left arm on 23Mar2021 at single dose for COVID-19 immunization. Medical history included asthma, the reported stated that it was quite scary. Concomitant medications were not reported. On 24Mar2021, the patient had bad cough couldn't stop coughing for 2 weeks, it was awful and the patient was a nonsmoker and he sounded like someone who had been smoking for 70 years. It was a deep horrible cough. He was afraid to get the second shot, and she doesn't want him to be afraid if the symptoms weren't from a reaction and the patient went to the emergency room and they sent him back. She almost lost the patient as an infant with aspiration pneumonia and had severe fatigue which had gone better just in the last day or 2. The reporter had minor symptoms, but her son's symptoms progressed to the point where they told him he had to get a COVID test. The patient was not feeling right beyond 48 hours and was still thinking it was a reaction from the shot. On 30Mar2021, the patient tested positive for COVID. On an unknown date in 2021, the patient started loss of appetite almost right away a couple days after he got the vaccine. He must have had COVID at the same time. Patient was gaining his appetite back. Patient had lost his sense of taste too. Patient had also lost her sense of taste and her sense of smell. He just said that everything tasted like metal. Nothing tastes normal it was the same for her as well. His appetite was coming back, and his cough was subsiding. The patient had inflammation, which was treated with steroids and inhaler and the patient was little overweight and lost 15 pounds in 2 weeks, feeling sick. The reporter asked 4 different doctors and got 4 different answers. Her son was exposed to COVID through his children from school. They had closed the classroom because the teacher had COVID. No one else in the house was positive. On 08Apr2021, (Yesterday), the patient felt a little better which was a blessing. She thinks he was getting better due to the medicine from the pulmonologist. He got a pulmonologist to have a virtual visit and they gave him steroids and an inhaler which has helped and just starting to get a little better. The patient was due for his second dose of the vaccine on 13Apr2021, but she doesn't know if it was okay for him to get it now. The patient had chest X-ray was negative and the patient did not have pneumonia. The outcome of the event cough, fatigue, ageusia, decreased appetite, dysgeusia, was recovering and the other events COVID-19, weight decreased, malaise was unknown. No follow-up attempts are possible. Information about batch/lot number could not be requested

I developed full anaphylaxis within 30 minutes of receiving my Covid-19 vaccine.; dizziness; nausea; inability to swallow; mouth going dry; unable to speak; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Jan2021 12:00 (Lot Number: el3248) as single dose (at the age of 41-years-old) for covid-19 immunisation. Medical history included Heart disease, hyperlipidaemia, hypertension, pituitary adenoma. It was reported that patient received concomitant medications in two weeks prior to the vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Patient stated that he developed full anaphylaxis within 30 minutes of receiving his Covid-19 vaccine on 16Jan2021 (Adverse event start time reported as 12:00 P.M.). It started with dizziness, then nausea, then inability to swallow and mouth going dry, finally unable to speak. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient was treated for the events with epinephrine (EPIPEN) on site by emergency medical services (EMS) and transport to hospital. The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 post vaccination. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 11Feb2021. Patient had no known allergies other than the Covid-19 vaccine. Patient recovered from the events on unknown date.

fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fatigue fatigue, irritability, confusion, body aches set in around 6:00 PM around 8:00 PM started alternating between feeling hot and chills, and presumabliy a fever (did not take temperature) went to sleep for the night around 1:30 AM on 5/3. Sometime between then and 7:00 AM woke up in a sweat, so fever presumably broke awoke for the day around 8:20 AM but was still too fatiuged to go to work as of now still feel some fatigue and headache

First day after vaccine (4/30/21): 102 fever, chills, severe nausea, vomiting, aches, migraine-like headache pain, malaise, and fatigue (took Tylenol with minimal effect). Second day after vaccine (5/1/21): aches, shakiness, fatigue, mild nausea, medium-intensity headache, diarrhea, malaise (took Tylenol, which helped with headache pain). Third day after vaccine (5/2/21): aches, mild nausea, shakiness, mild fatigue, mild headache, and mild malaise. Fourth day after vaccine (5/3/21): mild nausea, shakiness, mild headache, and mild fatigue. Fifth day after vaccine (5/4/21): mild nausea, mild headache. Sixth day after vaccine (today 5/5/21): mild nausea, mild headache.

Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off. Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak. I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches. The fever responded well to Ibuprofen. I hydrated with water and Gatorade. It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.

On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was nauseous although I did not vomit. On April 22, I began having severe sharp stabbing pains just to the right of my belly button. It felt like I was being stabbed with a very hot knife, and after about 15-90 seconds, it would go away. Anytime I reached for something, bent over, twisted, turned or tried to hug someone, I would get this same pain and it would double me over in pain. On Monday April 26 at 7pm, I finally checked into the Emergency Room at the direction of my Primary Doctor. They did a bunch of blood work on me and sent me for a CT Scan of my abdomen. All of the blood work came back in normal ranges, and the CT Scan showed my appendix was "borderline" according to the surgeon. They consulted with Dr and decided to admit me for a surgical consult and further examination. They gave me fluids and morphine through an IV for the first 24 - 36 hrs, and then switched to Norco by mouth. I continued having pain throughout my stay. On Thursday, April 29, they took me to surgery for "exploratory surgery" with the intention of removing my appendix and looking around to see if anything else stood out to them that would cause me this pain. They stated my appendix had scar tissue on it and they removed it, but said they did not know if this would stop the pain I was having. On Friday April 30, I was released from the hospital at approximately 6pm. By 9pm on Friday, I began having those same sharp, stabbing, burning pains in my abdomen again, now to the right of my belly button again and further towards my right side. I also had sharp burning pain in the inside of my upper right arm, between my bicep and tricep muscles. This pain continued on through the weekend occurring more frequently and more severe. On Monday morning at about 1:30am, I woke up with severe abdominal pains all over and went into the bathroom. I had diarrhea and nausea and felt like I was going to vomit. Between 1:30am and 7:30am, I went to the bathroom 6 times. I went to work on Monday and continued having abdominal pains and diarrhea all day and night. On Tuesday, I went to the bathroom a total of 17 times. On Wednesday, I saw my primary Dr., who examined my abdomen and pains. He suggested I take immodium for the diarrhea and a supplement for muscle pain, as he felt this was the cause of my pain. On Wednesday, I went to the bathroom 21 times and was very nauseaus. I started the Imodium and it had no effect on me whatsoever. On Thursday, I had to call off work because I couldn't stop using the bathroom. By 4pm, I had been to the bathroom 18 times. I returned to the ER. They took a stool sample and did an ultrasound in the ER. They decided to admit me again for surgical consult and pain management. On Friday, Dr ordered another ultrasound of my abdomen, specifically my gallbladder, kidney, and liver. He also sent me for a CT Scan with contrast. They completed a total lab workup of my blood. All of these results came back normal, and nothing on the images showed anything wrong with my organs. On Saturday May 8, Dr came to the hospital to examine me. He stated everything related to my GI was fine. He asked if I have back pain, which I told him I do. At this time, I was in extreme pain and I couldn't even touch my skin. Dr attempted to examine my abdomen, and just by placing his hand on my stomach, I screamed in pain. He then put his hand behind my back and pushed a little, and it cause extreme pain in my abdomen. At this time, Dr suggested that maybe the pain is caused by something going on in my back. Maybe a pinched nerve or something. He ordered an X-ray of my upper and lower spine. Later that day, the results of the X-ray came back and showed there was nothing wrong with my spine. With these results, Dr then ordered an MRI of my lumbar and thoracic spine. On Sunday May 9 at 1030am, I was taken to radiology for an MRI. The initial report shows that I do not have any pinched nerves and nothing notable that would cause this type of pain in my body. As of now, no diagnosis or explanation for the pain I am experiencing. The pain is gradually getting worse and at times I am unable to move at all without extreme severe pain in my body. At times, my right groin hurts and I am unable to stand on my feet, as it feels as if I have pulled a groin muscle. The pain in my abdomen takes my breath away and feels like I am being set on fire in that area of my body. The pain no longer goes away and is constant, but moves throughout my right side from my groin to my shoulder only. I am not able to put my right arm behind my back because I get this pain in the back of my shoulder area. This pain is only on my right side at this time. So far, there is no explanation for this pain. I never had anything like this until I got the vaccine.

Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site: 5hr Headache: 12hr

Began with mild abdominal pain which gradually increased to severe abdominal pain that lasted through the night (approx. 12 hrs). Contacted a telehealth doctor who suggested I monitor the pain and go to ER if I had trouble breathing. I took one 200mg ibuprofen to relieve the pain. The following day (5/11) the abdominal pain was moderate and seemed to decrease throughout the day. The day after (5/12) I felt discomfort but pain was minimal. Today (5/13) feel minor discomfort on occasion. Since the abdominal pain began I have not vomited or had diarrhea. The only symptom from the vaccine seems to be the abdominal pain.

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 presented to ER with flu sx that began after vaccine. Pt reports a constant fever (102 F PTA), constant generalized myalgias and a constant HA that all began on onset. He also reports multiple intermittent diarrhea episodes since onset. Pt c/o constant and non-radiating left foot pain with associated swelling that began yesterday. Left foot pain noted to be gout in ER.

41 yo male patient with history of renal transplant on immunosuppressive therapy, diabetes, CAD, CHF, HTN, HLD, OSA presents with a 9 day history of fatigue, congestion and a 2 day history of nausea/vomiting and intermittent fevers, but no respiratory symptoms. Pt received Pfizer COVID-19 vaccination: first dose 3/18 and second dose 4/8. Pt tests positive for COVID on 4/24; CXR on 4/30 showed no acute findings. Admitted for additional hyponatremia, AKI, and hyperkalemia. Pt remained on room air. Received 2 doses of remdesivir while inpatient and felt significantly improved afterwards. He was set up for outpatient COVID follow ups via telehealth and given a COVID home monitoring kit.

Patient was given vaccine and while waiting the 15 minute monitoring period he fainted. He was responsive right away and needed to throw up. We attended to him and called EMS. He said he had anxiety from the seeing the needle and is probably why he fainted.

Sever chills, headache, extreme fatigue, sore arm, worse migraine ever suffered and never had a migraine before, nausea, exhaustion. All of these lasted 48 hours and the migraine did not occur until 72 hours later.

After leaving vaccination site began to feel dizzy and nausea. Returned to vaccine site @ 12:30PM VS BP 145/104, HR 89, OxSat 98%, c/o headache, took Tylenol, has not eaten today. Blood sugar: 71. Banana given, advised to have lunch with protein.

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

appendicitis; Sunday morning: wake with mild stomach pain; pain increasing consistently/considerable and unbearable pain; Vomiting; Saturday: largely symptom free, though tired and lethargic; Saturday: largely symptom free, though tired and lethargic; moderate headache; Wednesday morning: developed mild to moderate fever and chills; Wednesday morning: developed mild to moderate fever and chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:45 at the age of 41-years-old (Batch/Lot Number: FIL30161) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Surgery for pinned broken thumb. surgical repair of achilles tendon. The patient previously took erythromycin and experienced known allergies: Erythromycin (Nausea). The patient received first dose of BNT162B2 administered in Arm Left on 03Apr2021 04:00 PM at the age of 41-years-old (Batch/Lot Number: ER8737) for covid-19 immunisation. The patient did not take other vaccine in four weeks. Other medications in two weeks included only post-surgery pain meds after vaccine. The patient did not get covid prior vaccination. On Tuesday evening 27Apr2021, Pfizer second dose administered. On Wednesday morning 28Apr2021 10:30 AM: developed mild to moderate fever and chills. On Thursday 29Apr2021: mild to moderate fever and chills continue, new symptoms include a moderate headache. On Friday 30Apr2021: fever and chills begin to subside, headache remained. On Saturday 01May2021: largely symptom free, though tired and lethargic. On Sunday morning 02May2021: wake with mild stomach pain. On Sunday noon 02May2021: pain increasing consistently. On Sunday early afternoon 02May2021: considerable and unbearable pain. Vomiting. The patient was transport to Urgent Care. Urgent Care recommended Emergency Room. On Sunday early evening 02May2021: admitted to ER, administered pain medication. Vomiting ensues. CT Scan administered and showed positive for appendicitis. On Sunday Evening 02May2021: transported to surgical center, prepped for surgery. On Sunday Night 02May2021: emergency surgery performed, appendectomy. Overnight hospital stay was required. On Monday morning 03May2021: discharged from hospital. The adverse events appendicitis, stomach pain, pain and Vomiting resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Pain medications and Surgery (appendectomy). The patient underwent lab tests and procedures which included computerised tomogram: positive for appendicitis on 02May2021, CT Scan administered and shows positive for appendicitis, Nasal Swab: negative on 02May2021. The outcome of the events was resolving. The case was reported as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage.

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.

Diarrhea; Headache; Bodyaches; Cold; Nauseous; Very, very, very tired; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 20Feb2021 around 3:10 pm (Batch/Lot Number: JSV6H-KD7BK) as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Prior vaccinations within 4 weeks, the patient had Flu shot but thinks that was a couple of months before the COVID shot. The patient previously took first dose bnt162b2 for covid-19 immunization and flu vaccine. On 21Feb2021 the patient experienced headache, bodyaches, cold, nauseous, very, very, very tired, and on 01Mar2021, diarrhea. The patient received second COVID shot 11 days ago. He was still feeling symptoms. Received second COVID shot on 20Feb2021 and was perfectly fine. Woke up the next day, 21Feb2021 and was sick. From what he has seen, most people are sick for a day or two. The patient clarified it was just what he has seen on the news. Was it normal to be sick for longer than a couple days. Stated the body aches got better, but he was still tired and still has a headache. Has been going on since 21Feb2021.Yesterday, 01Mar2021, started having diarrhea. The patient stated that the body aches got better, but he was still tired and still has a headache. Has been going on since 21Feb2021. The patient had called his doctor, but has not heard back. When querying address for vaccination facility, patient stated his brain was not working. Outcome of the events headache, nauseous, very tired were not recovered, outcome of bodyaches was recovering and outcome of cold and diarrhea was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack of energy; lost his voice; threw up; sleeping for 48 hours; terrible pain in his stomach which made him scream to the point where he lost his voice; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 23Apr2021 14:15 (Batch/Lot Number: EW0171, not sure if the 0 is a O or a 0) as single dose at the age of 41-year-old for covid-19 immunisation, administered not at a military facility. Medical history included ongoing Hashimoto's disease diagnosed about 10 years ago, ongoing vitamin D deficiency diagnosed about 8 years ago, ongoing vitamin b12 deficiency diagnosed about 8 years ago, lung neoplasm malignant. Family history included: dad had lung cancer, mother had thyroid issues and Alzheimer's. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient experienced terrible pain in his stomach which made him scream to the point where he lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, metallic taste in the mouth on 23Apr2021 with outcome of recovered on 24Apr2021, had diarrhea on 24Apr2021 with outcome of recovered on 26Apr2021, a fever of 103°F on 24Apr2021 with outcome of recovered on 26Apr2021, he was shivering due to lack of energy on 24Apr2021 with outcome of recovered on 27Apr2021, lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, threw up on 24Apr2021 with outcome of recovered on 27Apr2021, sleeping for 48 hours on 24Apr2021 with outcome of recovered on 27Apr2021. The patient underwent lab tests and procedures which included body mass index: 37 on an unknown date, body temperature: 103 Fahrenheit on 24Apr2021. Therapeutic measures were taken as a result of terrible pain in his stomach which made him scream to the point where he lost his voice, had diarrhea, threw up. The course of events was as follows: Within the 1st 24 hours, he mentioned that he was fine and easy but had a metallic taste in the mouth for 24 hours. He mentioned that the next 72 hours were really bad for him. On 24Apr2021, that night, he started to feel terrible pain in his stomach which made him scream to the point where he lost his voice. It was like knives cutting his stomach. He threw up everything he ate, had diarrhea for 2 days along with a fever of 103 degree F for 2 days. He would try to go to the bathroom and he was shivering due to lack of energy that he could not go to the bathroom. He slept for 48 hours after the 1st 24 hours after vaccination due to the side effects. By Monday afternoon, 26Apr2021, he noticed that his side effects were subsiding and by Tuesday, 27Apr2021, he was a different person and was like nothing happened, he was able to resume a normal life and go back to work. The events did not require a visit to Emergency Room or physician Office. He did not go he was taking orange juice and ibuprofen to treat himself. No relevant tests. He asked if this was contraindicated with him to get the 2nd dose. He has not spoken to his doctor yet. He queried if he should get the second dose or is it contraindicated. Patient mentioned he is very large at 6'6" and 320 lbs. He is wondering if he should have a different dose because he is so big. This report is not related to a study or program. Information on Lot/Batch number was available. No further information is expected.

About 8 hours after the 2nd dose my husband became very ill. Uncontrollably shaking, fever, terrible headache, nausea, etc. for 24 hours.

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.

Anal Swelling, Internal Cyst, Anal infection leakage, bleeding since March 30th, 2021. Anus swells every three days, then discharge with pus and blood. Development of Pilonidal cyst/sinus. Pressure and pain at anus.

Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.

He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tingling and numbness in his left arm, dizzy, nausea, "brain fog" and "loosing motor skills". Headaches are tapering off. He is on Amantadine from Neurology. His symptoms came on immediately after the 2nd shot. Severe symptoms- headache , brain fog. Had been in ED- had CT head. Saw neurology and then sent to Headache clinic. He has several people he knows with similar symptoms and had gone thru long term

104F fever; Vomiting; Aches; Chills; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route, administered in Left Arm on 14Apr2021 at 14:30 (at the age of 41-years) as single dose for COVID-19 immunization. The patient's medical history included allergy to cephalosporins and chronic hives of unknown origin. The patient had no other known allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication(s) included cetirizine and methylphenidate. The patient previously received first dose of BNT162B2 (Lot Number: ER8727), via an unspecified route of administration on 24Mar2021 at 19:15 (at the age of 14-years) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Apr2021 at 16:00, the patient experienced 104F fever, vomiting, aches, chills. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 104F fever. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr 2021. No follow-up attempts are needed. No further information was expected.

1.Swollen right lymph node, can be seen in a mirror. intense pain right side of neck. Right ear, pain hearing is effected, sometime hear pulse in ear other times ringing. , very bad headache. 2. hard to swallow anything, mouth producing saliva at a rapid rate. 3. nothing over the counter is helping with the fever or body aches, they come and go thru the day/night. 4. body aches/ joints hurt . 5. breathing thru nose hurts right lymph node area. 6. hard to talk. 7. when seeping /lying down, fell like i am chocking on by own Silvia.

3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room spinning around), anxiety (not problematic before), profuse sweating, feeling of doom, nausea/wretching, pronounced shaking. called 911, taken by ambulance to ER, prior symptoms continued in varying intensity for the next 3 - 4 hours. He was given IV fluids, antibiotics, then admitted to the hospital. He had loss of balance, continued lightheadedness, loss of appetite. Hospitalized for 3 days. Went home with a walker (not used before). He gradually improved over a two week period.

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.

headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, pain in testicals, and nausea

Upset stomach; heartburn; Gas; diarrhea - for around 48 hours. Fatigue also - maybe longer - about 60 hours. Tried to keep hydrated. Didn't see the doctor.

waking up at 4am with aches and some nausea; waking up at 4am with aches and some nausea; experiencing some chills; This is a spontaneous report received from a contactable consumer. A 41-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 18Mar2021 at 12:00 (at the age of 41-year-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 04:00, the patient woke up with aches, some nausea and experiencing some chills. It was unknown if the patient received any treatment for the events. 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 clinical outcome of the events aches, nausea and chills were resolved on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Event ache, nausea description updated to waking up at 4am with aches and some nausea, Event chills description updated to experiencing some chills, Final sentence in analysis tab updated to No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), visibly swollen left armpit painful to touch and with arm movement, severe rigors, fever ~101, rapid temperature changes (burning up to freezing), sweating, headache, nauseousness, dizziness, exhaustion/low energy, no appetite, brain fog Day 3: above started to slowly subside Majority of symptoms have gone away. Still get nauseous and dizzy at some point every day. Low energy, lethargic still, no real appetite, still have brain fog.

(MANUFACTURER UNKNOWN) in the past and experienced vaccine allergy. Prior to 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 -19 vaccine. On 20Mar2021, the patient experienced facial flushing, fatigue, dizziness, mild headaches and nausea with dizziness. No therapeutic measures were taken as the result of adverse events. The adverse event resulted in visit to the doctors or other healthcare professional office/clinic visit. The clinical outcomes of the events facial flushing, fatigue, dizziness, mild headaches and nausea with dizziness were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.

After the first does started having heartburn and intensified greatly after the 2nd shot; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 41-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208) on 01Apr2021 (at the age of 41-years-old) as a second dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not have any history of heartburn or acid reflux. 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 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 22Mar2021, around 2 weeks after first dose of vaccination, the patient started experiencing heartburn which was intensified greatly after the second dose of vaccination. The patient had varying degrees of intensity of heartburn every night and some during the day. The patient did not receive any treatment for the reported adverse event. 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 heart burn was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/05/21pfizer,Lot#EL3246 2nd dose: 01/26/21,Pfizer,Lot# EL9262 Diagnosed covid positive:07/21/21 symptoms started: 07/19/21 Exposure:Community exposure Symptoms:sore throat,diarrhea,runny nose

Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. Around 1545, while being monitored by a registered nurse, he leaned over and grabbed his head. The nurse asked if he was okay and he reported, "no". He stated that he felt nauseated. V/S obtained: B/P 158/80; pulse 99; resp 24; O2 sat 99% on RA; FSBS 267. Pupils were slow to react. Skin was flushed and red. Dr. was notified and assessed the employee. At 1558, the Dr. ordered Benadryl 50mg IM. This was given to employee in Left Deltoid IM at 1558 by RN. At 1559, patient complained of heache, chest tightness, being cold. At 1606, O2 sat was 99% on RA; B/P was 126/90. He reported that his headache was going away at that time and that the chest tightness was going away as well. Headache at that time was a 4/5 on pain scale. Recommended that he be checked at the ER. Between 1620-1625, first responders on site. At 1630, employee was transported to ER for evaluation. Status at time of transfer: Alert and Oriented; headache better, nausea getting better.

Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00 Chills (8) Other: Burning on urination, eyes burning, left side face tingling,

Went to ED 6 days after vaccination. "42yoM with a hx of covid-19 infection in 3/2020 with sequelae of chest pain, insomnia, SIBO, and distant hx of testicular malignancy who presents with chest pain and chest palpitations.  Pt received COVID vaccine on Monday, then started to have symptoms reminiscent of his original covid infection on Wednesday, including chills, myalgias, substernal chest pain, heart palpitations, and fatigue. Denies any fevers recorded at home. He feels like he has extra beats intermittently. Also reports some nausea, but denies vomiting or diarrhea. He has maintained good PO intake since symptoms started, but is worried he may be a bit dehydrated because he had a small AKI when he had covid back in March?. Etiology of chest pains unclear, but given all of the above workup, unlikely to be due to an acute cardiac or pulmonary etiology." He continued to have palpitations for the next week and had further EKG's don thru urgent care.

Dizziness, Diarrhea, HYPERtension & Tachycardia Narrative: Mild dizziness 5 minutes after vaccination. 167/110, heart rate 77 at 1408. 144/01, heart rate 68 at 1417. Reported mild anxiety. Observed 30 minutes. No e/o allergic reaction and anxiety resolved.

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

chills, fever, cough, chest congestion, nasal congestion, HA, nausea, fatigue, body aches. Feel like I have the flu. Ibuprofen with mild improvement.

Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gross"), dizziness, and nausea after getting the vaccine. Brain fog, dizziness, and nausea continued for the rest of the shift. 5 hours after the vaccine (10pm) he was very fatigued. When he woke up the next morning his arm felt like it "was in a vice" and he is still hazy.

Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onset of dizziness, nausea, and feeling flushed. He went to Emergency Department for treatment. He was discharged from the Emergency Department to home. On 1/12/21 he states nausea and dizziness gone. Slight headache. Feels better.

The day after the vaccine i started to feel this sharp pain in the right side of my lower back in the area of the right kidney and today being 12:49 am on 01/17/2021 the pain is located in both sides of my back in the kidney are but is going to the front of my stomach and giving me chills every now and then i have muscle pain from my back al the way to the legs no fever or problems to breath

Last night had heart burn worse then had in years. hot flashes with no temp. muscles soreness and soreness in joints. symptoms are still happening currently

Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon developed severe cramping in stomach, chest and upper back. Did not eat after cramping started. Got worse at approx 11 pm. Resolved by at approx 3 am on 1/19, after fever broke. Have continued to have headache through time of this report submission.

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.

01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/16: HEADACHE AND MINDGRAINE

Woke up at 1:30am with stomach pain, then chills followed by uncontrollable shaking - No fever - Left arm pain and constant head ache for 36hrs after second vaccine - No reaction after the first round of vaccine

1/28/2021- Seen by FNP for indigestion, chest pressure and palpitations. EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA. Patient was found unresponsive by his wife at their home. The last known well was at 1530 when she called him on the phone. The patient was pronounced at ~1850.

After 1st vaccination, patient had symptoms of pain in shoulder and neck with some difficulty swallowing. I directed the patient to be cleared by primary care physician before second dose would be given.

going to throw up; dizziness; This is a spontaneous report from a contactable consumer from a Pfizer sponsored -program, Pfizer First Connect. A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on 22Dec2020 15:15 at a single dose to prevent COVID. Medical history included retinal blood clot in his retina which was why he was tested for RA, and Meniere's disease for which he was asked to try meclizine which was for inner ear but he did not start taking meclizine, and six years ago, they did blood work and he was told he may have rheumatoid arthritis (RA) or he may have markers for RA but he has had no further issues and does not take any medication for this. The patient's concomitant medications were not reported. The patient experienced dizziness on 06Jan2021. The dizziness was increasing and he felt it most of the time. On 07Jan2021, he started feeling swimmy headed and he left work on 11Jan2021 since he was told he looked horrible. He never leaves work. He went to the clinic on the 11th since he felt like he was dizzy and going to throw up. The next day he did not feel better. The outcome of the events was not recovered.

On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.

Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night sweats, fever, Diarrhea

Received 2nd Pfizer vaccine yesterday (Thurs 2/4). Felt fine for several hours but then began to feel muscle pain, body aches, somewhat nauseous on Thurs. night, continued through Fri. Felt better by Sat. evening.

Muscle pain; fatigue; Headache; diarrhea; Fever 101.5; This is a spontaneous report from a non-contactable pharmacist reporting for himself. A 42-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 20Jan2021 02:00 PM at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm at 42 years old on Dec2020 03:00 PM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient experienced muscle pain, fatigue, headache, diarrhea, fever 101.5; all on 20Jan2021 06:00 PM. The patient required 12 hours in bed to recover. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Covid test post_vaccination (Nasal Swab,Bi naxNow) on 23Jan2021 with negative result. Outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Diarrhea; This is a spontaneous report from a non-contactable consumer reported for himself A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea in Jan2021 with outcome of unknown. The action taken in was not applicable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Temperature of 103, vomiting, chills, body aches, joint pain, head ache, joint swelling. Tylenol and fluids. It lasted approximately 48 hours.

appendicitis; This is a spontaneous report from a contactable consumer reported for self. This 42-Year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. No Covid prior vaccination. No known allergies. No other vaccine in four weeks. Facility type Vaccine: Hospital. He developed appendicitis after the vaccine on 11Jan2021. First symptoms appeared three days after first dose. Checked into hospital for an appendectomy the following day. Treatment was appendectomy. Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab on 15Jan2021: Negative. Outcome of the event was recovering. Information on Lot/batch number has been requested.

Day 1-headache-no treatment Day 2-fever, headache, nausea, body aches, chills-no treatment Day 7-rash, left arm, topical ointment on continued through today Day 7-carbonated drinks taste flat continued through today

Felt immediate headache, followed by extreme exhaustion, fatigue, body aches (the same day as the 2nd dose) within about 10 minutes after it; and for the next two days. Felt better by 02/14/2021. Began feeling ill again on 02/17/2021, body aches, extreme fatigue, feeling very hot but not having a fever, nausea. It seemed to get better on about 02/21/2021, but then on 02/22/2021, all of the same feelings and symptoms came back and are still present today. I have reached out to my primary doctor to let him know and he suggested that I submit this information here as well.

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

On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at the injection site. On Wednesday, I noticed light bruising up and down my arms. Thursday morning around 10 AM, I started to have side effect - some so severe they must be documented. At 10 AM, I felt lightheaded and had brain fog. By noon my head was pounding with a headache followed by an upset stomach. At 2 PM things started getting bad and continued to worse. It was not the headache or stomach that need to be noted but a sudden and severe onset of depression and anxiety. - Depression like I have not felt in years when I was at my worst. Throughout the day the depression worsened and by 7 PM, I was unable to stop crying and was overwhelmed with anxiety and PTSD panic attacks. While I have the training to understand this is temporary, - I am very worried about what I?m feeling , because there was no warning or mention of this side effect. I have the resources needed for this but people that are more fragile need to prepare for the sudden o set of critical/ debilitating depression.

42 yo male without h/o reaction to prior vaccinations or medical problems here for first covid vaccination. approx 9 min after vaccination with dizziness but no headache, no syncope np altered mental status no shortness of breath no wheezing no palpitation no chest pain no stridor no dysphonia no globus no rash no flushing no hives no angioedema. sx resolved with hydration. pt admitted to poor intake and anxiety.. pt discharged home alert and oriented.

Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in bed with multiple layers of clothes, under multiple blankets with heat cranking. Uncontrollable chills, shivering and teeth chattering. Hands white and lost sensation in fingers. 105 fever. Chills lasted a couple of hours, fever lasted 3 full days. Day 1: 105; Day 2: 102; Day 3: 100; Day 4: No fever. Stomach tightness remains.

Approximately 20-25 minutes after receiving the vaccination, it became difficult for me to swallow. My ability to breathe was unaffected, but it was incredibly difficult to swallow, like I could not generate any saliva naturally. Approximately 20 minutes after that, my tongue went numb. The symptoms went away several hours later after taking a couple of doses of Benadryl and Loratadine.

Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp started 12hrs after injection and lasted for 48hrs Blurred vision during onset of Temp. Muscle pain/ fatigue during onset of Temp. Full body aches during onset of Temp. Chills with moderate spells of hands shaking during onset of Temp Loss of appetite during onset of Temp.

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.

Patient reported severe stomach upset that last 12 hours. Severe pain indicated almost going to the hospital for pain

3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present. 3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted. 3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills. 3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.

After receiving vaccine patient complaints of feeling unwell, diaphoretic, nausea, increased heart rate. BP elevated at 226/107 HR 140. Patient assisted to stretcher given oral fluids and reassessed. patient states he does have a history of SVT, which he takes diltazem and lisinopril for.

Started was a very cramped stomach and then the rest followed. Whole body turned red including eyes. Upset stomach with vomiting and diarrhea. Body was shaking and didn?t have a fever. Skin felt like it was burning whole body felt swollen. Started around 2:30am with the cramping. It woke me up. Once I got up everything came so fast. Was rushed to hospital where I was admitted very quickly. I was blacking out on the drive there and blacked out while in their care. This was from one dose of Pfizer vaccine for Covid. I was put on a GI, Allergy, and steroid medications. I was hooked up to an IV and 3 drugs were injected. I passed out numerous times but was discharged at 5am.

Abdominal tightness with lower chest with tightness briefly lower chest that resolved with juice. Pt did not eat before coming out to vaccination center with pt feeling better on DC. Vitals stable

Chills, body aches, migraine headache, nausea. Nausea has continued to be a big issue from the night of injection until today, which is Monday, 3/29/2021. On Saturday night (3/27) I experienced overwhelming stomach pain and nearly passed out on my toilet multiple times during a bout of diarrhea.

He reports that his first symptom started the same day and he received the vaccination around 3 pm. He started to feels symptoms around 8 pm pain around hip area bilaterally. On the following day he experienced upper back pain/shoulder pain/abdominal pain. He reports to intermittent feelings of bloating/constipation following vaccination and took stool softeners which led to loose bowel movements. About 4-5 days after the vaccination the patient noted improvement in all his symptoms.

Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. Night cold sweats during brief sleeping periods. Third day was the same. Loss of appetite and dehydrated. Severe itching on my back. Today is the fourth day and I broke out with a rash on my back. Cortisone has relieved it thus far. My appetite is back. I did not vomit but still experiencing diarrhea.

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.

Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint and light-headed 3-4 minutes after shot. Passed out about 5 minutes after shot. Felt sweaty, disoriented, spacey, and nauseated shortly after coming back to consciousness. Went to hospital in an ambulance and released a couple hours later.

Fatigue/More fatigue; slight dizziness; slight nausea; slight fever; hot and cold flashes; This is a spontaneous report from a contactable consumer(patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN5318), first dose via an unspecified route of administration, administered in Arm Left on 02Feb2021 09:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02Feb2021, the patient experienced Fatigue, slight dizziness, slight nausea, slight fever, hot and cold flashes. More fatigue then anything. The patient's lab tests included body temperature: slight fever on 02Feb2021. The outcome of the event was recovering for Fatigue, unknown for Dizziness, Nausea, Pyrexia, Hot flush.

Flu like symptoms Sore muscles. Sore joints. Fatigue. Exhaustion. Loose stools. Lack of thirst, even when dehydrated.

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.

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, joint pain, fever (mild), nausea

Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects and asked him to wait 15 minutes afterwards in our waiting area. After about 5 minutes, the patient starting complaining of feeling dizzy. We asked him to sit back in the chair and brought him a bottle of water. I asked the patient if he had eaten today and he replied no. I offered a snack and also a glucose tablet to help with shakiness. As I went to get a bottle of glucose tablets off the shelf, the patient fainted and fell out of his chair. I immediately ran to get an Epipen while my technicians called for a Code White and 911. I was about to inject the patient with the Epipen when he came to about 10 seconds later. He said he was really hot, sweaty, dizzy, and nauseous. Paramedics and AP arrived to evaluate him and take a statement. Patient left on his own will and received a ride home from his mother-in-law, who is an associate at our store.

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.

small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when breathing; work up with terrible thoracic back pain with every breath; chills; low grade fever; Moderate stomach cramps; Much less arm pain then following first dose but still present; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via an unspecified route of administration in left arm on 03Mar2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) on 10Feb2021 at 11:30 am in left arm for Covid-19 immunisation. There were no other vaccines in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had 3/4 moderate stomach cramps day after vaccine on 04Mar2021. Much less arm pain then following first dose but still present on 04Mar2021. The patient 3/9 worked up with terrible thoracic back pain on 09Mar2021 with every breath and went to emergency room and received shot of Toradol and performed chest x-ray which was negative. Shortly thereafter, the patient had chills and low grade fever on 09Mar2021. Alternated naproxen and tylenol for the next two days as fever persisted. The patient had 3/11 moderate chest pressure when breathing and went back to emergency room on 11Mar2021. There was no fever or chills but had 3/12 light headedness, racing heartbeat and chills early afternoon on 12Mar2021. The patient went back to emergency room. The patient's symptoms improved over course of following 7 days. The patient underwent lab test and procedure which included flu test and resulted negative; blood work which showed positive D-dimer test on an unknown date and CT scan showed small pneumonia in lower left lung on 12Mar2021. The patient started to receive amoxicillin and Z-pack. Since the vaccination, the patient had been tested for COVID-19 by nasal swab on 11Mar2021 and tested negative. Events resulted in emergency room/department or urgent care. The outcome of event pneumonia was unknown; for other events was recovering. No follow-up attempts are possible. No further information is expected.

Every joint aches -started 4/9 @11 pm and still happening. Gastrointestinal distress, excessive gas, colon cramping- started 4/10 @ 1am Loss of appetite- am 4/10

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.

Patient started noticing dark stools the day after vaccination (4/15) and began vomiting blood on 4/16. One episode of vomiting resulted in a syncopal episode in which the patient hit their head, causing a laceration which required staples. The patient does report intermittent abdominal pain over the course of the past few weeks, but today is more severe and the first time he has experienced bloody emesis. Upon presentation patient was tachycardic, hypotensive, and pale. Patient reports he does not frequently consume alcohol. Patient received a pantoprazole bolus and drip, an octreotide drip, and PRBC. Patient also received several doses of ondansetron. Patient is being admitted for care.

72 hours after receiving the shot I had debilitating vertigo and nausea, as well as rapid heartbeat. I went to the ER and was admitted for 2 days. I am still currently experiencing dizziness on Friday April 16th 2021.

Extreme soreness and discomfort at base of skull, sinus cavity?s below eyes felt inflamed and dried, unable to sleep or get comfortable, alternated between feeling chills and feeling overheated, vomiting

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.

THe vanishpoint syringe retracted early. Could not tell if half of the vaccine was injected in the left arm. explained to patientin that case we sould inject again and he agreed. another dose was injected into the right arm. Patient had nausea, fatigue and fever that night but felt better on Saturday 04/24/21.

Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after vaccines. I gave him his immunization quickly and he did well. He stood up and watched as I immunized his wife. He said he was feeling okay afterwards so both him and his wife left the immunization room. Shortly after leaving he must have started getting dizzy, because next thing I hear is that there is an unconscious man in the waiting room. He is sitting in a chair with his head back unresponsive. His wife if rubbing his arms and lightly slapping his face. He comes to, and we decide to move him to the room that the clinic uses (we have a walk in clinic staffed with a NP). He lays on the floor, and within a minute he proceds to vomit approximately 4 times. He also lost control of his bladder. He was pale with cold and clammy skin. we moved him so we could put his feet up on a chair and allowed him to rest. Someone went to get him an ice pack to put on his head and chest. His blood pressure was low (90/50ish). He still was not feeling better after 30 minutes so we called the ambulance. He did not want to go to the hospital so the paramedics monitored him. his blood pressure slowly started going up and normalizing, and he left with his wife.

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.

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

72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; 72 hours after receiving the shot I had debilitating vertigo and nausea which still persists at the 5th and 6th day.; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: Ew0158) via an unspecified route of administration, administered on the right arm on 10Apr2021 09:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. 72 hours after receiving the shot he had debilitating vertigo and nausea on 14Apr2021 10:00 AM which still persists at the 5th and 6th day. The events resulted in Emergency room/department or urgent care visit, Hospitalization for 2 days. Therapeutic measures were taken as a result of the events which included Meclizine 25mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. COVID test post vaccination: Nasal Swab on 14Apr2021: Negative. Outcome of the events was recovering.

Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED) with myalgias, nausea, and fever. Denies chest pain, diarrhea, weakness, and shortness of breath. Oxygen saturation 88% on room air, rest of vital signs within normal ranges including temperature of 36.4 degress Celsius. Administered intravenous fluids, oxygen, antiemetics, acetaminophen, and NSAIDs. Patient's symptoms improved, oxygen saturation maintained within normal range on room air, and patient discharged to home stable.

Presented to ED on 5/10/2021 with abdominal pain, nausea, vomiting, marked leukocytosis of 30K with left shift. Admission screening PCR for COVID-19 Positive. No known history of COVID-19 in the past, no known contact with a person positive for COVID-19

Patient became diaphoretic, weak and pale. Blood sugar 254, B/P-134/85, P-62, O2 SAT-96% on room air. Assisted patient to floor and elevated legs. Patient stated, "I'm ok." Wife present and stated, "He has done this before but he didn't do this with his first shot." Patient vomited once. Staff called EMS. Patient refused to go to the hospital. Wife drove patient home.

Client received first dose of COVID vaccine @ 10:10am and complained of dizziness and nausea @ 10:25am. Client assisted to zero-gravity chair and given a cold ice pack. Vital signs assessed, initial blood pressure 77/50. Client reports only eating grapes prior to vaccine, snack and water offered. Client denies shortness of breath, no medical conditions, not taking medications, no know allergies. Client complained of abdominal pain that comes and goes @1029, reports no longer dizzy or nauseous. Blood pressure at the time is 98/65. Continued to monitor client, vital signs and blood pressure 105/65 @ 1039. Client reports no more symptoms @ 1050, able to walk out of observation area with steady gait.

On both events, I had stomach cramps that lasted about a week after both shots. The pain went away on its own. In addition, I currently have pain on the arm I received the shot on. This recently started and occurred several weeks after receiving the second dose. The pain is similar to a burn from a sunburn and itches. It varies throughout the day in pain and stretches sometimes from my hand up to the side of my left check. Also on my upper back and back of neck.

4/22--HA, vomiting, fatigue, sinus congestion, nonproductive cough; symptoms started mildly and progressively got worse i.e. sinus congestion and cough then HA, and finally vomiting. Symptoms resolved 4/24 5/13--severe myalgia, arthralgia, fatigue, slight sinus congestion; 5/15--severe radiating left arm pain; 5/16--myalgia and arthralgia improved; severe left arm pain continues today APAP and ibuprofen tried for pain without improvement in symptoms.

Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.

Abdominal pain; Diagnosed with Acute Kidney Failure; This is a spontaneous report from a contactable consumer, reporting for himself. A 42-year-old male patient received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 13Apr2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included ongoing asthma (diagnosed when he was serving around the year 1999-2000). Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma. In Apr2021, the patient was diagnosed with acute kidney failure, which required physician office visit and emergency room visit. On 14Apr2021, the patient experienced abdominal pain, which required physician office visit and emergency room visit. As reported, he took the vaccine about 3 weeks ago and immediately the next day he had abdominal pain. The patient reported that he stopped everything when he experienced the pain. The pain started mild and then increased and he went to the emergency room. The patient wasn't admitted to the hospital but after they checked his blood and urine with unknown results, he was given an IV. When he was released he was told to follow up the next week with his primary care provider. The pain still had not gone away and was in the right side of his abdomen. The pain changed day by day. He had been drinking a lot of water and had maybe 1-2 days where the pain was worse than normal. He had been in and out of the doctor's office and his kidney levels are a little bit high on an unknown date. Every 2 weeks, blood and urine tests were taken to measure his kidney levels to see how it is doing. CAT scan was performed and did not see anything. The patient reported that something was observed in blood and urine and that's how an issue with his kidneys was determined. The clinical outcome of the events was not recovered. The batch/lot number for the vaccine, btn162b2, was not provided and will be requested during follow up.

? Wednesday, May 19, 2021: ? 14:00 EDT - Patient got 2nd Pfizer vaccine. ? 17:00 EDT - arm started to get sore. ? 17:30 EDT - dizzy after sparring class. Blood pressure 107/71. Pulse 59 BPM. Burping. Gassy. A bit nauseous. Watermelon smelled like cut grass (awful). Forcing myself to drink orange juice. Tastes terrible, like Sweet Tarts (My wife says it's just me). ? 20:30 EDT. Found antidote. Antidote is pie. Cherry pie. After kimchi chicken and smokra. Update: Feelin' fine. ? Thursday, May 20, 2021: ? ~ 05:00 - hard relapse. Arm very sore (8/10). Fairly nauseous. Almost regurgitation level. At the same time I do feel hunger so I know it's not real nausea, yet I still can't eat. Bad headache (7/10). Muscle stiffness up the back and up to the neck, getting worse the higher you go; the neck is particularly bad. ? By 9:40, temperature up to 99.6. ? 11:57 temperature 100.7, blood pressure 125/66, pulse 79 ? 2:50 temperature 99.7 ? 3:30 temperature 99.6 ? Friday, May 21, 2021: ? Update about yesterday (Thursday): I ended up spending the entire day in bed. Very nauseous. Couldn't eat. Spiked a high fever (my baseline is around 97.5° F). Blood pressure fluctuated. High pulse (mine is usually around 50 bpm). Sore muscles on entire torso; pain in my lower back (above pelvis) makes it too uncomfortable to sit up. Except for not vomiting or coughing, it felt like the flu. ? Head still hurts (4/10). Weak. Tired. Arm still pretty sore (3/10). Was able to eat kimchi chicken for lunch and shawarma for dinner, but still not completely over the nausea. ? Saturday, May 22, 2021: ? Left arm still sore in a 2" radius from injection site (2/10), but the rest of the arm is fine. Still have the headache (2/10). ? Sunday, May 23, 2021: ? About mid-afternoon, the headache finally receded. Left arm still sore in a 1/2" radius from the injection site (1/10).

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.

Headache; Stomach discomfort; Diziness; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164, Expiration date: unknown), via intramuscular, administered in left arm on 13apr2021 at 15.30 (at the age of 42-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not undergo COVID-19 test prior to vaccination and Since the vaccination the patient has not been tested for COVID-19. On 13apr2021, 04:00, the patient experienced Headache, dizziness and a little stomach discomfort. The reporter assessed all events as non-serious. The outcome of the events Headache, dizziness and a little stomach discomfort was not recovered. No follow-up attempts possible. No further information expected.

pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. 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 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy. Headaches were present most of the first day. That night, around supper time I felt nauseous and then had some severe stomach cramps. I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head. Most of the symptoms were gone after 48 hrs.

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.

Patient was given has second dose of Pfizer. He did not have any reactions with his first dose. He felt dizzy, nauseous and had a stomachache. He was also feeling hot and complained of feeling a tingling sensation in his fingers. This was a few minutes after the vaccine was given and he was sitting at the post-immunization area. We directed him to sit on the floor and gave him 2 cold packs to put on his neck. Patient looked pale and weak so we also gave him some cold water. After a few minutes of sitting, he asked for us to call 911. We called 911 and alerted management. After paramedics came, patient was taken away. Patient seemed to be doing fine as he was leaving. He regained color in his lips, but was still feeling the other symptoms.

lot of pain at the shot location; body aches; headache; Chills; muscle aches; tiredness; nausea; diarrhea; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in left arm on 22May2021 at 15:45 (at the age of 42-years-old) as 2nd dose, single dose for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. The patient had penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0172), dose 1, administered in left arm on 01May2021 at 15:30 as 1st dose, single dose for COVID-19 immunization. on 23May2021 at 00:00, the patient experienced lot of pain at the shot location, body aches, headache, chills, muscle aches, tiredness, nausea and diarrhea. The patient did not receive treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

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

Pfizer-BioNTech COVID-10 Vaccine EUA Fever (spiked up to 101.6 three times), chills, headache, body ache, some nausea from 6/2/2021 12:30 PM through 6/4/2021 7:00 AM.

Within 5 minutes very sleepy, 5-10 min nausea and fever with chills sweat. Loss of vision and dissy. Medical staff checked and found skin changed color and very low blood pressure. After 25 minutes symptoms started going away.

a few weeks after he received the 2nd dose of the vaccine he started vomiting and continued to vomit through out the night. He was instructed by his Dr to call 911. He went to the ER and was admitted into the ICU for diabetic ketoacidosis. to this day, it is very difficult to control his blood sugars.

About 24 hours after receiving my second COVID-19 vaccination (Pfizer) on 4/30/21, I began feeling intense pain in my lower back. It was so painful that I could not even sit down or lie down without intense discomfort. I was unable to sit for periods longer than 10 minutes. I did not do anything physically demanding after getting the vaccine, so I'm convinced the vacccine caused the pain. I have had lower back soreness for several years and two doctors have diagnosed it as a possible torn disk. It took a full 30 days for the pain to subside. I also got severe flu-like symptoms from the shot beginning 12 hours after the second shot. These cleared up after about 8 hours. I also began feeling heart burn about 10 days after my first shot. It intensified after my second shot. I've never had heart burn before. I had to go on Omeprazole prescribed by my physisican. Abo

For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I had Covid, body aches, chills. For 2nd vaccine- after one week I experienced had excruciating headaches and shakiness that do not go away. I take Tylenol for pain and as a result have upset stomach. I went to see my PCP who performed exams, lab work, x-rays, CT scan of the head, CT scan of the abdomen and my doctor does not find anything wrong for me. To this day I continue wit the headaches that do not go away. I do not feel well to do my daily living activities and I get anxiety. I feel very tense and frustrated due to my symptoms. I do not have the lot # for my vaccines to provide.

Vertigo - positional; dizziness; nausea; his is a spontaneous report received from a contactable consumer, the patient. A 42-year-old-male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in left arm on 25Mar2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hypertension. The concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 20mg daily. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in left arm on 02Mar2021(at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Apr2021, the patient experienced vertigo -positional, dizziness and nausea. The treatment received for the events included meclizine 25mg three times per day. The clinical outcome of the events vertigo positional, dizziness and nausea was not recovered at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.

Approximately 7.5 hours after the fist dose, at a basketball game, I began to sweat profusely, my vision blurred, and became extremely nauseated. My partner had to help me out of the venue and drive us home as I sincerely thought that I might lose consciousness at any moment and was unable to operate a vehicle. By the time we reached home, my fever had spiked to 103.1 and I was vomiting. I was severely ill for the next 48 hours. Since the having the vaccine I my vision is still blurry for things closer than about 18 inches from my face. I have never required reading glasses before, but now do.

This is a spontaneous report from a contactable consumer, the patient. A 42 years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route administration in right arm on 20Mar2021 at 17:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication taken within two weeks included vitamin D (MANUFACTURER UNKNOWN) from unknown date and for unknown indication. The patient did not have any allergies to food, medications, or other products. The patient did not receive any treatment for events stomach cramps and nausea. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route administration in left arm on 27Feb2021 at 17:30 (at the age of 42-years-old) as a single dose, for COVID-19 immunisation. On 21Mar2021, the patient experienced stomach cramps and nausea. 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 events stomach cramps and nausea. The clinical outcome of the events stomach cramps and nausea was not recovered. No follow-up attempts are needed. No further information is expected.

Received first dose of Pfizer on 6/4. Four days later (6/8) I developed debilitating dizziness and accompanying nausea. After 24 hours of vomiting I visited the emergency room (6/10) and received IV fluids. Head CT scan, ECG, blood, and urine all tested negative. Nausea subsided but dizziness continued. Consulted ENT on 6/15 and was diagnosed with vestibular neuritis. Confirmed with ENG/VNG testing on 6/25. As of 7/3 I am still experiencing disorientation when moving head. Activities like driving and grocery shopping are difficult. Next step will be vestibular rehabilitation therapy. Not sure if this will be a permanent condition.

Abdominal muscles pain only in left side; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 21Mar2021 at 15:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included lactose intolerant. Concomitant medication included pseudoephedrine hydrochloride; cetirizine hydrochloride (ZYRTEC D) for an unknown indication from unknown 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 did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. On 23Mar2021 at 11:00, the patient experienced abdominal muscles pain only in left side. The event 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 event abdominal pain. The clinical outcome for the event abdominal pain was not recovered. No follow-up attempts are needed. No further information is expected.

4 days after the vaccine, severe muscle aches, fatigue, and nausea. Also had gastrointestinal bloating and nausea. These symptoms were severe for 3-4 days.

I experienced minor sneezing, diarrhea , headaches, nostrils discomfort, lower right leg felt weird, back of my ears started itching and general bodily itches. All the symptoms have subsided except mild headaches and mild itches.

Around July 1st, 2021 I started having pain in my right upper quadrant in my stomach, with nausea and vomiting. I saw Dr., to do some regular bloodwork. My liver tests came back abnormal. Dr. did a lot of bloodwork, he was calling all of my other doctors to go over the test results. Some of medications may have to be switched out if they are harmful to my liver. They are working on getting my liver numbers down. On July 26th, 2021 I went to the ER for pain in the right back of my leg, thinking it may be a blood clot. At the ER, they did an ultrasound. I gave myself a shot of Lovenox before hand that may have broken up the blood clot if it had been there.

10 min after injection, my mouth started getting hot, then it moved down my throat and it was difficult and painful to swallow. I got quite dizzy. They initiated rapid response, when they came they simply monitored symptoms and Vitals. Blood pressure and Heart rate were elevated. after about 10 min the symptoms eased, but swallowing was still difficult and slightly painful. then a second wave of dizziness hit me and I nearly passed out. my heart rate was elevated once again and had ringing in ears. these symptoms lasted another 5-10 min then eased. I then had a headache. The symptoms didn't return, just a headache and fatigue the rest of the day. i was then given option to go to ED, which i didn't feel at that time I needed, so I left. The next day, i had some standard symptoms of pain in left arm from injection, and fatigue, but then toward the evening i developed a fever of 101 deg F than continued for a couple of hours. I used ibuprofen and Tylenol rotating to keep the fever down. On day 3 only mild fatigue.

Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; This is a spontaneous report from a contactable Nurse. A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284), intramuscularly on 23Dec2020 08:30 at single dose on Left arm for immunisation. The most recent COVID-19 vaccine was administered at Hospital. Medical history was none. No other vaccine in four weeks and two weeks. No covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced tiredness, chills, body aches, diarrhea, persistent fevers even with tylenol or motrin taken 99.5-101.5degf on 23Dec2020 16:00. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for tiredness, chills, body aches, diarrhea. The outcome was not recovered. Covid test post vaccination included Covid 19 with type of Nasal Swab on 27Dec2020 with unknown results.

Anaphylaxis Narrative: Pt reported trouble swallowing around 20 minutes into the observation period and was transferred to the treatment area in the vaccine clinic. Vital signs were assessed by a Registered Nurse and a Physician. Oxygen saturation was noted to be 88% on 2 liters of O2 by nasal cannula. Verbal order received at 10:03am from Physician and EpiPen administered to right thigh with improvement of symptoms. She was transferred to the Emergency Department (ED) via stretcher. In the ED, she was re-dosed with an EpiPen secondary to her airway type symptoms. She was reevaluated after 15 minutes and received Solu-Medrol, Pepcid, Benadryl IV, as well as IV fluids. She also received Ativan for her generalized jitteriness and anxiety. She improved and felt significantly better at approximately 11:43am. She was monitored for 3 hours in the ED and was discharged home at 3:34pm in good clinical condition and advised to continue to take Benadryl as needed. She carries and EpiPen on her person and was advised to return immediately if symptoms return.

Felt weak, dizzy, blurred vision and nausea Vitals normal except for several episodes of O2 stat 89-90. No wheezing . One dose of Diphenhydramine 25 mg dose. Back to normal in 1 hr.

Extreme muscle soreness in whole body as well as injection site. Extreme shivering. Dizziness. Nausea. Severe headache. Severe coughing with some sputum.

Nausea, Diarrhea, Sore throat, headache and congestion. Started an hour after receiving the vaccination. Symptoms increased the following day.

Pain at injection site; headache; muscle pain; chills; joint pain; tiredness; fever; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via intramuscular route of administration, on 28Dec2020 at 09:15 AM (at the age of 43 years old) as a single dose in the right arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medication were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, at 11:30 PM, the patient experienced pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. No treatment was received for the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. The outcome of the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea was recovered on an unspecified date in Dec2020. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. DENIED SOB. NO TACHYPNEA, RASH OR ORAL SWELLING. NO AUDIBLE WHEEZING OR STRIDOR. SENT TO ER AT 2:19 FOR OBSERVATION. OBSERVED 1 HOUR.

Pfizer-BioNTech COVID-19 Vaccine EUA 1 episode of Diarrhea 3 hours after 2nd dose Sudden onset of fatigue and chills approximately 12 hours after 2nd dose Fever of 102.5 to 103 F and body aches approximately 18 hours after 2nd dose Symptoms all gone after approximately 36 hours

Vaccine recipient experienced nausea and vomiting after receiving the vaccine. At the end of the observation period of 15 minutes he developed nausea and vomited once. After he vomited, the symptoms resolved. He was sent to the ED for follow-up and observation. Vaccine recipient stated that they drank a lot of juice. He improved and was subsequently discharged. The next day vaccine recipient reported that they felt sluggish and had arm pain around the site of injection. On a follow-up call today 1/11/2021; he reported that his symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.

The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/10. The pain gradually increased, became more intense, and more constant. Mild fever and chills started happening, and I took Ibuprofen. By about 4 days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night. Pain was 6-8/10. I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis. I underwent laparoscopic surgery and it was found to be perforated. It was removed. I am currently recovering in the hospital. I received the vaccine as a health care provider at my hospital, specifically I am a practicing pediatrician physician for over 10 years.

Fever of 104.3. Chills. Severe body aches and headache. Nausea. Vomiting. Dizziness. Lasting more than 36 hours

Soon after the injection he noted a slight fever, body pain, migraine, slight nausea. These symptoms lasted for 2 days

A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy. If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate. The heart rate beat felt heavy. I went to bed early and slept through the night. I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated. no fever, no headache. i tried to take a shower but symptoms got worse. i was unable to go to work that day. I took a few naps during the day and by late afternoon most symptoms where going away. the last symptom was the issue with the hands and feet. Heart rate returned to normal. The next day i was able to return to work.

After the required wait period of 15 minutes I started to drive back home which is 77 miles from the hospital that administered the vaccination. Around 15 minutes down the road I started feeling like something was caught in my throat and was coughing a little. At that time I decided to turn around and go back to the hospital. I took an oral Benadryl 25mg and decided to wait in my car and see if it was something else. After 30-45 minutes I took a drink of water and realized I was having trouble swallowing. I then preceded into the ER and was admitted immediately. In the ER, they started an IV, administered Benadryl, methylprednisolone and a bag of saline. The physician discussed with me and we agreed to hold the Epinephrine to see how I reacted to the previous medications. I was then monitored for a couple hours then released with a prescription of Prednisone 60mg for 5 days and an EpiPen. One day out, no new symptoms besides injection site pain.

Patient received vaccine on 1/2 (Sat) and today went to the ED 1/5. On Sunday am began vomiting and diarrhea with no blood in stool or emesis. Denies fever. States he only coughs post vomiting and it is un productive. Pt has been urinating and has been able to keep food and fluids down. Noted with skin warm and dry/resps, NAD and color WNL. Pt denies any abdo pain except post vomiting. SARs CoV2 RNA test negative.

The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and heartburn/indigestion remain; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 43-year-old male patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number and exp date not reported), intramuscular (vaccine location: left arm) on 28Dec2020 for COVID-19 immunization. Facility type vaccine: Nursing Home/Senior Living Facility. Medical history included gastric sleeve and surgery. The patient had no known allergies. Patient did not have Covid prior vaccination. There was no other medical history. There were no concomitant medications. There were no other vaccine/s within four weeks. No other medications in two weeks. The day after patient received the vaccine, she got the common side effects on Jan2021: chills, loose stool, and nausea. She also began having heartburn/indigestion (Jan2021). It had been 16 days since the first dose, and the loose stool and heartburn/indigestion remain. Not sure if it's because of having the gastric sleeve done years ago, or not, as the surgery changed her metabolism and the like. No treatment was provided. Nasal Swab on 11Jan2021 was negative. The outcome of the events was not recovered. Information about lot/batch number has been requested.

numbness in right side of face and right arm; hard time swallowing; felt foggy; dizzy; disoriented; This is a spontaneous report from a contactable consumer. A 43-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on arm left from 11Jan2021 to 11Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The patient states about 24 hours later he felt foggy, disoriented, and dizzy (all three occurred on 12Jan2021), states he then woke up at 3 am this morning and had a lot of numbness on right side of face and arm and had a hard time swallowing (both occurred on 13Jan2021), states a couple hours later he went to hospital, went to ER and had to do an MRI, states the MRI of brain and neck came back clear and checked out, states doctors concluded it was an adverse reaction to vaccination. Outcome of the events was recovered on 13Jan2021. Information on the batch/lot number has been requested.

Malaise, nausea, headache, mild fever, arm pain. took one dose of acetaminophin,. Symptoms. have resolved 01/23/2021

Fever, chills, whole body ache, nausea, headache. Symptoms lasted about 24 hours, controlled with over the counter NSAIDs.

Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal response (previous history of syncope with vaccinations/procedures). Patient received 1st dose of Pfizer vaccine around 11am today. Within 2 minutes of receiving the vaccine, he started to feel dizzy and passed out for around 45 secs. He had cold extremities, looked pale and was sweating. He was immediately transferred from chair to floor and his legs were raised. Cold towel was placed on his head. He regained consciousness but was confused for less than a 1min. Vitals were checked and his BP was 95/50's and HR was around 56. Pulse O2 was 99% during entire event. He was able to converse well after that and was oriented. He informed having anxiety/panic attacks, had taken his medication that morning. He reported similar syncopal episodes in the past. He was monitored in same posture. He was gently hydrated orally with water and soda. He was given sublingual zofran due to nausea and retching. He did not vomit. We continued to monitor his BP on regular intervals. He had slow improvement in BP and after 2 hrs while sitting his BP was 104/65, pulse 56/min (reports being an athlete and previous records show baseline bradycardia). He denied any symptoms and was awake, alert, oriented. As he was not accompanied by anyone, his wife was contacted who came to clinic in 10mins and helped to drive him home. He was transported by wheelchair till entrance of clinic. He reported feeling better and thanked for helping. He does not have any contraindications to receive 2nd dose of vaccine.

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.

hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.

Vomiting. He anxiety with symptom vomiting. Heart rate decreased as relax sat in lobby away from people and felt better went home

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

Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased to 150/100. Vomiting and diarrhea. Went to ER on 02/01/2021 and had MRI of the brain to check for stroke/TIA. Had an EKG and carotid artery scan. All tests came back normal. Continued to have neuropathy only on the left side of the body since 01/31/21. Pain travels from nerve to nerve. Occasional HA with pain only on the left side of the head. Cold tightness in chest. Seen PCP numerous times and had bloodwork done, Symptoms have continued since onset on 01/31/21 with no increase or decrease in severity. PCP has referred him to a neurologist.

Pt reported before shot that has had history in past of fainting after vaccinations. After receiving the shot, had him sit in a chair next to the table for a few minutes to see if would occur again. After about 2 minutes, pt began reporting that he felt that he was about to faint again. He began to dry heave and passed out momentarily for 2 seconds before coming back to. Pharmacist caught him before he fell. Gave pt water and took blood pressure. Patient began to feel better. Sat for 30 minutes and then he felt fine to leave.

felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination Information on the lot/batch number has been requested.

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.

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.

Light headed followed by losing consciousness for about a minute. Then nausea and throwing up. Fatigue rest of the day.

Threw up foam and saliva in middle of night. Felt like I was choking, woke from a sleep coughing and spit up foaming mucus. Right leg was tingling as well.

Bloody diarrhea. Blood dripping from anus. Fever. Lethargic. Sleeping constantly. Body aches all over. Extreme abdominal pain.

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

Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation of increasing nausea and vomiting. The patient has gotten worse the past 24 hours. She got her second COVID-19 shot yesterday here at the VA Medical Center. She is complaining of consistent nausea and vomiting and can't keep any fluids down. She is here for evaluation of possible dehydration and weakness. The patient feels markedly improved after oral Zofran. I counseled her at length about this is a possible intolerance to the second Covid 19 immunization. She will be discharged home with Zofran 4 mg tablets 3 times a day as needed for nausea #20, increase fluids and rest, no work until Thursday, March 11, 2021. First covid19 vaccine: 2/15/2021, no adverse events Second covid19 vaccine 3/18/2021: presented to ED

significant persistent nausea unrelieved by zofran. no vomiting. same reaction with vaccine on 2/7 but reaction is more severe this time causing work loss

Adverse affects after 2nd shot , 3/9/21 - ongoing undulating headaches at back of skull/ears. Headache pain 3 to 5 out of 10. Tightness in upper neck. Occasional nausea. Headache usually stronger early waking hours and late afternoon. Scheduled Doctor appointment Tues 3/16/21 with health care provider. Taking 325 mg aspirin to help manage pain - only slightly effective. Side effects have gone well past average 72 hrs reported as normal.

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.

Severe spinning, nausea, vomiting, occurred at 2:15 a.m. while on duty, was transported to ER and diagnosed with Peripheral Vertigo. Follow ups with ENT, Neuro and PCP have continued with Vestibular Rehabilitation. While in ER, the MRI, MRA, CT, CT with Contrast was done, showed no signs of anything that could have caused this. Ironically tracking back, I received my 2nd Dose of the Pfyzer Vaccine on January 6, 2021 at 8:45 a.m. and this occurred on February 13th at 2:15 a.m. I have not had any other issues before this nor any signs of damage to the nerve or ear that regularly affects Vertigo Patients per my Neuro and ENT. The incident took place 4 weeks and 2 days after the 2nd vaccine. 2 days after the 2nd dose, I experienced Low grade fever, chills, and body aches that lasted only 12 hours, but nothing with the 1st vaccine nor anything after the 2nd dose issue until the Vertigo. I am unable to drive, conduct my job, which requires me to go to emergency calls and carry a Taser (CEW). I have been off work since this occurred and still not eligible to go back to work.

Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22/21 all day Joint pain Dizziness Nausea Vertigo Foot pain Insomnia

Dry mouth, "feels like a knot in my throat" ED Note: 43 y.o. male with a history of hypertension and eosinophilic esophagitis presenting s/p allergic reaction. Patient received his first dose of the Pfizer COVID vaccine around 17:30 today and states that he developed hives down his left arm and was having difficulty swallowing. He does have a known egg allergy and states that he has had prior anaphylaxis reactions to the flu vaccine. Patient was given PO Benadryl with complete relief of his symptoms. He has no complaints at this time and states that he feels "perfectly fine". At bedside for initial evaluation. Discussed plan for continued Benadryl throughout tomorrow and follow-up with his PCP. Patient is agreeable. Plan for discharge. The patient is comfortable with further observation of his symptoms at home. I discussed our workup, answered all questions and made sure there were no other concerns. I provided counseling about standard home and self-care measures and advised on standard return precautions including new, persistent, or worsening / concerning symptoms.

Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. Loss of appetite. Did not eat for three days. Decreased cognitive functions. Sweats and chills (sometimes simultaneously)

Approximately 4 hours after second dose, light nausea coupled with body aches and fatigue. Symptoms persisted for 6 hours, at that point nausea subsided. 22 hours after shot, fatigue and body aches persisted.

Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles". Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.). A loud noise was heard and participant was observed laying out prone on the floor. Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands. After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down. Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby. Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak. Offered water to sip and by now lip no longer bleeding. When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well. Reported a h/o HTN but did not take his medication today...other history is unremarkable. Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility. Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.

A phone call was made to the patient a couple days after his second vaccination and he reported that he had experienced feeling hot, nausea and fatigue starting the night of his vaccination.

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.

Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth swelling on April 8th about 2 in the morning.

Severe muscle spasms from muscle scarring from an accident 20 years ago. See earlier accident history for more details.

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.

Severe exhaustion, headache, body aches, nauseous, chills. Everything but the nausea lasting for at least 5 days.

Hot Flashes, Cold Flashes, Fatigue, Muscles Aches, Headache/sharp pain down to right shoulder, diarrhea

Woke up ~14 hours post injection to moderate fever (101 F) , severe chills, and very severe aches and pains in joints and muscles. Struggled to get up and down a set of stairs and had to go one at a time including holding the handrail (~43 year old male in very good shape, lifts heavy weights and runs 2-3 miles 3-4 times per week) . Managed to fall back asleep and woke up ~2.5 hours later with the same symptoms , plus higher fever (102 F) and additionally mild nausea and a very bad headache. Took Tylenol and upon another 2-3 hour sleep had the fever more managed but dealt with the nausea, headache and aches/pains for the next 24 hours after that. Symptoms resolved after about 36-48 hours , although I did not feel 100% back to normal until about 72-96 hours after this 2nd dose.

Initial soreness at injection site. Approximately 18 hours after injection, nausea, chills, severe headache. No fever. Chills and nausea decreased in severity throughout the next 12 hours but body aches and severe headache persisted. Nothing taken to treat symptoms (no ibuprofen or acetaminophen) In conclusion: initial reaction began 18 hours after injection and lasted approximately 12 hours.

Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny taste, weird feeling lips

pt felt light headed and sat down on the floor. He was attended quickly by an rph , checked for signs and symptoms , pt was talking all the time,, paramedics were called. he was given fluid (gatorede) as he mentioned not having enough food / fluids through out the day, paramedics came and checked the vitals , he was alright and refused to go with paramedics. He sat for a while after, ate some food and left with an uber

One minute following the shot, began to experience rapidly increased heat and pressure from my chest/breastbone area. Akin to having a heart attack with a feeling of a die pumped from a CAT scan. Sweating, dizziness, and rapid heart beat. Paramedics on site measured my vitals within 3 minutes and reported pulse over 100, BP at 160/100. This feeling gradually subsided over the next 15 minutes but the chest felt as if it was punched. Day 2 and day 3. Extreme fatigue and uncontrolled Heartburn. Was unable to quench heartburn that radiated through my neck, face, whole chest. Took 4000 mg of tums and Pepsid 20mg . Heartburn feeling persisted for 5-7 hours both days.

No side effects with the exception of minor irritation at injection site, until 96 hours later, sever flu like symptoms, chills, nausea - which lasted around 1 day. Feeling much better at this point but the delayed response was unexpected. I'm fairly sure there wasn't another event that prompted the symptoms but anything's possible.

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.

I awoke at approximately 02:00 of the morning following the second dose, in a cold sweat and shivering so hard that I could not move (locked in a fetal position). This lasted about 30 minutes, after which I fell back asleep, exhausted. The next time that I woke up, I was walking into wall between the bedroom and the bathroom (I have no history of sleepwalking). For much of the remainder of the night I experienced multiple episodes of somnambulance, each time awakening when I ran into some object (bathroom counter, television, bookcase). The last time that I woke up, at approximately 07:00, I must have been standing and simply fell over; my head bouncing off the ground is what caused me to wake up. For the entirety of the day after vaccination (04/12/21) I felt as if I had the flu: chills (though no/very mild fever < 99 F) accompanied by shivering, sometimes convulsive; sore muscles; hyperalgesia (light touch perceived as painful); lethargic; strong sense of malaise; loss of appetite. As stated, this lasted for the entire day, through the time that I went to sleep for the night (2300). The next day, 04/13/21 I felt completely back to normal with the exception that some muscles were slightly sore, possibly due to the exercise of an entire day spent shivering.

Shingles on left abdominal region. Rash and blisters present. Pain began the day following the vaccination in back and began to wrap around side to midline over time.

Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 days, Ringing in ears interrupted sleep for 1 month, had decreased some although continues to this day. Malays for 2 weeks. Vomiting for the first 4 days.

Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swollen lymph nodes 24 hours of moderate symptoms followed by mild lingering symptoms

Pt. had a Syncopal episode post 10 from vaccination. Was lowered to floor without injury .Did not recover immediately . Became nauseous and shaky then began vomitting. Pt remained lightheaded and near syncopal whenever brought to a sitting position or standing position. Pt. refused Benadryl . Pt. admitted having nausea and diarrhea for past 1-2 days intractable vomitting 5 yrs ago Agreed to EMS transport to ED

Left shot clinic after 15 min with no adverse effects. Driving home mouth and tongue went completely dry instantly and could not swallow. This was 28 min after initial shot (2nd dose). Concerned that airway would be restricted. In a panic went to ER at different hospital that I was near. No signs of anaphylaxis. Waited in hospital for ~3 hours. Symptoms did not get worse and could breath through nose. Decided no steroid shot (did not want to negate covid shot). Went home without additional treatment. Mouth was dry for 1 additional day, but not as extreme as initial dryness.

body aches and chills; body aches and chills; dizziness and nausea; dizziness and nausea; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced body aches, chills, dizziness and nausea on an unspecified date. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Extreme Tiredness, Headache, Muscle pain everywhere, Cold and Hot Flashes, Fever, Nausea, pain on left arm, congestion, coughing up mucus, and coughing.

acute appendicitis; I had severe abdominal pain beginning on 02Apr; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, administered on the left arm, at the age of 43 years, on 30Mar2021 10:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 03Apr2021 to an unknown date. Concomitant medications included paracetamol (TYLENOL) and nystatin (STATIN [NYSTATIN]), both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2, at the age of 43 years, on 09Mar2021 in the left arm at single dose for COVID-19 immunization. The patient stated, "I had severe abdominal pain beginning on 02Apr2021; I went to the emergency room at 3am on 03Apr2021 and was diagnosed with acute appendicitis". The patient was hospitalized for the events. The outcome of the events was recovered on an unspecified date. Information about Batch/Lot number has been requested.

On the day of the injection, within a few hours I had some mild symptoms like light-headedness (head rush when I stood up), and slight fatigue. It was the next day, more than 24 hours after the injection that symptoms became more intense. At that point I developed a bad headache with moderate nausea, as well as significant fatigue, and a little bit of runny nose. Now it is over 40 hours since the injection and my headache is not as bad, but I still do have a headache and mild fatigue.

Pt had sudden onset of diaphoresis, pallor to face, left hand tingling and nausea @ 1135.BP 99/69, HR 78, RR 16, temp 97.8. Pt provided bottled water and consumed 2 bottles, tolerated well. Color returned to normal and no longer diaphoretic. Patient nausea and left hand tingling resolved.

Fever ranging from 99 to 103 degrees F onset 2 days after vaccination shot and last for 4 days, chills, muscle aches, headache, nausea, constipation

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).

Shingles. I received the second dose of covid vaccine on Wed, April 28. Three days later, Saturday May 1, I woke up with intense abdominal pain, spanning the entirety of my stomach, and wrapping around my right oblique and kidney area. I had thrown out my back one week prior, assumed this was more muscle pain, and treated it as such. The Monday following, May 3, I went to the chiropractor, still in intense pain, but also with a tingling sensation on the affected area, sensitivity to the touch without pain. I assumed that I had burned myself with the heating pad. Wednesday a rash began to form in the affected area. My pain was nearly gone, I no longer felt muscle tightness, and assumed that the condition was resolving itself, and that the rash was heat rash from the heating pad. Friday the rash was redder and my abdomen showed signs of significant swelling. I still thought this was muscular, that perhaps I had pulled the abdomen, treated with ice and decided to visit Orthopedic urgent care Saturday. Saturday the pain had increased. I went to Urgent care, and was told I have shingles. I asked if the covid vaccine could have caused shingles to flare, was told "theoretically", but thar we do not really know enough to say whether the vaccine contributed, or whether it was coincidence. At home, I read a bit on the covid vaccine qnd shingles, saw what appeared to be anti-vaccer propaganda, but also read about this self-reporting system...so, I thought that I might as well submit my info.

client received of 1st dose Pfizer Covid Vaccine approximately 1400. Ancillary signaled PHN client was not feeling good. Client sitting in chair, pale, stated feeling dizzy and seeing blurry. EMT began taking vitals at 1405: blood pressure 142/110, pulse 75, oxygen 98%. Per client had just received vaccine. Client able to transfer self to anti-gravity chair at 1407. Client asked for water, PHN advised to take small sips. Vitals 1410: blood pressure 140/110, pulse 77, oxygen 99%. Per client vision slightly better, dizziness same, new onset of headache and nausea. PHN gave client emesis bag. Per client no pertinent medical history, no current medication and no history of allergies. Per client does not know if he has hypertension, does not regularly follow up with provider. No history of vision problems. Vitals at 1415: blood pressure 138/110, pulse 75, oxygen 98%. Client stated feeling the "room was spinning", nausea. Vitals at 1420: blood pressure 138/108, pulse 77, oxygen 97%. Per client dizziness, nausea same, vision improving slightly. PHN asked client if someone would be able to pick him up, per client no one, he would drive home. Vitals at 1425: blood pressure 140/106, pulse 74, oxygen 97%. Client stated headache to temporal and occipital area. 1430 client stated feeling eyesight heavy. Client alert and oriented. Vitals at 1431: blood pressure 134/108, pulse 75, oxygen 97%. Per client when he moves head quickly is when dizziness worsens. Client denied history of vertigo. 1434 PHN offered client paramedics so client could be further evaluated, client denied. Vitals at 1435: blood pressure: 132/103, pulse 73, oxygen 97%. Per client blurry vision, nausea and dizziness same. Per client wanted to leave facility and go home. PHN advised client to stay longer in observation as symptoms had not resolved and he wanted to drive home. Client declined, stated he felt well enough to drive. PHN asked client to stand by chair to see check dizziness and if client could walk without complaints. Client was able to stand and take steps without assistance. PHN gave client ER precautions, asked client if he wanted to anyone else to pick him up and he declined. Client left facility with steady gait at 1441 against medical advise, symptoms had not resolved.

While in observation, patient reports stomach cramping and lightheadedness. Pt provided a snack and vital signs continuously monitored. Pt. declined wanting to go to ED/UC. After about 40 minutes, patient reports lightheadedness and stomach cramping improving. Patient states he feels okay to go home and states his mom is driving him. Pt. given precautions to return to ER if symptoms worsened.

Patient developed acute kidney injury 3 days after he received the vaccine. He initially presented with emesis, myalgias and weakness and then found to have acute renal failure

Fever; chills; malaise; vomiting; This is a spontaneous report from a contactable consumer (patient) via company representative. A 43-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 at the age of 43 years old (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation. It was reported that after Second dose of BNT162b2 vaccine (week of 12Apr2021), patient experienced fever, chills, malaise and vomiting on 12Apr2021 for 24 hours and symptoms resolved. Events took place after use of product. The outcome of the events was recovered in Apr2021. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

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.

Diarrhea within 5 hours, arm sore at 8 hours, fever (100.2), headache and chills and body aches at 18 hours. The fever kept increasing from 100.2 to 103.5 from hours 18- 36. At hour 36 the fever dropped to 100.7. I'm still fevering with a headache and body ache. It's now 53 hours after the shot. I also had covid badly for 28 days straight. It turned into pneumonia and bronchitis. My bout with covid and did 33 days before my vaccination.

Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in face. Severe fatigue, low blood pressure readings of 112/60 and 110/90. Hot flashes and nausea. Non-coherent with glassy eyes with no awareness. Fluctuations in symptoms and slept for Three days in and out. Pt. Took approx. Three days to feel back to himself.

PATIENT STATES ABOUT FIVE MINUTES AFTER HE RECEIVED HIS VACCINE HE STARTED TO FEEL LIKE HE WAS GOING TO PASS OUT. HE BECAME NAUSEOUS, DIZZY AND EXTREMELY DIAPHORETIC. HE DID NOT PASS OUT. HE JUST HAD SYMPTOMS. WE GAVE HIM SOME APPLE JUICE AND GRAHAM CRACKERS. HE WAS FEELING BETTER ALMOST IMMEDIATELY.

The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling, and vomits.

client had reported effects after 1st dose and medical team had approved for client to receive 2nd dose today. Baseline vitals: blood pressure 162/90, pulse 94, oxygen 97%. Within 5 minutes of receiving vaccine client reported feeling dizzy, nausea, and blurry vision. Upon arrival client sitting in anti-gravity chair, pale, with mild diaphoresis. Client alert and oriented x4. RN took vitals at 1610: blood pressure 140/80, pulse 85, oxygen 97%. 1613 client reported blurry vision had resolved. Vitals at 1615: blood pressure 150/85, pulse 82, oxygen 97%. Per client dizziness and nausea had also resolved, skin color normal for ethnicity. Client denied chest pain, shortness of breath, headache, palpitations. Per client history of hypertension but provider had removed medication years ago as it resolved. No allergies. Client reported not following up with provider after first dose or for regular check-ups. Vitals at 1620: blood pressure 170/110, pulse 79, oxygen 97%. Retake blood pressure 172/110. Per client "feels fine". Vitals 1625: blood pressure 168/118, pulse 84, oxygen 95%. Per client no symptoms at this time. PHN advised client to follow up with provider regarding blood pressure. ER precautions given. Per client would make appointment with primary. Last vitals at 1653: blood pressure 160/110, pulse 80, oxygen 97%. Client able to stand with no complaints of dizziness, blurry vision, or nausea. Client denied chest pain, palpitations, headache, blurry vision at this time. Client stated drove alone and felt fine to drive. Client left facility with steady gait at 1640.

chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time; his penis sensations are a lot different; has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen; when he falls asleep he wakes up in an hour; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; limbs twitch; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), 1ST DOSE SINGLE via an unspecified route of administration, administered in Arm Left on 27Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time, has had a bad headache where it feels like he has vibrating inside of his head, in his chest and on 31Mar2021, when he falls asleep he wakes up in an hour 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, limbs twitch on 31Mar2021, his penis sensations are a lot different. It was reported that 5 days after he got the first dose of the COVID vaccine he started getting pains and the major thing is at night. If he falls asleep, he wakes up in an hour and that has been every night for a month and a half. That is the main thing that is pissing him off. He confirms that he is having issues with his chest and his intestines like he mentioned previously and he has started keeping track and has kept a journal of the pains. This stuff is new. He has never experienced this before and it has been happening every day starting 5 days after when he got the COVID vaccine. He had the COVID vaccine on 27Mar2021 and on 31Mar2021 he got the first shock in his chest at 0120 in the morning when he was sleeping. Then that went on for a week, he had it on 31Mar2021, 01Apr2021, 02Apr2021, 03Apr2021 and 04Apr2021 where he was getting shocked in the middle of the night when he is sleeping. On 04Apr2021 he had to go to the emergency room and have them look at him. But since 31Mar2021 he has been getting up every hour after he falls asleep. This was all worse when it first started because he has never experienced anything like this. The first shock he had was a hard feeling in his chest and then he couldn't go back to sleep. It is so bad. After he went to the emergency room, that is when it started being not as much of a shock pain that woke him up but he was still waking up every hour. The pains are in his upper chest and in his intestines. Also his limbs twitch and he has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen. He confirmed that these also began on 31Mar2021 and have been happening whenever they want and he has never experienced all of that before. Never. Everything has all stayed the same. The sad part is that he just thinks that he is getting used to this "new normal" because he is now going on the second month of this and his body is adapting but this is not normal. Also, he guesses that he shouldn't be shy now but the last thing is that his penis sensations are a lot different and he didn't notice until the first time that he was having relations with his wife after the COVID vaccine and it is all different. He noticed and she did too as far as whenever they were trying to have relations. It has been more than once, it has been every time they have tried afterwards. He says his doctor is going to send him to a sleep lab but he wasn't expecting that. He thought that maybe he would need to go somewhere else. But there he will go to sleep and be hooked up and they will read his whole body and tell the reason why he is waking up every hour. The outcome of the event headache, sleep disorder, chest discomfort, muscle twitching was not recovered and penis order, headache was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Mild Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 12:30 (Lot Number: EL3247) as single dose (at age of 43-year-old) for covid-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medication in two weeks included salbutamol sulfate (VENTOLIN HFA) inhaler. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild diarrhea on 05Mar2021 06:00. No treatment was received. Patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination, on 05Mar2021 underwent polymerase chain reaction (PCR) test (Nasal Swab): unknown result (pending). Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium

I woke up disoriented; I had severe double vision; loss of balance; severe nausea; diagnosed a 4th nerve palsy of my left eye; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176), via an unspecified route of administration at the age of 43-year-old administered in arm left on 18May2021 10:30 AM at single dose for covid-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. The patient's concomitant medications included ibuprofen received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0176), at the age of 43-year-old at the arm left on 27Apr2021 01:30 PM for COVID-19 immunisation. The patient had his second dose of the Pfizer COVID vaccine at 10:30am on 18May2021. By 2:30am on 19May2021, he woke up disoriented and realized that he had severe double vision resulting in loss of balance and severe nausea. A 19May2021 visit with his primary care doctor diagnosed a 4th nerve palsy of my left eye. This was confirmed by a 19May2021 visit to an ophthalmologist. It is now 21May2021 and nothing has improved and an MRI (Magnetic resonance imaging) was pending. The adverse events result in Doctor or other healthcare professional office/clinic visit. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was not recovered.

Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued tinnitus and migraine symptoms (photo sensitivity and sound sensitivity, sinus pressure, intermittent headaches)

With my 1st vaccine I just had soreness around the injection site. After the 2nd vaccine I woke up at 4am on 1/31/2021 with muffled hearing in my left ear and mild numbness in the entire left side of my body from top of my head to bottom of my feet. I experienced vomiting and diarrhea also. I had blood pressure of 150 /105 and pulse rate of 100. My doctor was afraid I had a stroke, so I went to the ER and had a CT scan in brain. I tried to go to work the next day but my head was foggy so I had to leave work. I had a test for carotid arteries and heart test that came back fine. I was sent to a neurologist. He suspected I had possible swelling in the spinal cord, but since I was feeling a little better he thought it was ok to wait to have a spinal tap. He described that the symptoms were MS dialed symptoms but did not feel I had MS. I've gotten better but continue to have a neuropathy pain in my left foot, left hand, and left side of my face. It tends to get worse at night but in the morning it is ok. It continues through the day. None of these symptoms were there before the vaccine.

Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at arm/injection site, muscle cramps in feet, and very painful colon inflammation which made it difficult to move around. Also felt feverish for two nights after the injection but did not take temperature to confirm. All other symptoms and body inflammation appeared to have resolved with the exception of painful inflammation in the knees which appeared after all other inflammation symptoms at various other body sites dimminished.

shortness of breath and chest pain have subsided; Dizziness; swelling underneath my armpit; not feeling well; nausea; This is a spontaneous report from a contactable consumer. This 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 43 years) as a single dose for COVID-19 immunization. The patient's medical history included shortness of breath and chest pain. The patient's concomitant medications were not reported. On 06Feb2021, the patient experienced dizziness and it was getting better. On an unspecified date in Feb2021, the patient experienced nausea and was not feeling well. The nausea was getting better. Last night (on the day of reporting), the patient had a little bit of swelling underneath his armpit. The swelling under the arm had improved previous day night. On an unknown date, the patient underwent COVID test and shown negative results. The shortness of breath and chest pain had subsided after the patient got vaccinated. The outcome of the events was recovering. Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Extremely tired; Extremely sleepy; Fever; Nauseous; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:30 (at the age of 43 years old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 as single dose for COVID-19 immunisation. The patient previously experienced allergies to food, medications, or other products which is unspecified. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extremely tired, extremely sleepy, fever and nauseous on 20Mar2021 at 12:00. The patient did not receive any treatment for the reported events. The clinical outcome of extremely tired, extremely sleepy, fever and nauseous was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.

Mild headache; Mild nausea; Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal hay fever. The patient was allergic to tree nuts. Concomitant medication included cetirizine hydrochloride (ZYRTEC) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the right arm on 02Mar2021 at 11:30 (at the age of 43-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 tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 06:00, approximately 24 hours after second shot, the patient woke up with mild headache, mild nausea and sore arm at injection site. 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 headache, nausea and sore arm at injection site was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

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.

Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed. I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS Still having very achy joints all over my body. Diarrhea, sweats/chills

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient received vaccine and 10 minutes later, he fainted. We sat with patient until emergency services arrived. Patient reporst history of fainting for the past 10 years and takes no medication. Patient was breathing normally and regained consciousness fully AxO x3 after recovering from fainting. Patient drank water. After emergency services arrived, patient began vomiting under their care. Patient ended up leaving with the emergency crew.

mild nausea (on a scale of 1 to 5 ---like 2 to 3); little light headed (2 on a scale of 1 to 5); This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 28Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included Epstein Barr, shingles in Oct2020 (2 months previous), detached retina in 2016 (4.5 years ago), and covid prior vaccination. There is no covid test done post vaccination. The patient's concomitant medications were not reported. The patiently previously had allergies to gentamycin. On 28Dec2020 12:00, the patient just had some mild nausea (like 2 to 3 on a scale of 1 to 5) and a little lightheaded (2 on a scale of 1 to 5). There is no treatment received for the adverse events. The outcome of the events was recovering. The report is considered non-serious. Information on the lot/batch number has been requested.

Injection site soreness only first 24hrs.; fatigue; chills; fever of 99.8 F; body aches; headache; vomiting; Diarrhea; This is a spontaneous report from a contactable other health professional (patient). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose at right arm for COVID-19 immunization. Medical history included Asthma, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), omeprazole. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that injection site soreness only first 24hrs. At 30 hrs, fatigue, chills, fever of 99.8 Fahrenheit (F), body aches, headache, vomiting and diarrhea. These lasted for 24hrs. Diarrhea persisted for 48 hrs. To the best of his knowledge he had not ever been exposed to Covid. The events onset date reported as 23Dec2020 23:00 (pending clarification). Treatment received for the adverse event reported as "Called nurse line". The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown.

Achey joints & muscles, fatigue, diarrhea, chills, sweats, headaches, sore left arm (injection side more sore than rest of sore body), pain & edema at injection site limiting shoulder range of motion for two days.

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.

Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vomiting - 4 hours Fever, chills, myalgia, malaise - 12 hours (treated with acetaminophen)

Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next day, still experiencing fatigue and body aches but not as much. 1/12/21 feeling flu type symptoms again body aches, muscle, nausea, chills, severe sweating during night sleeping awoke several times . 1/13/2021 feeling flushed and sweating again while working, stomach cramps, nausea and then vomited x1. Tiredness and extreme fatigue, almost hard to walk, heavy head, chills, fever 100. Has taken Tylenol some relief

Fever 100.5; myalgia; headache; nausea; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) in the left arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 11Jan2021 19:00, the patient experienced fever 100.5, myalgia, headache and nausea. No treatment was received for the adverse events. Clinical outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

After dose 2, extreme fatigue and muscle ache ongoing since the day after. Also, nausea for about a week after the second dose.

Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestines; Low grade fever; Muscle soreness; Muscle tiredness; Hands were a little shaky; Very diaphoretic; This is a spontaneous report from a contactable other Nurse. This 44-year-old Nurse (Patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) at single dose for vaccination in Jan2021 around 9:45am. Relevant medical history included ongoing Mild shrimp allergy and ongoing Hypertension. Relevant concomitant drugs included amlodipine at 10 mg once daily for Hypertension since Feb2020 and ongoing. Prior Vaccinations (within 4 weeks): None. Family Medical History Relevant to AE(s) was None. The patient was administered the COVID Vaccine around 9:45am; about 10 minutes later he had onset of little muscle twitches on the left side of his body that started in the calf then the glute, then the quadricep, then the bicep and then just started bouncing around everywhere on left side. Approximately a half an hour after that those little muscle twitches started on the right side of his body. Now the little muscle twitches are just everywhere; his hand, his heel, right now as he is speaking he is having the little muscle twitches in his heel; This event has been ongoing since onset; but changed today around 5:00am when he felt muscle twitches really deep in his abdomen, almost like in the intestines which is probably impossible, but it feels like it is not just muscular now, like it is happening in his intestines which concerns him. The little muscle twitches do not hurt, he thinks that is probably why he has waited a week to call; but the fact that they are ongoing and changed today, worsened is unsettling. He reported since that first dose of COVID Vaccine was administered he has also had low grade fever; muscle soreness; muscle tiredness. He reported that a rapid response team was called immediately because of the initial reaction he had. Later that day his hands were a little shaky, he got very diaphoretic and the nurses on the unit of the hospital said he almost fell which he does not recall at all; in response to those events he was taken to the emergency department where they did a complete workup including labs: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), checked his heart and everything was fine; no notable results from any of those tests. The patient was not admitted to the hospital; under observation in emergency room only. Outcome of events Little muscle twitches, Low grade fever, Muscle soreness and Muscle soreness was not resolved, outcome of other events was unknown. Information about lot/batch number has been requested.

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.

Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021). He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/"clouded" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.

I have had fever, chills, body aches, congestion, headaches, slight nausea, loss of appetite, almost every day since the injection. I sleep at night, and wake up around 2am with sever chills, take 800mg Ibuprofen, and within an hour my chills break and I start feeling better. The process repeats itself in the afternoon and then again in the evening. I'm constantly tired and fatigued, and have been unable to exercise or work out since. I'm still experiencing the symptoms as of today.

Twelve hrs. after the second dose on 1/7/2021; I developed fever of 103 with severe chills, headache,bodyaches faligue,nausea,loss of appetite ,joint pain, unable to get out of bed due to weakness. Severe symptoms lasted around 24 hrs , better next day but persisted for another 24 hrs then fatigue lasted another 7-10 days

Woke up the day after I got my first vaccine shot. Was nauseous and dizzy/unbalanced. This lasted for two days. Slight unbalance feeling still persists on day 5 after the vaccine.

The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a half hour I suddenly stopped sweating became very chilled (shivering), weak, very nauseous, felt rapid heart rate.

Dizziness, Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: dose 1-day 2-3-soreness inj site; day 2-3 nausea; aches; dizziness; ha Other Relevant History:

About 12 hours after the vaccine shot I woke up feeling nauseated and had a fever. The fever lasted about 8 hours but fatigue and body aches have continued now 15 hours after first sign of symptoms. I took exerting about 2 hours after the first symptoms and nothing else so far.

pt got vaccine and was sitting for observation. Pt thought he was having a panic attack so he put his head between his knees, he fainted, hit is head on the floor, and a witness said he was shaking on the floor. The patient came to quickly and said he passed out due to stomach cramps . EMS was on site and did an evaluation. Pt was given ice for his head and had vitals checked and and EKG done. EMS recommended hospital transport but patient refused.

Five minutes after receiving the vaccination on her left arm, she developed nausea and lightheadedness and weakness. No vomiting or syncope. She was escorted to a private session of the arena and monitored. Her initial blood pressure was 140/80. She was given water to drink and ate an apple.

Arthralgia, NauseaVomiting, NAUSEA, HA, CHILLS, KNEE, HIP AND HAND PAIN Narrative: NAUSEA, HA, CHILLS, KNEE, HIP AND HAND PAIN after 2nd Covid Pfizer vaccine

Bloody diarrhea for nearly 6 days after second injection. Blood tapered off after day 6 but is still occurring.

1410:Pt c/o nausea and dizzyness 9/10. BP:86/57, P:66, T: 96.5, Spo2:96.5% RA. Hx: Hypothyroid, DM.Pt instructed to hydrate. 1422: Pt reported feeling better, 3/10. 1433: BP: 104/71, P: 87, T: 96.6, Spo2 100% RA. 1437: Pt released and instructed to notify PCP for persistent and/or worsening of symptoms.

Third Pfizer COVID vaccination caused chills , urgent and explosive diarrhea, vomiting, cant keep anything down. Monitoring for dehydration

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.

4/9 - No issues 4/10 - Woke up with alternating sweats/chills throughout day. Temp never above 99.6. Slight headache and nausea. No energy at all. Took doses of ibuprofen throughout day. 4/11 - Continued with alternating sweats/chills. Continued taking ibuprofen and generally able to function. 4/12 - Morning of 4/12 similar to 4/11.

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

Severe, nausea, diarrhea ( at least 6 episodes day one) onset two days after vaccine with severe HA, bodyaches, , rigors. No one else sick in family

4/21/2021 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: nausea and tingling and numbness to cheeks and tongue/ c/o of tiredness. Assessment : Time of assessment *1634. Alert and oriented, Tachycardia, Pallor, Diaphoretic, Clammy and Nausea. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Water x 2 and 1 juice, VS taken at 1634- BP- 141/89, P- 110, O2- 98%, 1642, BP- 139/88, P- 102, O2- 100 %, 455pm, BP- 123/78, P- 97, O2- 100%, 514pm, BP- 123/81, P- 100, O2- 100% Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1645. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1645. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: x 2 doses at 1634 and 1645. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 4:16 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735 NDC: 59267-1000-2 Electronically signed at 4/21/2021 5:33 PM Immunization on 4/21/2021 Detailed Report Note shared with patient

Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water and as I was giving it to him he started to pass out. He was conscious but slightly convulsing. He appeared to have a minor seizure for approximately 5-10 seconds. He was transferred to a wheelchair and sent into our recovery room. As we were transporting him, he had two episodes of vomiting and continued to feel diaphoretic and weak. He rested laying down but was not feeling better. He could not tolerate any water or juice.

Bruise-type pain at injection site starting +5 hours lasting for about a day. Mild Diarrhea starting +8 hours roughly every 1-2 hours for a day or so. Persistent headache starting +12 hours for a few days (somewhat hard to judge causation given being a long time regular migraine sufferer but seemed more than usual / different). Mild vertigo / balance issues starting +2 days lasting for 3-4 days. Can't confirm causation but definitely atypical / no other known cause. Difficulty maintaining balance (like walking while drunk only I don't drink anymore) NO nausea/spinning just balance.

Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection. Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.

12 hours after first shot, had 48 hours of chills and nausea, recovered, 8 days after first shot had 5 days of chills, fever, nausea, headache. 12 hours after second shot, had 24 hours of chills, nausea, fever, headache, recovered. 13 days after second shot, all symptoms returned for the 4th time

This is sharing a concern / reporting a concern. This is not a complaint against anyone. This is not reporting side effect. The adverse effect date and time is a mandatory field. This is the reason I filled adverse date and time. I had my 2nd dose of vaccine on April 25, 2021 at campus at 1.20 PM. I just felt the syringe just touched the peripheral of my skin. I told the nurse that I do not feel I get the shot. Later, I do not feel any side effect any effect. I had no pain, or the site of injection was not swollen. I am worried I did not get the 0.3ml dose. During the first shot on April 4, 2021 at 1.43 PM, I felt pain on shoulders. I felt my tongue got thickened/ some tingling sensation on tongue and a little slur in speech. After 6 hours, I felt headache, a little chill, light head, nausea, more pain on shoulders and the next day, I felt light headedness and I felt tired for few days. I consider these as normal side effects and nothing unusual from what I read in internet and what I heard from others. So, I did not report it and it was a normal thing for me. Since I experienced this in first dose, I expected a more severe reaction than first dose. But I did not even feel pain at the site of injection nor any usual symptoms that usually appear. This made me to doubt I got required dose or the vaccine was correctly withdrawn from the vile. I do not know how to confirm that I got correct dosage. If I have not received the full dose, I am ready to take an additional shot and I would be flexible to take the shot at the available time near to my living place on any day. Again, I am not complaining anything. Probably the nurse is very proficient in taking shot with no pain. I do not know why my body does not react to the second dose.

nausea, headache, fatigue on 4/19/21. He begin having difficulty concentrating today, 4/20/21 and admits to sleeping poorly last night. He has not taken anything for his symptoms. It was advised for him to obtain quality restful sleep tonight, take multivitamin with D and C, APAP/NSAID for pain/fever, drink plenty of fluids. 4/21-Woke up this morning feeling better after a restful nights sleep. He did not take anything for his symptoms and his symptoms resolved completely.

chills; sweats; nausea; This is a spontaneous report received from a contactable consumer. A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EN6198), via an unspecified route of administration in left arm on 22Feb2021 15:15 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced chills, sweats, and nausea. The outcome of the events was reported as recovered on an unspecified date.

High fever, bad chills, bad body aches, loss of appetite, coughing up mucus infection from chest, nasal congestion and infection, very weak and tired

subjective fever, malaise, right upper quadrant abdominal pain, pain, cough, sneezing, poor appetite, decreased smell and taste

Vision and gait disturbances began 4/9/21, progressively worsened and he began nausea/vomiting 4/11/21, requiring ER visit on 4/12/21 then hospitalization for 5 days. Comprehensive labs done. Follow-up advised with Dr. (has not occurred). Per Dr. (Neurology), do not get second dose of Covid-19 vaccine as there is a chance the vaccine contributed to development of these symptoms. Doctor said it could possibly be Guillain-Barre Syndrome. As of 5/11/21, significant vision impairment still exists and patient is unable to work. Patient is uninsured.

Severe headache/His headache is severe it feels like he is being hit on one onside of his head; Fever; Fatigue; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Apr2021 at 44 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, fever, fatigue, shaking, pain and diarrhea in Apr2021 with outcome of not recovered. The patient reported severe headache, a fever and fatigue, not sure when he will get relief. The patient wanted to know when he will get some kind of relief. His headache was severe it feels like he was being hit on one onside of his head. He felt like it was shocking his body because of the pain all over, his body shaked because of the pain. He was surviving on Tylenol and Ibuprofen right now. The patient clarified having a maybe a little diarrhea along with the pain all over, fever, fatigue and severe headache. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the entire night with a bucket. For the next week every morning, diarrhea and unsettled stomach, lack of energy, excessive sleep, no ability to exercise without severe fatigue or a return of digestive problems. This lasted a week. Sexual activity also impossible, erection quality greatly reduced. Many of these symptoms got better but have now returned with my second dose. Second dose has given me significant fatigue, digestive problems again, diarrhea, and reduced erection quality once more. I hope these problems resolve themselves. The vaccine has made going to work very difficult and I will seriously reconsider taking any vaccine in the future.

possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.

This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches for about 7-8 days. Says was having body aches for about 8 days, had COVID 19 vaccine first dose on 5/14/21. Since then, had worsening body aches and also started having fever(not sure how much). Urine color changed to brown in the past week. No change in appetite or nausea or vomiting prior to admit as per him. No new medications and does not consume recreational drugs. Not an alcoholic, no recent trauma, does not work out and was not exposed to extreme heat or cold recently. In ER, patient was found to having AKI, shock liver, CK level which is too high to be calculated, had 1 episode of high-grade fever. He was therefore started on IV fluids and admitted for further management of rhabdomyolysis. Overnight had no urine output and having poor urine output since this a.m.. Had 1 episode of nausea and vomiting this morning. No more fever since on the floor. Complaining of epigastric pain that woke him up from sleep this afternoon.

Pfizer-BioNTech COVID-19 Vaccine EUA Extreme stomach distress followed by massive red hives 1' wide surrounding entire torso and back.

Throwing up all day-started 2hrs after the vaccine.; This is a spontaneous report from a contactable non health care professional, patient. A 44-years old male patient received BNT162B2{COVID-19 MRNA VACCINE BIONTECH} [batch/lot number# 6205], via unspecified route in the left arm on 03Mar2021 for COVID-19 immunisation. Medical history included high blood pressure, dilated ventricle, ascending aorta dilation and left ventricular hypertrophy. Concomitant medication included lisinopril HCTZ (unknown manufacturer). The patient experienced "Throwing up all day" which started two hours after receiving the vaccine on 03Mar2021. The patient underwent Nasal Swab test twice, on 07Mar2021 and 13Mar2021, both reported as negative. The patient had not been diagnosed with COVID-19 before vaccination. The patient underwent PCR test for COVID-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have any allergies related to medication, food, or other products. Patient received anti-nausea medication as a therapeutic action for the event. The clinical outcome of the event was reported as recovered. No follow-up attempts are needed. No further information is expected.

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 started getting constipation around May 17th, and felt really backed up. I started getting sorer progressively each day and on Wednesday night, the pain was so bad that I checked into the hospital. They found that I had acute appendicitis and removed it on the 21st of May.

sensitivity to light, nausea, migraine (5 days), lightheadedness overall lasted for approximately 15 days with various symptoms

Client came to vaccination site at 1715 for his 2nd Pfizer dose on 06/13/21. After being seated with RN, he expressed concern about receiving his 2nd dose due to the reactions he experienced after receiving his 1st dose. RN requested Lead RN speak with the client regarding his concerns. At 1720 Lead RN spoke to client. Client stated that 1 ½ days after getting his 1st dose, he experienced soreness & tenderness in the axillary area of the left arm. Client stated that 3 days later his axillary area began swelling. The swelling continued below his axillary down the left side of his abdomen and onto the left side of his back. Client stated the pain level was a 4 on a scale of 0-10. He also stated there was no discoloration or redness in any of the areas where he experienced swelling. On day 10 the left side of the client?s neck began to swell. He also started to experience discomfort at the injection site and arm fatigue. Client stated at no time did he experience any trouble breathing, shortness of breath, or chest pain. Client stated he has been dieting and lost 145 lbs. in the last year. He previously had high blood pressure, but no longer does. He also stated the only other underlying conditions he has is a thyroid problem (hypothyroidism), and he is not medication compliant. Over the last 6 months he has only taken his levothyroxine intermittently. In the last 2 months he has not taken any of his levothyroxine until a few days ago. Client takes no other medication, but is allergic to penicillin-based antibiotics. Client stated he gets dizzy, hallucinates, and swells up in various places on his body. However, he does not experience shortness of breath or trouble breathing. Client did not take any medication for the side effects he experienced after receiving his first Pfizer injection or seek medical treatment. Client stated all the swelling began to subside on day 17. Lead RN performed a medical consult with Clinical Care Coordinator who authorized moving forward with administering client a Pfizer 2nd dose in the opposite arm with a 30-minute observation. Prior to RN administering vaccine, Lead RN educated client on normal vs adverse effects of the vaccine. Lead RN confirmed with client that he has access to a HCP for follow-up, if needed. Lead RN also recommended client follow-up with his HCP regarding his hyperthyroid condition. Lead RN instructed client to seek emergency care if he experienced shortness of breath, trouble breathing, or chest pain at any time after leaving the vaccination facility.

Sore at injection site; Bloody nose; Diarrhea; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). This 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unknown route, on 02Feb2021 11:30 (at the age of 44-year-old) as single dose for COVID-19 immunisation, administered at hospital. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient did not have a relevant medical history and concomitant medications. On 03Feb2021 at 10:00, the patient developed sore at injection site, bloody nose, diarrhea, and fatigue. The patient was not treated for the events. The patient had recovered from the events on unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Nausea; Vomiting; Cold shakes; Entire body aches; 101.6 temp; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 09:00 am (age at vaccination 44-year-old), as single dose for COVID-19 vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: En 6202) via an unspecified route of administration in left arm on 20210225 at 11:30 am as single dose for COVID-19 vaccination. Medical history included high cholesterol and penicillin allergy. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, was not tested for COVID-19. The patient experienced Nausea, vomiting, cold shakes, entire body aches and temperature of 101.6 (units unspecified) on 17Mar2017 at 22:00. The patient did not receive any treatment for the reporting events. The clinical outcome of nausea, vomiting, chills, general body pain and high temperature was not resolved. No follow-up attempts are possible. No further information is expected

Since the day after my first injection (4/3) I have had a constant headache. Every single day since that headache has not left. It varies in intensity, it is generally the worst in the morning and evening or at least I block it out enough to do my job. Pain is in the back of my head/upper neck, in front of my ears on the sides of my head, sometimes I also get it on the crown of my head. I have also been nauseous pretty much every day since then. I have vomited once. Nausea is worst in the mornings. Occasionally I feel like I have a concussion, hard to describe that feeling.

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.

Vertebral artery dissection and cerebellar infarcts. Nausea, vertigo. Hospitalized x 2 days (6/28-6/30/21). Started on elliquis. To follow up with Neurology

Nausea; Full body muscle ache; Fever; Excessive tiredness; Dizziness; headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 44-year-old) at 17:30 as a single dose for COVID-19 immunisation. Medical history included HIV and obesity. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ergocalciferol 50,000 (MANUFACTURER UNKNOWN), dolutegravir sodium (TIVICAY), emtricitabine, tenofovir alafenamide fumarate (DESCOVY) and fenofibrate (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested with COVID-19. On 30Mar2021 at 02:00, the patient experienced nausea, full body muscle aches, fever, excessive tiredness, dizziness and headache. 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 nausea, full body muscle aches, fever, excessive tiredness, dizziness and headache was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Nausea; This is an initial spontaneous report from a contactable reporter (Physician). This contactable reporter reported for a 44-year-old male patient that: A 44-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Mar2021 (at the age of 44-year-old) as dose 1 single for covid-19 immunisation. Medical history included neoplasm of left kidney from 2007 to an unknown date. Patient had no known allergies. It was unknown that prior to vaccination, patient diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient was not received any other vaccine four weeks prior vaccination and it was unknown that patient receive any medication two weeks prior vaccination. The patient experienced nausea on 15Mar2021. It was unknown that since the vaccination, patient been tested for COVID-19. Adverse Event resulted to visit Doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The outcome of the event was reported as not recovered. Information about lot/batch number has been requested.

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.

Nausea; fatigue; decreased appetite; This is a spontaneous report from a contactable physician. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose intramuscularly, administered in Arm Right on 05Apr2021 (Lot Number: EW0150, expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation. Medical history included neoplasm left kidney from 2007 to an unknown date. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route on 15Mar2021 (Lot Number and expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation and experienced Nausea. The patient experienced nausea, fatigue, decreased appetite, all in 2021. Nausea, fatigue and decreased appetite which has persisted after his second Pfizer COVID-19 vaccine 05Apr2021. The outcome of the events was not recovered. The report was reported as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for events.

21 hours after; hives all over left side chest, waist, ankles, inner thighs. Although after a Benadryl it subsided, it did come back several days again. Otherwise 24 hours after the shot exprienced, slight fever, chills, muscle aches, headache, head sinus pressure, joint pain, diarrhea and nausea. Also several days later arm still hurts. 3 days after had shooting pain in injection arm, leaving me to not use my left arm. 4th day much better.

Loss of appetite; Coughing; High fever (104); chills for over a day; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EW0175) via an unspecified route of administration in the left arm on 02May2021 at 11:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02May2021 at 16:00, the patient experienced high fever (104 degrees), chills, loss of appetite, fatigue and coughing. The patient underwent lab tests and procedures which included body temperature on 02May2021 and resulted as 104 degrees (units unspecified). The clinical outcome of the events fever, chills, loss of appetite, fatigue and coughing was resolving at the time of report. No follow-up attempts are needed. No further information is expected.

Dizziness; Tiredness; Stomach pain; Headache; Feeling sick; This is a spontaneous report received from a contactable consumer(patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 25May2021 15:00 (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included gastritis from an unknown date and unknown if ongoing. Patient said he had bad gastritis for a while and cyclic vomiting syndrome from an unknown date and unknown if ongoing. It was reported that patient has cyclic vomiting syndrome adult, which was diagnosed two months ago. Patient concomitant medications were not reported. He got no other vaccinations in the four weeks prior to getting his Pfizer coronavirus vaccine shot. On 26May2021 the patient experienced dizziness, tiredness, stomach pain, headache and feeling sick. The patient got his first dose of the shot, he is not sure what it was, yesterday, and he is having some side effects that are common, he would like to know how long they will last. He later clarified that the shot was the Pfizer coronavirus vaccine. Patient said he doesn't have his vaccine card with him to provide NDC/LOT/EXP from it, his vaccination was at 3PM. He said his side effects were basic dizziness, tiredness, stomach pain, headache, and feeling sick. His side effects started next morning when he woke up. Patient just took pills for stomach pain and let it pass. Therapeutic measures were taken as a result of stomach pain. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected. Information on the batch number not available.

Received vaccine on 12/21/2020. Developed constipation that cleared on 12/26/2020 with use of colace. Had episode of diarrhea on 12/28/2020. Abdominal pain began at 2330 on 12/29/2020 and worsened through the night. Went to ER at 0500 hours on 12/30/2020 where I was diagnosed with appendicitis and underwent appendectomy on the same day by Dr. I have no idea if this is related to the vaccine or simply a coincidence. In error of caution, I am reporting this. Thank you.

joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will randomly start sweating; headache; muscle pain/mild muscle aches; gastric upset; Fatigue; he had mild arm soreness right after he got the vaccine; This is a spontaneous report from a contactable Other-HCP (patient). This 45-year-old male Other-HCP received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, NDC number: 59267-1000-1) on 22Dec2020 at single dose in his right arm for COVID-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient experienced Fever on 27Dec2020 with outcome was recovered on 29Dec2020, chills and night sweats on 27Dec2020 with outcome was not recovered, Headache on 27Dec2020 with outcome was not recovered, muscle pain 27Dec2020 with outcome was not recovered, gastric upset on 27Dec2020 with outcome was Recovering, Fatigue on 27Dec2020 with outcome was unknown, arm soreness on 22Dec2020 with outcome was not recovered, joint pain with outcome was unknown, it doesn't seem to be feeling well with outcome was unknown, sweating with outcome was unknown. All events were serious (medical significant). Caller stated that he thought having a reaction to the vaccination, spoken with Occupational Health at his job and with a doctor, stated everyone is a bit stumped. Caller stated he has had for over a week now, fever, chills, night sweats, that he will randomly start sweating, headache, joint pain, gastric upset, and it doesn't seem to be feeling well. Stated the joint pain is actually more muscle pain. Stated he got the vaccination on Tuesday 22Dec2020, stated he has been having these symptoms for over 5 days now. Stated he does not think this is something infectious, that no one in his family is getting sick, his wife or child are not catching it from him. Stated he tried to do research online for data about delayed side effects, would like to know if we have any information on delayed side effects. Stated he considers these events medically significant because he cannot be cleared to go back to work. Stated he had mild arm soreness right after he got the vaccine, states he had mild muscle aches Wednesday and Thursday, then they went away and came back all on Saturday night and Sunday. Stated he is worried about getting a second vaccine. Stated he tested negative for the COVID on 29Dec2020. Stated he has a CBC and other blood work scheduled for today, results unknown at this time. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the 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.

While on duty and in uniform as an emergency paramedic I received my second scheduled covid19 vaccination. Approximately five minutes after receiving C19 dose 2 vaccination (1335hrs). I experienced a syncopal episode while walking back to my work area and was lowered to the ground by another EMS provider. I was then placed in a wheelchair by the EMS provider and an RN and taken to the emergency department at Medical Center. (1337hrs) I regained alertness and felt severe nausea and general weakness and was assisted into in ER bed. Staff doctor attended along with RN . An assessment was completed, 12 lead EKG completed, IV established, 8mg Zofran administered, 1000ml of Normal Saline was bolused. Labs were drawn. ED staff continued to monitor me for the next 2 plus hours I was monitored for anaphylaxis and other symptoms. My symptoms of nausea mostly resolved and my strength returned. A Resident MD completed a final evaluation and determined it was safe for me to be discharged. (1607hrs)

Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body

He developed episodes of vertigo like dizziness, allong with feeling like he was going to pass out, feeling unsteady, sweaty, nauseated. They would last for about less than a minute, but he had several episodes. He had pulsatile tinnitus. He also had an elevated LFT.

PRONOUNCED PAIN @ INJECTIONS SITE TRAVELING DOWN ARM. HEADACH AND BODY ACHES. NAUSEAS. TOOK ADVIL FOR PAIN, PEPTO AT NIGHT (1/12) AND MORNING (1/13)

Appendicitis, presenting as periumbilical tenderness at onset (26 hrs after vaccine admin) migrating to RLQ approx 20hrs later (46hrs after vaccine admin) accompanied by fever, chills, sweats, and nausea. Presented to ER that evening and CT confirmed appendicitis (52hrs after vaccine admin). Surgery following day laparoscopic appendectomy (69hrs after vaccine admin). Recovery and clinical improvement over next 8hrs (77hrs after vaccine admin). Discharged following day (96hrs after vaccine admin)

The arm muscle that received the shot became quite sore overnight, and lasted throughout the next day. The rest of me felt like I had a mild case of the flu. Aches and fatigue all over, with some chills. I have been training for a half marathon, and this through off my training due to knee pain. I also had diarrhea that has lasted through Saturday. The first day after was the worst, and things have improved each day since.

Low grade temp (100 deg f) beginning about 3 hours after receiving shot. Became very tired and loss of appetite followed by diarrhea about 8 hours after shot followed by mild headache through the next 24 hours. I am reporting this mainly because my reaction was unexpected and happened on the first dose. I have not yet received my second dose.

1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful Lymph-nodes : Location Right cervical , Right side supra clavicular and infra clavicular , lasted for 1 week 3. Light headed lasted 2 days 4.nauseas lasted 3 days 5 diarrhea mild lasted 2 days 6. Chills , lasted for 3 days 7 weakness , lasted 10+ days

fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.

PATIENT STATES IS HAVING DIFFICULTY SWALLOWING ON HIS OWN . PATIENT APPEARS IN NO APPARENT DISTRESS BUT SEEMS ANXIOUS. PATIENT GIVEN WATER AND DRANK WATER WITH NO DIFFICULTY. HEART RATE 80 AND REGULAR. PATIENT MONITORED ADDITIONAL 15 MINS AND STATES STILL HAS SYMPTOMS BUT ARE LESS INTENSE . PATIENT APPEARS TO HAVE NO APPARENT DISTRESS AND DOES NOT APPEAR AS ANXIOUS. PATIENT REFUSES ANYMORE MONITORING AND LEFT. PATIENT WAS INSTRUCTED THAT IF SYMPTOMS PERSISTED OR GOT WORSE TO FOLLOW-UP WITH EMERGENCY DEPARTMENT.

1st Vaccine 1/9/21; 2nd Vaccine 1/28/21; symptomatic 2/18/21 with sore throat, mild SOA, and diarrhea ; seen at Facility 2/19/21 for symptoms and tested COVID + ; >14 days post 2nd vaccine

Patient is a 45-year-old male that five (5)-minutes after receiving COVID-19 vaccine, experienced nausea and became light headed. Patient indicated that he always has been afraid of needles and in particular he was afraid of receiving the COVID-19 vaccine. Paramedic on site evaluated the vitals on the patient, revealing an oxygen saturation of 98%, HR 100, RR20 and BP 110/70. The patient was placed on a medical cot for about 20-minutes (supine position) and recovered without the need of administering any medication. At 12:30pm. the patient left the facility accompanied by his wife and walking on his own without any assistance.

At 7am after a good night's sleep I started feeling a mild headache, naseua, muscle aches and chills. Took Tylenol and slept 3.5 hrs. Woke up w a mild elevated temperature, but all other symptoms had nearly completely subsided. Rested the remainder of the day and felt fine the following day.

ABDOMINAL PAIN, MORE INTENSE IN THE LOWER LEFT SIDE. RASH ALL OVER THE BODY MORE INTENSE IN HANDS AND HEAD.

Fever, chills, sweats, nausea, muscle aches and headache. Happened about 12:30am. Took some nausea medication and Tylenol. Was able to get back to sleep after an hour of fighting off vomiting . Nausea is mostly gone this morning. Headache and muscle soreness still persist.

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.

After vaccine vaccination, patient has vasovagal syncope. Patient states swelling of tongue, blurry vision, nauseous hands tingling, dizzy and lightheaded. Called code green, paramedics arrived. Laid patient down flat down on cot. Patient is stable. BP 106/67 98% o2sat HR 65 RR 16

Right ear pain started on the Wednesday afternoon, two days after Vaccine shot. By Friday evening the ear pain was intense and it had moved below the ear to lymphnode area. Saturday, his ear was really swollen and red. He went to the Urgent Care and they prescribed an antibiotic Cephalexin thinking it could be some sort of ear infection or insect bite. Sunday morning he woke up with his face droopy. We tried to get an appt. with Urgent Care, but they sent us to the ER. The ER did a physical assessment and concluded he had an ear infection and Bells Palsy. The prescribed another antibiotic Doxycycline, an antiviral Famciclovir and a steroid of prednisone. By Monday he was extremely nauseas and had started having vertigo. We went to Urgent Care and they prescribed him Ondansetron for nausea and made the assessment that he had Shingles in his ear. We saw PCP on Wednesday and he assessed that this was a zoster ear infection causing facial paralysis and vertigo, also known as a rare condition called Ramsay Hunt Syndrome and that it was most likely attributed to his Covid vaccine shot and not to get the second vaccine shot. The Dr. took him off the antibiotics and put him on a higher dose of prednisone, a different antiviral (valacyclovir) and Meclizine for vertigo symptoms. He sent referrals for Neurology, ENT and Eye Dr. He saw the Neurologist that Friday and he concurred Ramsay Hunt Syndrome, most likley from Covid Vaccine and do not get the second vaccine shot. The neurologist referred him to Physical Therapy to treat his vestibular issues. He ordered an MRI and some blood work. We are still waiting for the results. We saw an ENT an he had him have a hearing test which showed moderate high frequency hearing loss. The ENT prescribed Gabapentin for the ear and face pain. He started to see a physical therapist this week, he had his MRI on Wednesday and we see the ENT again on Monday. He has no improvement yet, other than the nausea has subsided.

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

27 MAR: Received dose #2. Gradual onset of headache and unusually fatigued. 28 MAR: Slight headache, achy joints, sore lower back (kidneys), diarrhea, congestion and runny nose, slight fever (100), unusually fatigued. 29 MAR: Significantly improved, but severe congestion on left side while extremely runny nose on right side. 30 MAR: Regression - complete congestion (only able to mouth-breathe all day). By mid-day, achy joints returned. 31 MAR: Still heavy congestion, but able to breathe through nose. Very sore lower back. Minor achy joints. Mild sweating (with no fever - 98.5) shortly after waking up.

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.

All started the morning of the day after the vaccine shot and got progressively got worse the entire day. They were all gone by the next day. Fatigue Nausea Muscle Aches Confusion/dizziness

sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhea, bowel discomfort, arthritis flare-up

patient developed malaise, abdominal pain and nausea 2 days after the vaccination. It did not improve for a week and he presented to the hospital and was diagnosed with acute superior mesenteric vein and portal vein thrombosis along with pancreatic edema

Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, dizziness, blood pressure low, chills. The pharmacy had to call 911 for a paramedic. I'm still feeling symptoms almost 24hrs later. I chose not to go to hospital in ambulance.

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.

Severe diarrhea about 72 hours after first dose, persisting for about 5-6 days. Also experienced some aches and temperature of about 102 degrees F about 72 hours after first dose, but this only lasted about 1 day.

Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.

Chilled and feverish, drowsy, all over body aches, dizziness, nausea in the morning, injection site pain. Symptoms did not require a dr appointment. Symptoms appeared morning after Vaccination and lasted only one day.

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.

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.

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

After receiving her vaccine client states she has tingling in both hands and nausea. Vital signs BP 100/67, HR 67 O2Sat 96%. Client states she feels better. Client d/c home by EMS.

- 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.

2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.

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

I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes in the span of 2 weeks and ongoing. A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness-feel tipsy Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly This has affected my work. My doctor told me to report this to you. I got the 1st vaccine shot on 04/05/21. I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes n the span of 2 weeks and ongoing. . A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly My second does is scheduled for 04/26/21, should I take it?

CHILLS, SEVERE FATIGUE, NAUSEA, SWOLLEN ARIAL LYMPH NODE LEFT SIDE (INJECTION SITE), AND HEADACHE. TOOK TYLENOL AND MOTRIN. REST. SYMPTONS LASTED 24-48 HRS

Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol. Was still feeling poor at 1am but coherent and talking, not thinking that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache. At 6am, he was found blue/dead in his bed.

After first dose, Subject was on the way to observation area when staff were summoned to an adverse event. Responding staff observed Subject had vomited on himself in the car. Subject reports he felt very euphoric, leaned his head back and was floating. Thinks he may have passed out (does not know how long) and woke up with vomit all over him. Thinks he may have had a seizure as his neck was stiff and had bite marks on his tongue. As of 4/23/2021 Subject reports full recovery. Has passed out before after having blood drawn x 2 in the past, but not shots.

Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizzy. Nausea. Like bad flu symptoms, like the worst flu I have ever felt.

#1 ...extreme fatigue, sleepiness, drowsiness. (several days) #2 mild low grain headache (3 hrs) #3 mild nausea (short period) #4 sniffles... runny nose. #5 soreness on right arm I have a general negative disposition to the Pfizer vaccine, overall I felt much better before taking the vaccine then after. There are well defined 'side effects' that are notable. Overall feeling after the vaccine is unwell. (Nothing like the side effects for say the flu virus) The side effects are much more pronounced. The side effect that is/was most notable is fatigue and drowsiness. I've felt unusually fatigued and sleepy over the past few days with the severest fatigue occurring the day after taking the vaccine. (I've felt fatigue like symptoms over the past few days since taking the vaccine on 4/22.)

Abdominal pain, diarrhea and fever starting 48 hours after injection. Lasted 4 days. Required treatment with antibiotics.

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

VIOLENT BOUTS OF VOMITING AND DIARRHEA. NOT ABLE TO EAT OR DRINK ANYTHING (SOLID OR LIQUID) FOR 72 HRS AFTER SHOT. SEVERE STOMACH CRAMPING AND EXCESSIVE BLOATING AFTER EATING OR DRINKING ANYTHING.

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.

so nauseated; hot flashes and chills; hot flashes and chills; Caller reports one minute feels hot, next minute feels cold; started having abdominal pains in stomach; has absolutely no energy and no strength; Arm was sore; so fatigued and so tired/extremely exhausted; This is a spontaneous report from a contactable consumer (patient). A 45 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150) in left shoulder (arm) on 08Apr2021 14:45 at age of 45 years old at single dose for COVID-19 immunization. No medical history (including any illness at time of vaccination) reported. There were no prior vaccinations within 4 weeks. There was no adverse event (AEs) following prior vaccinations, this is the first he can ever recall. There was no family Medical History patient can think of. Patient knew his Dad got the Covid-19 second dose about the same time patient got his first shot Pfizer Covid-19 vaccine and his Dad was not doing so well. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medications were not reported. Patient was a consumer reporting he received the first dose Pfizer BioNTech Covid-19 vaccine last Thursday in his left shoulder was calling about his side effects. Patient stated his arm was sore for a couple of days. Patient confirmed it was his left arm that was sore. Reports this arm soreness was still ongoing. Stated his arm is still sore if patient touches his arm. The pain in the arm has faded but it is still there, if patient bumps his arm, he noticed. By starting Saturday, patient was so fatigued and so tired, reported he could not stay awake. Then yesterday the patient was so tired and went for a walk for a few hours. Patient was still extremely exhausted. Reports tiredness is ongoing today. Patient still felt exhausted and did not get out of bed until 14:00, just seems ongoing. Last night (11Apr2021) after patient went to bed, started having abdominal pains in stomach, not able to sleep all night because of the pain. Reported the abdominal pain in stomach was touch and go. By morning (12Apr2021), patient was so nauseated, had to call out of work, patient did not get out of bed until 45 minutes ago. Had absolutely no energy and no strength, ongoing. Patient reported the only other side effect had today (12Apr2021) was hot flashes and chills, took hot bath to get rid of chills. Began about 0900 or 1000 this morning. After patient started getting really nauseated this morning, tried throwing up to empty out stomach and nothing there. A little while later patient noticed hot flashes real bad, later on had to take hot bath to get rid of chills. It was still going on but it was minor, not as strong as what it was, seems to be improved but still having hot flashes and chills. Patient reported one minute feels hot, next minute feels cold. Patient wondering if they should try to go to work tomorrow or if patient should let his body rest more. He was not sure what to do. The adverse events were not required a visit to Emergency room or Physician office, but a friend of the patient's says he should go. Outcome of event arm was sore and hot flashes and chills, one minute feels hot, next minute feels cold was recovering, for event so fatigued and so tired/extremely exhausted, no energy and no strength was not recovered, for abdominal pains in stomach was recovered, for so nauseated was unknown. No follow-up attempts are needed. No further information is expected.

stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; 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, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.

Acute Pancreatitis Stomach pain began around 16:00 4/8/2021, Progressively worse, 3 trips to ER. Last trip on 4/10/2021 noon, diagnosed pancreatitis and admitted. Saw my PCP on 4/9/2021.

fever and malaise began 4/12/21 followed by migratory headaches and myalgia, several days morbilliform rash, brief diarrhea and abdominal pain

cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that were also painful; stomach cramps; diarrhea; he threw up several times; nauseous; disorientated; just not feeling good at all; tired; neck pain; felt weird; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; /Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 04Apr2021 (at the age of 45-years-old) at 14:00 as single dose for covid-19 immunisation. Medical history included COVID: he had gotten diagnosed with COVID back in December or January and twice tested positive for covid and his body had fought it off (as reported). Medical history included also back pain Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken to sleep, start and stop date were not reported. The patient reported that around the night of vaccination he experienced cold sweat, headache, and cramping for several hours then subside and come back later. Patient had some bumps appear on the side of his neck. He stated that he could not say that's from the shot, something may have bit him. The patient did bump his head a chandelier and went to the ER. He received Ibuprofen for the symptoms. Patient stated that the reported events occurred the same day as his COVID Vaccine and began a couple of hours later and wakes up every night in a cold sweat; stated he was in and out of the emergency room in about an hour and they gave him Ibuprofen 400mg and a of nights had to take two Ibuprofen because his head and body was hurting so bad and he had to take some kind of relief and he does not like taking stuff like that and pain pills make his stomach hurt. Patient stated he did a whole Ibuprofen and did not feel good after that and can't take the Ibuprofen anymore and then took 1-2 Aleve after that and does not like taking pain medication. He stated he was healing with the bumps but had this every day since the Pfizer Vaccine and he was starting to heal but the bumps were still there on the side of his neck and were improving and healing and he had the bumps on his head that were also painful; states the bumps occurred the same day as his Pfizer COVID Vaccine; states he was up in his attic and could have gotten into a spider nest and might have poison in him from the spiders and then went to the hospital emergency room with these issues. States he told the emergency room about the bites and bumps and that he had the Pfizer COVID Vaccine and they gave him the Ibuprofen and sent him home. The patient stated that this was a real concern for him due to the blood clots stuff coming out about how people have different reactions after a vaccine. States he felt like the hospital did not even do anything; he could have hit his head a couple of times on a chandelier; states the emergency took an image of his head and they did not address the bumps or anything else and said his head was not bleeding and gave him Ibuprofen and he did not think you should take Ibuprofen like when you have COVID and they sent him home and nothing was done. Caller states he does not know but when he received the Pfizer COVID vaccine he noticed a patch of bumps in his neck, and his neck got really tight and his neck still hurts on the left side; states he could have gotten bitten by something. The patient reported that after he had the Pfizer COVID vaccine, he was waking up every night with cold sweats, and recently last night had extreme cramps in his stomach area like was crawling around the floor getting away from the pain and is still having abdominal cramps. He ate a burger and had extreme cramps and diarrhea for days and this was after his Pfizer COVID vaccine and he is doing this again with stomach cramps and diarrhea; he can't distinguish what the cramps and diarrhea were from and maybe he ate something bad and is confused about his body; states the cramps are way worse and the diarrhea began after the burger. States the diarrhea is a lot and this time is less diarrhea but more abdominal cramps and he threw up several times last night and did not throw up a lot but was so nauseous and threw up twice a little bit. Patient stated that the reported events were just like when he had covid and after waking up at 12:00 he had body pains and was not able to go back to sleep until 4:00; states he had pretty bad headaches which are ongoing and had had headaches ever since he was diagnosed with COVID, stated it is the same thing also as when he had covid; states with covid he got sick and was up from 12:00 4:00 and had fatigue, had body pain, had headaches and nausea and then it got better and he started sleeping through the night. States the Pfizer COVID shot and it was like the same all over again where he was up from 12:00 4:00, had pain and was disorientated, just not feeling good at all which has gone on since the shot; states there were two nights where he slept through the night and was up in a cold sweat which wakes him up and drenches him head to toe and he has to get out of bed to change clothes and sit there til he is tired again and sometimes goes to sleep in the chair and then sleeps ok. Patient stated he took Benadryl just to sleep through the night and did not and got up once and then went back to sleep. He stated on the left side where the headaches were and he had neck pain and it was kind of the left side and felt weird. The patient stated also that in the emergency room he was given Valium in his arm and also has a knot on the back of his neck and tried to address it with the emergency room and they said it was a spasm and did not seem concerned and it felt hard and not a bump under his skin in his neck and it just felt like maybe a pea sized hard knot and noticed this after his Pfizer COVID Vaccine. Caller stated he actually felt pretty good and was sleeping through the night after he had COVID and felt back to normal and then after his Pfizer COVID vaccine everything went downhill. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Deep vein thrombosis (DVT). Woke up on 4th day after vaccine (May 5, 2021) with pain in calf. Swelling continued to get worse. Went to an emergency room just over one week after vaccine (May 8, 2021) and was diagnosed with DVT in the lower left calf (after D Dimer test and ultrasound). No family history of clotting issues. And no personal history of clotting issues. Currently on Rivaroxaban (Xarelto), 15 mg twice per day. Will be on for at least 3 months (moving to 20 mg once per day after the first 21 days).

I have a severe sore throat and believe due to me my daughter also got this infection, she has been not tested Covid but has same issue as me. She first got the sore throat, fever, and stomach pain, then I got and we both are at the recovery stage.

headache; naseau; tiredness; bones aching; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 07:45 as 1ST DOSE, SINGLE (at the age of 45-year-old) for covid-19 immunisation. Medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan potassium (LOSARTIN) once daily, colecalciferol (VITAMIN D [COLECALCIFEROL]) and Men's one a day multivitamin. The patient previously took codeine, neomycin and experienced drug hypersensitivity. The patient experienced headache, naseau, tiredness, bones aching 5 days after vaccine. The outcome of the events was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

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.

A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.

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.

Bowel discomfort and stuffed right ear, partial hearing loss, vertigo, nausea, shingle like rash on right side of the body. Treated with antibiotic and beclomethasone , seems to help with vertigo. vertigo came back one week later after finishing the antibiotics round. now on 30 days round of doxycycline, no vertigo , very little dizziness and nausea. 2 weeks back started a high dose of vitamin C that it seems to help with the dizziness and nausea. Right ear still stuffed and feeling weakness from time to time.

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

muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 (at age of 45 years old) 09:00AM (Lot Number: EW0179) as 1st dose, single for covid-19 immunisation. Medical history included covid-19, No known allergies. The patient's concomitant medications received within 2 weeks of vaccination were none. The patient experienced muscle pain, joint pain, headache, fever, injection site swelling, nausea, diarrhea, vomiting and arm pain, all on 19May2021 11:00 PM, no treatment received for events, and patient was not recovered from events. Adverse events result in Congenital anomaly or birth defect and Seriousness criteria reported as Congenital anomaly/birth defect (pending clarification). Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts possible. No further information expected.

Unwell feeling; Nausea; diarrhea; heart beats a bit higher than normal at rest (+10 mre than usual); This is a spontaneous report from a contactable Other Healthcare Professional. A 45-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 Left arm on 11Feb2021 at 02:30 PM, (at the age of 45-years-old) as a 1st dose single for COVID-19 immunization at Public Health Clinic The patient's other medical history was not reported. Patient had Advil PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) the day before, and a Pre-workout supplement in two weeks both on unspecified dates. Patient did not have any known allergies. The patient did not receive any vaccine within 4 weeks prior to the dose of vaccine. He did not have covid prior vaccination. On 12Feb2021 patient experienced Unwell feeling. Nausea, diarrhea and heart beats a bit higher than normal at rest (+10 mre than usual). Patient did not have any treatment for the events. He had tasted for covid post vaccination for Nasal Swab, on 02Jul2020 which was Negative. The Outcome of the events was not recovered. Information about lot/batch number has been requested. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.

Lymph node swelling. It started on his left side then it spread all over; Nausea; Fever; Lymphedema in some areas; believes the vaccine went into his lymph node/lymph system instead of the muscle tissue in his arm; ER doctor believed the caller had a hernia due to the swelling in the lower abdomen; ER doctor believed the caller had a hernia due to the swelling in the lower abdomen; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182; Expiration Date: Aug2021, NDC number: unknown) via an unspecified route of administration, administered in left arm on 19May2021 at 13:00 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included sinus infection in 2011 (for which he visited a doctor 10 years ago to get an antibiotic). Other than that, he was healthy. Patient had no family history. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 28Apr2021 13:00 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient had no problems after first dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 6 hours after vaccine, the left side blew up. About 12 hours after the second shot in the middle of the night, patient had the initial reaction and pretty normal side effects (little nausea and fever). Patient had a lymph node inflammation/swelling, which was severe on his left side including his arm pit, down his side, even down into his groin. The reaction died down after about 2 days but spread to rest of the body. On 28May2021, Friday of last week (about 10 days later), everything just blew up. Every one of his lymph nodes went crazy. So many were down in his groin area, the lymph nodes blew up so badly. It was putting enough pressure in that region, it was cutting off circulation to his manhood. Patient had to go to the hospital around 1:00AM. Patient was diagnosed finally at 04:56 and clarified it to be an emergency room visit. Patient was seen in the ER for about 3-4 hours. He was never actually admitted into the hospital. ER doctor believed that patient had a hernia due to the swelling in the lower abdomen. Patient did not know all the tests that were done in the ER. When patient mentioned the swelling that cut off the circulation to manhood, the ER doctor had them ultrasound his manhood, but the doctor never actually listened to the patient. The doctor basically did not want to hear that there were any problems with the vaccine. Patient felt that administration led to lymph node reaction. Instead of sitting in arm for a couple of days or going into a fatty or muscle tissue, vaccine went into the lymph system and now his lymph system was going crazy. He believed this one time when the person jabbed the COVID vaccine in and squeezed the plunger, it put the product right into a lymph node and all of it right into the lymph system. Patient never had a lymph node problem. Patient still had severe lymph node problems. Patient was getting lymphedema in some areas. The only reaction that was abnormal was the extreme lymph node swelling. Outcome of the events was unknown. Investigation Assessment: Yes

Within 24-36 hours of my second dose on 4/19/21 I developed diarrhea, multiple times per day, which worsened to include abdominal cramping and blood after several days. These symptoms, along with weight loss, continued/worsened until my appointment with a GI specialist (Dr. info provided on first page) on 6/7/21. I was scheduled for a colonoscopy with biopsy on 6/8/21, and received a diagnosis of Ulcerative Colitis/Ulcerative Rectosigmoiditis. I began treatment with medication on 6/9/21 and to date have not experienced an improvement in symptoms. As of my second vaccine does on 4/19/21, I had no prior history of GI symptoms or disease.

PATIENT COMPLAINS OF SUNDAY NIGHT STARTING TO FEEL RANDOM NAUSEA IN WAVES THROUGH THE DAY/NIGHT WHEN DRINKING WATER; GATORADE GOES DOWN FINE BUT WATER CAUSES NAUSEA

Symptoms started morning after 1st shot and increased in severity through out the day. Vertigo, dizziness, light headed and fainting. Mobility was mildly impaired in the morning. By midday mobility was severely impaired, not able to walk straight, head spins, mild nausea.

Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm, on 09Mar2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of diabetes, blood pressure high (high blood pressure) and high cholesterol. Concomitant medications include simvastatin (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN) and metfor (MANUFACTURER UNKNOWN). The patient had no allergy to medications, food, or other products. The patient had not received any vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination and since the vaccination the patient had not been diagnosed with COVID-19. On 14Mar2021,the patient experienced headache and nausea. The patient had not received any therapeutic measure or treatment taken for the resulted adverse event. The clinical outcome of headache and nausea was not resolved. No follow-up attempts are needed. No further information is expected.

Bilateral lower extremity pain; pain 9/10 ankle swelling w pain; pain 9/10 ankle swelling w pain/Knee pain; Unable to difficulty to ambulate; Night sweats; Chills w/o fever; Nausea; This is a spontaneous report from a contactable other hcp. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 19Jan2021 14:30 (at the age of 45-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included none. The patient concomitant medications were not reported. AE treatment was given at physicians office visit. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 the patient experienced bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate. Night sweats, chills w/o fever and nausea. On 24Jan2021 the patient underwent lab tests and procedures which included pain assessment: 9/10. Therapeutic measures were taken as a result of bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate, night sweats, chills w/o fever and nausea. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected

Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild

The day after second COVID vaccine, patient developed flu-like symptoms of fever, cold chills, nausea, and no appetite. Symptoms lasted 1.5 days.

Pt is 46 yo male, employee at this institution. He is s/p Pfizer COVID-19 full vaccination: first dose on 1/21/2021, second dose on 2/11/2021. Underwent voluntary COVID-19 rapid testing on 7/14 after experiencing symptoms including fatigue, muscle or body aches, sore throat, diarrhea and congestion/runny nose. Pt reported possible exposure to COVID-19. PCR test resulted positive.

Fever; Diarrhea; Chills; Aches; Nasal congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old, adult male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications 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 01Apr2021, the patient experienced fever, diarrhea, chills, aches and nasal congestion. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever, diarrhea, chills, aches and nasal congestion was not resolved. No follow-up attempts are needed. No further information is expected.

Client reported anxiety and nausea about one minute after receiving the COVID vaccination Pfizer. Client moved from a regular chair into the in anti-gravity chair. The client reported feeling anxiety and nausea. The client denied any other s/s of anaphylaxis. The client reports a history of anxiety with is controlled with an oral medication he takes daily for "stress". The client was unsure of the name of the medication name. Vitals obtained at 7:04PM were as follows: automatic BP 135/96, HR 88, O2 99%. The client stated he was "feeling better." The client denied any history of anxiety with injections. The client his current status was a new feeling for him. The client began drinking a juice. Repeat vitals obtained at 7:10PM were as follows: automatic BP 129/88, HR 96, O2 98%. The client denied any persistent nausea at 7:13PM. The client reported "numbness" around the vaccination site. No redness was observed around the vaccination site. Palpated around the vaccination site and client reported in tact sensation to physical touch. Repeat vitals obtained at 7:10 PM were as follows: Client ambulated to EMT observation area unassisted with a steady gait. At 7:23 PM asked the client if he was feeling okay, and the client replied "yes." At 7:36PM the client stated that he "still feels good." Repeat vitals obtained at 7:36PM were as follows: automatic BP 132/86, HR 88, O2 98%. The client left the vaccination site at 7:36PM. The client ambulated unassisted with a steady gait.

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

Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent headaches,; warmth throughout the body,; severe exhaustion.; 100F; 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: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 14:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthmatic and mushroom allergy (Food allergy). The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 06:00 the patient experienced vomiting, body chills, 100 degrees Fahrenheit, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion. The clinical outcome of the events vomiting, body chills, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion and 100 degrees Fahrenheit were recovering at the time of the report. No follow-up attempts are needed; information about the lot number cannot be obtained.

Abdominal pain; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 20Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID 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 29Mar2021, the patient experienced abdominal pain. On the same day, the patient underwent Computed Tomography (CT) scan and colonoscopy and the result was clean for both the tests. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the event abdominal pain was resolving at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

migraine; slight burning in chest; body aches; warm/hot feeling on arm where the dose was administered; nauteous feeling; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 16:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 17:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation and Buckwheat. 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 01May2021 at 06:00 the patient experienced migraine, slight burning in chest, body aches, warm/hot feeling on arm where the dose was administered, nauseous feeling which lasted most of the day, until around 19:00. The clinical outcome of the events migraine, slight burning in chest, body aches, warm/hot feeling on arm where the dose was administered and nauseous feeling was recovered on 01May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the day with mild chills and nausea starting around 7:00 pm (Approx 11 hrs after injection). Chills steadily intensified, with fever beginning, became severe over the next 2-3 hours, and persisted throughout the night. Along with the fever/chills & nausea, there was also moderate muscle/joint pain (mainly neck and back), moderate to severe fatigue and weakness, weird freaky dreams, restlessness, and moderate headache. Symptoms started to relent around 6:00 am the morning after injection, however fatigue/weakness, nausea, and mild fever/chills have persisted throughout the day with minimal improvement.

Pfizer-BioNTech COVID-19 Vaccine Approx 8 hours after receiving the vaccine, I suddenly became slightly dizzy and moderately nauseous. I also became very tired even though I was well rested. The nausea and dizziness lasted approx 2-3 hours. At that time I developed moderate injection site pain. I was very fatigued for the remainder of the night and through the next day (6 Jan). I was no longer fatigued as of 7 Jan but starting that morning I had a very difficult time focusing mentally. That condition lasted until late on the evening of 7 Jan. As of 8 Jan, all symptoms have resolved and I feel fine.

Approx 8 hours after injection I suddenly became slightly dizzy and had moderate nausea. I also became very tired and fell asleep for about 1.5 hrs even though I was well rested. For the remainder of the night of 5 Jan and all day on 6 Jan I was fatigued and had moderate injection site pain. On 7 Jan, I felt much better (no fatigue or injection site pain) but had a very hard time mentally focusing. All symptoms resolved by the night of 7 Jan and as of 8 Jan feel normal.

Headache, Myalgia, Arthralgia, Fever, Chills Narrative: 2nd vaccine on 5th at 14:45 2245 Nausea, low-grade fever 99, bad headache like a migraine. Used ibuprofen, "living on it" Had headache all night extending down to shoulders. Chills x 2 hours.

Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarrhea consistently and increased. Woke up in the middle of the night with more diarrhea and cold sweats. Temp 93.4. Sugar 112 in the middle of the night. I feel completely like trash, feel sick all over. Stomach hurts and lots of gas and diarrhea consistently.

Vaccine recipient experienced shivering, fever, severe headache, nausea, and generalized ache 12 hours after receiving the vaccine. On a follow-up call on 1/8/2021, he reported that the symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.

About an hour after taking vaccine I begin to get a headache. I went to get breakfast & coffee thinking that would help but it didn't. While eating I become nauseous. I stopped eating but still vomited (only once). At this time I started having shoulder pains and headache was worsting so I left work. About 2/3 hours after taking vaccine my entire upper body(shoulders up) was stiff! I took muscle relaxers and rested remainder of day. About 10/12 hrs after vaccine my headache was gone but still had moderate muscle pains. Upon waking up up my body aches were only moderate so I went to work. 26 hrs after vaccine, I'm still having mild/moderate body aches.

Within 5 days of vaccination, he developed severe right-sided facial pain, and about two days later developed complete right-sided facial paralysis. In the following days he also developed balance problems and nausea/vomiting. His facial pain has begun to improve with high-dose prednisone.

Roughly a hour after vaccine was administered I started getting a headache. I went to get coffee/breakfast thinking that would help however that was not the case. While eating I began to fill nauseous so I stopped but still vomited(only once). I started to feel pains i started to feel pains in my back as well as increasing headache so I left work. Roughly 2/3 hours after taking vaccine my entire upper back was stiff and it hurt to turn my head left. I took muscle relaxers and rested throughout the day. About 10 hrs after vaccine my headache was gone but still had moderate muscle aches. When I woke up (20 hrs after) the muscle pains were moderate so I came into work. 26 hrs later I I'm still having mild body aches.

Arthralgia; Rigors; Severe headache; Severe myalgia; Nausea; Sore throat; Fever; first dose on 18Dec2020, second dose on 07Jan2021; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable Physician reported for himself. A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 in left arm at single dose for COVID-19 immunization. Medical history included carotid dissection. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included atorvastatin, acetylsalicylic acid (ASPIRIN). The patient experienced arthralgia, rigors, severe headache, severe myalgia, nausea, sore throat, fever all on 07Jan2021 20:00 with outcome of recovering. No treatment was received. Information about lot/batch number has been requested.

feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 24Dec2020 10:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 31Dec2020, the patient experienced headache, "lungs felt uber clean and clear," and nausea. The patient stated about a week afterward he started feeling "not quite right" He stated his arm was sore for about 12 hours after the shot, but this has resolved. He has already seen his PCP, lungs are clear, and Covid test was negative. He said that a week ago, he started to feel not quite right. He said that his lungs felt uber clean, but stated that he had a headache and nausea every now and then. He was wondering if it is related to the vaccination. He said that he went to the doctor and his O2 sat was 99% and she did not even think he needed a Covid test, but the rapid test was Covid negative. He stated that on the website that it says that up to 7 days after vaccination 77% of people reported fever, chills, headache and other symptoms. He said that he did not know that you could experience side effects a week after getting a vaccine. He said that his eases his mind a little bit. He wanted to know if it could be because of the vaccine? He stated that sometimes he feels fine and other times he feels strange. He stated that sometime he just feels different. He said that he received the vaccine on 24Dec2020. Caller said that sometimes he is perfectly fine and then he will get the headache or nausea for a few moments and then it would go away. Caller said that at the doctor's office his blood pressure was 118/78 and his O2 sat was 99% He stated that he does work around Covid patients and takes all precautions when he is around them. He said that exactly 12 hours later after receiving the vaccine at 2200 24Dec2020, he said that it felt like someone shot him in the arm. 2-3 hours after he got up on 25Dec2020 it was gone. Caller said that he rarely gets sick and has not had the flu vaccine. The outcome of the events nausea, and headache was not recovered, and arm was sore was recovered on 25Dec2020, while unknown for the event feeling abnormal.

Began on the 21st of December, sores on the tip of the tongue and progressed to canker like sores on the inside of the bottom and top lips , burning sensation that covered the facial area. Doctor instructed to keep taking Valtrex and prescribed a Z pack , I was already taking the Valtrex with little to worsening effect BUT after administering the Z pack condition quickly deminished and went completely away within 2 days.

Dizziness/lightheaded; mild nausea; patient received first dose on 22Dec2020 and second dose on 15Jan2021; This is a spontaneous report from a contactable physician (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 09:00 (at the age of 46-years-old) at a single dose for COVID-19 immunization. The patient had no medical history, concomitant medications within two weeks of vaccination, or known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), in the left arm, on 22Dec2020 (at the age of 46-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness/lightheaded and mild nausea on 17Jan2021 at 06:00. The events were reported as non-serious. The patient received first dose on 22Dec2020 and second dose on 15Jan2021. The patient did not receive any treatment for the events. The clinical outcome of dizziness/lightheaded and mild nausea was not recovered and of patient received first dose on 22Dec2020 and second dose on 15Jan2021 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.

fever (up to 101.8); mild nausea; slight fatigue; aching joints; runny nose; slight headache; breaking into sweats; injection site pain; This is a spontaneous report received from a non-contactable other healthcare professional. A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in the right arm, on 13Jan2021 15:15, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 5730), via an unspecified route of administration in the right arm, on 23Dec2020 at 16:00, for COVID-19 immunization. On 13Jan2021 at 18:00, the patient experienced fever (up to 101.8), mild nausea, slight fatigue, aching joints, runny nose, slight headache, breaking into sweats and injection site pain. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

report Diarrhea 4 hours post vaccination. Treatment: none. Outcome: Improving and does not Interfere with ADLs.

tired; not feeling well; nausea; dizziness/almost passed out; This is a spontaneous report from a contactable nurse and a consumer. A 46-year-old male patient received the first dose of BNT162B2 (lot number: EL3247, expiry date: 31May2021), via an unspecified route of administration in left deltoid on 15Jan2021 12:56 at single dose for COVID-19 immunization. Medical history included had allergies as a child and carried as an epi pen. Concomitant medications were not reported. Reported to the waiting area for 15 minutes observation and left then came back to facility at 14:05 was not feeling well, reported dizziness and nausea. RN assessed patient, vital signs 122/84, pulse was 78 and O2 97 on room air, respiratory rate was 20, alert and oriented, was monitored for 30 minutes, reassessed at 14:25 188/76, heart rate 76, respiratory rate 18, O2 sats 98% on room air, encouraged patient to follow up with PCP or ER. Patient walked out with companion and stated he was feeling better. On 18Jan2021, patient was called for follow p, only complained he was as still tired, all other side effects had resolved. Stated he almost passed out upon coming back to the observation unit on 15Jan2021. Reporter stated it was noted that when patient returned for 2nd dose, would monitor for 45 minutes. Outcome of the event tired was not resolved, of event not feeling well was unknown, and of other events was resolved.

Possible symptom 1: Within approximately a day or two of the shot, I developed a severe and persistent lower abdominal/groin pain. The pain was very pin point in location and lasted for approximately 10 days before easing up. Very small isolated pain severe enough to go to the DR, but I could not afford to on account of my wife having severe unknown abdominal pain and being in the ER and DR multiple times herself (she got the same vaccine an hour before me?). Possible symptom 2: 4-5 days after the shot I developed an isolated and severe pain in a preexisting nodule/mass (lymph node?) located on my mid right thigh, it has never had any sensation before. The pain was persistently severe for approximately 7 days before easing up.

Nausea and light headed on Feb 7, day of shot. Light headache and more severe muscle and join pain on Feb 8.

12/15 vaccination 1/1 4:30 started having tingling and numbness in face, L side. Felt 'off'. My left arm started to tingle and numb. Didn't last very long. Would come and go. Laid down. Ate some dinner; queasy. 1/2 Still felt 'off' 1/3 Symptoms occurred again with the numbness; face down to arm. HR was high for resting; 130's. BP 200/100. ED - CTA head/neck EKG, blood panel Symptoms resolved in ED; vitals normal 1/7 Neurology. Normal exam. MRI of brain; normal. Referral to cardiologist. Echocardiogram; normal Heart Monitor - waiting on results COVID - negative *DR/MGR of vaccine clinic

On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.

Lingering headache for 6 days. Hot flashes/night sweats and on-going chills. Tiny mouth sores. No appetite. No libido. All symptoms have lasted for 6 days.

Extreme fatigue; headache; diarrhea; stomach pain; joint pain; chills; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date not reported), via an unspecified route of administration in the left arm on 29Jan2021 18:15 at single dose for COVID-19 immunization. Medical history included COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown, expiry date not reported) in the left arm on 08Jan2021 07:15 PM at single dose for COVID-19 immunization. On 30Jan2021 13:00, the patient experienced extreme fatigue, headache, diarrhea, stomach pain, joint pain, chills, and upset stomach. No therapeutic measure was taken as result of the events. Clinical outcome of the events was recovering. Information on the lot/batch number has been requested.

1/10/2021-Approximatley 34 hours after vaccination developed left facial numbness followed by severe dysequilibrium 5 hours later. 1/11/2021-left facial numbness and dysequilbrium significantly worse along with severe rotary nystagmus in the left eye. Had appointment with primary care and then ENT , who started me on prednisone 30 mg and antivert. ENT refered me to Neurology. Neurology ordered MRI/MRA that night and increased my prednisone to 60mg/day for 5 days followed by a taper over next five days. Currently, Symptoms of dysequilibrium and numbness have not subsided, on a second course of prednisone 60 mg/day for 3 days followed by taper. MD , Neurologist, provided Diagnosis of vaccine induced polyneuropathy affecting cranial nerves 5 and 8. Since the onset on January 10, Cannot work(physician/anesthesiologist) , drive, or perform minor tasks due to the severity of the symptoms. Symptoms during 1/10/21-1/17-21, bed-ridden, slept 18-20 hours/day, could not walk without assistance-would fall to the left, could not read, nystagmus of left eye, had to keep eyes closed due to severe vertigo/dysequilibrium, nausea. 1/18/21-1/24/21 slight improvement in disequilibrium/able to walk, no change in facial numbness severity , started on 100 mg gabapentin at night, and low dose valium 1.25 mg to 2.5 mg to help with dysequilibrium 1/25/21-1/29/21 50% improvement in facial numbness, began vestibular PT, slow improvement in dysequilibrium and ability to walk and read 1/30/21 Symptoms worsened again, facial numbness returned, dysequilibrium returned to its original severity, difficulty reading/focusing 2/1/21 Followed up with Dr, started another prednisone 60mg/day for 3 days, followed by taper over the next 5 days 2/4/21 Left Facial numbness not improved, dysequilibrium still severe, having difficulty focusing and reading

This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 13Jan2021 12:15 PM at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient reported that he felt fine after the shot for the rest of the day and the first night other than the soreness where he received the shot. The patient went to bed around 11 pm and woke up the next day (14Jan2021) at around 6:30 am with very bad dizziness. He felt like his eyes were rolling around in his head which made him very nauseous and sick to his stomach. His wife called a friend who is a nurse and she said to keep an eye on him for a little while and see how he was in an hour or so. She said that if it gets worse call 911 otherwise get him to the clinic at 10 am. He reported that he was feeling much better by then but went to clinic at 10 and doctor saw him asked questions gave me something for nausea and dizziness. He felt good the rest of the day with slight lightheaded. He mentioned that he needs get his second shot on 03Feb2021 and was concerned about getting it. He inquired on what is the recommendation on getting dose #2. It was not reported if the patient been tested for COVID-19 since vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse events. They gave me ondansetron (ZAFRAN ODT [orally disintegrating tablets]) 4 mg for nausea. The patient considered the events was non-serious. The outcome of the events was recovered on an unspecified date with sequelae (recovered with lasting effects).

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

1.) Moderate GI issues, diarrhea. (8 episodes) Pepto Bismol. 12 hours duration. Resolved. 2.) Moderate fatigue. 24 hours. "Not normally fatigued. Very fit". Resolved. 3.) Mild headache, OTC ibuprofen. Resolved.

Patient received his Pfizer vaccine at 08:10 and at 08:25 he started feeling light headed and nauseated and had a vagal response. Episode lasted about 40 seconds but he did not become cyanotic or stop breathing. Pt denies any chest pain but was diaphoretic after episode. Called EMS for transport to CPH. Pt had syncopal episode with persistent Bradycardia. Current VS are P=40 R=22 BP 101/63 Pt A&O x4 with no focal neural deficits. Pulse ox is 100% on RA and pt states still feels a little "foggy". No rash or evidence of an allergic reaction.

Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat and mouth, mild SOB, tachycardia, nausea, and rash over chest, abdomen, upper arms, and back over the next 30-60 minutes. Treatment: Benadryl 50 mg PO, Zofran 4 mg PO, Loratidine 10 mg PO, ranitidine 150 mg PO. Repeat doses of Benadryl, Zofran, and Loratidine given later that day. Patient stated improved symptoms within a few hours. The facial redness and rash on chest persisted until the next morning.

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.

vomiting last night but has resolved, still presents with sore throat referred to primary provider if symptoms worsen

Fatigue started around 2pm on March 9th and progressed throughout the afternoon/evening to sore throat, runny nose, headache chills, nausea, cough, feeling feverish but no fever.

Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, literally constant burping. My stomach has been in constant pain. I?ve also had a slight fever and a very sore arm. Tylenol and rest has worked for the fever and arm, and I've had some addition body aches. Not sure how much is due to being in bed for an extended period. Also on Friday (about 24 hrs after getting the shot I was pretty fatigued. I just woke up from 13 hours of sleeping. But the stomach cramps/pains was severe and prompted me to try to find a way to report it, especially since it doesn't seem to be too common. It's been really bad.

Initial 24 hrs: Injection site pain, slight headache and slight nausea; After 24 hrs through 72 hrs: fatigue/tiredness, headache, nausea, muscle pain, chills, fever (100.5 deg), significant joint pain

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.

found blood in his stool; This is a spontaneous report from a contactable consumer (patient). This 46-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 6205), via an unspecified route of administration in the right arm on 02Mar2021 at 06:30 PM at single dose for COVID-19 immunization. Medical history included allergy to beef (was informed may have an allergy to beef but not be fully tested due to covid restrictions). Concomitant medications were none. The patient had no other vaccine in four weeks, no other medications in two weeks. The following day the patient found blood in his stool on 03Mar2021 at 09:30 AM. It was unsure if this was related to the vaccine but never had an issue prior to the vaccination. No treatment was received for the event. Outcome of the event was not recovered. The patient had no covid prior vaccination, no covid tested post vaccination.

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.

After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EMS responded to the patient the patient went unresponsive slumped over in his chair with seizure like activity. Patient was being moved when he regained consciousness. Patient was moved to EMS area. Patient was pale, lightheaded and nauseous. Blood pressure was taken as well as oxygen and heart rate. Blood sugar was checked and an IV was started. Patient was stable and transported.

Chills and Shakes started at time indicated, 2 hours later vomiting. Vomiting only lasted 20 minutes. Second night, extreme sweating. Sunday still have some sweating and nausea but feel 90% better than Friday night.

Patient complained of feeling nausea and lightheaded around 3:54 pm. The patient was assisted to patient room and sat in chair. Patient began to sweat and skin was pale. The patient verbalized he felt like he was "going down". EMS called. Vital signs at 3:56 pm were blood pressure 82/50, pulse 58, oxygen saturation 95%. 0.3 mg of epi administered intramuscularly to right arm at 3:58 pm. Patient verbalized improvement in symptoms around 4:03 pm. Oxygen dropped to about 88% and back up to 96% and heart rate 88. EMS arrived around 4:10 pm and took blood pressure of 133/86. Patient transported to ER for further evaluation. Patient alert and oriented x4 at time of transfer.

lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3; fatigue; loss of appetite; constipation; nausea; This is a spontaneous report received. A contactable physician reported for a 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 06Feb2021 (at the age of 46-year-old) as single dose for covid-19 immunisation. Patient had historical vaccine (at 46-year-old) BNT162B2 on 16Jan2021 for Covid-19 Immunization. Other medical history included, colitis ulcerative, Primary sclerosing cholangitis and allergies from amoxicillin (Allergies to medications, food, or other products: Amoxicillin (prior DILI)). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included mesalazine (LIALDA) (within 2 weeks of vaccination), 1.2 g twice a day (BID) taken for colitis ulcerative. The event of patient reported as Patient had PMH significant for quiescent UC on Lialda with recent diagnosis of PSC without history of cholangitis, prior DILI Dec2019 2/2 amoxicillin. Patient had first COVID vaccine (Pfizer) on 16Jan2021 with second on 06Feb2021. Patient works in healthcare and is testing weekly for COVID as part of his job and has been negative. 10 days after first dose he developed fatigue, loss of appetite, constipation and nausea. Patient got the second dose on 06Feb, symptoms persisted so he reached out on 10Feb2021. On 11Feb2021 lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3. No herbals, new meds, NSAIDs, APAP, alcohol. No fevers or chills or pruritus. Full serologic workup negative (viral, etc). Patient had Liver biopsy on 12Feb2021 showed mild cholestasis, mild portal inflammation of lymphs, eos, rare plasma cells and neutrophils. Mild bile ductular proliferation. Trichrome and reticulin with focal portal/periportal fibrosis associated with the bile ducts. Peak labs: bili 3.9 (direct 1.7), alk phos 179, ALT 594, AST 249. Adverse event result the doctor or other healthcare professional office/clinic visit. No covid prior to vaccination, Since the vaccination, the patient has been tested for COVID-19. Patient did not received any treatment for the events. The outcome of all events was Unknown. Follow up information has been requested for Lot/Batch no.; Sender's Comments: The event of hepatic enzyme abnormal is assessed as more likely due to concomitant medication mesalazine. although suspect product "BNT162B2" role 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.

Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hotline 3 days after initial symptoms and states fatigue is more moderate. Patient experiencing loose stool. Patient has hx of IBS however symptoms are worse than baseline. Patient describes mild headache and increase in agitation/moodiness. Hx of bipolar disorder.

Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient's wife communicated that patient was nervous before getting his shot. Shortly after getting shot, he vomited.

Left arm lymph nodes are swollen and painful. My entire arm hurts down to my fingers. Diarrhea, body pain and fatigue.

I feel very light-headed, as with fever but no fever. My whole body has kind of a dull ache...aspirin doesn't seem to help. I feel a little nauseous. Nothing debilitating, but all in all an unpleasant morning at work.

fatigue; loss of appetite; constipation; nausea; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 46 years of age), dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, primary sclerosing cholangitis, prior NAFLD (nonalcoholic fatty liver disease); and had allergies to medications, food, or other products, all from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced allergy and DILI (Drug induced liver injury) in Dec2019. Concomitant medication included mesalazine (LIALDA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior vaccination and was not tested since vaccination. It was reported that the patient got first COVID vaccine (Pfizer) on 16Jan2021 with second dose on 06Feb2021. He mentioned that he works in healthcare and as testing weekly for COVID as part of his job and has been negative. On 26Jan2021, 10 days after first dose, he developed fatigue, loss of appetite, constipation and nausea, all with outcome of recovering. The events are reported non-serious. No treatment received for the events. Information on the lot/batch number has been requested.

Here are my side effects: 1. Low grade Fever 2. Arm so sore that you dont want to move it 3. Body Aches 4. Fatigue 5. Headache 6. Metallic Taste in my mouth. Nothing tasted good yesterday. 7. Nasal Drip with Nausea

Started the night of the injection. Nausea. Felt like I was going to vomit. Kind of dizzy too. Went to bed to sleep it off. Woke the next morning feeling better. Still some light nausea. Had diarrhea though. But when using the bathroom only a small amount would come out and it was mostly bile. That was all day yesterday (Saturday). No solid BM?s at all. Today I?m kind of constipated. When I feel the urge for a BM it?s little bile wrapped pellets. Def not my normal BM.... so, I haven?t had a solid, relieving BM Since Friday and I?m starting to feel bloated. Hopefully this will work itself through.

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.

Headache, nausea, cloudy thinking, overall body aches, swelling in neck and under arm pit-breast area on arm where shot was given, fatigue not able to sleep, day 5 and symptoms have continued and are getting worse.

patients appointment is the same day as Covid vaccine, 28Feb2021; States he was told by the physician that it is possible the Covid vaccine is note safe; them on Saturday and his kinase was 1015; he wasn't feeling well; nausea; unable to articulate how he feels due to depressed ability to speak; panic; anxiety; This is a spontaneous report from a contactable pharmacist. A 46-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 04Feb2021 15:45 as single dose for COVID-19 immunization. Medical history included learning disability (found out last March he has a genetic disability, MECP2, which is a gene that carries Rhett's, autism, and Asperger's), rectal hemorrhage, fecaloma. The patient previously took Lipitor and experienced blood creatine phosphokinase increased, Aricept (2 doses, 1 in am and 1 in pm) and experienced gait inability and rhabdomyolysis, simvastatin (20mg for years and that was discontinued back in Jan or Feb of 2020), atorvastatin and experienced rhabdomyolysis and coumadin and experienced atrial fibrillation. Concomitant medications was not reported. Around Apr or Mar of 2020, the patient was hospitalized, and his creatinine kinase level was about 6000 and got better and was diagnosed with rhabdomyolysis. The creatinine kinase level on 16Jun2020 was 131 and on 17Dec2020 his creatinine kinase total level was 56 and that the range is 44-196. After receiving the first dose of vaccine, the patient wasn't feeling well, he reportedly has at baseline of being unable to articulate how he feels due to depressed ability to speak, but "he began talking to himself, had nausea and wasn't feeling well". So they took him to the doctor and had labs drawn on 12Feb2021 which showed elevated creatinine kinase levels measuring 1,019. They were instructed to speak to a rheumatologist and got another level on 22Feb which came back as 66. The pharmacist reported that back in Dec2020, the patient's kinase level was 55. Kinase was 1015 (blood creatine phosphokinase increased) on 12Feb2021, feeling unwell, nausea, unable to articulate how he feels due to depressed ability to speak, panic, anxiety in 2021. The pharmacist reported that he was told by the physician that it is possible the COVID vaccine is not safe. They were instructed to speak to a Rheumatologist and got another level on 22Feb which came back as 66. The patient's appointment is the same day as COVID vaccine, 28Feb2021. The patient is scheduled to receive his second dose of the vaccine this Thursday and he asked if it is safe to receive the second dose of the vaccine after reacting to the first. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 6000 on 2020, 131 on 16Jun2020, 55 on Dec2020, 56 on 17Dec2020, 1015 on 12Feb2021, 1019 on 13Feb2021, 66 on 22Feb2021, magnetic resonance imaging: diagnosed with MECP2 on 12Feb2021, weight: 180-190 lbs, weight: 141-142 lbs, weight: 140.2 or 140.8 lbs on 12Feb2021. The reporter assessed the events to be non-serious. The outcome of the events was unknown. Information about lot/Batch requested.

Tinnitus. Continuous ringing in ears that will not go away. I was perfectly healthy before the shot.. then several days after developed an ache in my right abdomen, fatigue and constant ringing in ears that will not go away. I'm also having a very hard time sleeping.. sometimes only being able to get 2 or 3 hours a night regardless of how tired I am. I'm very disappointed and not sure if I should get the second shot or not given how I'm feeling now. Before the shot I was perfectly healthy. I eat well, exercise and have never in my life experienced tinnitus or any type of hearing problem. This shot was the ONLY thing that could have caused this. I'm not sure what to do next or if I should get the second shot which could make it worse. I'm very worried because the ringing and aches have been constant for 10 days.. some days worse than others.

Pfizer-BioNTech COVID-19 vaccine EUA Patient passed out after waking up at 3 AM the day after the shot was administered. Symptoms included nausea and dizziness. Fever around 100°F begin the following day April 11, 2021 and persisted throughout the day.

The day of the vaccine patient started feeling tired, and weak with arm pain . As the days went by the patient started deteriorating and was feeling more tired and and weak and abdominal pain 4 days later patient decided to go to urgent care (March 4,2021) Patient was declined because he had Covid symptoms such as chills and fever. Patient instead got Covid tested, results came back negative. Abdominal pain that patient had was getting worse and fever and chills had not improved. On Monday March 8,2021 patient was admitted into hospital and underwent 2 surgeries. He also had 6-8 inches of his colon cut and was left with and Ostomy bag and will be needing a 3rd surgery in June. patient was released from the hospital Wednesday 24th, 2021

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.

Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: difficulty walking had to call 911-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: per Nurse, pt developed severe vertigo and pt had developed weakness and lead to difficulty walking

Facial/mouth tingling of left mandibular area that started approximately 10 minutes after injection. Client given Benadryl 50mg po x1 approximately 5 minutes after symptoms began. Client reported increased in facial/mouth tingling and complained of nausea. No vomiting. Client continued to report increasing symptoms of facial/mouth tingling which resulted in transport to the local ER. No notable external edema observed in facial area or otherwise.

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

On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the left side of my neck and head. By March 28 the pain had become so excruciating I went to an Urgent Care facility and they sent me to the Emergency Room. While in the ER I had blood tests and a CT scan which all came back negative. I was given Oxycodone-Acetaminophen for the pain and prescribed Cephalexin in case there was some type of infection. They also ruled out Shingles. I continued to have pain and contacted my Primary Care Physicians Office and spoke with one of the Physician Assistants two times the next week. She prescribed Baclofen 10 mg and took me off the Cephalexin and put me on Amoxycillin because we thought the problem might have been an ear infection. The next week I spoke with my Primary Care Physician, and he believed I was suffering from Trigeminal Neuralgia, so he put me on Carbamazepine 200 mg twice a day. That same week, on April 9, I was finally able to meet with the Physician Assistant at the Neurologists office and she also believed I was suffering from Trigeminal Neuralgia. I continued to take the Carbamazepine daily and the Baclofen and Oxycodone-Acetaminophen as needed. On Monday April 12 I informed the nurses at the Neurologist office that I was experiencing several symptoms/side effects that included dizziness, weakness, difficulty swallowing and a pounding heartbeat. The nurses talked with the PA and the PA took me off the Carbamazepine and put me on Oxcarbazepine 150 mg twice a day and she prescribed Methylprednisolone 4 mg. On Thursday April 15 I began to have intense prolonged pain behind my left ear down to the neck and in the Trigeminal nerves in the forehead and top of the head on the left side. I was in so much pain I slept for less than 2 hours. The next morning, I vomited and went to the Emergency Room again. At the ER they treated my pain with a headache IV cocktail that included Ibuprofen, Benadryl, an anti-nausea medication, Fentanyl, and a steroid. Within an hour my pain level dropped from a 9 to a 3 and I was released. The ER prescribed Gabapentin 300 mg (3 times a day) which I started the evening of April 16. I have had less constant pain since leaving the ER and starting the Gabapentin, but I continue to have pain in the Trigeminal nerve areas and neck with some flare ups that reach a 7 out of 10 in pain. I am scheduled for an MRI on April 23 and a visit with the Neurologist on May 10.

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

Patient was initally a 15 minute observation period after his first vaccine. Around his 15 minute time, he started to complain of itching and nausea. His vitals were taken and were stable, but elevated Blood pressure of 160/98. Patient was given 50mg of PO Benadryl and monitored for an additional 2 hours with no resolve of symptoms. Denied complaints of chest pain or shortness of breath, but continued to have itching, nausea and appeared pale even after prolonged time to lay down. VSS. Sent to the ER for further evaluation via private vehicle after refusal for 911 to be called. Last BP: 130/78, RR=20, HR=90 and 95% on RA. Patient walked without assistance to his fathers vehicle and verbally commited to going straight to the ER.

After two hours of putting the first dose, I experienced headache, pain in the joints of the feet and hands, abdominal pain in the lower part of the back. A little fever at night and nausea. I took acetaminophen for the fever and the pain subsided quite a bit in my symptoms.

Pt became nauseated, c/o burning hot/cold, diaphoretic, head spinning, feeling weak. PB 170/100 left arm. Pt still symptomatic and was taken to Emergency Department.

Client reports that on 4/23/2021 received Pfizer vaccine in left arm. Client reported that around 1:00 pm started with symptom of diarrhea, next day chills, fevers, mild sweats and coughing. Client stated the coughing may be from his smoking. Client expressed that he is still experiencing diarrhea now for four days. Per Client does have underlying medical condition. No follow up MD and no medication taken for symptoms. Client has been drinking Pedialyte to try and stay hydrated. PHN suggested that Client follow up with PCP, urgent care, ER and call 911 for medial emergency. Client verbalized understanding information provided by PHN during TC and plan to follow up with ER, due to, no longer having a PCP.

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.

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

After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart pounding out of my check for 30-40 seconds. My heart settled down and I was shaky and jittery the rest of the day.

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.

Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have slight chills about 5 minutes after receiving vaccine. Patient's symptoms were on and off. Blood pressure was taken and fluctuating. Paramedics were called per patient's request. Patient did not leave with paramedics and signed waiver. BP 1: 90/60 Pulse 1:104 BP 2: 124/86 Pulse 2:74 BP 3: 114/74 Pulse 3: 61 BP 4: 109/75 Pulse 4: 84

Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate & skipped heart beats, i.e. arrhythmia - for about 7 days but improving each day. Terrible, splitting, constant headache - 2 days. Stuffy nose - 1 day. muscle pain, chest, both shoulders, arms - 4 days. Joints pain - 2 days. Pain in the lymph nodes - 2 days. Pain in the lower back around kidneys - 1.5 days. Fatigue - 3 days Nausea and stomach ache - could not eat protein of any kind, only bread and cheese for 4 days.

Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic Taste in my mouth; Nasal Drip; Nasal Drip with Nausea; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the right arm on 30Mar2021 at 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. Concomitant medications included atorvastatin, pantoprazole, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC) all from unknown dates for unknown indications. The patient previously received morphine on an unknown date for an unknown indication and experienced drug allergy, and the first dose of BNT162B2 (lot number EN6208) on 09Mar2021 at 13:15 (at the age of 45-years-old) for COVID-19 immunisation. On 30Mar2021 at 08:45 the patient experienced low grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, further reported as nothing tasted good yesterday (as of 31Mar2021), and nasal drip with nausea. No treatment was provided for the events. The outcomes of low-grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, and nasal drip with nausea were not recovered. It was also reported the patient had not been tested for COVID since vaccination. No follow-up attempts are needed. No further information is expected.

Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills. Took Benadryl tablets about an hour after receiving the vaccine. Took Tylenol for the fever. Took some nausea medication during the night about 6 hours after receiving the vaccine to stop the vomiting.

I had my second Pfizer vaccine on 1pm April 23rd. I had headache, nausea and tired feeling from Friday afternoon and it improved Saturday afternoon. Sunday I had a slower but normal day. Monday morning I felt normal but by 2pm I started to feel drowsy and by 4pm the headache and nausea returned to the point I had to go to sleep. This morning I have a light headache and nausea. I have taken Tylenol. Thursday I went to the gym and had higher than normal heartbeat and would get lightheaded. Went to gym today and all is was back to normal.

For both the first dose and the second, I experienced belching that tasted very bad, watery diarrhea, gas, bloating, and abdominal cramps.

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.

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.

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

NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HIVE LIKE BUMPS ON BOTH ARMS SMALL BUMPS ON FOREHEAD, LOSS OF APPETITE, KIDNEY, LIVER PAIN, BACK ACNE. COGNITIVE CLARITY LOSS.

Approximately 6 minutes after vaccination, patient experienced a syncopal event and passed out. He became nauseated after the event then vomited. Pt was seen in the emergency department, patient admitted to hospital for overnight observation.

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.

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.

My blood pressure rose 30 points on both systolic and diastolic pressures to 160/130 with tightening of my chest. EKG showed no sign of heart attack and I was released from the emergency room after 3 hours of monitoring at which time the blood pressure normalized to 130/90. 12 hours after the injection I had pain at the injection, extreme full body aches, mild headache and slight nausea. All side effects were gone within 36 hours.

Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All symptoms have not subsided since the day after the 2nd vaccination shot. It has been 10-days.

Pt presents to clinic with c/o S/E to Pfizer Covid 1st Vac. to L delt 3 days ago, states since yesterday has felt drained/tired then today while at work was nauseated.

Extreme vertigo, full feeling behind ears, nausea, vomiting, involuntary eye movements left right like pendulum Started 7 days after 2nd dose. Worse into 8th day.

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

Initially started of as pain in lower abdomen. Went to the family dr after about a week, since pain was still lingering. I was diagnosed with a mild case of Shingles by the Dr. The shingles started to crust by the time I went to the Dr office. No other major symptoms.

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 is a 46 year old male who admitted to hospital for Facial nerve palsy. Patient felt with left sided facial droop and tingling sensation for 2 days. He reported symptoms onset at 1330 on 6/10/2021 while driving a truck. He also had left sided occipital headache and rested for 1 hour. His symptoms improved after the nap but never resolved completely. He got into a location and rested there for 1 night. In the morning after waking up he was having difficulty chewing food on his left side. He called EMS and was brought to hospital. While in the ED, he received workup including CT Head W/O, CTA Head/Neck with perfusion scan that were all negative. Other labs obtained included BMP, CBC, Troponin x1, Coag studies & CXR which were largely unremarkable. Neurology were called for stroke alert and given ASA 325mg and ordered MRI. Patient's MRI was unremarkable for stroke or masses. He was started on Prednisone 40mg once daily for Facial Nerve Palsy. He was seen by physical therapy and occupational therapy, they recommended him go home to family. His symptoms improved after therapies were initiated but are not completely resolved. Patient will continue taking his home medications per his primary care doctor. He will complete a 7 day steroid course, has 3 days remaining. He will take Acyclovir 5 times per day for 10 days. We also gave him lubricating eye drops since he continues to have difficulty closing his left eye. He spends a lot of time outdoors and works with horses. He reports getting tick bites before in his body but never noticed a rashes. He has never received treatment for Lyme Disease. He is a long-haul truck driver and has driven all around. He reports walking in wooded areas when he stops in the rest area. We obtained Lyme Titers, which were eqivocal for IgM and negative for IgG. Western blot was ordered to rule out Lyme disease. He should followup with PCP for treatment if he is positive. We will call him with results when available. Of note he received Pfizer 2nd COVID vaccine on 6/9/21 (LOT #EW0178). He reported fever and diarrhea that night and next morning. He then reports having presenting symptoms after 7 hours of driving. We also believe the cause of his facial nerve paralysis could have been a side effect of his vaccination.

Have been having strong stomach discomfort ever since the second dose on 4/15/21. Symptoms are dull pain to sharp pain sometimes to an extremely tight stomach.

Pt also had the TDap vaccine on 4/19/2021 Pt started to have abd pain on 4/22/2021. Pt pain became worse despite treatment and then started to have lower ext wkness and numbess and unable to walk. Pt also had loss of hearing Diagnosed with Guillain Barre syndrome while in the hospital by a neurologist

PATIENT CLAIMED HE WAS ITCHY, HAD METALLIC TASTE, SKIN CRAWLING, NAUSEA AND SWEATING INSTANTLY AFTER RECEIVING VACCINE. AMBULANCE WAS CALLED BUT HE REFUSED TO BE TREATED AND LEFT UNDER HIS OWN POWER.

Pain, nausea, fever - diagnosed with acute Appendicitis - surgery to remove appendix (17 days after 2nd dose)

light headache lasting over 5 days, fatigue lasting over 5 days, initial back and chest pain 30 minutes after vaccine followed by dizziness and nausea. the back and chest pain come and go.

vertigo; large, painful swollen lymph node under right arm; nausea; headache, severe pain at injection site. No treatment, symptoms occurred over Fourth of July weekend and everyone is closed...

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.

Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 46-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 in left arm on 26Mar2021 at 14:00 as single dose (at the age of 46 years) for COVID-19 immunisation. The medical history of the patient included high blood pressure. The patient had no known allergies. Concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 01:00, the patient experienced nausea, dizziness and headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nausea, dizziness and headache was unknown at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week and nauseous for about 4-5 days. I fely hung over, achey, had slight fever and chills for 5 days. I am feeling 95% better now going on 9 days. I'm scared 2nd shot will be worse?

Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; This is a spontaneous report received from a contactable consumer (patient himself). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: Ew0164) via an unspecified route of administration in left arm on 05May2021 10:00 for COVID-19 immunization. Patient medical history included High blood pressure and acid reflux. Concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL) and esomeprazole magnesium (NEXIUM) 40mg. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE and lot number: Ew0164) administered in left arm on 01May2021 10:00 for COVID-19 immunization. On 29May2021 06:00 patient was experienced with Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting. Patient was went to physician office/clinic visit, Emergency room/department or urgent care. Patient was treated with Steroid shot and prednisone 50mg from urgent care. Outcome of events was not recovered.

Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/17 went to casino, came back 6/18. ate a bag of sausage. dog bite that Friday. stomach felt weird. 3 days of HA, stomach ache, vomiting started Monday, went to urgent care the 21st - noticed some nystagmus, given tdap, given meclizine. was told if still not better, to ER. ER yesterday - was told dehydration, got IV fluids, got zofran IV, no imaging, had bloodwork and urine (WBC normal, h/h normal, abn neutrophils/lymphocytes. normal CMP), per wife was told blood in urine. since yesterday, continued HA, nausea, vomited in ER x 1. after zofran no vomiting today was ok, was getting out of car, felt like tripped, then almost fainted. no head trauma, no LOC. heaving. no chest pain, no shortness of breath, has not eaten today. Did take Tylenol today. 325 mg x 1. and ibuprofen 200 mg x 1. 730 am. since out of town, has been drinking couple drinks per day. marijuana gummies. marijuana from dispensary. no other drugs, no cigarettes. no hx of HA or lightheadedness sometimes when flying gets sinus HA on landing. no fever did have 99F when sleeping/hot, normal since then no blood in stools. primary sx is HA - constant throbbing 10/10 (currently 6/10) b/l frontal HA, nonradiating, better with lying down. +light sensitivity. no sound sensitivity. +nausea, +vomiting, several times per day. 2 episodes in 24 hours. no abdominal pain. has had lower back pain. tolerating PO. has had zofran and Tylenol. 2 days ago also had meclizine x 1. per pt always had low HR. no other changes to diet/medications. no facial droop, no one-sided weakness no speaking nonsense. several weeks ago "my heart felt like constant adrenaline" thought was stress - felt like something scared you adrenaline, lasted several days, coming on for several minutes at a time. last dose tadalafil was 1 week ago Pt sent to ER after this visit, but was then discharged home. pt presented to urgent care couple days later and was transferred to hospital after findings below

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.

Body aches, chills, temperature of 99.2F, diarrhea, injection site swelling, redness and pain. Symptoms resolved within 48hrs of vaccination

1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: fever, chills, body aches, nausea, sore left arm. Treated with 600 mg Ibuprofen every four hours. Fever would break and then come back. 2. Onset roughly 51 hours after injection lasting until approximately 55 hours after injection: fever, chills. Treated with 600 mg Ibuprofen. No symptoms since.

fever >100 , body aches/whole body muscle spasms, chills, nausea (no vomiting), headaches, physical exhaustion, all symptoms resolved approx 1.5 days of vaccine administered, symptoms began approx 12 after vaccine received.

Swollen under arm and a knot/upper part of shoulder and chest area was swollen.; Nauseated; Real dehydrated; Kidneys started hurting and felt like kidneys were overworking; Mouth dry; Kept having to go to the restroom; Kept using restroom and had to pee a lot; He is a little sore, but the pain is not as bad; Pain in kidneys woke him up from sleep.; Arm is still swollen but swelling went down; red spot under his arm that looks irritated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 via an unspecified route of administration in upper right arm on 02Jan2021 between 07:00-07:30 at single dose for covid-19 immunization. Medical history: None. There were no concomitant medications. The patient experienced swollen under arm and a knot/upper part of shoulder and chest area was swollen on 03Jan2021 18:00, nauseated, real dehydrated, kidneys started hurting and felt like kidneys were overworking, mouth dry, kept having to go to the restroom; kept using restroom and had to pee a lot, he is a little sore, but the pain is not as bad, pain in kidneys woke him up from sleep all on 03Jan2021. Got COVID Vaccine on Saturday. Was swollen up under arm. Over kidneys, started hurting. Swelling went down. Took Naproxen and Ibuprofen. Mouth was really dry. Felt like kidneys are overworking. Keeps drinking water and going to the restroom. Kidneys started hurting. Received through work. Employed at a mental health and mental retardation school. Arm swollen with a knot. Got off Sunday morning, 03Jan2021. By 18:00, under arm was swollen. Thought he slept wrong or he had an issue with an artery. Under arm and into upper part of shoulder and chest area was swollen. He was nauseated. Felt really dehydrated. Kidneys started hurting. Felt like kidneys were overworking. Felt similar to when he previously had a kidney infection. Knew something wasn't right. Kept using restroom and had to pee a lot. Kept drinking. Kidneys were hurting from 03Jan2021 to yesterday. He is a little sore, but the pain is not as bad. Was drinking water, cranberry juice, and orange juice to flush the COVID vaccine through. Pain in kidneys woke him up from sleep. Is a little swollen. Pain is better than what it was. Between 02:00-03:00 it was done. Swelling was really bad. Start taking Naproxen and Ibuprofen. He was hurting too. Arm is still swollen but swelling went down. There is a red spot under his arm that looks irritated. Supposed to receive second COVID Vaccine on 30Jan2021 but was not going to take it. Clarified he took Naproxen with Ibuprofen in it for the anti-inflammatory. Confirmed he was only referring to one product. Naproxen was just bought from the store. Unable to provide NDC/Lot/Exp because he does not have product at time of call. Formulation: 200mg per pill, took two pills then six hours later took another two for Voluntary; high number of COVID Cases at his work. Scared to take second COVID Vaccine. The patient underwent lab tests and procedures which included Covid Test: unknown results on an unspecified date (He has to take COVID tests twice a week). The outcome of events was unknown. Vaccination Facility Type: which is a mental health and mental retardation school. He has to take COVID tests twice a week. No additional vaccines administered on same date of Pfizer suspect. The event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Prior vaccinations within 4 weeks was none. Adverse event follow prior vaccinations was none. Relevant tests: none. Information about Lot/Batch number has been requested.

1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830. By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.

About six hours after shot I started to notice weak, rubbery arms. Today, I was a little nauseous, very sore all over, and very tired.

On monday night Jan 11 after the covid vaccine shot i had a runny nose and flem. i also felt muscle aches and very tired and disoriented. the symptoms continued through the week. on Wed i got covid tested and the results were positive. i began to have light chills through the week but no fever. on Jan 15-16 my symptoms peaked and i had a low grade fever and diarrhea for 2 days. i also developed a rash on my tighs and torso. on Jan 19 my fever went away along with my other symptoms except for an occasional flem cough.

nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report from a contactable physician reporting for himself. A 47-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EJ1686) vaccine , intramuscular in the left deltoid on 07Jan2021 11:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Previously on 17Dec2020 the patient received the first dose of BNT162B2 vaccine. The patient experienced nausea and vomiting on 10Jan2021 23:59 with outcome of recovered , mild headache on 07Jan2021 20:30 with outcome of recovered , arm was hurting/left arm soreness on 07Jan2021 20:30 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 20Nov2020. Nausea and vomiting were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events nausea and vomiting cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

One hour after shot, was able to raise arm. Monday night (01/19/2021) started to get chills, body aches, fever (103), vomiting and severe headache. All symptoms gone except headache Thursday morning (01/21/2021). Headache pain has lessened.

About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed and didn't want to use it. Went to work but about 7:00 am- I noticed my right arm began to work as well - almost in the the same severity. Spell- lose consciousness alost- had bad headache; - it abated and it happened again - almost lost consciousness. It left. And it happened again a third time and went to a stretcher - nurse took my BP 220/110 - blood pressure - very high for me and laid on the stretcher and had nurses hook me up ot monitors; No change on cardiogram and my oxygen saturation level never altered and never dropped; My BL remained elevated - significantly. 180/90 before I went home. Continued to check my BP when I went home - queasy; nauseated - upset stomach and then fever the following day - remained for 4-5 days. Fever was one day and got 100.5 and then was gone after that day. BP continued to check regularly through next few days - it did improve a bit but was still elevated - 180/150 (systolic) and 110/95 (Diastolic) - Slowly got back to normal by day 7 after vaccination. Went to work the 30th the day before New Year's Eve, finally and had dizziness never got quite as severe - 50% but left arm pain very very painful - almost numb; right arm hurt some, too. Blood 190/110 .Oxygen Saturation remained good. Arm pain very bad - ordered EKG - was normal Admitted my self to ER - Had a full work up - repeated EKG - negative; two sets of troponins - negative; chest x-ray - nothing - BMP - elevation in my creatine which I've never had before. CBC - normal; They treated me with fluid hydration; Tylenol; fentanyl and hours later I felt a bit better. Things calmed down and I was released. BP remained elevated for next two days. I got better after two days _ enough to work - but still would get a little disequilibrium not enough to pass out but just like an odd feeling and then it would go away after a few seconds. And that is only recently disappeared - within the last week or so. I feel better now but my BP remains elevated - 160/140 (systolic) over 105/95 (dystolic) - that's al new for me. I have declined the second vaccination. Have sort of recovered but it did come back after time and so it may come back again - don't know. I may have been exposed to COVID the week before my vaccination. About 4 days after the severe symptoms that lead to my leading to take off work; I took test for COVID - PCR at CVS (returned positive) and COVID test PCR and rapid antigen (returned negative) at Public Health -

Approximately 48 hrs after my second Pfizer vaccination for covid I experienced chills, migraine, lethargy, loss of appetite, and general digestive discomfort. Treated with plenty of fluids, naproxen, and rest. Experienced mild fever but never > 100 degrees that I know of.

I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were being ripped apart, tired/fatigue, blurry vision, dizziness, my body felt hot from the inside out, tingling sensation in feet and hands.

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.

Stomach upset; This is a spontaneous report from a contactable pharmacist. A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), intramuscular in the left arm on 10Jan2021 (at the age of 47-year-old) as a single dose for COVID-19 immunization. Medical history included hypertension. 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. The patient's concomitant medications were not reported. . The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL0140), intramuscular, left arm on 20Dec2020 for COVID-19 immunization. On 10Jan2021, the patient experienced stomach upset. The patient took Compazine for the stomach upset. The clinical outcome of the event stomach upset was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, numnous in hands

body aches; muscle soreness; headaches; being tired; chills; throwing up; This is a spontaneous report from a contactable other healthcare professional (patient himself). A 47-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer -Biontech Covid-19, lot/batch number and expiry date were not reported), intramuscularly in the left arm on 19Jan2021 20:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included CHF (congestive heart failure). He was not diagnosed with COVID-19 prior to vaccination and did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 22Jan2021 17:00 he started to have body aches, muscles soarness, headaches, felt being tired with chills and throwing up about a week. No treatment was given. The events were reported as non-serious. The outcome of events was unknown. Information on the lot/batch number has been requested.

Injection site pain, headache, chills, nausea, feeling unwell. Injection site pain and chills went away after two days. Headache, nausea, and feeling unwell is still going on but intermittent as of 8 days after the first injection.

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.

Feeling unwell; Injection site pain; Headache; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 29Jan2021 (13:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included diabetes. Concomitant medications included amlodipine, atorvastatin, lisinopril and metformin HCl. On 29Jan2021 (19:00), the patient was feeling unwell; had injection site pain; headache; chills; and nausea. The patient did not receive any treatment for the reported adverse events. The outcome of the events was not recovered for 'feeling unwell' and 'headache'; was recovered on 01Feb2021 for 'injection site pain' and 'chills'; and was unknown for 'nausea'. The patient was not diagnosed with COVID-19 prior to vaccination; and had not tested positive post-vaccination. Information about lot/batch number has been requested.

Shingles outbreak 3 starting about 3 days after first shot. First experience with shingles Had chicken pox when I was a toddler Ramsey Hunt syndrome 2 was diagnosis Got second shot as scheduled shingles rash was clearing and pain was beginning to subside at the time. Two days after second shot pain from shingles increased and new vesicles formed. Second rash has been less severe than first so far but pain is equal to that at the time of the first rash.

After leaving facility, had numbness in tongue, trouble swallowing. Waited 20-40 more minutes, then felt dizzy and began to have hives in addition to previous reactions. I went to Urgent Care where they took vitals. Blood pressure and heart rate were elevated, throat was abnormal, and I had hives. They gave me antihistamine and steroid shot. After 30minutes - and hours, vitals returned to normal.

I had to miss work for two days due to these symptoms: nasal congestion, fever of 100 degrees, joint pain, severe fatigue, severe dry mouth, muscle and body aches, nausea, pounding headache, also just feel "out of it"

Headache, Myalgia, NauseaVomiting, fatigue, chills occurred within days of 3/15 and 3/17 which resulted in unable to work 3/16/2021 and 3/17/2021.

47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after 5 days of gait instability, and about 4 weeks of altered mental status, confusion, short term memory deficits and malaise. ADEM suspected and extensive infectious, inflammatory and neoplastic workup was initiated. CT brain - reported NAD MRI brain consistent with Acute Diffused Encephalomyelitis and suspected ADEM. MRI cervical spine with evidence of demyelination involving posterior cord. ICU course complicated by new onset of aphasia, partial left frontotemporal seizures, LGIB due to proximal rectal laceration and central diabetes insipidus. Admitted 3/15/21. On 3/17 he developed aphasia with right sided facial droop and stroke alert was called. Later on 3/17 he developed GI bleeding and was taken for emergent colonoscopy, from which no significant conclusions could be made due to lack of preparation and subsequent poor visualization. No foreign body was reported. After he continued to have ongoing bleeding, the patient had a sigmoidoscopy, during which the migrated clip could be removed and two new hemostatic clips were placed. He subsequently developed large volume urine output and nephrology was consulted; the patient was diagnosed with likely diabetes insipidus. On 3/20 acyclovir was discontinued after HSV PCR was negative. High dose solumedrol for ADEM completed 5 day course 3/21. VDRL was non reactive. There were no oligoclonal bands. Solumedrol 1g daily was started 3/24/21: MRI showed L>R patchy enhancement and diffusion abnormalities consistent with ADEM. Repeat MRI showed new restricted diffusion of the left superior cortex, bilateral medial temporal lobes and hippocampi, genu of the corpus collosum, and pericallosal white matter, with ddx including status epilepticus, autoimmune encephalitis and infectious encephalitis including herpes simplex. Completed 5 day course of high dose steroids, 6 days of IVIG and on ongoing PLEX. Neurological improvement noted 3/25

Got my first Pfizer shot on March 24 at 2 pm. The first day I felt way off like I was drunk or on some kind of drug that gets you high with bouts of dizziness and some major hypertension. My back and chest were very tight the whole time. The tension finally subsided around 11 pm that night but I was still uneasy. The 2nd day I felt ok in the morning and throughout the day until about 3 or 4 pm I started getting really nauseated and tired. I went to lay down to sleep and felt a little better when I woke an hour later. Day 3 I started feeling extremely tired and fatigued with some major chills. Basically slept most of that evening and throughout the night. Woke that next day and couldn't get that dizzy foggy feeling out of my head the whole day. Day 4-5 still bouts of dizziness, chills and fatigue with some nausea also I noticed I developed a wheezing dry cough which points towards respiratory distress. Day 6 still feeling yucky, tired, fatigued, some nausea and that dam cough. Today 03-31-21, still feeling weak and tired with some episodes of dizzy spells, nausea and respiratory distress cough. Also forgot to mention on day 2 and 3 I had some major tingling on the right side of my head for most of the day. Felt like spiders crawling on my head and face. The last time I felt tingling like that I got shingles which also got me very sick and put me in the ER and ICU years ago. So there is also some post traumatic stress from that as well. Made an appointment to see a Doctor on 03-30-21 to have my blood pressure checked and get an overall check up. My blood pressure is elevated and stress levels are high with anxiety. Dr prescribed me some anxiety medication. No other recommendations from the Doctor.

Experienced mild flu-like symptoms; including chills, fatigue, exhaustion, some nausea and general unwell feeling. Onset was approx 30hrs after receiving 2nd dose.

3/31 pt call: Pt states he's has progressively worsening nausea for over a week. Woke up this morning and could hardly get out of bed. Denies abdominal pain but feels nauseated and has been vomiting off and on all day. No other GI sx. Pt has known hiatal hernia but doesn't take anything for GERD right now because he doesn't have heart burn sx. Denies chest pain. Gets sweaty randomly and chilled, but this is more chronic. Sees neuro for early onset parkinson dx but no change in medicine in over a month. No new supplements. Denies dark stools. Pt taking all his medications with compliance. Has been getting more headaches lately too but thinks this is stress and from wretching. Has chronic headaches. Pt has OSA and has been wearing his Cpap with compliance. Gave patient zofran, prilosec, carafate for suspected gastritis sx. Recommended he come get labs in the morning as well. Pt agreed. 4/1 ER HPI: 47 y.o. male who presents with complaints of nausea vomiting abdominal pain ongoing now for the past day reports that is better with rest worse with movement denies any other complaints issues 4/1 Admission HPI: 47 y.o. male that was recently diagnosed with Parkinson's disease. He presented to the emergency room with the a several day history of fluctuating blood pressure and nausea/vomiting and generally feeling very poorly. He has been having a lot of new onset health issues lately and so his wife and family were concerned. He was brought into the emergency room. He denies any severe abdominal pain. However, he states he has been feeling extremely nauseous. He is vomited at least once a day for the last 5 days. He does admit that he is under an extraordinary amount of stress between his new onset Parkinson's, his insurance business, and his full-time job as a pastor. The patient also does have a history of alpha-gal allergy. He states it is possible he ate some cross contaminated meat, but states that this nausea and vomiting does not act like his typical response to eating something that he is allergic to. The patient states that about a month and a half his neurologist did increase his Requip up from 0.5 mg 3 times a day to 1.5 mg 3 times per day. However, it has never made him nauseous before. He denies any definite chest pain. He denies any exertional dyspnea. He does admit that his blood pressure has been fluctuating for quite some time. He states he was having a skin biopsy done last week and they almost abandon the procedure because his blood pressure was so high. He currently takes a combination of Benicar and hydrochlorothiazide. In the emergency room his lipase was found to be a little bit elevated. Creatinine was found to be a little bit elevated. His blood pressure was very elevated in the systolic 170 range and he did require some IV labetalol. The patient states he really has not missed any doses of his medications.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Vision changes-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient presented with sweating, and pale face. Chest pressure/pain and left arm pain. Face was pale. Pt reported nausea and vision bluring in and out. Reported unable to stand and verbalized the desire to call an ambulance to evaluate. 911 was called and all advice followed until EMS arrived. Rph remained with patient until EMS arrival. Pt had NO swelling of lips/eyes or difficulty breathing. No hives. Unable to reach patient to assess curent status

first 3 days tired, headache, cold chills followed by sweating in bed. Now through day 10, I still have headaches and upset stomach pain/nausea.

Same night as shot: right arm soreness lasting 24 hours 2 Days after shot: really bad diarrhea lasting 12 hours Both cleared up on their own

Discomfort at shot site, fatigue, aches, sour stomach, headache, congestion, runny nose. Symptoms were strong day of shot and day 2. Day 3 symptoms 50% milder. No symptoms day 4.

Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours after injection with a metallic taste in my mouth, Aches and pains, diarrhea, nausea, racing heart, confusion, exhaustion, 5 days after injection energy is better. All other symptoms are slowly subsiding.

Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progressive jaundice, feeling unwell and eventually went to the hospital, found to be in cardiogenic shock with bi-ventricular failure, acute liver failure and acute kidney failure. Currently still hospitalized for workup of his cardiomyopathy.

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

abdominal pain; feeling bloated; This is a spontaneous report received from a contactable consumer (Patient, self-reported). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 other, via an unspecified route of administration, (Batch/Lot Number was not provided) as SINGLE DOSE for covid-19 immunisation. Medical history includes Chron's. Concomitant medications were not reported. It was reported that Patient had colonoscopy about 6-7 weeks prior to the Pfizer Covid vaccine. After receiving his first Pfizer Covid vaccine he experienced abdominal pain & feeling bloated. Caller went to the ED and had a CT scan which showed a larger amount of air in the abdominal area, that wasn't there during the colonoscopy. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Extreme nausea, followed by immediate passing out on bathroom floor. I hit my face on the floor and woke moments later after my wife found me. I got in bed and had the chills for 30-60 minutes and neck pain.

Low level headache (~20 hours), body aches (~20 Hours) and mild diarrhea (1 time) Took Advil for body aches, worked OK

Afyer first dose, extreme nausea and dizziness for about an hour. Almost called 911. Slowly subsided over the course of day one. After that, ten days of extreme fatigue. Ringing in my ears that resurfaced after second dose.

Within two weeks of the first Pfizer shot, I experienced significant joint pain in both shoulders, and more disconcertingly, significant pain and locking of the right knee. It continues today, though somewhat reduced in intensity. I assumed there was some significant structural issue with the knee, but an MRI indicates there is not. Furthermore, I have experienced pain on a periumbilical hernia, which I have had my entire life, but never experienced any pain from until approximately 2 weeks after the first vaccine dose. I can provide more detail if requested. To be clear, I don't know that any of this is causally connected to the COVID vaccine, but it is at least correlated, and these medical symptoms I have had are unprecedented and thus far unexplained.

Next day of vaccine, I got severe pain at my lower back with bloating. had low bowl movement. Pain was so sever, I could not even sleep, could not walk, and could not stand for minute because of pain. Also got constipation like symptoms. after two days, I got some relief in pain, but still have it

At 1118 patient fainted, had fixed shaking, pale, loss of speech. Once patient reactted he was able to speak and gave Past medical history of Asperger syndrome and no fainting spells before. Patient complained of stomach pain. numb lip, tingling sensation on fingers. Hands began to flexion and tense up. Vital signs were with in normal range. clinet began to show normalized sign and symptoms. Ems was still called and was taken to hospital for furhter observation at 1153.

Rapid heart rate, slight nausea, slight numbness to front right cheek and lips. Onset within 1 minute of injection. No treatment given. Heart rate started to decrease after 10 minutes and returned to normal within 30-40 minutes. Numb areas returned to normal within 45-60 minutes. Slight feeling of anxiety for several hours, but this could have been simply from stress from the initial reaction. I also occasionally have random panic attacks and could have potentially had a small one at the onset of my face going numb which could have contributed to the length of unease.

The day following the initial vaccine administration, the patient developed scleral icterus which progressively worsened to full body jaundice, elevated LFTs (Bilirubin of 21.8 mg/dL), diffuse abdominal pain, with ascites and profuse diarrhea that have remained constant over the last 4 months.

I received my 2nd dose of the Pfizer vaccine on April 1 2021 around 8:00 a.m. At approximately 8:00 pm. I went to bed, within 1 hour I started having chills, within 2 hours I started sweating. Within 3 hours of going to bed I started vomiting every hour on the hour, until 8:00 a.m. on April 2nd 2021. During that time, my temperature got to 102.5...The sweating and chills, lasted until April 4th 2021, with my temperature getting down to 96.5...During this time and the next 2 weeks, I've had headaches on & off for about a month now. Today, I actually have pain in the injection site, after 1 month of getting the shot, not sure if this is normal?

Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermic, 3 days later seen in ED, hypotension, septic shock, and DKA/AKI. Also noted to have mild prominence of right oropharyngeal well with normal epiglottis and larynx on CT. There is noted uvular edema of unknown etiology

passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 18Apr2021 10:45 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and allergy. Concomitant medications included chlordiazepoxide, clidinium bromide (LIBRAX), Multi-Vitamin, colecalciferol (D3), ascorbic acid (VIT C), fish oil. No other vaccine was received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient received first dose of BNT162B2 (lot# ER2613) in left arm on 27Mar2021 12:00 PM for COVID-19 immunization. The patient experienced extreme nausea 19Apr2021 00:30, then he passed out and hit the bathroom floor. The patient woke up a few moments later, when her wife found him. The patient had a cut lip. The patient then had extreme chills for 30-60 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. It's unknown if treatment was received. The outcome of events was recovering.

Within 72 hours, constant ringing in ears, headaches, slight vertigo and nausea, trouble focusing. Ringing and headaches persist to this day. -Antibiotic as well as Claritin and Flonase prescribed with no change in symptoms.

2nd dose lot: 4/21/2021 He reports that after his initial vaccination he developed significant skin rash incorporating mostly the trunk and collar region. He reports this was significantly itchy however tolerable at that time. After his booster he had a significant flare of his skin reaction including severe dermatitis, severe urticaria, severe swelling involving the trunk neck and face which prompted him to be seen in the ER where he was given parenteral steroids as well as oral steroids.

Severe diarrea and vomiting that begin late on Day 2 after receiving the second Pfizer covid-19 vaccine dose. Conditions lasted for over 36 hours. Drinking any liquids including water to stay hydrated during this time was not possible. Plain water created a severe gastro reaction too. Slowly recoved by going on a liquid diet on Day 4 and small bites of solid food Day 5. Week long body fatigue and dehydration as well.

Vertigo, Vomiting, Dizziness, face numbness, double vision, left arm is difficult to use, went to the emergency, given Meclizine, baby aspirin, Atorvastatin Calcium I still have difficulty walking, double vision comes and goes my balance is still off

No immediate effects other than soreness at the injection site on Wed 4/28. Upon waking on Thurs 4/29, I had a fever of approximately 99.5F. Took acetaminophen afterwards for the next 24/48 hours as the fever steadily rose throughout the day peaking at approx 102F around 5 pm. Also developed chills, fatigue, all over muscle soreness, a headache, and nausea. Overnight 4/29 into 4/30 was pure misery but by 4/30 a.m. the fever starting to break. Took pain relievers and antacids(for the nausea) through Sat 5/1.

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.

Abdominal pain - patient was diagnosed with acute RUPTURED APPENDICITIS . I am not sure if this is related or not but given prior reports of similar issue after the vaccine and the fact this happened right after the vaccination I thought it might be related.

nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely fatigued all day; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 28Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included spinach allergy, UC (Ulcerative colitis). Concomitant medication included mesalamine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 07Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 29Apr2021 01:00, less than 24 hours of second vaccine there was nausea, vomiting, diarrhea and a rapid heart rate and severe dehydration. This progressed and led to hospitalization from Saturday 01May2021 to 04May2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient also experienced unable to eat or drink and extremely fatigued in 2021. As of this message (10May2021), still unable to eat or drink without vomiting and hear rate up to 170+. This was up from a normal resting heart rate of near 60. Extremely fatigued all day, vomit several times per day and loose stool to diarrhea multiple times per day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19, covid-test (blood test) on 02May2021: negative. Treatment was received for all events. The outcome of the events was not recovered. Information about batch/ Lot number has been requested.

I have diarrhea; intense body aches all over accompanied with fever; intense body aches all over accompanied with fever; didn't have an appetite; I had a splitting headache; arm felt heavy like it was falling asleep; pain at the injection site that I expected and radiated down to my wrist.; pain at the injection site that I expected and radiated down to my wrist.; he had pain in his shoulder, arm and forearm down to his wrist; he had pain in his shoulder, arm and forearm down to his wrist; His hand on the left side (on the injection site arm) felt very cold; He is tired and exhausted too; This is a spontaneous report from a contactable consumer reporting for himself. This is one of the two report from same reporter. A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Apr2021 (Batch/Lot Number: EW0179; Expiration Date: Aug2021) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Apr2021, within a half hour after vaccination the patient arm felt heavy like it was falling asleep and recovered on the same day (reported as His arm felt heavy for 3 hours). Eventually that turned into pain at the injection site that he expected, and the pain radiated down to his wrist. On 30Apr2021, he had a splitting headache for a couple days. On 02May2021, reported as the next couple days he experienced intense body aches all over accompanied with fever. Also, he didn't have an appetite. The outcome of the event splitting headache was recovered on 02May2021. Reported as "today he still doesn't feel 100%". On 03May2021, he had diarrhea (reported as Yesterday and today). He did not have a prescribing doctor. He went to the clinic from the local health department. The body aches were starting to go away. He kept himself informed and up with the science, but he was just mostly concerned the effects have lasted this long. On an unknown date in 2021, he had pain in his shoulder, arm and forearm down to his wrist. His hand on the left side (on the injection site arm) felt very cold. It felt as though it was not having the circulation it should. As that went away, he could feel the pain in the injection site. He had a splitting headache that lasted Friday, Saturday, and Sunday. He recovered completely. He didn't normally get headaches. He was tired and exhausted too on unknown date in 2021. It was reported that, he didn't typically take naps, but he took a nap yesterday. His stomach feels a little better, but yesterday and today he did have diarrhea. He was a very healthy person. The injection site pain has gone away on unknown date in 2021. The body aches are starting to go away (recovering). On an unknown date in 2021, the events wrist pain recovered. On an unknown date in May2021, the patient recovered from the event fever. The outcome of the event diarrhea was recovering. The outcome of the events decreased appetite, pain in his shoulder, arm, and forearm down, felt very cold, and tired and exhausted was unknown. No follow-up attempts are needed. No further information is expected.

He has a major headache; dizziness; nausea; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in right arm, on 01Mar2021 at 14:15, as single dose, for COVID-19 immunization. The patient medical history and concomitant medication were not reported. No vaccine was taken in four weeks. Prior the vaccination, was not diagnosis with COVID-19. post vaccination, no COVID test was performed. On 01Mar2021 at 14:30, patient experienced major headache, dizziness and nausea. No treatment was received for the events. The outcome of the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

12 hours after shot and a period at least 36 hours had fever between 99.5 and 100.3, chills, headache, muscle and joint pain, fatigue, and diarrhea.

Next day: debilitating fatigue, headache. Nausea and chills. Slowly going away, but its been 6 weeks and still have the symptoms, just not as severe. It is preventing me from exercising and doing activities and eating like I normally would.

Fever; chills; body aches; headache; fatigue; loss of appetite; This is a spontaneous report from a non-contactable consumer (patient). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 10Mar2021 at 14:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient received first dose of BNT162B2 on 19Fewb2021 at 12:30 pm (lot number EL3248) on left arm. Relevant medical history included Asthma, seasonal allergies, hypertension and Shellfish allergy. Concomitant medications included lisinopril and lansoprazole. On 11Mar2021 at 09:00 am the patient experienced fever, chills, body aches, headache, fatigue and loss of appetite. No treatment was received for the events. The patient recovered from the events on 12Mar2021. No follow-up attempts are possible. No further information is expected.

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.