Pfizer

Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures   MDM   Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday.  

fever 101.8 (resolved within 24 hours) lymphadenopathy (ongoing - submandibular, anterior/posterior/deep cervical) edema of soft tissues i throat on right side making it difficult to swallow SOB n/v/d

Shortness of breath; chest pain; body aches; joint pain; headache; nausea; congestion; This is a spontaneous report received from a non-contactable nurse (who is also the patient). A 26-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0140), intramuscular in right arm, on 29Dec2020 17:30, at single dose, for COVID-19 immunization. Medical history included spontaneous pneumothorax x2 on the right with VATS surgery on an unspecified date and multiple food allergies. The patient is not pregnant. Concomitant medication included montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient experienced shortness of breath, chest pain, body aches, joint pain, headache, nausea and congestion, all on 30Dec2020 at 05:00. The patient did not receive treatment for the events. The patent did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The reporter assessed the case as non-serious. No follow-up attempts are possible. No further information is expected.

Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration

1123 Patient received vaccine 1132 Patient complained of shortness of breath and throat closing, 0.3 MG Epinephrine administered and MOVE/SWAT notified, Vital Signs taken and within normal limits 1135 50 MG IM Benadryl given, SWAT arrived and report given. Patient reports feeling better 1140 Patient transferred to ER by wheelchair

States she became tachycardic on 1/5/2021 while at work. State HR 105-153 x 1 hour while at work. State she was at rest when this happened. She also had CP and SOB. Later on same day, employee had fever T100 F and body aches.

About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.

Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.

Patient experienced shortness of breath, sensation of throat swelling, fatigue, body aches, and sore throat about 1 hour after vaccine was administered at a hospital setting and was seen about 6 hours later a different medical office. These symptoms gradually became worse throughout the day. Patient was given Benadryl 25 mg oral syrup one time and emergency medical services were called to the clinic. Patient was transported to the emergency room by paramedics. Patient was called today by provider for a wellness check and notes shortness of breath and sensation of throat swelling resolved after being treated by paramedics and emergency room providers. Patient states she is overall feeling much better.

Within seconds increased heart rate shortness of breath light headedness and dizziness but thought it could have been anxiety. Did not say anything and sat there for the 15 minutes with continued shortness of breath and high rate think it was anxiety. When the time was up I continued to stay at the hospital for an hour due to fear of bad reaction. Started to become extremely nauseous within 30 minutes and loss of appetite. Went to bed and woke up with a terrible headache, body aches, extreme fatigue and a 100.3 degree fever. Slept for 8 hours during the day waking up due to the pain in my body and chills but the symptoms went away by 5 pm the following day of the shot.

Patient reported perioral numbness which progressed over 24 hours to include difficulty breathing. Patient was transported to the nearest Emergency room for further evaluation/monitoring. Patient was given Benadryl 25mg by mouth x1 dose

Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.

Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over. Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.

?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Pt also received diphenhydramine and famotidine in ER

Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Patient also received diphenhydramine and famotidine in ER.

Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Diphenhydramine and famotidine given in ER

Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.

sore throat; mild difficulty breathing; mild fever (99.1); fatigue; throbbing headache(6/10 pain); This is a spontaneous report from a contactable healthcare professional. A non-pregnant 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH 9899), via an unspecified route of administration in the left arm on 18Dec2020 16:00 at a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS), gastritis, asthma, anxiety/depression, allergies: penicillin. Concomitant medication included salbutamol (ALBUTEROL HFA), pantoprazole (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN), cholestyramine (MANUFACTURER UNKNOWN). The patient previously took cefalexin monohydrate (KEFLEX) and lactose (MANUFACTURER UNKNOWN) and experienced allergies. On 18Dec2020, the patient experienced a sore throat, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). Clinical details were reported as follows: On 18Dec2020, the patient had a sore throat and mild difficulty breathing. The patient took albuterol, which helped a little. The patient had a mild fever (99.1) for two days after the shot, as well as fatigue, and a throbbing headache (6/10 pain) for a week and a half. Acetaminophen (TYLENOL) helped manage the pain, and sleep helped the pain get better. The patient underwent lab tests and procedures on 18Dec2020 which included pain: 6/10 and body temperature: 99.1. The clinical outcome of the events was recovering.

After the vaccination I began to suffer from SOB and tested positive for covid-19 on 12/29 and was given an enhaler to help with the breathing. I had a sore throat, fatigued, a headache and diarrhea

Throat tightness within 5 minutes of vaccine, mild to moderate, 5/10. No shortness of breath and was swallowing and moving air fine.

Pfizer-BioNTech COVID-19 Vaccine EUA: One day after vaccination, patient presented to the emergency department with substernal chest pain and shortness of breath. History significant for COVID-19 "a few months ago". Initialy patient felt fatigued with muscle aches and fevers that were "worse than COVID itself". No cough, nausea, vomiting, abdominal pain, or rash reported. Initial vital signs: pulse 81 beats per minute, blood pressure 117/82 mmHg, temperature 36.7 degrees celsius, respiratory rate 18 breaths per minute, and oxygen saturation 97%. Patient observed, administered potassium and ketorolac, and symptoms resolved. Vitals remained within normal ranges and patient discharged home ambulatory and stable.

Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath and the feeling of pins and needles which also brought itching and some minor hives with it. The dizziness, nausea, and feeling of fainting went away after about 10 minutes and I had to go to the Emergency Department to take care of the shortness of breath and hive like reaction. I was given some medications and they diagnosed it as a moderate allergic reaction to the vaccine. I was completely fine with the first one.

Fever, chills, cough, shortness of breath, HA, nasal congestion. Started about 2 days after immunization and lasted about one week.

Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 hour later while the charge was eating lunch on plaza and c/o of face swelling/feeling flushed. RN walked patient to ER. In the ED, pt reports bilateral eye swelling, facial redness, scratchy throat. Pt initially felt SOB but breathing ok now. No tongue swelling.

Received the Covid-19 vaccine. She reports symptoms of throat tightness externally and tingling tongue. Patient denied sudden warm feeling, hives, itching, swollen lips/tongue, dyspnea, wheezing, dizziness, tachycardia, crampy, abdominal pain and vomiting. I have observed only what was reported by the patient. Treatment/intervention: patient was given water and a hard candy to suck on. After sucking on the hard candy she stated that helped with her symptoms. Pt was monitored for 30 minutes and stated she felt better with no symptoms before leaving. Informed what to do in case of a severe allergic reaction. Pt was asked if she would like to go to the ED and pt denied.

As patient was waiting in waiting area approximately 5 minutes after receiving her 1st COVID vaccine, pt's friend called pharmacist over as patient felt she was about to faint. She had her eyes closed and said she felt faint. Notified incident command to call for provider. We moved her to an exam room so she could lie down. She said she felt warm and dizzy. Pt breathing heavily. Denied chest pain. Had stomach pain and some nausea. Pt was given water. ER provider arrived about 4:30 and listened to lungs, carotids, talked to patient regarding vasovagal reaction. Pt slowly began to feel better and was talking and laughing. Waited with patient until 4:50, able to stand on own, not dizzy anymore, felt okay to leave.

Patient advised staff she felt swelling of the throat, patient requested epi pen informing she left her's at home. Patient self administered epi, first set of vitals were taken with a blood pressure of 179/74, pulse of 105, oxygen stat of 98%, 16 on breaths, patient was reassessed every 5min, with a pulse of 116 and breaths of 20 only due to monitor going out of service, third assessment with a pulse of 146 and patient informed staff that condition was worse than the start, 911 was contacted, forth assessment withpulse of 152 and 20 on breaths, flight and fire squad on scene, where transfer of care took place with a last set of a blood pressure of 164/105, pulse of 118, O2 stat of 85% and breaths at 20. -EMT

Itchy throat, swollen tongue, difficulty breathing. Approximately 17 minutes following injection, lasted longer than an hour following epi injection.

Patient complained of throat itching and swelling, along with tongue swelling a few minutes after the vaccination. Took 2 doses of 0.3 Epi at clinic and with EMS. Patient transported to ER. Upon arrival, symptoms resolved and patient had no other co's or distress with V/S being stable. Patient given prednisone, diphenhydramine and famotidine orally as a precaution, and discharged from the ER.

After receiving the second dose of the covid 19 vaccine, as I was walking to the elevator, my vision started to become blurred and I began to see stars. I walked over to a nearby chair and as I sat down it felt as if my throat was closing. I began sweating profusely and my whole body was flushed. My heart rate was tachycardic and my blood pressure was hypertensive when checked in the ED. When I got to the ED, my vitals were obtained like I described but my heart rate had slowed down by time I got there. A nurse passing by explained that my heart was tachycardia when he assessed me in the chair. The ED did an EKG of my heart that determined my heart rate was normal sinus rhythm in the 70s. They observed me for roughly an hour and let me go home. My discharge papers explain I had a vagal response.

lip swelling/tingling/numbness, tongue numbness, tightness in throat, tightness in chest Symptoms started around 5-10 mins after the injection in the initial 15 min observation. Was observed for additional 15-20 mins, on-site nurse took vitals. Blood pressure was a little high, heart rate a little escalated, but oxygen saturation 99%. After the total 45-60 mins, symptoms did not lessen, but did not get much worse. Opted to take Benadryl tablet over epinephrine. Patient found some relief of symptoms from the Benadryl.

Patient received 2nd dose of COVID vaccine (Pfizer) 24 hours before adverse reaction began. Patient was originally having fever, muscle aches, and fatigue. Patient began having sharp, non radiating pain to substernal area and began feeling short of breath which brought her to the hospital.

Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Went to ED on 1/14/21. emailed caregiver for information. As far as what happened, I received my 2nd dose of Pfizer on Jan. 13th @ 05:15 at hospital and started feeling symptoms roughly six hours later, symptoms being nausea, chills, splitting headaches, muscle fatigue, feeling tired and joint pain. I had understood that these side effects were common and not to worry, however, the next day on Jan. 14th around 11:00am, I blacked out at home. Luckily, my partner had caught me before I feel to the ground, but he stated that my eyes had glazed over, my breathing was shallow, and I hardly had a pulse. He was getting ready to do chest compressions, but I had come out of whatever fog that had knocked me down and became responsive. Around 12:00 pm I had arrived at the ED where they had given me a bag on NS, Zofran for the nausea and Toradol for some inflammation management. I believe I discharged from the ED around 15:20.

hard large lump that hurts at the injection site /Left arm has a knot in it from injection site; hard large lump that hurts at the injection site; chest pain; shortness of breath; This is a spontaneous report from contactable consumer (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration into the upper left arm on 05Jan2021 at single dose as a precaution because she works in nursing home (COVID-19 immunisation). Medical history included Covid positive back in Oct2020. Concomitant medication included biotin and one a day women's vitamin. Family members have medical issues. Dad has heart tumors, seizure, sleep apnea and osteoporosis. Mom has asthma, diabetes, has had cancer, neuropathy and macular degeneration. The patient received first dose of the covid vaccine on 05Jan2021 and had some symptoms after the vaccine. On unspecified date in Jan2021, the patient hard large lump that hurts at the injection site, chest pain and shortness of breath; similar to when she had Covid positive back in October. She still has a lump at the injection side which has gotten smaller in size but still hurts to touch. Left arm has a knot in it from injection site; does not reuired ER or visit to physician's office. It feels like a bump with something in her arm. She doubts that is the case. She wanted to see if that was normal and when it might go away, especially since she should be getting second dose on 26Jan2021. She is a speech therapist. There is no prescriber. They came and gave to everyone all at once. It was really big at first. It felt like someone punched her. It was a big giant lump, but it is getting better. The injection was given in the upper left arm and it felt like it went into the muscle. The outcome of the event vaccination site mass was recovering, and the outcome of the remaining events was unknown.

Patient experienced tightness in her throat and difficulty breathing. She was still able to breath just expressed that it felt more difficult and the feeling was increasing. We administered diphenhydramine 50mg IM and monitored patient for more than 1 hour afterwards. Patient reported breathing became easier within 10 minutes and the tightness had eased. She was a staff member at a long term care facility. Family picked her up and she took the rest of the day off. Tried to contact for follow up but was unable to reach patient.

Event #1: I experienced a small outbreak of hives on my left cheekbone within 15 minutes of receiving the vaccine. The staff gave me an injection of Benadryl into my right arm. The spot reduced in size over the duration of an hour and I was sent home with instructions to take OTC Benadryl until the swelling disappeared completely later that evening. Event #2: Shortness of breath and chest tightness beginning exactly 74hrs after the vaccination (Sunday, 01/31/2021 at 2:15pm). This side-effect continues to persist and is not due to a true Covid-19 infection.

Patient had long hauler symptoms after a previous presumed COVID-19 infection beginning March/April 2020. Symptoms of severe exertional tachycardia, fatigue, shortness of breath, dizziness, and brain fog had improved and the patient was back to full duty at work October-December 2020 with mild-moderate exertional tachycardia and shortness of breath remaining. After vaccine given on 12/21/2020 the patient the next day had sweating, fatigue, dizziness, tachycardia, and mild shortness of breath. Was seen by PCP and an allergist that recommended premedication with Xyzal prior to second vaccine which resulted with no worsening symptoms after second vaccine. Relapse-like symptoms remain into February but are improving.

I felt exhausted, nausea. dizzy, & headaches. On 1/8/2021 I had sever stomach pain as the days past by it got worse it was a sharp pain. I also felt throat pain I felt like my throat was closing. All this symptoms lasted about 6 days. I had a appointment on 1/11/2021.

Abdominal rash/hives that is itchy, hives on neck, back and Left elbow crease. SOB with daily activities. Lightheadedness. Symptoms began 3 days post 2nd vaccine and continue to progress.

Patient had received vaccine on 2/20 and started to have extreme fatigue the night of the 20th. patient states on Sunday 2/21 she was very short of breath and had some chest heaviness. Was taken to the ER where she was diagnosed with a vaccine reaction.

Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.

After receiving Pfizer Covid vaccine, patient developed symptoms of dizziness, nausea, a little shortness of breath. Reported she had a history of asthma and said she felt like "her limbs weren't working". She agreed to be taken to ED for evaluation. Was treated with fluids, ondansetron, and lorazepam IV push one time. Never treated for allergy/anaphylaxis.

trouble breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that she is a 26-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization at a hospital. Patient has a history of breathing problems (unspecified). On 06Feb2021, patient went into hospital due to trouble breathing. Treatment included antibiotics (unspecified) and prednisone 125 mg intravenous (IV) in the hospital and then took oral prednisone 40 mg for 4 days after being discharged on 10Feb2021. Patient further stated that she was in emergency for 4 days, and was given 125 mgs of prednisone, and that she was there in the emergency, but didn't want to stay, and was sent with prednisone and antibiotics, she was off the antibiotics not the prednisone after discharge. As of 11Feb2021, patient was off of prednisone. The patient had an unspecified blood work in the hospital and was reported to be everything was fine in Feb2021 had blood work. Outcome of the event was unknown. The patient does not feel like her breathing problems were related to the COVID-19 vaccine since she has a history of breathing problems that were aggravated in cold weather. The patient was to receive the second dose on 18Feb2021 and has inquired if she can take the shot given her problem. Information on batch/lot number has been requested.

Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.

Starting later in the day of the injection she began having chills, fatigue, body aches and chest pain/tightness. The chest symptoms are more on the right side than the left. She does have some mild shortness of breath with significant exertion. She has not taken any pain relievers.

15 minutes after receipt of dose #1 patient developed blurred vision and dizziness. I arrived to the patient's side and conducting an abbreviated history as well as a neuro exam. Patient had new onset tremor in upper extremities, positive Romberg, and ataxia. HR ranged from 130-140 w/ SPO2 at 99. No signs of difficulty breathing noted. 911 was called and an ambulance was dispatched. Patient's symptoms remained unchanged upon EMS arrival and she was evacuated to a healthcare facility.

High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is still swollen. It is still hurting.; Tenderness; Feeling faint/Felt dizzy; Some trouble breathing; disoriented; Fatigue; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318), via an unspecified route of administration at left arm on 28Jan2021 at 16:55 (reported as 4:55 PM) at SINGLE DOSE for COVID-19 immunisation. It was given at a vaccination clinic. The patient had no prior vaccination within 4 weeks and had no adverse events following prior vaccinations and that was why she thought she would be fine. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included anxiety, peanut allergy, tree nut allergy, and has had anaphylactic reaction in the past. Family history included her dad has heart disease and her half sister has heart disease. There were no concomitant medications. Historical vaccine included flu vaccine on an unspecified date for immunization. The patient stated, "You kind of feel yucky after the flu vaccine, but she has never had this with a flu shot." The patient stated that she hasn't had a flu shot in years. The patient asked if arm swelling was a normal occurrence after vaccination and if side effects can last for 4 days. The patient reported that she received the first dose of the COVID vaccine on 28Jan and afterwards experienced, arm swelling, and tenderness that has last for 4 days. She also reported experiencing feeling faint, high blood pressure of 150/100 and some trouble breathing on an unspecified date and nausea. The patient further reported that she was calling because she got her first dose of Pfizer's vaccine and she was curious if this was normal and if she needs to go see her doctor and she wants to report the symptoms. After she got the injection she felt super faint and got really high blood pressure on an unspecified date. She was not sure if it was because she had anxiety, but she had trouble breathing on an unspecified date. She got nauseated afterwards. Her arm swelled up really big and the swelling has stayed there for four days. Her arm was still swollen on an unspecified date. She has allergies and has had anaphylactic reaction in the past. She was still nauseated and feels super tired. The patient asked how long do the symptoms last. The patient's weight was reported between 122 to 123 pounds. The patient clarified that the nausea started 15 minutes after she got the shot on 28Jan2021. The nausea has lasted through this. She got chills the next day (29Jan2021) after the shot. She has felt super fatigue. The swelling has gone down, but it was still swollen. It was still hurting. She has no idea if that was normal. She also felt dizzy and disoriented after getting the shot. She was not sure if it was because her blood pressure was so high. It was high for her because her blood pressure was normally low. She thinks her blood pressure 150/100 after she got the vaccine. The outcome of all the events was unknown.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tachycardia-Mild, Additional Details: patient is able to swallow and drink water .Just complained of sore throat,. Called 911 , assessed patient \"Anxiety Reaction\".\r\n

At about 7:30 I started feeling extremely weak followed by coughing. Soon after my throat was tightened and it became difficult for me to breathe. My eyes have been blurry since and I?ve had a fever, cold, and my entire right side of my body hurts when I move especially from my hips down. My eyes are extremely heavy and I feel better with them being closed

Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.

5:28pm received 1st Covid-19 vaccine. At 5:40 c/o slight throat tightness. O2 sat 99, Pulse 100, B/P 128/80. At 5:45pm c/o tongue tingling. 5:49pm hives on chest and c/o chest tightness. Denies SOB. O2 sat 99, pulse 130, B/P 124/72. 5:50pm 0.5 mg Epi administered IM left thigh and EMS activated. 5:50pm pulse 110, B/P 130/82, O2 sat 98%. Transported to hospital at 6:02pm per ambulance.

Approx 5 minutes after receiving the vaccine client started c/o severe breathing difficulty. Client carries an epi pen with her at all times. Albuterol given, Husband administered epi pen in her right thigh. she was placed on o2. she was monitored for 30 minutes and felt better and released to home with her husband. she did call her PCP which told her to take 2 doses of Benadryl that evening.

Paralysis on the right side of the face, numbness inside the mouth, swelling of face, lips, throat, and neck.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Medium

Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.

As soon as the vaccine was injected my arm hurt through my neck to the back of my shoulder blade. I was immediately feeling woozy and dizzy. I sat for 20 minutes and took a Tylenol. I left the site and about 30 minutes later I was feeling extremely tired, and out of breath. Talking was difficult and taking too much energy, my shortness of breath was alarming. It went away within 4 hours. 2 days later I was feeling fine, and was sitting having a coffee. Out of nowhere I had a rapid heartbeat and started feeling woozy and light headed again. I didn't have as much shortness of breath but it felt like if I were to try and do anything it would exhaust me. I took Tylenol again and things calmed down in about 2-3 hours.

Almost immediately after having the shot had feeling of tightness of the throat and some redness of the face. Refused an epipen shot but did take benadryl. Paramedics were called but did not go to the Emergency Room. At all times could breath, just a tightness of the throat. Continued to take benadryl until I fell asleep that night, still had tightness of throat until I went to sleep. Woke up with a slight sore throat and some pain at injection site.

Shortness of breath; chest tightness; stated that she got the first shot in her left hip; soreness to left hip; burning at her left hip; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received BNT162B2 first dose (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 14Jan2021 at 16:20 (Batch/Lot Number: EL3249) as single dose, then via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included rotator cuff injury from 2020, unknown injury from 2018 to 2019 and repeated injuries to her shoulder (occurred before the vaccine) from an unknown date and unknown if ongoing. The concomitant medication was not reported. The reporter stated that she is a healthcare worker with repeated injuries to her shoulder that occurred before the vaccine. Stated that she had rotator cuff surgery in 2020 and the another injury 1-2 years prior to that one. Stated that the first booster that she received was three weeks ago in her hip on 14Jan2021 16:20. Stated that she went to get the second dose today in her thigh. Stated that she was told that it was being given in her thigh because it was conclusive to being effective. Stated that she was told that the first dose may not be effective. Wanted to know the current information where it should be administered. Wanted to know if she should get first dose again. Clarified that the booster is for the Pfizer Covid 19 vaccine. Stated that she got the first one on 14Jan2021. Stated that she gets repeat vaccines every year and had a declination to IM sites to the shoulder/arm area due to her injuries. No further details provided. Later clarified first booster was to her left hip. The reporter stated that with the first shot that she had soreness to left hip and burning at her left hip on 14Jan2021 16:20. Stated four days after the vaccine that she did a lot of cardio and had chest tightness and shortness of breath on 17Jan2021 16:00 within 10 minutes after that lasted for an hour. Stated burning only lasted 15 minutes. The outcome of the events the first dose may not be effective due to being given in her left hip was reported as unknown. The outcome of the events stated that she got the first shot in her left hip and burning at her left hip reported as recovered 14Jan2021. The outcome of the events soreness to left hip, Shortness of breath and chest tightness was reported as recovered 17Jan2021.

Patient reported history of tongue swelling after receiving the 1st dose of Pfizer COVID-19 vaccine. Patient consulted MD and MD recommended patient to receive the 2nd dose of vaccine. Patient declined premedication with Cetirizine . Approximately 5 minutes after receiving the vaccine, patient reported swelling in tongue. Patient remained talkative and was able to speak in full sentences. O2 sat decreased to 90%. Patient placed on 02 via nasal canula at 2 lpm. BP 129/72, HR 88, O2 sat 96% on 2 lpm of O2 via nasal canula. Patient Benadryl 50 mg was attempted to be given IM however at least 50 % of the medication leaked out of the injection site. Patient continued to breath comfortable but talked with shortness of breath. 2nd dose of Benadryl 50 mg given IM. Patient continued to be monitored . Patient released home with sister and will be observed at home overnight.

Client reported difficulty breathing, in distress/anxious. VSS. Relaxed on cot under EMS supervision for 10 minutes.

In 24 hours , had rashes/hives on face and neck which were itchy, also had slight wheezing . Contacted pharmacist who advised Benadryl and once I took it symptoms subsided.

Patient is here today for COVID-19 immunization per federal guidelines/written order. See immunization activity for details. Patient was observed post-immunization for a minimum of 30 minutes due to previous history of immediate allergic reaction to a vaccine or injectable therapy and/or history of anaphylaxiswith evidence of throat tightness and itching. Anaphylaxis Management Standing Order protocol initiated. Physician/APP notified of patient condition. Additional orders received: per Doctor: Benadryl 50 mg IM x one. COVID-19 (MRNA) VACCINE Allergen added to patient's Allergies. VAERS reporting completed as appropriate. . 1400: At end of 30 minute observation period (due to hx of latex allergy), patient complained of itching on chest and throat with some 'tightness' in her throat. Patient escorted to exam room and met with RN and the doctor. 1405: Benadryl 50 mg IM given right deltoid per order of the doctor who examined and talked with patient. Will monitor additional 30 minutes post injection per MD order. 1412: BP 120/64, P 61, Pulse Ox 100% on room air. 1414: Patient states she can now swallow with ease. 1418: Patient states swallowing is good and itching is subsiding. 1425: Patient states feeling much better, just sleepy (spouse is driving her home). 1432: Redness on chest gone, patient states itching has resolved and throat is open. Breathing unlabored with no additional symptoms. Discharged ambulatory to meet husband downstairs who will drive her home. Per direction of Doctor, patient will premedicate with oral Benadryl prior to receiving 2nd COVID vaccine. Patient verbalizes understanding. COVID-19 post-vaccination Patient Instructions added to After Visit Summary for patient to review.

When I first got my shot I had a wave of heat go through me and then my throat and moth went dry. I waited my 15 minutes and get fine. 40 minutes after my shot I developed swollen face, lip, tongue and throat numbness and get like I couldn?t breathe. Then I went to ED. They gave me Benadryl and steroid and eventually sent home. Today 04/10/21 I woke up. Took my Benadryl and prednisone and about and hour after that my face has been extremely red, numb, and burning. It?s been 9 hours and I?m still having these symptoms. Called ED they said to stop the prednisone and only take Benadryl but my face is still really hot, red and burning.

After 2 hours, congestion and headache followed by numb throat and thumb around 4 hours after vaccine, dizziness, feeling of tightness in throat, swollen throat /difficulty swallowing, and some trouble breathing. Symptoms persisted until about 9 hours after vaccine

Pfizer dose one vaccine given at 9:50 AM, went over for observation before leaving and started having symptoms at 10:20 AM. Symptoms were throat tightness, flushed skin, numb/tingly feeling on face and chest, rash/hives, itchiness. I was given 50 mg Benadryl via shot in right arm. Symptoms worsened and I was taken to the emergency department at the hospital. I was given zofran via IV, steroids via oral pill, and monitored. Symptoms started to get better and I was discharged around 1:30 PM.

The patient is a 26 year old female who presents to the practice today for a transition into care.The patient is transitioning into care from an emergency room and a summary of care was reviewed. Note for "Transition into care": Patient went to ER 4/9/21 for facial swelling, numbness and feeling like she could not breath and was discharged 4/9/21. Patient states she had the covid vaccine Pfizer 4/9/21 and had reaction after about 40 minutes. Patient states the right side of face started to swell, numbness across her face (lips, tongue, throat) and she felt like she could not breath. Patient was given Benadryl, Pepcid and Decadron. Patient was prescribed for Benadryl and Prednisone. Patient states on 4/10/21 she had a reaction to Prednisone with beet red face, facial warmth, rash, and facial numbness again. Patient states when getting the Hep A vaccine 3/17/21 she felt a wave of heat go over her body and her mouth and throat were super dry and the same thing happened when she got the Pfizer covid vaccine.

APPROXIMATELY 12 MINUTES AFTER THE VACCINE WAS GIVEN THE PATIENT STARTED TO COMPLAIN OF FEELING LIGHTHEADED AND HAVING BLURRED VISION ALSO ASSOCIATED NAUSEA. SHE WAS BROUGHT BACK TO A STRETCHER AND VITALS WERE TAKEN AND STABLE. SHE SUBSEQUENTLY STARTED TO HAVE SOME DRY HEAVES AND FEELING OF ITCHING IN THROAT WITH PROGRESSION OF HER SYMPTOMS. HER PULSE OX WAS 93-98%, bp 110/82 AND HR 67. iT WAS DECIDED TO ADMINISTER AN EPIPEN AND SHE HAD AN INCREASE OF HR TO 102; AT THIS POINT EMS WAS CALLED. SHE DID START TO DEVELOP THROAT TIGHTNESS, ITCHING, AND COUGH AT WHICH TIME OXYGEN WAS ADMINISTERED. SHE WAS TRANSFERRED TO ER AT THE MEDICAL CENTER FOR FURTHER EVALUATION. REPORT FROM ER NOTES SHE DID HAVE SEIZURE WHILE ENROUTE WHICH WAS TREATED. THE PATIENT WAS KNOWN TO HAVE UNDERLYING SEIZURE DISORDER.

Shortly after vaccine was administered member began to feel weak and heavy. Reports losing feeling in her extremities and having a hard time breathing, felt like heart was racing. Pt was slumped over in her chair but conscious and coherent with staff supporting her upright in chair. A wheelchair was brought and pt assisted in transfer to the wheelchair. Pt was taken to a private observation area. Vital signs were checked and were stable. Pt reported feeling cold and weak. Pt was transferred by staff to a cot and her legs were elevated. She was covered with her jacket and 2 blankets as she began to shiver. Reported tingling and numbness in extremities but had adequate color, good radial and pedal pulses. Reported numbness but able to feel with touched and able to move on command. Spouse was present during evaluation. When pt reported feeling difficulty with breathing but O2 sats were stable at 98-99%. Member was given directions on how to slow her breathing and engaged in conversation. Spouse stated she has a history of syncope and that this happens regularly. Member was brought back at 1021 and by 1051 she was able to sit independently and drink water. She sat in Cot for another 5 minutes and requested to leave. Member was able to stand independently and stably. She walked around observation area and again requested to go home. ER precautions were given to spouse. Spouse stated he would drive her home and in the event of another episode would go to emergency room. Member walked out of facility independently with spouse near by. Member began to feel weak outside facility and dropped to her knees. She remained conscious. Pt refused to return for evaluation and asked to be wheeled to her car. She was breathing at a normal rate and rhythm. No signs of distress. Spouse reported this was not out of the ordinary for her condition and would also like to be released home. Pt was offered several times evaluation which she declined. She was assisted to personal vehicle and left the site.

Patient started to feel "tightness in throat" before leaving observation area. VS Stable. Patient felt it was anxiety and was educated on all follow up options. No evidence of distress noted.

Throat tightening around 2:30 pm on day of injection and again around 9 am the day after. Both relieved after taking allergy medicine

Second COVID19 vaccine was administered the evening of 4/16/21 around 6 pm. Extremely mild left arm (injection arm) pain that first evening. Felt more tired than usual so went to bed around 10 pm. Morning of 4/17/21, woke at 7:30 am with a high fever (101 degrees), chills, sweating, fatigue, headache, mild nausea. Fever and chills were very severe until around 2 pm, then tapered very slowly but remained impactful until bedtime around 11 pm. Between 8 am - 2 pm, I was sleeping on and off with a lot of sweating, chills, fever. Intermittent but not severe nausea during that timeframe as well. From 2 pm - 11 pm, was still having chills and sweating. Starting around 6 pm, muscles around hips and lower back were very sore--not painful but extremely uncomfortable. Slept from 11 pm on 4/17/21 to 8:30 am on 4/18/21. On the morning of 4/18/21, mild shortness of breath was noted while doing light stretching. Still felt slightly feverish and prone to sweating, but mostly feeling better. By 4/19/21, just slight shortness of breath occurred in the morning, but by that afternoon I was able to do a light workout/lift weights. On 4/20/21, no shortness of breath and full, deep breaths are felt. No other lingering symptoms.

Patient received first dose of Pfizer Covid-19 Vaccine. Patient has a history of allergies to shrimp. Patient was directed to observation for a 30 minute waiting period. Patient stated that she was feeling constriction in her throat, SOB, chest tightness. Patient presented as anxious and having trouble breathing. Patient was assessed by RN, vitals were taken and recorded upon further exam, patient presented with more symptoms of anaphylaxis. ED proceed out was called. RN administered epinephrine to the L lateral thigh. ED team arrived and patient was evaluated and patient was taken to ED with ED team. In ED patient received diphenhydramine oral tablets and was observed for few hours. No further complaint was reported. Patient was discharged home afterwards.

Brain fog, dizziness, headaches, pain and numbness to left side of head, chills, body aches, trouble breathing, heart arrhythmia, anxiety, left breast pain, upper left arm pain, confusion, trouble concentrating and focusing eyes. All these symptoms began 5-10min after shot was administered and have continued for 2 weeks off and on.

Chills, fever (100.8), trouble breathing, chest congestion, exhaustion, body/joint aches and inflammation, nausea, brain fog lasting for 24 hours follow the 12 hours after getting the shot. Following day continuing exhaustion, trouble breathing, chest congestion, brain fog. Third day continuing trouble breathing and chest congestion.

About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; My throat was also just a little bit tight and breathing was labored/Little tightness around the throat; My throat was also just a little bit tight and breathing was labored; allergic reaction; rash all over my face; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at the age of 26-year-old on 07Apr2021 14:40 (Lot Number: 7131121) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included lung transplant from 2016 (recipient of double lung transplant in 2016), Slight damage to the windpipe, Asthma, immunocompromised. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone; metoprolol; magnesium chloride. The patient previously took cefdinir (OMNICEF) and experienced drug allergy, clarithromycin (BIAXIN) and experienced drug allergy. Patient got her shot at 2:40 pm. Seemed fine, waited at the star for 15 minutes and went on her way. About an hour after patient looked in the mirror and saw that her entire right cheeck was bright red, hot, and itchy on 07Apr2021 15:30. Her throat was also just a little bit tight and breathing was labored on 07Apr2021 15:30. Patient went to the emergency room and was given 25mg of oral Benadryl, 20mg of famotidine, and a dexamethasone shot. Patient was then observed and released once her reaction started to calm down. Consumer stated, she was calling because she had a allergic reaction to her first dose of the Pfizer Vaccine yesterday (07Apr2021). It did occur just after half an hour of the Vaccine on 07Apr2021 15:10. She broke out in a rash all over her face in Apr2021. Little tightness around the throat. Therapeutic measures were taken as a result of 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored'. Adverse events 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored' result in Emergency room/department or urgent care. The outcome of events rash all over my face and allergic reaction was unknown. The outcome of other events was recovered in Apr2021. No follow-up attempts are possible. No further information is expected.

Nausea, severe vomiting, head ache, high fever, fatigue, body aches, chills, running nose, cough, shortness of breath

Full arm to fingertip numbness in left arm, extreme dizziness, shortness of breath, fainting, low fever (for 1 day) and fatigue, all from 4/16 - 4/23.

Fainting; Fever of 103; Vomiting Green Fluid; Nausea; Body Aches; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 03Apr2021 15:00 as single dose for COVID-19 immunisation. Medical history included psoriasis. The patient was not pregnant and had no known allergies. There were no concomitant medications. The patient received first dose of bnt162b2 on 13Mar2021, 14:30 for COVID-19 immunisation. On 04Apr2021 03:45, the patient experienced fainting, fever of 103, vomiting green fluid, nausea, body aches and shortness of breath that lasted 7 days after the second dose. There was no therapy for the events. There was no other vaccine in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination and was not covid tested post vaccination. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope 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.

Immediate pain in left arm, sudden dizziness, increased heartbeat, and nausea with the first 5 minutes of administration. After waiting ~30 min felt less dizzy and went home. Took a Tylenol and just had weakness and severe pain in the left arm. Next day around 9 pm had severe chills, fever, nausea, and a panic attack. Continued pain in left arm for another 2 days and continued feeling of weakness and fatigue until today. Have suffered shortness of breath and randomly increased heartbeat and feeling hot last week. This week is just continued fatigue and increased anxiety.

Throat closure sensation 3 hours after second dose. Currently on day 3 and still experiencing symptoms.

rash all over her upper body: her belly, some on her back, and mostly on her neck and shoulders; rash has worsened in redness/rash is red; a little bit of difficulty of breathing; feels shaky/nervousness/she is nervous; This is a spontaneous report from contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 at 15:00 (lot number: EW0162) on the left arm as single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included paracetamol (TYLENOL). The patient next dose was scheduled for 03May2021 at 11:40am. On 14Apr2021, patient reported to have a rash all over her upper body: her belly, some on her back, and mostly on her neck and shoulders. Patient mentioned she had a very severe rash all over her body and neck that it was pretty extreme and all over. It was the first time that something that extreme happened to her. Patient mentioned that she also had a little bit of difficulty of breathing and attributed it to her nervousness. She denied having a closing up throat. The rash all over body was reported as worsened and rash had worsened in redness. The patient's rash was red, patchy, and on her stomach it was more needle point looking. The patient wasn't feeling sick and didn't have any of the other symptoms. The patient felt shaky but it may be because she was nervous. The outcome of events "a little bit of difficulty of breathing" and "rash has worsened in redness/rash is red" was unknown, while the other events was not recovered. No follow-up attempts are needed. No further information is expected.

26y/o F presented to DET covid vaccine clinic for 1st dose Pfizer. While pt doing observation period, pt c/o of SOB. Pt noted to be hyperventilating and hands stiffened up. Pt reports sxs started w/ fatigue and dry throat, followed by sensation of choking. Vitals at 3:15pm: BP 139/97 O2 Sat 100% O2 at RA HR 156 Oral temp 98.4F Albuterol inhaler x2 puffs given at 3:18pm. HR improved to 110. Pt reports sx improvement, but notes whole body numbness. Transported to ED via wheelchair for further eval. Advised she had to be cleared by provider for 2nd dose Pfizer.

On 4/27/2021 in the afternoon, I felt not bad in the morning so I went to animal room to help lab mates? experiment. However, I felt hard to breath and dizziness I. That room (the AC in that room probably also had some problem and the circulation system as well) then, I went outside to breath fresh air and came back again to do the experiment. Felt better after 4:00 pm. At night, I tested my temperature and saw 37.7 C. The next day, I felt dizziness all day. Then, Friday of this week, I went to the center and tested COVID, it showed negative.

Cough starting an hour after injection. Feeling of heart racing (unverified, no oximider available), feeling of 2 heart palpitations, and shortness of breath around 1hr and 20 minutes after injection.

Reports she developed hives and wheezing same day (initially said within 4 hours, then shared it might have been within 7 hours) as her 1st COVID vaccine Pfizer dose. She reports calling her allergist and was recommended to take benadryl 50 mg po. She reports her symptoms improved so she did not go to seek emergency care. She reports numerous food and environmental allergies.

Caller states she has had SOB since receiving her vaccine on Sunday. Able to talk in full sentences during call, denies SOB at this time, however, states that her SOB is constant. Encouraged to seek care from her MD.

Shortness of breath; Weakness; Fatigue; palpitations; Myalgias at injection site; This is a spontaneous report from a contactable Other healthcare professional, the patient. A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 20Jan2021 at left arm as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9231) on 30Dec2020 11:13 pm and experienced myalgias, diffuse, causal relationship was reported as related; on 31Dec2020 16:33 experienced fatigue and causal Relationship was reported as unknown; On 31Dec2020 16:33 experienced weakness and causal Relationship was reported as unknown; and on 31Dec2020 16:33 experienced sore throat and causal Relationship was reported as unknown. The patient was not admitted to hospital. One second dose the patient experienced weakness, fatigue, palpitations, and shortness of breath on 22Jan2021 and myalgias at injection site on an unknown date in Jan2021. The outcome of the events was unknown.

Pt. verbalized that head is killing her and states her throat and tongue are swollen. BP 116/82, P 96, SPO2=99%. Pt. states that she is still not feeling well. She verbalized that she always feels unwell after vaccines. She stated that after the first dose of COVID-19 Pfizer, it took 2 hours to feel better. At 3:50pm she stated that she is feeling a tiny bit better. @3:53pm she stated that she is feeling slightly better and that her tongue aren't worsening. Pt. stated that she doesn't want to go to the hospital. But they will stay in the area because her doctors are nearby. EMS instructed pt. to call 911 or primary doctor if symptoms worsen. @ 4pm pt. eating and saying she feels better. Pt. stated that she would like to stay 5 more minutes.

After receiving the vaccine about five minutes later my Chest became very heavy and painful my throat felt like I?m knot closing and I passed out I was woken up at the site but I was unresponsive all I remember was them telling me to stay awake the ambulance is on the way I became very nauseous

05/04/2021 4:30am - 05/05/2021 9:00 - aches, chills 05/04/2021 - 5/13/2021 - fatigue 05/04/2021 12:00pm - vomited 05/04/2021 7:00pm - fever 100.6°F - took fever reducer (ibuprofen) 05/05/2021 4:00am - 05/11/2021 9:00am - sore throat, coughing, congestion, heavy breathing (hard to breathe)

After the second shot of Pfizer vaccine, I had trouble breathing. When I have to talk, I need to do harder breathing to feel better.

Anaphylaxis 2 hours after vaccine. Extreme swelling/tightening of throat, difficulty breathing, talking, dizziness and feeling faint, spots in vision, choking, coughing, chest tightness.

Pfzier second dose on 5/4/2021 few days later on Thursday night I got rapid heart rate with shortness of breath and cold/shivers and continued to get rapid heart rate every night sometimes around 8-9pm sometimes waking me up at 1am or 4-5am for the next 2 weeks or so

The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included fexofenadine (ALLEGRA) and rabeprazole from unknown dates for unknown indications. On 17Apr2021, 24 hours after the vaccine, the patient experienced shaking and chills. She was feeling fatigued. The patient slept for 3 hours, woke up around 20:00 on 17Apr2021, and had severe allergy attack all night even though allergy medications were taken. No medications were working. She had symptoms such as severe nasal congestion, sinus pressure, difficulty breathing after using inhaler, burning throat and nasal passages, shortness of breath. It was the worst allergy attack she had ever had. It felt like her immune system shut down and was reacting to everything she was allergic to on a large scale. The patient reported she did not receive any treatment for the events. The outcomes of shaking, chills, severe nasal congestion, sinus pressure, difficulty breathing, burning throat and nasal passages, and shortness of breath were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Severe migraine 24 hours after, worsening migraines since. Moderate-severe fatigue since 24-36 hours after that has not changed after 6 weeks. Shortness of breath 24 hours after for 5 hours (same time as migraine), SPO2 93 when checked with personal pulse oximeter.

Site: Pain at Injection Site-Mild, Systemic: Bell's Palsy-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium

-severe night sweats -elevated temperature of 100.9 -alternating between being very cold/shivering and being very hot/sweating -body/joint aches -involuntary full body tremors -loss of appetite -nausea -pounding headache -fatigue (slept the entire next day, had no energy to move at all) -shortness of breath

Jaundice of skin and eyes, symptoms of anemia (shortness of breath, extremity tingling, difficulty exercising), dark urine, yellow tinged stool, yellow tinged body fluids, shortened menstruation. Physically noticed symptoms in early February 2021. Symptoms did not improve so scheduled a clinic visit. Lab tests revealed critical low H&H with no signs of hepatic malfunction or disease. ER visit and consultation with hematologist pointed to diagnosis of Warm Autoimmune Hemolytic Anemia. No family history of autoimmune disease, no previous history of condition, no previous cancer, no prescription medication. Suspect that the vaccine caused condition. Current treatment is high dose prednisone. Treatment ongoing.

Heart pounding. Could not sleep because of heart pounding as well. The next day, I played tennis, and for the first time, I felt shortness of breath and accelerated heart beat / tachycardia. These seem very unusual given I have no pre-existing condition or other health conditions/ illness

Quickly after receiving the vaccine I started with a bad head ache, fever, chills, achy, tired, sore and weak. I tried to sleep it off, I did maintain a bad head ache for about 3 weeks after. I did not feel 100% for a few days. I then started with "allergies" - sinus pressure, stuffy nose. After a week I went to Minute clinic who diagnosed me with severe allergies and a sinus infection and put me on 7 days of Augmentin. Day 5 I was feeling worse (shortness of breath, tightness in chest, low energy) and called my primary dr asking for a change of medication. Out of protocol, my primary saw me outside and covid tested me, and prescribed z pack. The next day, I received the lab results that I tested positive for covid. At this point, it was day 15 since my "allergies" started which was discovered to have been covid the entire time. When the state called me for contact tracing they determined that I was at the end of having covid and was only contagious the first 6 days. I went for a new covid test 4 days later and it was negative. Around day 22 - 25 my headaches finally stopped, I started being able to catch my breath more and was getting more energy. I waited until 5/12 for second covid dose as primary care dr said to wait a month from testing positive. I had another head ache and soreness.

I received the Pfizer vaccine at 11am on that Thursday and felt no reaction during the 15 minute wait period. I arrived home and began my regular activities and at approx. 2:30pm started to feel a swelling of my tongue, lips and throat. At around 3pm I took benydral and my symptoms started to slowly go down. I took another at 9pm. I took another in the AM the next day. My throat had started to go down but my tongue and my lips were still swollen. As the day went on my tongue started to go down. By Saturday my lips were the only thing left that were still swollen but that was also going down. By Sunday I was all cleared.

I would get winded very easily and felt my heart rate go up dramatically. When taking my blood pressure and heart rate the heart rate would be in the upper 90s. My blood pressure would be around 121/85. This typically happened in the afternoon although I would get winded at any time.

RN note: Patient received vaccine at 1615, at 1620 patient stated she was dizzy and seeing stars, quickly after patient was unresponsive and eyes rolled back and patient postured and was shaking slightly. Patient remained in chair and did not fall, RRT and emergency responders notified. Patient recovered in under 1 minute. Initial vitals signs at 1622 BP: 98/64, HR 101, Respirations 34, SpO2 99%. Paramedics arrived at 1630 and BP at that time was 113/72, HR 114, Respirations 30, SpO2 99%. Patient stated no current medications or medical history. Patient handoff given to Paramedics and she left with them per our recommendation. Also reviewed that patient should follow up with her doctor regarding getting the second dose of the vaccine.

Immediate numbness following injection. Later that evening ~7:00 p.m. joints and muscles in left arm/shoulder curled and seized-up. Tingling pins and needles with loss of sensation and dexterity. At bed time May 20th - continued pain, stiffness and swelling accompanied by high fever, chills, excessive sweating, and muscle convulsions. Intense ringing in ears. Next morning (May 21st) I had to miss work. Continued fever, chills, loss of appetite, mild nausea, nerve spasms and locked joints throughout entire body. I felt as though my body was poisoned. The weekend consisted of major fatigue and falling asleep during the day intermittently. Numb arms, weakened grip - could barely make a fist, and had a loss of coordination. Brain fog, delayed thoughts and physical responses. CONTINUED MUSCLE WEAKNESS AND NERVE SPASMS. I contacted doctor for help since my PCP's office was not open until Monday. I began taking Magnesium and B vitamins. I was drinking 1.5 gallons of water daily and still feeling thirsty. Called Doctor on the 24th to report involuntary muscle spasms in neck shoulders and lower back, joint stiffness, numbness, slowed circulation (pins and needles), and a vertigo-like falling sensation at bedtime. Cannot get to sleep comfortably without the spasms and my head rolling. He recommended Benadryl and Tylenol which I began taking which helped the numbness but not the shakiness and nerve spasms. He also offered a muscle relaxer, but I was concerned about waking up and driving to work in the early mornings so I declined since having trouble waking up with all the fatigue. It didn't matter anyway because since then I have missed work due to the sudden weakness, head fog, indigestion, and nerve tremors. Wednesday, I needed assistance going up and down stairs because my limbs felt limp like rubber bands. My joints are unusually cracking while my breathing is more labored. My resting heart rate was elevated and I could feel it beating harder than normal. Thursday, I drove myself to the E.R. because I feel as if I have aged 30 years in under a week. Their blood tests, EKG, and x-rays found nothing abnormal and I received fluids through an IV. However my nervous system feels absolutely shot. THIS IS NOT NORMAL. I WAS INCREDIBLY HEALTHY BEFORE THE SHOT. I WAS NOT INFORMED OF THESE RISKS. I LIVE A CLEAN, ACTIVE LIFESTYLE WITH REGULAR DIET AND EXERCISE. I HAVE NEVER NOT BEEN ABLE TO ARTICULATE MY BODY MOVEMENTS FLUIDLY AND PRECISELY. my doctor suspected I previously had an asymptomatic case of Covid, and that I had an allergic reaction directly related to the vaccine that attacked my nervous system. I FEEL SO MISERABLE AND WRONG. I worry about my quality of life from here on out even though I'm told these symptoms will pass. Today, over a week post my first shot, I have loss of sensation in my arms, tingling in my extremities and base of skull, neck, and lower back (worse at night and when resting). My nerves are still randomly firing and I feel shaky. My body feels as if it has slowed down its automatic functions.

The feeling is different than what she had before; Period advanced/Usually has period every 30-35 days. This time it started in 19 days.; Dizziness; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE, Batch/Lot Number: ER8729; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 28Apr2021 (26-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Vaccination Facility Type: Stadium at college campus. The patient took first dose of bnt162b2 (Lot: EP7534, Expiration: 30Jun2021) on 07Apr2021, administered in the left arm for COVID-19 Immunization. Patient received the second dose of the Pfizer Covid-19 vaccine on 28Apr2021. Shortly afterwards, her period advanced on 08May2021. Usually she has her period around every 30-35 days. This time it started in 19 days. She is unsure if it is really a period or abnormal bleeding. The feeling is different than what she had before. Today is the 6th day of bleeding. She is unsure how long it will last. She does not have health insurance. She is asking if she should purchase health insurance. If she continues to bleed she may have to go to the doctor. She was asking if there was anything that can protect her. She will be moving at the end of the month because she graduated. She provides the address of a friend. She also experienced dizziness on 30Apr2021 (or 03May 2021) which lasted 20-30 minutes, she had to lay down and rest at the time, she felt good now; and she also experienced shortness of breath from 30Apr2021 (or 03May2021) which lasted a few minutes, unsure if related because she was working in the sunshine in the garden. She thinks she maybe was exposed to Atrazine while in the garden. She is unsure if this was related or not. She pulled weeds up where this had been spray a month ago. The half life of chemical is half of a year. She asked if she goes for a screening or clinic for any diagnosis or treatment for breathing will Pfizer be able to help with the cost of expenses? The outcome of the event period advanced/usually has period every 30-35 days. this time it started in 19 days was not recovered, dizziness and short of breath was recovered on 30Apr2021, while other event was unknown.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: contacted paramedics pt did not want epipen...did not want to go to er

PATIENT HAD REACTION WITHIN ABOUT 10 MINUTES AFTER RECIEVING THE FIRST PFIZER DOSE. 911 WAS CALLED. PT WAS AMBULATORY AND WAS ABLE TO WALK TO GET ON THE STRETCHER TO BE TAKEN AWAY BY AMBULANCE. REACTIONS WERE: DIZZINESS, NAUSEA, HEADACHE, MUSCLE CRAMPS, CHILLS, COLD SWEAT, TINGLING SENSATION IN MOUTH, LIPS WERE VISIBLY SLIGHTLY SWOLLEN, BLOOD PRESSURE DROPPED 107/59 HR 84, THEN 99/54 HR 88, WEAKNESS/FATIGUE AND DIFFICULTY BREATHING. BLOOD PRESSURE WAS MEASURED BEFORE SHE WALKED TO THE STRETCHER, IT IMPROVED TO 124/80. PT WAS NOT TREATED BY EMS AT THE PHARMACY, PT WAS AMBULATORY, AWAKE AND ALERT AND COHERENT.

Pleurisy in her left lung; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8729), via an unspecified route of administration, administered in the left arm on 15Apr2021 (at the age of 26-years-old) as 1st dose, single for COVID-19 immunization. Medical history included acid reflux and allergy to honey. The patient was not pregnant at the time of vaccination. Concomitant medications received within 2 weeks of vaccination included ibuprofen (ADVIL 12 HOUR) and cetirizine hydrochloride (ZYRTEC). The patient previously took sulfamethoxazole/trimethoprim (BACTRIUM DS). The patient reported that after receiving the shot, she started to have brain fog for a couple of days and she knows that she have pleurisy in her since - both on 21Apr2021. It has been a month and it hasn't gone away. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were treated with prescription ibuprofen so far. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 18May2021, the patient has been tested for COVID-19 with pending results. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.

Swollen mouth and swollen throat, appears vestibular nerve is swollen causing vertigo to flair up. Temp 101+, vomiting, labored breathing when laying down, and chills, aches, and other regular symptoms in unison with combined issues

After receiving the vaccine I passed out. Waited the 15 minutes then got into my vehicle. At that time my entire body felt as though it was on fire and I broke out in hives. Had trouble breathing. Went home, took Benadryl and waited it out. Breathing went away a few minutes later but hives stayed for 3 days. My arm was swollen and tender the next day and stayed swollen for 4 days.

Extreme chest burning/pain/tightness, shortness of breath, pressure in my neck around my throat. Persistent nearly 7 days after 2nd vaccine.

in the pt's words received my 1st (5/5/21) and 2nd (5/26/21) doses of Pfizer at County Fairgrounds. I want to document my experience as I had some pretty severe reactions to my second dose. Evening of the 26th I got chills and a fever of 102.9F. I took one ibuprofen and the fever went away. The next morning I had a slight headache. Around noon I got intense chest pains/pressure that lasted 30 minutes. I could not take a full breath as it was very painful. On the 28th, I woke up with a terrible headache for no apparent reason. Some ibuprofen helped. After a few hours it was gone. At 2am on the 29th, I woke up with very intense stomach cramps. I went to the bathroom and was able to pass out some stool over the course of about 30 minutes in the bathroom, and the cramps went away. On May 31st, I got what seemed to be a blood clot in my left index finger. It went away after about 20 minutes but still felt sore the rest of the day.

Can't taste or smell; Can't taste or smell; Severe muscle pain in upper back; Fatigue; Shortness of breath doing minimal activity; Strange chemical "smell" coming up from respiratory tract; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration in the left Arm on 10Mar2021 at 14:30 (at the age of 26 years old), as a single dose for COVID-19 immunisation. The patients medical history included asthma and obesity. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient did not received other vaccine in four weeks. The patient did not receive any other medication in two weeks. The patient had no concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient experienced can't taste or smell, severe muscle pain in upper back, fatigue and shortness of breath while doing minimal activity and strange chemical smell coming up from respiratory tract on 13Mar2021at 16:00. The patient did not receive treatment for the reported events. The clinical outcome of the events taste loss, smell loss, muscle pain, fatigue, shortness of breath and strange smell sensation was not resolved. 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: Reporter's First/Middle/Last Name initial was captured in corresponding field, cannot only capture in First Name field, patient's Initials captured in First Name field, patient's age/units captured as 26 years per event's onset on 13Mar2021, for suspect vaccine: Indication COVID-19 Immunization was captured twice, removed one; Unknown removed from lot number field. For all events: treatment received was captured as no per source if treatment ae: No. For event severe muscle pain in upper back: Coding updated from Muscle pain to Localized muscle pain as per MedDRA. Final sentence no follow-up attempts are possible; information about lot/batch number cannot be obtained was updated as No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected. Concomitant medications were not reported was captured in consolidated narrative while concomitant therapy captured was none. Initial information need be review: The patient did not received other vaccine in four weeks. The patient did not receive any other medication in two weeks. For adverse events Can't taste or smell a week after receiving vaccine. Severe muscle pain in upper back. Fatigue and shortness of breath doing minimal activity. Strange chemical smell coming up from respiratory tract: onset date and time were updated.

I have been experiencing ongoing side effects since I got the 2nd dose of the vaccine. I am having fever-like symptoms including fatigue, dizziness, a lot of tension/pressure in my head, difficulty breathing and abnormal heart rate, etc, every single day since I got the vaccine. These symptoms have persisted for nearly TWO months now, and are not going away. These side effects have a big impact on my daily life, make it difficult for me to perform daily activities.

Bad Shortness of Breath; Severe asthma exacerbation; Elevated D-Dimer; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0185) at the age of 26 years old, as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing asthma (she has had this condition her whole life) and ongoing allergy to polysorbate. There were no concomitant medications. Historical vaccination included bnt162b2 for COVID-19 immunization received on unspecified date (Dose number: 1 and Lot Number: EW0183). The patient wanted to make sure that Pfizer is aware about her reaction that she was in the hospital for. The patient had severe asthma. After her second dose of the vaccine she developed bad shortness of breath. She used her regular asthma treatments. She ended up in the hospital for severe asthma exacerbation due to the inflammatory response of the vaccine. Stated that maybe Pfizer needs to look into more studies with asthmatics. The patient stated that her symptoms started the same day as her second dose of the vaccine. She was admitted to the hospital this past Tuesday, 08Jun2021 and was discharged last night (09Jun2021). She stated that she was pretty sure that it is the vaccine that caused these events. She states she had an elevated D-Dimer on Jun2021; she believes this was related to the vaccine also. The event bad shortness of breath required emergency room visit. The patient was hospitalized due to bad shortness of breath and severe asthma exacerbation from 08Jun2021 to 09Jun2021. Outcome of the events was unknown. No other vaccines received 4 weeks prior to first COVID vaccination. No follow-up attempts are possible. No further information is expected.

Difficulty breathing for 3 days, unable to take a deep breath for 7 days, whole left arm numbness/tingle, left arm pain in hand for 1.5 days, unable to sleep night after injection

Body aches in arm, back and pelvic area. Fatigue and body weakness after first vaccine for two days. Diarrhea, stomach discomfort, mild fever and body aches after second vaccine. Month following adverse reaction to vaccine, new allergies to food and products, GERD, diarrhea, mild fever, fatigue, dehydration and body ache at vaccine sites on arms. Diarrhea was continuous during the months of April, May and June as a result to certain food. Specific food was eliminated from diet. Such as carrots, broccoli and egg. Diet consisted of fruit smoothies, turkey/ham with crackers and steak tacos. In continuation, body aches/pains and shortness of breath developed as a result to certain food. New diet restrictions were placed in accordance to food allergy test that showed new food allergies. Constipation was treated after using bismuth. Treatment for GERD, body aches/pains, mild fever, allergies, dehydration, UTI: pantoprazole, Tylenol, allergy liquid medication, antibiotic, IV and cranberry D-mannose.

Severe Heart ache, Left arm severe pain. Swelling, shortness of breath, hearing loss, low blood pressure, rapid heart rate.

Immediate throat tingliness; Numbness in chest, neck, and lower face; Immediate throat swelling; Numbness in vaccine arm; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration in Arm Right on 17Mar2021 (at the age of 26 years old) as a single dose for covid-19 immunisation. Medical history was not reported. It was unknown if patient had any known allergies. Patient previously received first dose of BNT162B2 via an unspecified route of administration in Arm Right on an unspecified date (Lot Number: EN6198) as a single dose for covid-19 immunisation. Concomitant medication included spironolactone. 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. The patient experienced immediate throat tingliness/swelling, numbness in vaccine arm, chest, neck, and lower face on 17Mar2021 09:15, still lasting through today (20Mar2021). Patient received Epipen and steroid as treatment for events. Event caused emergency room/department or urgent care. The outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.

Approximately 15 minutes post vaccination, patient started to show signs of anaphylactic reaction. Patient stated to the interpreter that her tongue was swelling and her throat was starting to close up. I administered 1 injection of Epi Pen to her left thigh. We summoned the resident RN on site. A pulse oximeter was placed on her left hand. She was administered oxygen via nasal cannula. I called 911 from my cell phone. Paramedics arrived on site in about 5 minutes. The paramedics made the decision to transport her to the local hospital

dizziness, syncope, pale complexion, sob/difficulty breathing/ gasping for air, nausea after about 5-10 minutes after vaccine given. EpiPen given by pharmacist, fluids given by rescue. breathing improved, Vitals were stable upon transport to hospital

Sudden onset of symptoms on 5/11/2021. Symptoms include dyspnea, dizziness, fatigue, brain fog, and high heart rate. Symptoms are episodic and last an hour or so at a time. Dyspnea gives a feeling of not having enough air flowing to the belly. Patient attempts to take fuller breaths and complains of not achieving a satisfying full breath every time during these episodes. Patient complains of dizziness and having a difficult time keeping the head and neck up. High heart rate and palpitations are often the worst after getting out of bed in the morning, with bpm hitting 135. Patient complains of a racing heart upon waking up. Patient's resting heart rate is consistently 85-100 bpm. Oxygen saturation always above 95%. Patient has experienced these episodes previously for a few days at a time but these incidents self-resolved after a few days. No headaches. Sharp chest pain experienced twice, both times under the left breast. First time while running on the treadmill, the second time the chest pains awoke patient from sleep. Negative Covid test as of 5/14/2021. Second Covid vaccine (Pfizer) administered 5/4/2021, may be mild myocarditis. Patient recovering but not back to normal yet.

WHILE SETTING AFTER GETTING THE SHOT, THE PATIENT STATED HER HANDS WERE NUMB AND NOT WORKING CORRECTLY, SHE FELT LIKE THROWING UP, THEN PATIENT GOT REAL SWEATY AND BEGAN WHEEZING. WE WERE CONCERNED AND CALLED 911, WE BELIEVED IT WAS A PANIC ATTACK. PATIENT WAS ASKED ABOUT PANIC ATTACKS AND PATIENT STATED SHE HAS HAD PANIC ATTACKS BEFORE NOT THIS SEVERE. WE FANNED HER, TALKED TO HER AND SHE CALLED HER BOYFRIEND AND AFTER ABOUT 15 MINUTES SHE RETURNED TO NORMAL BREATHING, NO MORE SWEATING. EMS CHECKED HER OUT AND SHE LEFT LATER WITH HER BOYFRIEND.

Asthma exacerbation. Difficulty breathing, dyspnea at rest, chest pressure and chest congestion, feeling of throat closing up. Symptoms started approximately 36hrs after vaccine was given. Was taking albuterol inhaler every 4hrs. After 1 week of no improvement, was treated with PO prednisone and a new long-acting, everyday inhaler.

very high fever (105.8), shortness of breath, throbbing headache, body aches, chills, excessive sweating, chest pain --- received care at ER; given IV fluids

Fast Heartbeat; Have difficulty with my chest pain and irritation; Difficulty breathing; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 26 year old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No any prior vaccination and no any family event history. The patient experienced increased heartbeat rate, had difficulty with chest pain and irritation, difficulty breathing on 10Jul2021. Patient stated she just had first Pfizer shot (Covid-19 Vaccine) she had very fast heartbeat few hours later and yesterday she felt like she have almost difficulty with my chest pain and irritation may be. she was not quite sure. Last night she had difficulty with her chest pain and difficulty in breathing. When probed if still having the problem (event) patient stated Last night she experienced again. Therapeutic measures were taken as a result of these events with one pill of Advil. The patient is scheduled for the second shot of covid-19 vaccination on 31Jul2021. The outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.

Injection site pain; Fever; Sore muscles; Sore body; Nausea; Hot flashes; Swelling of tonsils; Throat pain; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 15:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 19:45, 4 hours after the vaccination, the patient experienced injection site pain, fever, sore muscles/body, nausea, hot flashes and swelling of tonsils/throat pain. The adverse events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive treatment for the reported adverse events. The clinical outcome of the events injection site pain, fever, sore muscles/body, nausea, hot flashes and swelling of tonsils/throat pain was resolved on unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Chills; Muscle pain; Chest pressure; Fatigue; Loss of apetite; Shortness of breath; Joint pain; Headache; Fever; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female 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 24Mar2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 20:00 the patient experienced chills, muscle pain, chest pressure, fatigue, loss of apatite, shortness of breath, joint pain, headache and fever. On 30Mar2021, the patient underwent lab test which included COVID-19 virus test (nasal swab) and the result was found to be negative. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events chills, muscle pain, chest pressure, fatigue, loss of apatite, shortness of breath, joint pain, headache and fever was recovered with sequelae on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

15 minutes after administration: began experiencing light headedness, nausea, and tightness in chest 1 hour after administration: began experiencing tightness in throat, irregular heart beat, and hypertension, anxiety/feeling of impending doom

Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.

Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches

Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.

Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination

Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then resolved. Approximately 20 mins after administration of vaccine minor swelling of the throat and limited rash on the throat present. 50 mg oral Benadryl taken an hour after vaccination.

Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain like cramps and pins and needles if skin rubbed, joint pain, sharp brief headache that comes and goes in random spots of head, fatigue, malaise, mental fog

This may not be related to the vaccine, but is strange enough that I'm reporting it. I got my vaccine at around 3, and didn't have any immediate reaction. I have an exercise bike at home, and tried to work out but had to stop after only half an hour of very low effort biking because I couldn't get a deep breathe. usually I can bike for an hour at high intensity no problem and have never had to stop because I felt like I couldn't breathe. I woke up in the middle of the night feeling achy and unwell. When I woke up in the morning I was extremely fatigued and my eyes were itchy and puffy.

PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.

Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath, Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain

When I received my first dose of the Pfizer COVID shot I had no issues. When I received the second dose I had the vaccine injected and then I got up and walked to the monitoring room where we sit for 15 minutes. Immediately upon sitting down in that room I felt very woozy, lightheaded, and my heart was beating out of my chest. I checked my pulse on my smart watch and it was in the 80s but my resting HR is normally in the 60s or 70s. I got nervous at that point so I took some deep breaths and tried to relax and my symptoms improved within a minute. I sat for the remainder of the monitoring period and right at my 15 minute mark all of my symptoms returned. HR in the 100s, lightheaded like I was going to pass out, chest heaviness, and shortness of breath. I alerted the nurse in the monitoring room and she took my BP and HR and they have me a bottle of water. My throat felt a little weird too and I was worried that it was starting to close up, but I was able to swallow water normally. I remained in the monitoring room for about 15 more minutes and at that point my symptoms mostly resolved and I felt well enough to leave. For the next approx 48 hours I have had some mild- moderate chest heaviness. More worse in the initial 24-36 hours after the vaccination.

Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, medicated with Benadryl P.O., started with throat itching, medicated with Benadryl IM, EPI IM, EMS called, placed on O2, diminished breath sounds bases, slight stridor, EPI IM, Solumedrol IM, EMS transported to local ED. Patient called NP later in day and said she was admitted to the hospital.

Throat swelling and chest tightness three days after administration of vaccine. Symptoms were managed with over the counter antihistamines until 1/11 when the antihistamines were not working and my throat was swollen and tight, my chest was tight and my voice was horse. I got prescribed prednisone on 1/11 and have been on a long taper of that, with scheduled benadryl, pepcid and zyrtec.

Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling, constant need to clear throat, tingle/tickle in throat

Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Heart rate elevated to 150 and above, shortness of breath. Went to emergency room. Admitted with blood clot in lung. Previously had COVID in 2020, and we are unsure if this is related to previous illness.

Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/2021. Rash erythematous and raised with no hives. Rash started on chest and has spread to bilateral arms, bilateral legs, and back. Face, palms, and soles spared. Reports cough and shortness of breath for an hour when rash first appeared that resolved and has no returned. Since rash has started has taken OTC Benadryl every 6-8 hours. Patient presented on 01/22/2021 for evaluation of the rash.

Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.

Patient received vaccine on 01/06/2021 and developed a diffuse rash on 01/20/2021. Rash started on the chest and then spread to the bilateral arms, bilateral legs, and her back. Her face, palms, and soles are spared. Rash is mildly pruritic and not painful. Patient reports at the time the rash started she had a cough and SOB for 1 hour that has resolved and not returned. Patient has been taken OTC Benadryl PRN every 6-8 hours since the rash presented. Patient presented to Clinic for evaluation on 01/22/2021.

SEVERE shortness of breath (basically hyperventilating) for 2-3 hours, very sharp pains/heartburn in the chest when trying to take a deep breath, nausea, vomiting, diarrhea, joint pain, fatigue, chills/hot flashes, sudden uncontrollable fatigue (deep sleep for 2-3 hours after)

within minutes after my shot, I started to have difficulty swallowing. i was monitored for 30 minutes at the vaccine site before being escorted to the medical observation area. While in the medical observation area I tried to take a sip of water but could not swallow it. At that moment I began having a tight feeling in my chest. I began to hyperventilate followed by difficulty breathing or talking. This was accompanied by feelings of impending doom, and uncontrollable trembling and inability to concentrate on what the medical observation area Doctor was saying. The time from the drink of water until I was able to breathe, speak, and concentrate normally was about 20 minutes. Tightness in my chest has improved but not fully recovered. General malaise and headache have developed.

Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.

Large amount of Bleeding at time of injection. Enough to spill all over the floor and my arm and clothing. Rhen i had a severe rash weeping snd bleeding and red and bruised face and neck. Itching and hard to breathe as well as pain all over Face where rash is scabbing and oozing.

Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.

20 minutes after receiving Covid 19 Vaccine /Pfizer, employee complaints of shortness of breath, chest tightness, pulse = 100. Medical team was called and Employee was taken to the ER.

I received the 2nd dose of the Pfizer COVID-19 vaccine around 9:15 am on 2/23/21. Initially, my only symptoms were injection site soreness and minor swelling. Gradually throughout the day, my entire left arm become more and more sore. By 5:00pm, I felt exhausted and dizzy and was having chills. My temperature was 99.8 degrees Fahrenheit. I took a dose of Extra Strength Tylenol, but felt no change. My joints and muscles began to ache around 6:00pm on 2/23/21 and did not stop aching until around 9:00pm on 2/24/21. During the evening of 2/23/21, my dizziness increased and I felt as if I would pass out any time I sat up or stood. My temperature had returned to 98.2 degrees Fahrenheit by 10:00pm on 2/23/21. I then took a dose of Motrin to help with my soreness. On 2/24/21 from morning until 8:30pm, I had no fever or chills, but still felt exhausted and had minor muscle/joint achiness. I took 3 doses of Motrin on 2/24/21 to help with the soreness. Throughout the day, I had some difficulty breathing (felt like a mild asthma attack) and used my emergency inhaler once. At 8:30pm on 2/24/21, my temperature was 100.5 degrees Fahrenheit. I took another dose of Motrin and went to sleep. Around 3:00am on 2/25/21, I woke up drenched in sweat, but feeling better. My temperature was normal then. When I woke up at 7:00am on 2/25/21, I no longer felt achy, dizzy, or tired. I still feel (now at 1:30pm on 2/25/21)as though my asthma is aggravated, but am not having difficulty breathing.

intense upper stomach pains (difficult time bending over, etc); Difficult time breathing/shortness of breath; This is a spontaneous report from a contactable healthcare professional. This 27-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3247) intramuscularly in the left arm on 25Jan2021 (at the age of 27-years-old) at 09:00 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO) from an unknown date for an unknown indication, dicyclomine from an unknown date for an unknown indication, doxycycline from an unknown date for an unknown indication, levothyroxine from an unknown date for an unknown indication, birth control from an unknown date for an unknown indication and women's multivitamins from an unknown date for an unknown indication. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 08:00 the patient experienced intense upper stomach pains (difficult time bending over, etc.). Additionally, she experienced a difficult time breathing/shortness of breath. The patient reported the events resulted in an emergency room or urgent care visit. It was unknown if the patient received treatment for the events. The clinical outcomes of intense upper stomach pains (difficult time bending over, etc.) and a difficult time breathing/shortness of breath were recovering. It was also reported that since the vaccination the patient had tested negative for COVID-19 on 26Jan2021 via nasal swab and polymerase chain reaction tests.

Stomach pain. Diarrhea. Headaches. Nausea. Wheezing. Troubling breathing. Mucus. pain in lungs when breathing.

Patient developed shortness of breath, swelling sensation and tingling of the tongue. Vitals stable. Airway patent, no voice change, no wheeze. Symptoms improved with observation. Tongue symptoms continued with some swelling. Patient offered IM Benadryl which she refused. Patient transported to ED via EMS.

After 5 minutes of reciving the vaccine I immediately felt my tongue swell and tingle and my throat felt like it was closing. For a few second I could see anything and then went straight to someone to help me.

Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).

5 minutes after injection I experienced a metallic taste in mouth and slight tightening of throat. I waited 20 minutes in observation and spoke to nurse and PA who assured me I should be fine if I had no history of anaphylactic shock. 20 minutes later I still felt tightness in my throat, metallic taste in mouth, headache, and now slight difficulty swallowing, at which time I used my Albuterol rescue inhaler. Tightening in throat resolved within an hour. Metallic taste and headache is still present +2 hours after injection.

She felt numbness in the throat, the impression was that her throat was closing up. she was also dizzy/lightheaded. her heart beat was up. she felt her heart racing as she described. Patient took self adminstered benadryl liquid, 20 minutes after the shot, 25 mg, then after 5 minutes she took another 12.5 mg. EPIPEN administered after 40 minutes of vaccine administration. 911 was called. She was shaky for 10-15 minutes after the epipen then the shakiness stopped. paramedics checked blood pressure, was normal: 120/80 as I recall. paramedica checked her oxygen saturation and it was fine. Patient didn't want to go to the hospitals , I stayed for an extra 45 minutes after using the epipen, she was normal.

Shaky, numbness in tongue, tightness in throat, tingling on tongue, evaluated by EMS-transported to nearest ER.

I thought I had Covid-19 and needed to see a doctor because of a dry cough. My chest was tight and it was hard to breath. I had a fever of 100.3. I was prescribed an Albuterol inhaler and Tessalon(suppressant). I had been taking Nyquil every night and round the clock Tylenol and Ibuprofen. I had full body fatigue and terrible body aches. My muscles hurt. A few days later my fever was down and I was having chest tightness. I tested negative for on the rapid test on the 10th PCR test negative repeated that same week and negative. I felt bad for nine days after vaccination. I was still exhausted for another week at work. I got the second dose and had no problems.

Pfizer-BioNTech COVID-19 Vaccine EUA: Vaccine recipient reported that they had shortness of breath and felt that their throat was closing. EMS administered diphenhydramine, solumedrol, and was transported to the emergency room.

Patient received first dose of Pfizer vaccine. Patient was told to wait in the observation area for 15 minutes post dose to monitor for allergic reactions. Patient after 10 minutes advised the pharmacist that she was having a bit of difficulty breathing, short of breath, and her throat was feeling funny. Patient remained conscious, breathing, and alert during this period, while sitting down. Pharmacist called 911. Pharmacist proceeded to draw up Benadryl for injection. However, as dose was being drawn up, EMS arrived. Within 5 minutes, EMS arrived to assist patient. EMS took patient to provide additional care. Patient was conscious, breathing, and alert as EMS took her for further care.

About 5 minutes after vaccine, pt feels warmness in her body and sob. It resolved about a few minutes. Denies chest pain, dizziness, swelling, rash and itching.

Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.

arm hurt; achy; weird lung pain; splitting headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 15Jan2021 at (at the age of 27-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified). On an unknown date after the first vaccination the patient experienced, she is achy, her arm hurts, some weird lung pain and a splitting headache. It took until the next day for her arm to hurt. The clinical outcome of the events achy, arm hurts, lung pain and headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Patient experienced facial rash with dose 1 that was relieved with Benadryl 50mg PO. Patient experienced spreading body rash with difficulty breathing experienced as persistent cough with dose 2. Symptoms were not relieved with Benadryl 50mg PO and continued to worsen. Patient was administered 0.3mg epinephrine IM (as EpiPen), 911 was alerted, and an ambulance took patient to hospital.

One day after vaccine developed diarrhea with nause and vomiting. She also reported general malaise similar to "Influenza like symptoms". She stay at bed and improved from the general malaise symptoms but persisted with nausea and vomiting. On day 3, she reported at night that her pulse Ox dropped to 88% and was taken to ER. She was admiited with suspected atelectasis of left lower lobe abd possible pneumonia which is difficult to evaluate due to her chronic lung condition. She had improved and is no longer having vomiting or general malaise and expected to be discharge home soon.

Patient complained of itching and hives 5 minutes post vaccination. Benadryl 50 mg IM @RD given at 1:32pm. Patient felt dizzy. Laid down with feet up. Patient complained of difficulty swallowing and breathing at 1:47pm. Epipen administered on left outer thigh intramuscularly. 911 called. Transferred to Hospital via ambulance at 2:01pm. Vital signs: 1:25pm BP 110/75 O2 sat 98%, 1:30pm BP 110/80 HR 86bpm; 1:54pm BP 120/95 , HR 137 bpm, O2 sat 98%; 1:57pm HR 124 bpm. Lungs clear to auscultation. Called patient at 6:12pm for follow-up. Patient is still in the hospital for observation. She received treatment and under observation.

PATIENT DEVELOPED RASH IN BOTH ARMS W/IN 10 MINUTES WHICH SPREAD FURTHER TO HER FACE AND BACK, FEW MINUTES LATER SHE DEVELOPED SHORTNESS OF BREATH AND SENSATION OF HER THROAT CLOSING. SHE WAS GIVEN BENADRYL 50 MG IM AND EPI 0.3 MG IM. THEN PARAMEDICS TRANSFERRED HER TO THE EMERGENCY ROOM.

anaphylaxis; throat tightness; shortness of breath; lip swelling; throat swelling; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the first dose of bnt162b2 (lot number EN6199) via intramuscular on 04Mar2021 at 13:45 PM at single dose in left arm for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history included ADHD, obesity, anxiety, history anaphylaxis to peanuts and allergies: peanuts. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERRAL), diphenhydramine hydrochloride (BENADRYL). "5 min after injection", the patient developed throat tightness, shortness of breath, lip and throat swelling consistent with anaphylaxis. Events onset date reported as 04Mar2021 at 13:45 PM. Events resulted in emergency room/department or urgent care. The patient received epinephrine as treatment. The outcome of events was unknown. It is unknown if COVID tested post vaccination.; Sender's Comments: Based on temporal association and known drug profile the reported anaphylaxis with throat tightness, shortness of breath, lip and throat swelling are assessed as due to bnt162b2. Case will be reassessed if additional information is received.

After almost a week after the second dose I am still having symptoms from the vaccine Throwing up nausea diarrhoea fever body chills and body aches have all occurred after the vaccine this has been going on for over a week now One day going and to work coworker felt me throwing up again in the stall in advised me that I should report to the ER that I work at I have been on bed rest due to these events it was described steroids in inhaler because it is hard for me to breathe.

Death 5 hours after second shot. Decedent contacted her mother around 3:30 c/o difficulty breathing. Died on 4/1/20

Anaphylactic Reaction, given epi pen at clinic and transferred to hospital by ambulance, had breathing tube inserted because swelling in throat and mouth would go down with epinephrine treatments, stayed in ICU for 4 days with epinephrine, Benadryl, and steroid treatments. Breathing tube was removed on third day in hospital.

Day 2, 3/25, with a fever of 100.5 and mild chest pain with difficulty of breathing. Woke day 3, 3/26, with severe chest pain, difficulty of breathing and a heartrate while resting from 140-180. Symptoms persisted all morning resulting in a call to 911 for assistance. Hospitalized evening of 3/26 with symptoms persisting until late night of 3/28 after struggling with bringing down the heartrate. Diagnosed with Supraventricular tachycardia paroxysmal, Respiratory Distress, and Thrombocytosis.

Within 5 minutes of receiving the Pfizer COVID-19 vaccine, I had terrible hot flashes and was unable to focus. This subsided within 15 minutes. Within an hour of the vaccine, my tongue went numb and mildly swelled, my face grew hot, and my throat swelled. It was difficult to swallow saliva and water. Within two hours, I grew progressively weaker, light-headed/dizzy, and experienced mild confusion (unable to understand what folks were saying on the onset). I also had quite low blood pressure when observed by the EMTs. My swelling subsided within 5 hours, both through time and the eventually emergency room treatment of Benadryl, Prednisone, and saline.

Injection site pain in left arm (started at 7pm 4/1/21, ended 4/3/21 around 12pm) Redness around injection and across left shoulder, injection site/left shoulder felt very hot (started around AM of 4/2/21 - exact time uncertain). Slight chills (started around 3AM 4/02/21, ended shortly after) *Skin sensitivity - My upper torso (arms, chest, back, shoulder, neck, and abdomen) felt hyper-sensitive to all touch (not painful, but significantly uncomfortable). This started around 11AM 4/02/21 and ended around 9AM 4/03/21. Slight shortness of breath - not significant or burdensome. (Started 4/01/21 around 9PM, ended around 10PM 4/02/21). No other symptoms to 2nd dose of Pfizer. All symptoms were gone by 4/03/21. Took 1 Tylenol tablet around 11AM 4/02/2021 for injection site/left arm pain.

At 1 AM the following night, she woke up with a jolt, having trouble breathing, feeling very hot, sore throat, and nasal congestion. She sat up in bed and took a few deep breaths and felt better, breathing-wise. She woke up a few times after that with no breathing trouble, but having the other symptoms. She didn?t sleep well all night. After waking up in the morning around 8:30 AM, she felt very tired and had a sick feeling, but not the other symptoms. The tired and sick feelings persisted all day. She took her temperature and pulse ox at 8:30 AM AM and at 5:30 PM and they were normal (temp of 97.7 and pulse ox of 97 at 8:30 AM and temp of 98.2 and pulse ox of 99 at 5:30 PM)

Chills and fever of about 100F lasting through the night. Next morning, severe headache and extreme tiredness . Slight nausea and food unappetizing. Extremely sore/weak legs (mostly right) developed mid day after fever/chills gone. After around 24 hrs most symptoms gone. Some remaining tiredness 36 hours afterwards as well as pain in neck and slight pain when breathing deeply (like caused by muscle strain) . No follow up with any physician as effects when away on own after 36-48 hours.

Experienced tightness of the throat and some difficulty breathing about half an hour to an hour after. I also experienced difficulty breathing for about a week so much so that my employer had me evaluated in the emergency room and tested for COVID-19 twice (results were negative both times). I received a saline IV for hydration, chest x-rays, and blood tests to rule out infection. My normal side effects consisted of chills, body aches, tiredness, headache, and nausea.

Hives from head to toe and tightness of throat. Provider gave me a Decadron (steroid shot) and high dose oral prednisone. Even with shot and oral steroids it took 5 days for the hives to go away and another 4 days for my throat to feel normal again.

On 4/16, I was unable to move my muscles weren?t working. I was in a lot of pain that over the counter meds couldn?t help. I had severe migraines. For 4/17, I have shortness of breath and slight chest pain. My voice is going in and out I?m losing it.

Received Pfizer COVID vaccine around 1550 in the left arm. A few minutes after receiving the vaccine, she began to feel short of breath, with associated coughing, followed by an episode of nausea and emesis. She received PO and IM Benadryl which resulted in improvement in her breathing and coughing. Transported to ER by EMS. She was given prednisone for 5 days with prn H2 blockers and H1 blockers.

About 15 minutes after injection patient reporting shortness of breath , difficulty swallowing. throat felt swollen and tingly sensations. On assessment patient clear but diminished breath sounds, thready/weak pulse, swollen lips , BP 130/80. At 1359 pharmacy gave first dose of Epi in left leg, pt symptoms only mildly improved, then second dose of epi given at 1406. ER rapid response on site to take patient to ER and assume care.

Around 25 minutes after vaccine, patient began to feel dizzy and stated that her tongue and throat felt scratchy and tight. Patient took a Benadryl 25 mg tablet. After about 20 more minutes patient said her chest felt tight and her left side of face was numb. She could take deep breaths easily but her shallow breaths were difficult.

Symptoms: Severe chest tightness and shortness of breath, intermittent chest pain, uncomfortable pain and chill sensation down the spine from the neck area radiating down the left shoulder and arm, down the spinal cord area, or up the left side of the brain / head area. Severe feeling of malaise similar to having a severe flu (feeling "like garbage" or "like getting hit by a train"). Treatment: None Time Course: Better in the mornings, almost unbearable at night.

Patient reports feeling short of breath, nauseous, clammy, and chest tightness. This RN assisted patient to wheelchair and wheeled her to the private observation area. Assisted patient into recliner with feet elevated. Vital signs at 1410: BP 125/81, P92, RR 20, 98% RA. Patient reports a similar reaction to the second Gardisil vaccine approximately 10 years ago. Patient reports being 17 weeks pregnant, but the symptoms she is experiencing do not feel pregnancy related. Patient reports getting the ok from her OB to get the Covid vaccine. Patient also reports not eating or drinking anything in a while. Provided a Gatorade and granola bar. After about 20 minutes patient reports she is back to her baseline. Patient reports her husband will be picking her up.

Systemic: Dizziness / Lightheadness-Severe, Systemic: both hands tingling, crampimg-Medium, Systemic: Hyperventilation-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling of both hands, both hands cramping

4/20/21: Vaccination @ 1:40pm. Vaccination site sore only when pressed. 4/21/21: Upper left arm sore when moved. Upper throat swollen. Began to feel feverish & lethargic c. 9am. Feverish feeling passed c. 11am. Slept 2-6pm. Slept 11:30pm 4/21/21-4/22/21. 4/22/21: Woke up at 1:20pm. Unresponsive to regular alarms. Vaccination site sore only when pressed. Upper throat still swollen, but less-so.

Patient had injection and within 20 minutes began to have tingling in her arms and then swelling in her throat and wretching. Patient was taken to ER by EMS and was given zofran for nausea which resolved. Patient had no other symptoms.

First shot: evaluated heart rate, BP increased within 3 minutes of receiving the first vaccine. Throat itchy/ closing 1 hour after first shot. Treatment Benadryl and ibuprofen. Small rash on chest and lower left and right leg and buttocks 2nd shot: Rash/ hives on left and right arms and left and right legs, stomach and chest. Treatment outcome: steroid injection from urgent care. No change. Prednisone 10mg for 6 days. (21 tablets) Prescribed by my primary doctor Dr. No change therefore I contacted my dermatologist and she prescribed Triamcinolone acetonide ointment for 2 weeks twice a day for the itching and inflammation. No change.

Pt is a 27 yr/o female who presents with general symptoms Had Covid vaccine yesterday Today describes multiple symptoms including headache, fatigue, low energy, chest pressure, shortness of breath, swelling, rash, flushed feeling, etc. No history of true syncope or palpitations No definite fever, chills No history of blood clot or bleeding disorder No current cough or bloody cough

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild

After 13 hours from the shot, I had onset chills and body aches. These lasted for 6 hours. I then had a fever of 101 for the next 6 hours. Throbbing headache came around 18 hours after reviving the shot, my arm was also extremely tender to touch. I took ibuprofen 800mg around hour 20. This helped the headache. I had a racing heart rate through the fever. The symptoms lasted for about 36 hours. Following this, I had onset allergies (stuffy nose, dry cough, difficulty breathing, swollen face, watery eyes). Claritin had helped a little bit and swelling went down.

Hot flashes, swelling of mouth and throat, fatigue, bloody nose, shaky, nausea, loss of appetite and taste, achy and pain and nerve aching, migraines

Fever above 105 degrees for 5 days; Enlarged lymph nodes on left side of neck; tremors; causing difficulties breathing; pushing on esophagus; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was unknown and expiry was not reported), via an unspecified route of administration, in Left arm on 04Apr2021 at 13:00 (at the age of 27-years-old) at 1st dose single for COVID-19 immunization. Medical history included environmental allergies and Hashimoto's. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) in two weeks of vaccination. The patient previously took Ceclor 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. Patient was not pregnant at the time of vaccination. The patient had fever, above 105 degrees for 5 days and unable to reduce with Tylenol, causing tremors; had enlarged lymph nodes on left side of neck causing difficulties breathing and pushing on esophagus as per ER physician on 05Apr2021 at 12:00 after the first dose. The events resulted in emergency room/department or urgent care (2 visits to ER needed in first 5 days following vaccine). Residual issues remained. Treatment was given for the events. The outcome of the event fever was recovered with sequel on 10Apr2021 while the other events (enlarged lymph nodes on left side of neck causing difficulties breathing and pushing on esophagus) was recovered with sequel in Apr2021. The event tremor was recovered in Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained

facial drop; chest pains/pressureweakness of limbshot face(no fever)facial dropmuscle spasmtingling in arms and faceswelling of throat(could still swallow/breath/speak); chest pains/pressure; chest pains/pressure; weakness of limbs; hot face (no fever); chest pains/pressureweakness of limbshot face(no fever)facial dropmuscle spasmtingling in arms and faceswelling of throat(could still swallow/breath/speak); tingling in arms and face; This is a spontaneous report from a contactable consumer. A non-pregnant 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 24Mar2021 (Batch/Lot Number: EP7534) as 1st dose, single (at the age of 27 years old) for COVID-19 immunisation. The patient medical history included prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on left arm on 24Mar2021 (Batch/Lot Number: EP7534) for COVID-19 immunisation. he patient's concomitant medications were not reported. The patient experienced chest pains/pressure, weakness of limbs, hot face (no fever), facial drop, muscle spasm, tingling in arms and face and swelling of throat (could still swallow/breath/speak) on 01Apr2021 03:00. The patient received benadryl and saline solution. The patient was tested for as nasal swab and the result was negative on 21Apr2021. The outcome of the events was recovering. The patient received dose 2 via an unspecified route of administration, administered on right arm on 14Apr2021 (Batch/Lot Number: pfizer EW0162). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Beginning about 30-40 minutes after the injection I noticed that my throat was feeling strange, which quickly progressed to a mild allergic reaction causing my throat to feel blocked up (at around 1 hour after shot). I also noticed mild puffiness in my cheeks and around my jaw at around the same time that I first noticed the reaction. At an hour after the injection i could feel that my throat was somewhat tight and felt as though it was blocked, but I was still able to breathe with only very mild difficulty and chose not to seek medical attention. I took a full dose of Benadryl when I first noticed the reaction (at about 40 minutes after the injection) which controlled the symptoms and at about two and a half hours after the injection I could feel that my throat was beginning to loosen up and feel less blocked

*Saturday afternoon, 3 p.m.: Shortness of breath, chest tightness, drowsiness *Sunday (05/16): Nothing *Monday (05/17): Nothing *Tuesday (05/18), 1 a.m.: Tense back, chest tightness -same Tuesday, 05:30 p.m. approx.: Quick and sharp head pain from within expanding outward, followed by vertigo that lasted until Wednesday (05/19) *Thursday (05/19): -4 p.m.: Sharp pain running from front left to back left side of head -approx. 9 p.m.: Swollen lump at clavicle that can be felt when rubbing said area *Thursday and Friday (05/19 - 05/20): Lingering chest tightness that causes slight coughs, dizziness when in a vehicle

She developed shortness of breath, swollen upper lip and tongue tingling within 5 minutes of her first dose of the Pfizer Covid Vaccine. Sent to the ED for treatment and observation. Released without further incident.

The patient presented to hospital with anaphylaxis without clear precipitating cause, possibly secondary to Pfizer COVID 19 vaccine. She presented to hospital on 5/22 with a lacy rash over the entire body and a change in her voice with a sensation that she couldn't breathe. She was given several doses of epinephrine, and steroids and improved, and was admitted to medicine for observation. She reported getting initially COVID-19 vaccine dose on 4/19/21. Thereafter had lacy rash over entire body for 3 days which she took as needed benadryl with improvement. After her second dose on 5/10/21 she initially had no symptoms. Approximately 6-7 days after her second dose lacy whole-body rash returned, worse than when she initially had it after first vaccine dose. She took benadryl several times but rash worsened. She had an odd sensation in her throat and noticed a change in the tone of her voice, and felt like she was having difficulty breathing. She presented to the emergency department.

Patient reported new onset dyspnea, dysphagia, and dysgeusia starting several hours after vaccination, but in the same day. Patient reached out to me on 5/24/21 reporting that her symptoms were worsening, not improving at that time. Based on her symptoms, I advised she seek medical care. She did not report having a primary care physician.

Pt c/o dizziness, headache, difficulty breathing, OxSat 99%, HR 107-109, dropped 75-79. Fire department took over care

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Mild, Systemic: Weakness-Mild

pt states her heart started beating out of control. She was SOB and had some burning and pain in her chest. Her heart rate was 235. She went to the Hospital ER. They did lab work (troponin levels were high), CT and EKG (abnormal results). She was given O2 and was given a medication. Her DX was Supraventricular Tachycardia. She was released to go home w/ supervision. She was told to FU w/ a Cardiologist. She saw a doctor on 4/7/2021. She had EKG and echo. Both test were normal but pt was told she could have another episode. She will FU in 6 months.

1st dose facial numbness for 13 hours after vaccination; pain when breathing 8 hours after vaccine; Now have recurrent idiopathic hives since being vaccinated; This is a spontaneous report received from a non-contactable female consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm left on 21Jan2021 (at the age of 27-year-old) at a 1st dose, single for COVID-19 immunization. The patient's medical history included psoriatic arthritis, idiopathic autoimmune hives, allergies to bactrim, penicillin, peanuts, shellfish, watermelon. Concomitant medications included Humira, prednisone, Zyrtec. On an unspecified date, the patient experienced 1st dose facial numbness for 13 hours after vaccination, pain when breathing 8 hours after vaccine and now have recurrent idiopathic hives since being vaccinated. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of 1st dose facial numbness for 13 hours after vaccination, pain when breathing 8 hours after vaccine and now have recurrent idiopathic hives since being vaccinated. AE treatment allergy medication included epi pen, allergy testing. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no covid prior vaccination. Patient has not been tested for COVID-19 post the vaccination. Outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

27 yo F c/o dizziness and throat swelling 20 minutes after receiving her 2nd dose of the Pfizer vaccine. Patient stated she felt like it was difficult to swallow and that her throat felt num. Patient evaluated by on-site EMS and NP. Vital signs (129/78,84, 22) and EKG (NSR) started by EMS. Due to patient holding her throat, 911 called and Iv started. 50mg of Benadryl given per NP. No PMH. NKDA. EMS arrived, re-assessed and transported patient to Hospital for further evaluation.

Immediate severe reaction including difficulty breathing, nausea, vomiting, light headedness, dizziness, shaking, muscle weakness, body aches and pains, chills, pain and weakness in the entirety of my left arm which spread to my entire left side including neck and head. I waited out the worst of it and received Benadryl for the reaction and ondansetron ODT for the nausea and was monitored by hospital staff for an hour and clinic staff for an hour.

I received my first does of Pfizers on 4/15/2021. 2 days later i ate truffle fries and i was having trouble breathing, my eyelids were swelling up and i was out of breath. A week later I was working at my job again and this time i didn't eat or drink anything out of the norm and i had trouble breathing again and only one eyelid swelled up. In between the first and second shot i would periodically have trouble breathing for a few hours if that. I received my second shot on 5/13/2021. On 5/26/2021 I got lettuce wraps. I ate one lettuce wrap and my lips started to burn when i started eating the second one. By the time i was done with my second lettuce wrap I couldn't breath i instantly stop eating them, chugged water, took and allegra to help my breathing within 45 minutes my whole face was itchy and really red and my whole body was filled with hives from head to toe. I immediately went straight to urgent care, they gave me a steroid shot and a benadryl shot. I waited there for 15 minutes to make sure no reactions happened, thankfully it went away. On 6/1/2021 I was working and around 12:00pm when i went on my lunch break, I had 1 hot dog and the rest of the day I could not breath at all.

I went to the Family Care the day after receiving my first dose of the Pfizer vaccine. I was experiencing very sore throat and low grade fever (I believe the highest was 100.1). The symptoms felt similar to times I had strep in the past. I did note that my posterior pharynx, in addition to my tonsils, looked abnormally swollen that morning. I truly thought I had strep but the test was negative. I was also tested for the flu which was negative. Later that week I had a Rapid Covid test at the hospital where I work which was also negative. After my second dose, I had no issues.

Patient reported having hives in two places (left thigh and left flank), hot face (not noticeably red), shortness of breath, pulse 68, BP 118/76; occurred within 15 mins of immunization, Benadryl 50 mg PO capsule x1 dose was administered and all symptoms resolved (per patient report) within 10 minutes. She reported a history of similar reactions, resolved using Benadryl. She also carries an epi pen and has one at home if needed.

At 8:45am, I woke up with a tight pain in my chest on the left side and pain in my left arm, left side of neck and left ear. The pain was severe enough that I considered going to the hospital because I thought I was having a heart attack, but decided not to because I am a healthy and fit 27year old. The pain got more severe. I alternated between laying down while struggling to take deep breaths and stretching because my left neck and arm hurt. I drank about 16oz of water. At around 11am I threw up water. At around 12pm I was able to fall back asleep. When I woke up around 1:30pm I felt much better with just very mild symptoms and by about 4pm I felt completely better. I have had no symptoms since.

Pt reports 2 days after she received the vaccine she developed intermittent, mild stabbing pain under the left collar bone/left chest area, states pain was worse when taking a deep breath, did not require OTC, and resolved on it's own. The patient states the next evening the pain returned, pain was under the breast bone/rib cage and in the back, pain would come and go, better after resting, worse with activity, and again resolved spontaneously and has not returned.

headache; like my throat was swelling; heart rate accelerated; I felt tight in my chest and throat; I felt tight in my chest and throat; I felt warm; nauseous; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 02:45 (Batch/Lot Number: EN6204) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included drospirenone, ethinylestradiol (NIKKI) taken for a contraception, LORATADINE taken for an unspecified indication and start and stop date were not reported. The patient previously took sulfa drugs. 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. The patient was not pregnant at the time of vaccination. The patient experienced headache, like my throat was swelling, heart rate accelerated, i felt tight in my chest and throat, i felt tight in my chest and throat, i felt warm, nauseous on 07Apr2021 03:30. The patient reported that patient was stayed almost 30 minutes on site with the emt and then on the car ride back home patient started feeling like her throat was swelling and she tried to brush it off but then her heart rate accelerated and she felt tight in her chest and throat and then patient felt warm. patient started feeling nauseous and developed a headache so patient drove to the ER. Her throat continued to swell and release for the next few hours. Therapeutic measures were taken as a result of events includes PREDNISONE. The outcome for all events was recovered on unknown date in 2021. No follow-up attempts are needed. No further information is expected.

metallic taste in my mouth; slight tightening of my throat; my throat swelling worsened making it difficult to swallow; my throat swelling worsened making it difficult to swallow; slight headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 27-Year-old Female patient (age at vaccination: 27 year) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Mar2021 at 13:30 PM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, environmental allergies and known allergies of chickpeas, pet dander and dust mites (from an unknown date and unknown if ongoing). Concomitant medications included loratadine (CLARITINE); fluticasone propionate (FLONASE) and multivitamins (Vitamins not otherwise specified (NOS)) daily (taken for an unspecified indication, start and stop date were not reported). Patient had no other vaccine in four weeks. It was unknown if patient had COVID prior vaccination. The patient was not tested for covid post vaccination. On 05Mar2021 at 13:35 hours (5 minutes after injection), the experienced a metallic taste in her mouth and a slight tightening of her throat. While in observation, this persisted so she told a nurse and PA on site, they assured her that she was fine if she had no history of severe allergic reactions. She left observation at 25 minutes after injection. Upon driving home about 35-40 minutes later her throat swelling worsened making it difficult to swallow, the metallic taste persisted, and she also had slight headache. She used her Albuterol HFA rescue inhaler. The throat swelling and difficulty swallowing resolved shortly thereafter. The metallic taste and headache persist currently +2 hours after injection. The patient received unknown treatment for the events metallic taste in my mouth and slight headache. The outcome of the events metallic taste in my mouth and slight headache was not resolved and for all other events, it was resolved on 05Mar2021. No follow-up attempts are needed. No further information is expected.

Lightheadedness, dizziness, legs feeling heavy and tingly, chest pain (this started one day after receiving my dose), shortness of breath, back pain

The day after receiving my second dose of the COVID vaccine, I began to feel fatigued and started getting body aches (June 9). By June 10 I was taking 500mg of ibuprofen and having to lay down at work because of back pain, upper stomach pain, chest pain and migraine. By June 11 I began running a fever of about 101 degrees. The pain was getting progressively worse so I was on bed rest for the next few days, by this time (June 12-13). Every morning I was waking up with the sweats, but specifically on the morning of June 13, I woke up at 4:30am, shivering and sweating. I was to the point where my entire body was vibrating for 1.5hrs while I was profusely sweating. I had a sore throat so bad that I could hardly swallow. I was taking 1,000mg of Tylenol, which would only improve my symptoms about 30%. on June 14, I got a COVID, Flu and Strep test with the county, all which came back negative. At this point, I was in so much pain that I was not able to work or get out of bed, so I knew I needed to see a Doctor (after being told by many nurses that I should just "push through" the pain). On June 16 I was running a 103 temperature and went to urgent care (day 8 of side-effects). I was tested for Mono, also negative. The Doctor determined I was suffering from adverse side effects from the vaccine. I have this in a report. I was prescribed prednisone which almost instantly helped with all of the inflammation/pain. Today marks day 13, I still have slight back pain but have been taking the prednisone daily. I still am having shortness of breath, chest pain and upper stomach pain. The only thing that has truly helped the other symptoms is the prednisone.

My initial reaction to the vaccine was extreme tingling and falling asleep of my left arm where I had the injection. This occurred for the entire day of June 7th. On June 8th I woke up with slight tingling in my left arm but also with chest pain. A couple of hours after that I had shortness of breath and a tight throat. The tightness in my throat and shortness of breath lasted off and on throughout that day and the chest pain remained the same. The next few days my chest pain still remained with a tingling sensation and a fullness that came and went. That Friday, June 11th I had to use my inhaler as my throat felt very tight and I was having a hard time breathing. My heart immediately started beating so fast and I knew from using my inhaler here and there that I have never had that reaction. I went into urgent care that night and was told I have Costochondrtis.

After the second shot of covid vaccine i went to the ER for dizziness,a weird feeling on the chest,extreme shortness of breath,heart rate over 180 bpm,a near fainting feeling and fatigue.

Allergic reaction when getting COVID-19 vaccine l was given a Pfizer COVID-19 vaccine at the Pharmacy at around 1pm and around 1:05pm she presented to the pharmacy window with s/sx of SOA, sweating, tingling of hands/feet, and slightly elevated BP. She was assessed by the pharmacy team and it was determined the most appropriate to call 911 to have her accessed. She was assessed by EMS and it was determined that she was stable to be released on her own accord. She was given 25mg of diphenhydramine by pharmacy staff, but no other intervention was taken.

Swelling in arm, redness previously, Chest pains on the 29th , and this morning had problem with breathing and temp 103.9.

Roughly 5 weeks after the second dose of the Pfizer\BioNTech vaccine, patient caught Covid. During the first few (3-4) days symptoms were mild and limited to shortness of breath and being easily tired. After a number of days with symptoms, patient continued feeling worse and worse. Around the 4th day of symptoms patient's face (eyes, lips, lymph nodes, throat) began to swell which prompted a visit to the ER. Once admitted, patient spent 9 days in the hospital as she moved towards a stable condition. Upon further investigation and visits with multiple specialists, a dermatologist concluded this was a case of Stevens-Johnson syndrome which may have been brought on due to vaccine (and suggested contacting CDC about this case as to his knowledge this has yet to be documented).

In Post vaccination area pt stated "throat feels smaller", & "I feel hot". Pt seated in chair, appeared very anxious, pt tachypneic w/short, rapid breathing, diaphoretic, denies allergies to foods & meds, & denies hx of anaphylactic reaction, denies med hx, states no meds. Pt throat appeared WNL visually, no abnormality seen, pt also able to swallow & speak clearly, RN sat w/Pt to help calm down, used therapeutic nursing, calm voice, & active listening for Pt teaching of vaccine & what to expect post vaccine upcoming days, how to treat & care for common s/e to vaccine, & informed pt when to call dr & when to go to ER & call 911. Pt verbalized all understanding & stated "feel so much better & throat feels fine". States no needs at this time. Please see vitals below.

walking to her bed, and started to see stars, and felt like she was starting to faint; had trouble breathing, along with chest pain.; her daughter had the same thing happen again, but it was worse.; had trouble breathing, and some other side effects, like a sore throat, and nasal congestion; had trouble breathing, and some other side effects, like a sore throat, and nasal congestion; had trouble breathing, and some other side effects, like a sore throat, and nasal congestion; This is a spontaneous report from a contactable consumer (patient's mother). A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0138), dose 1 via an unspecified route of administration on 07Apr2021 at 17:30 (at the age of 27 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she she was calling on behalf of her daughter who had her first Pfizer COVID-19 Vaccine dose on 07Apr2021 at 5:30PM. She said her daughter woke up with a jolt at 1:00AM (08Apr2021), and had trouble breathing, and some other side effects, like a sore throat, and nasal congestion. She said her daughter had a COVID-19 Virus test done and the test was negative. Stated She said 5 days later, out of the blue, her daughter had the same thing happen again, but it was worse. She said her daughter was in the shower and had trouble breathing, along with chest pain. She said her daughter was walking to her bed, and started to see stars, and felt like she was starting to faint. She said her daughter sat down on the bed, and put her head between her knees, and was able to stop herself from fainting. The reporter stated her daughter was worried her symptoms were a side effect of the COVID-19 Vaccine. She said she hadn't read anywhere of that kind of side effect. She said the first time her daughter had trouble breathing, her daughter thought it was definitely a side effect of the COVID-19 Vaccine. She said for the same thing to happen to her daughter 5 days later had both her and her daughter wondering if what she had experienced was a side effect, or an allergic reaction to the COVID-19 Vaccine. The reporter said she was calling to find out if her daughter could get the second COVID-19 Vaccine after what she had experienced with the first COVID-19 Vaccine dose. The reporter stated that she had provided the Pfizer Pharmacist with the wrong COVID-19 Vaccine Lot Number yesterday (EW0138). She would like to find out if her daughter could get the second COVID-19 Vaccine after what she had experienced with the first COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Reported her daughter received her COVID-19 Vaccine at the . She said she believed that the was a federal COVID-19 Vaccination site. No further details provided. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts completed. No further information expected.

About 4 days after my vaccine, 07/04/2021, my mouth just hurt, really bad at 1st. I was unable to eat solid food for like a week and a half. Then I developed a sore throat and it was really swollen and red, but like spots that were swollen. I still have the sore throat as of today, 07/13/2021, my throat is still swollen and the spots kind a red and white. Dr. believes it was ulcer that were a side effect of the vaccine. She told me to wait it out and take Tylenol. No, I have not recovered because I still have swelling, redness and white spot, It's just less painful, as of last week.

pregnant at time of vaccination On 5/25/21, patient presented to ED and was admitted O24.420 - Gestational diabetes mellitus in childbirth, diet controlled O42.02 - Full-term prem ROM, onset labor within 24 hours of rupture On 6/10/21, patient presented to ED: O99.893 - Other specified diseases and conditions complicating puerperium CHEST PAIN SHORTNESS OF BREATH BACK PAIN

Started having left sided chest pain on 6/27 which progressively worsened over the next few days, called OB on 6/30 who instructed me to go to emergency department to be evaluated. Throughout the day the chest pain became progressively worse especially on inspiration also accompanied with difficulty to take a full breath. After testing done in emergency room I was admitted and diagnosed with pericarditis and said to be having an acute inflammatory response post covid vaccination. At time of adverse event I was 26 weeks pregnant with an uncomplicated pregnancy, estimated delivery date is 9/29

After second dose I have really bad headaches; Lips tingling/Tongue tingling; My eye starts drifting up or twitching when I try to chew,; Jaw pain; Have pain in my chest; Dysphasia; Can't eat food gets stuck; Tingling feet and hands; Burning in legs; Pain in neck and back; Pain in neck and back; Shortness of breath; Fatigue; Weakness in body; Stomach pain; Trouble sleeping; Brain fog; Dizziness; Depersonalization; Feels like spasms; Feels like whole in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07May2021 08:00 (Batch/Lot number was not reported) as dose 2, single (age at vaccination 27-year-old) for covid-19 immunisation. Medical history included, known allergies: Codeine, cinnamon, latex from an unknown date. Concomitant medication(s) included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 10Apr2021, administration site (right arm), administered at 10:00 AM (age at vaccination 27-year-old) for COVID-19 immunization experienced Leg pain, Fatigue and Weakness. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021 12:00, the patient experienced after second dose i have really bad headaches, lips tingling/tongue tingling, my eye starts drifting up or twitching when i try to chew, jaw pain, have pain in my chest, dysphasia, can't eat food gets stuck, tingling feet and hands, burning in legs, pain in neck and back, pain in neck and back, shortness of breath, fatigue, weakness in body, stomach pain, trouble sleeping, brain fog, dizziness, depersonalization, feels like spasms. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 04Jun2021. The patient not received treatment for events. The patient visited to emergency room visit/ physician's office for the events. The outcome for all events was not recovered. Information about batch/lot number has been requested.

Client became anxious 5 minutes following injection. Complained of short of Breath, being dizzy .R.N working with her and mom. in observation area, Assessed by EMT's. Vital signs stable. At 15 minute mark, EMT's evaluated client to be medically Stable and able to be discharged home.

Rapid heartbeat; Spotty vision; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 13:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included heart palpitations. The patient was allergic to past drugs acetaminophen (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR). Concomitant medications included propranolol (80mg) (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE) (50mg) and an unspecified birth control medication (MANUFACTURER UNKNOWN), all from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021 at 14:30, the patient experienced rapid heartbeat, spotty vision, and shortness of breath. It was reported that all symptoms were mild. 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 outcomes of rapid heartbeat, spotty vision and shortness of breath was unknown. No follow-up attempts are needed; information about lot number cannot be obtained.

Chest pain, feel like blockage to chest area, worsening on deep breathing and laying down, get some relief once sit up or stand up. Had short period of fast heart beats on Sunday night, but went away after a few hours.

on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back; headache; on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back; patient had increased heart rate; swelling of the throat; a very sore arm; sore arm proceeded the next day and the following day arms soreness was very minimal on 11Jul2021; This is a spontaneous report from a contactable consumer (the patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FA6780, expiration date was not reported) via an unspecified route of administration, in the left arm, on an 10Jul2021 at 12:45 (at the age of 27-year-old), as single dose, for COVID-19 immunization. The patient's medical history included allergies to Metal. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since the vaccination. On 10Jul2021 at 16:00, a few minutes after the first dose, patient had increased heart rate, swelling of the throat and had a very sore arm; sore arm proceeded the next day and the following day arms soreness was very minimal on 11Jul2021. On 13Jul2021 at 16:00, on the fourth day, patient had a headache, increased heart rate, and on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back (injected arm). Outcome of the events was not recovered. Follow-up actions are needed. Further information has been requested.

At 2:00 am in the following midnight, I started shivering. I couldn?t control my body and my jaw. This is the weirdest experience I?ve ever have in my life. Then I took my temp, 101.5. I followed the instruction, drunk a lot of water. Then thing got worse. I couldn?t stop vomiting. Even drinking water made me nauseous. I also couldn?t lie one my back bc this position made me dizzy and cannot breath smoothly. As a result, I spent whole night sitting on my bed, drinking water and then vomiting. Temp kept raising. In the morning, I couldn?t stand these symptoms. And I took one tablet Tylenol with some watermelon. I started sweating, A LOT. The med lowered my temp but not stop the symptoms. Still vomit, headache, joint/muscle pain, dizzy. The only thing I can do it stuck in my bed and breath. After two days, on Sunday , things finally got better. During this period, I took Tylenol every 6hrs and drink a lot of water. My vaccinator informed me it was better to let the body fight for the vaccine, but I really cannot do that. Without Tylenol I cannot survive. Anyway, the lady who gave me vaccine is really nice and knowledgeable. I kind of believe I am gonna have high Level of antibody since I have such strong reaction.

asthma; fever; chills; flu; coughing; body aches; could not breathe; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced asthma, fever, chills, coughing, body aches, could not breathe. She and her daughter got the first Pfizer covid vaccine on 09Apr. Nothing happened to her but her daughter, who is special needs and has asthma, has a fever, chills and it feels like she has the flu. She is coughing, has body aches and her lungs closed up and she could not breathe. Her doctors gave her prednisone, albuterol and budesonide as well as promethazine with codeine for her cough. She has a fever up and down. It's been going on for 72 hour now.Therapeutic measures were taken as a result of coughing. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

7/27/2021 @ 9:00pm broke out in hives, swollen lips & eyes, tight chest, short of breath. Took Benadryl for treatment. 7/28/2021 @ 10:30am broke out in hives. Took Benadryl for treatment. 7/29/2021 @ 03:00am broke out in hives. Took Benadryl. 7/29/2021 @ 12:30pm woke up with palpitations and shaking. No treatment. Called employee health to let them know to document my reactions. I was told by employee health @12:38pm to follow up with my PCP if this continues or worsens.

Fever of 103.0; Vomiting; Chills; weakness; shortness of breath; intense headache; lingering headache; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 10Apr2021 at 11:15 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN) for an unknown indication from unknown date. The past drug history was reported as latex and peanuts. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 20Mar2021, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 05:00, the patient experienced fever of 103.0, vomiting, chills, weakness, shortness of breath, intense headache and had lingering headache for a week after. The patient underwent lab tests and procedures which included body temperature on 11Apr2021 and resulted as 103.0 (units unspecified). The clinical outcome of the events fever, vomiting, chills, weakness, shortness of breath and headache were recovered with sequelae on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to amoxicillin sodium on an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness on 27Dec2020 with outcome of recovered , dizziness on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: racing on 27Dec2020. The patient received diphenhydramine (BENADRYL) to treat dyspnea.

I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.

Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.

After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.

Pt reported difficulty breathing, tightness in her throat and felt very dizzy. She was noted to be red faced along with redness in her throat and chest. Pt given Benadryl 25 mg liquid po at 0925 am and coaching for slowed breathing and symptoms recovery. She reported feeling better gradually and with in 15 minutes pt felt much better she declined ER transport

Headache, Myalgia, Fever & CoughWheeze Narrative: Employee took cough medications. (Robitussin, Day Quill)

Anaphylaxis Chest tightness started @ 6:00pm following vaccine. Developed wheezing in all lung fields (confirmed by MD.) Developed hives- Albuterol, Benadryl and epinephrine administered @ 700pm. EMS called and transported to Hospital.

Same day extreme lethargy, woke up with severe muscle and joints pain, specifically my hips, general body weakness, headache, low grade fever 99.4 and taking Tylenol 01/9 still feel lethargic and 1/10 intermittent cough and heaviness when I breathe

Anaphylaxis c/o chest tightness and "unable to breathe"-epi pen administered with immediate response. Narrative: c/o chest tightness. epi pen administered with immediate response. "I can breath now," pt. stated. Monitored, d/c'd to home/released from work.

Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime. 2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.

1/11/2021 9:00pm - injection site arm sore, body aches, fever up to 100.8 degrees Fahrenheit, chills, and headache. 1/12/2021 8:00am - severe body aches, fever up to 101.0 degrees Fahrenheit after takingTylenol and chills. 1/12/2021 6:00pm - fever 100.6 degrees Fahrenheit after taking Tylenol, shortness of breath, and deep dry cough. 1/13/2021 11:00am -shortness of breath, deep dry cough worsening with tachycardia. Went to urgent care diagnosed with upper respiratory infection due to second covid vaccine reaction prescribed prednisone.

The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.

difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Reporter received the second COVID-19 vaccine on 1/20/2021 at 08:25 AM. She had proactively taken diphenhydramine following the reaction to her first dose. Around 08:40 AM, she began to feel tightening in her throat and some heaviness in her chest. She was evaluated by a nurse who took her blood pressure (normal), however, her heart rate was elevated (noted this could be that she was nervous following initial reaction and repeat tightness in throat). Around 08:55AM, she began to feel like her tongue was swelling and that she had a "bubble" on the top of her throat. She was taken to the Emergency Department for evaluation. She was given hydroxyzine, famotidine, and dexamethasone in the ED and was discharged and felt stable. She reported a continued odd sensation in her throat the evening of the second vaccination. This feeling resolved the next day, and she reports no additional side effects from the vaccine. Of note, patient had experienced a similar reaction following her first vaccination (E-number 261589)

Reporter received the first COVID-19 vaccine on 12/30/2020 and waited the recommended 15 minutes for observation. After the observation period, she left the facility and started to notice tightness and what she describes as a "bubble" at the top of her throat. She also noticed a tingling sensation in the top of her lip, but did not notice any swelling. Reporter took 25 mg of liquid Benadryl and within an hour the sensation in her throat began to go away. Reporter received the second COVID-19 vaccine on 1/20/2021 at 08:25 AM. She had proactively taken diphenhydramine following the reaction to her first dose. Around 08:40 AM, she began to feel tightening in her throat and some heaviness in her chest. She was evaluated by a nurse who took her blood pressure (normal), however, her heart rate was elevated (noted this could be that she was nervous following initial reaction and repeat tightness in throat). Around 08:55AM, she began to feel like her tongue was swelling and that she had a "bubble" on the top of her throat. She was taken to the Emergency Department for evaluation. She was given hydroxyzine, famotidine, and dexamethasone in the ED and was discharged and felt stable. She reported a continued odd sensation in her throat the evening of the second vaccination. This feeling resolved the next day, and she reports no additional side effects from the vaccine.

Labored breathing/shortness of breath; Extreme fatigue; Resting heart rate 104 bpm; Full body myalgias; Nausea; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at the left arm on 09Jan2021 17:00 at a single dose for COVID-19 immunization at a clinic. Medical history was reported as none. Patient has no known allergies. The patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (VELIVET). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at the left arm on 21Dec2020 14:45. The patient experienced full body myalgias, nausea, extreme fatigue, resting heart rate 104 bpm, and labored breathing/shortness of breath on 10Jan2021, 04:30. There was treatment for the adverse events. Patient has not been tested for COVID 19 prior and post vaccination. The patient was recovering from the events.

Anaphylaxis shock- patient became hypoxic with shortness of breath, chills and tachycardia. EpiPen was administered and 911 was called. Patient was transported to ER.

My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .

patient experienced swollen tongue and throat. Also onset headache. Given DiphenHydramine with good effect. No breathing difficulty.

Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; Right breast implant exploded and spread to her neck where she was having difficulty breathing/Right breast implant erupted. Silicone in breast implant spread into her neck where patient was having difficulty breathing; This is a spontaneous report from a contactable Physician. A 28-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 13Jan2021 10:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. Vaccine location was right arm. No prior vaccinations within 4 weeks. Patient called stating she wasn't feeling well. She was in the resident lounge and all of a sudden, the right breast implant just popped. Silicone in her breast implant spread into her neck where patient was having difficulty breathing on 14Jan2021. The patient was hospitalized on 14Jan2021, with pain medication and will have to have the implants removed. They think it is vaccine related. Patient was waiting for general surgery. The outcome of right breast implant exploded was unknown. The outcome of difficulty breathing was not recovered. Information on the Lot/batch number has been requested.; Sender's Comments: The reported breast implant rupture and associated difficulty breathing were more likely due to breast implant surgery and the quality of implant, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Chills, joint pain, chest pain, shortness of breath, low grade fever, nausea, vomiting, headache. Recovered from COVID in 8/2020.

After client received her COVID-19 Pfizer vaccination, client was sitting in the observation area of the vaccine clinic (as required after receiving the vaccination) and it was observed by the EMS person and Public Health Nurse that was there, that client was itching her forearms. Client had developed a red rash, starting on her arms and then her neck and chest (blotchy red). She complained of itching on her arms, neck and then her head. She reports she felt like she was "on a boat", feeling lightheaded. Client was taken to the emergency room where client reports she received IV Benadryl. Client reports that after being at the ER for 1.5 hours, her rash resolved and she no longer felt lightheaded. Reports no other symptoms after that.

Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization. Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship. Of note, the patient has a medical history of seizure disorder. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Hives; itching; shortness of breath; chest tightness; severe hip and low back pain; severe hip and low back pain; headache; concomitant medications included mercaptopurine; concomitant medications included mercaptopurine; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular at right arm on 19Jan2021 at 15:00 at single dose for COVID-19 immunization. The patient medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient's concomitant medications included mercaptopurine, mirtazapine (REMERON), sertraline hydrochloride (ZOLOFT), cetirizine hydrochloride (ZYRTEC). The patient previously took ADDERALL, HUMIRA and REMICADE and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at right arm on 30Dec2020 at 15:45 at single dose for COVID-19 immunization. On 20Jan2021 at 06:00, the patient experienced hives, itching, shortness of breath, chest tightness, severe hip and low back pain and headache. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine, EPI PEN, TORADOL, acetaminophen, DECADRON, DILAUDID. The patient outcome of the events was resolved with sequel.

10 minutes after vaccine, patient became unconscious and fell out of chair. Began gasping for air and clenching fists. Epinephrine was administered immediately. Patient began breathing normally after a few minutes. The whole event lasted about 5 minutes. Patient disclosed afterwards she had a fear of needles. This did not look like a panic attack, it appeared to be a true anaphylactic response.

Chest pain started on 01/30/2021 around 1pm. At this time the chest pain was constant. The next couple of days the chest pain was only on exertion. The chest pain got better and I only experienced slight SOB of exertion over the next few days. Last night (02/07/2021) I experienced extreme dizziness (when walking and lying down). While laying in bed the room was spinning.

1 week after receiving 2nd vaccine 8 started to have tachycardia, palpitations, flutters. It has also been a little harder to breath. I got a ZIO monitor placed 2/5/2021 to monitor my episodes.

I had a fever, chills, headache, and fatigue. A week later, I'm still not feeling 100%. The scariest reaction was a rash that broke out all over my chest. I also had one on my forehead. It looked like lacerations and I still have marks left behind. The rash on my chest was very hot and I had trouble breathing at night. I took pictures.

Fever Shortness of breath Chills Unable to move my arm My arm was swollen and red around the area where the vaccine was injected. Sore throat

Within minutes of pt receiving injection, pt verbalized feeling butterflies in the stomach, lightheadedness and tightening of the throat. Epi-pen and Benadryl 50mg were given 5 minutes after symptoms were reported. Pt was transported via EMS to ED

10 minutes After injection, tongue and throat began to swell, breathing became labored, and skin on neck was itchy and red. Liquid Diphenhydramine was attempted, however was unable to be administered without slight aspiration, so injection of Epinephrine was administered. Within 5 minutes, airways returned to normal, SPO2 on room air was 98%, and was cleared to go home.

Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. 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.

12 hours after her second COVID-19 vaccine, the patient experience shortness of breath that seemed to be an asthma attack (which she hasn't had in 10 years). She used a short acting inhaler. Then she experienced hives 1 hr after shortness of breath which she treated with benadryl. She was asymptomatic by the morning and has continued to be stable since event.

Blindness (loss of vision); Neurocardiogenic syncope; Tingling in hands and feet/lower legs; Panic attack/unable to breathe; Nausea; Vomiting; Dehydration; Tiredness; Body aches

fever up to 39, continue to have fever for 2 days. acetaminophen is good to relieve but can't eliminate. start to have chest pain under breast when heavily breathing in after 48hrs.

Little shortness of breath; Dizzy; very tired; Chills; Stiff neck/ head and neck are very stiff; Felt crummy; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 21Jan2021 at a single dose on the left arm to be prevented from COVID 19. The patient's medical history included COVID from 04Dec2020 and after that, on unspecified date, COVID test was negative. Concomitant medication was reported as none. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 on the right arm at 28- years of age to be prevented from COVID 19. On 21Jan2021, the patient had what everyone was talking about, the chills and stiff neck, she felt crummy, muscle aches, thought it was the normal. The next day (22Jan2021), she had a little shortness of breath, she felt dizzy on and off and her head and neck are very stiff, and she is very tired. The outcome of the events stiff neck/ head and neck are very stiff, felt crummy, and dizzy was not recovered while the other events was unknown. Information about lot/batch number has been requested.

Swelling of face and throat, did not require epinephrine. Treated with steroids and allergy medications.

Dizziness, fainting, difficulty breathing, pressure on chest, heart palpitations, high blood pressure, elevated heart rate, body temperature increasing.

Right after vaccine injection, patient started having tingling in her face and feeling sob. Episode last about 5 mins. Afterwards, pt felt fine. Denies chest pain, rash, itching or dizzy. RR 18 BP 120/73 HR 74 and oxygenation of 99%.

Shortly after receiving the shot at work, I developed worsening dizziness as well as a headache and internal tremors, which resolved. I later developed generalized itching, worse on the back of my hands and feet, which resolved. The following day, I developed palpitations while at rest and mild shortness of breath. I also had a brief bout of nausea, which resolved, but I still have palpitations and mild shortness of breath.

Patient received her 2nd dose of Pfizer Covid-19 vaccine, Lot #EN6199, in her left deltoid on 3/11/2021 at approximately 9:24am. Patient disclosed to nurse and medic at vaccination clinic that she had allergies to peanuts and eggs and would need to wait in the parking lot longer than usual. Nurse and medic confirmed this and advised she wait a minimum of 30 mins but longer if she felt necessary. While waiting in the parking lot, at approximately 10:25am, patient began to have shortness of breath and made the medics aware. Patient also had facial redness and nausea. Medics administered 50mg of Benadryl , 0.3ml Epinephrine, and started IV with IV fluids. Patient was transported to Medical Center.

Metallic taste in mouth, then following with numbness, tightening, and tingling in throat and mouth. First treated with Benadryl, then decadron and Pepcid. After reaction did not stop, I was taken to the ER and given IV steroid(s). On discharge I was given epinephrine and prednisone. This occurred over a four hour period.

Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fatigue, migraine, un-productive coughing, chest tightness, difficulty breathing.

Patient started complaining of difficulty breathing, difficulty swallowing and nausea. Wheezing noted, epi administered. Patient stated that her symptoms improved following epi. EMS called and patient transferred to the hospital.

Itchy swollen fingers and palms the following morning (Thursday, 3/11). Red itchy bumps (hives?) on left wrist, then later on right wrist. Heels and feet had same reaction on Friday. I took Benadryl and was OK for all of Saturday. Today (Sunday, 3/14), I broke out the same rash but one my face, mostly around my jaw and hair line, and my neck. Some coughing and wheezing, which I had not been experiencing prior

28 yo F who had SOB and wheezing and itchy throat that occurred about 10 hours after receiving her vaccine. Symptoms resolved after 2 days and now feels fine.

aside from the normal body chills I felt my throat get slightly swollen, reaction was stronger during the first several minutes & was less but still felt for the following hour and a half

Lung pain; splitting headache; could not sleep; feels run down; developed bubbles filled with fluid all over her lips; feels bad; achy; arm hurt; swelling and tingling sensation around my lip; swelling and tingling sensation around my lip; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 09Feb2021 at (at the age of 28-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified) for Meniere's disease. The patient previously received the first dose of BNT162B2 on 15Jan2021 and experienced achy, arm hurts, weird lung pain and splitting headache. Within minutes of receiving the second dose on 09Feb2021 the patient experienced swelling and tingling sensation around the lip and arm hurt. On 10Feb2021 the patient experienced bubbles filled with fluid over her lips in the morning, she felt bad and is achy; from an unknown date the patient experienced feels run down, weird lung pain, a splitting headache and she could not sleep. Therapeutic measures were taken as a result of the headache which included Aleve and she drank a bunch of water with her daily vitamins. The clinical outcome of the events lip swelling, tingling lips, lung pain, insomnia, fatigue was unknown; lip blister, feels bad, achy and arm hurt was not recovered; and headache was recovered The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

1450- pt requested assistance for tachycardia, tingling lips and dizziness. Requesting benadryl, 50mg given PO. VS 128/54, P90, 20R, 98% sat. 1500- increased dizziness, throat tingling. VS 130/89, 104P, 24R, 98% 1508- increased throat tingling, "hard to breath" declines epi or EMS to be called. 1511- self-administered epi pen, EMS notified. 1516- remains light-headed/dizzy, resp adequate at 22/min, O2 sat 98% 1524- speaking clearly, remains fully conscious. Resp regular. Lungs CTA, MM pink. VS 130/70, 83P, 20 R, 98%sat 1530- Await EMS arrival. Pt able to easily talk on phone with family member. Still c/o itchy throat and lips. 1535- EMS here, pt escorted out building with EMS at 1537.

Throat Swelling, did not really affect breathing, also lymph node swelling, muscle weakness, tiredness. Did stop at doctor's on way home and got high dose benedryl and steroid shot.

tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient). A 28-years-old female patient receive dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation. Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil) to an unknown date. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis. The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season. Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years. The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia on 08Jan2021 with outcome of unknown and "Vacematter 08:45". Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28. Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia. The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.

Syncope, tachycardia, shortness of breath, chest pain/tightness, throat tightness. Resolved in 10 minutes. No treatment needed.

Collapsed; difficulty breathing; weakness; Pain in chest; tingling all over body.; This is a spontaneous report from a contactable consumer (parent). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 10Mar2021 at 12:15 (Lot Number: EN6206) (at the age of 28-year-old) as single dose for COVID-19 immunisation. Medical history included bipolar from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMICTAL); amphetamine aspartate/ amphetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) and alprazolam (XANAX); all taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 at 12:15, the patient collapsed and experienced difficulty breathing, weakness, pain in chest and tingling all over body. The events resulted in physician office visit. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.

I had sore for three days days, then on Monday afternoon I started having difficult breathing, I can?t really work because I?m not breathing properly. It?s been like this for 4 days. I?m not sure if this is a an allergic reaction like it says or something serious. I?m going to the doctor tomorrow and see if something is wrong with my lungs because I get panic attacks cause I can?t breath.

About 10 minutes after my vaccine, I felt a tightness in my throat, heart rate increase, and a wave of dizziness. That?s when I called the paramedics over. They noticed irregular heartbeat and I was taken to the ambulance - I could walk. In the ambulance they took an EKG and my heart rate continued to be irregular. I felt some face numbness and said I wasn?t feeling better. I was taken to hospital where I started to feel better.

Waited for the 15 minute observation period and felt fine, but while driving home (approximately 20 minutes after injection) I caught a glimpse of my face in the rearview mirror and noticed that it was swollen, specifically in the cheeks and under eye regions. When I got home 5 minutes later, it was more swollen and my throat was feeling tight, though not obstructing my breathing. I monitored the reaction and did not take any medications. About 30 minutes after the reaction began (50 minutes after injection), the facial swelling began to diminish and both the facial swelling and throat swelling went away within about an hour from the onset of the reaction, I was very tired and had a headache the rest of the day, which I understood to be more typical symptoms.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild

C/O throat tightening so was monitored and offered fluids, Sensation worsened and voice became hoarse. 110/75 P-108 02-99% 8:39 AMEpi 0.3mg IM, patient reported immediated relief. She had had some throat tightness following the first dose and saw her primary care provider who stated she was cleared for 2nd vaccine

This is a spontaneous report from a contactable consumer. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 to 15Feb2021 (Lot Number: EL3247, at the age of 28-years-old) as single dose for covid-19 immunization. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (Lot Number: EL3247) as single dose for COVID-19 immunization. The patient did not have known allergies. There were no concomitant medications. The patient experienced shortness of breath, nausea, vomiting, dizziness when going from a sitting to standing on 15Feb2021. The outcome of the events was not recovered.

Anaphylactic reaction, throat swelling, tongue swelling, confusion - Epi pen administered 15 minutes after the vaccine and transported to the ER via ambulance. Gave me Benadryl, zofran, headache medicine, fluids

After 10 min waiting she felt tightness in the throat, as if something was stuck in her throat, she went to the bathroom to throw up, the nurse went to check her and she realized it was the allergic reaction, she was taking to the nurse's room, by then which she was showing symptoms of difficulty breathing, that was when the epi pen was administered. A nurse stayed with her for observation. EMT came into the building bringing more equipment. Once her condition improved, the nurses suggested her that the next step should be going to a hospital to follow up and to be under care and observation. She declined, then the EMT offered her to take her in the ambulance to the hospital, which is the protocol, but she declin

Fever ranging from 100-103 for approximately 4 days (now gone) Chills that last for 5-10 minutes for approximately 4 days (now gone) Intense muscle and joint pain throughout body still ongoing; affecting ability to do nearly anything but go to the bathroom Inability to keep most food down Intermittent chest pains Difficulty breathing Gas Nausea Treatment has been with the use of Tylenol to reduce fever and manage pain, Tums to assist with the gas-related issue.

felt very faint; lost visual clarity; profuse sweating; ears ringing; severe dizziness; heart palpitations; tension in my throat; severe nausea; This is a spontaneous report from a contactable consumer (patient) who reported for herself A 28-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN5318), in left arm on 25Mar2021 at 14:30 (at 28 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Mar2021 at 14:30 (as reported) the patient felt very faint, lost visual clarity, had profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in her throat and severe nausea. Events were also described as follows: about 2 mins after (as reported) felt very faint, lost visual clarity, profuse sweating, ears ringing, severe dizziness, heart palpitations, tension in throat. Remained for about 5-10mins. Then severe nausea. No treatment given for the events. The final outcome for all the events was reported as recovering.

Asthma exacerbations without any triggers. I could be sitting watching TV, doing absolutely nothing and not around any triggers, and my chest becomes tight. Had to use ProAir Albuterol inhaler at least 3 times a day.

tongue and lip tingling then swelling sweaty palms nausea bladder and fecal incontinence black out/ loss of vision vision coughing labored breathing complete throat swelling burning all over resulted in epi pen usage then admitted to the emergency room

Hot flashes, nasal and chest congestion, occasional trouble breathing, bodyaches, fever and chills. Difficulty breathing was worse when I would talk too much or move. Treatment has consisted of stress doses of my Hydro Cortizone, ibuprofen, equate cold and flu and Benadryl.

Day 1 (4 hours after vaccine): Hives breakout all over body (legs, arms, stomach, back), pain in sternum Day 2: Pain in sternum, hives on arms Day 3: Swelling of lips, tongue and throat closure, hives all over body - went to urgent care Day 4: Swelling of lips, hives all over body, shortness of breath, pain in sternum Day 5: Hives all over body - blotchy, pain in sternum Day 6: Hives covering arms and legs, pain in sternum

Patient reported feeling like throat was swelling close. Onsite EMS was called vitals normal. Patient given benedryl and was told to pull over and call 911 if syptoms come back on the way home.

Slight swelling in face within 5-10 minutes of shot. Swelling of throat within 15-20 minutes of shot. Epinephrine, Benadryl, methoprednisone, and Pepcid given 30 minutes after shot. Symptoms decreased over 20-30 minutes

With in a few minutes of the injection on 04/14/2021 I got a metal taste in my mouth, the left area of my lower jaw became numb, my throat felt itchy, my pulse skyrocketed and my chest constricted. I have a similar reaction with contract during a CT scan and didn't think much of it and assumed it would dissipate. As the day continued my chest began to feel tighter and I was having a difficult time breathing. I became easily winded walking 100 feet. About an hour later I was nauseous, had abdominal pain, fatigued, dizzy, pain at injection site and felt itchy everywhere. The numbness of my face disappeared about 3 hours later. My symptoms are still continuing as of 04/15/2021. As of 4/15 my breathing has been more labored, I've dizzy standing and sitting and eating has become more difficult. When I eat, I get the sensation that my throat is about to close. Otherwise, the rest of my symptoms have not gotten worse, but they also have not gotten and better. As of the afternoon of 4/15 I've begun taking Benadryl, if this does not lessen my symptoms, I will be speaking with a doctor.

Patient began to have an asthma attack after receiving COVID vaccine. Patient given 50mg benedryl. Patient then had family member drive her to instacare to be seen.

Pt received vaccine, was observed for the standard 15 minutes and left, driven by her mother. In the car, pt started to complain to mother about ?fire in her throat? and difficulty breathing, itchy/rash on right arm, coughing nonproductive.First set of vitals 1550/110 99 98%, no difficulty breathing noted, but pt seemed anxious. After 10 minutes, vitals improved to 138/98 90 97%, respirations 16-18. Pt seemed calmer, mother felt comfortable taking her home after about 20 minutes, cleared by EMS. REVISED: Allergies to mycins, latex, once experienced Steven -Johnson?s in response to an antibiotic

Per Safety Officer to this RN: was in post observation after her 1st dose Pfizer. Pt states hx of anxiety attacks and this feels the same. Pt states hx of allergies to oxycodone, cefapime and benedryl. Pt c/o chest pain 3/10, dizznes, and SOB. EMS with patient to assess and released home with boyfriend. Pt boyfriend to drive Pt home and will stop for food along the way. VS 1257 BP 118/70 HR 73 RR 18 Temp 98.3F temp O2 sat 99% on RA

The morning after the shot I got body aches chills and fatigue. I woke up from a nap with my heart pounding. My heart rate was elevated and it did not calm down. I started to have trouble breathing. I was advised by my OBGYN to go to the ER. My heart rate was 100-115 and my D-Dimer level was abnormal. I was given a saline drip and my heart rate was still elevated. My breathing was still a little labored. when I tried to breathe deeply. I was prescribed with a blood thinner for the weekend. I returned for a repeat CT scan. My heart rate returned to normal after about 48 hours. I had not had any symptoms with the first dose. Due Date: 07/17/2021 Pregnancy: First

After 20 minutes, the tongue started to swell and lips. An hour later I had some hives on my stomach. This continued for a couple of days. 5 days later my face, eyes, lips and tongue are swollen. Difficulty breathing at times.

Immediately after second dose: injection site pain, body aches, extreme fatigue, nausea, trouble breathing One month after second dose: early onset menstrual cycle, heavy bleeding, intense flow/clotting, hemorrhage-like event, prolonged period (over 7 days)

Client had her vaccine grabbed her throat, pinching her neck leaving bright red marks. Interpreter said she was short of breath. Taken to the monitoring room to lay down. PSO2 98% heart rate 178, blood pressure 138/94. Reports through interpreter waves of being hot and being tired. Monitored client heart rate went down to 158 reporting still some shortness of breath. Continued to rest. Client then reporting via interpreter that she was cold. 0847 blood pressure 138/88, heart rate 124. remained tired and not feeling well enough to sit up. Client then taken to ER via wheel chair for further evaluation.

13:10 After 2nd covid vaccine, pt reported feeling "very dizzy and weak" and that her legs from thighs to calves felt numb bilaterally. Reported SOB intermittently. Lungs clear to auscultation. VSS BP 140/72, HR 116, R 20, O2 sat. 76-87%. 13:20 25 mg IM benadryl to right deltoid. Pulse ox replaced to r. finger = 90-94%. This RN consulted with RN director of vaccine clinic, RN who recommends pt follow up at urgent care. 13:40: Pulse ox continues 90-94%. Pt reports legs continue to feel numb. Pt advised to f/u at urgent care. Pt agrees with plan and will be driven there by her sister. 1344: Urgent care called and notified of pt imminent arrival and report given to RN. Care relinquished.

Patient received Pfizer vaccines on 12/19/20, 1/13/21. Tested positive for COVID-19 by PCR on 4/7/21. Symptoms of cough, myalgia, sore throat, mild dyspnea, congestion/rhinorrhea. Treated w/ Prednisone course.

On 4/21 at approximately 1505, received her 2nd covid 19 vaccine (Pfizer, BioNTech lot ER2613) at her desk, vaccine was given in right arm. She was going to be monitored by other MA's and Dr in area who was working with her at time of injection. At approximately 1513, calls clinic to report she has hives on her face and throat feels tight. Two RN responded to . RN reports had red rash on right side of face and itchy throat. Administered diphenhydramine 25mg IM right deltoid at 1525 and depo Medrol 80 mg IM right deltoid at 1528. After 15 mins of administration, reassessed and reports throat symptoms decreased. Check with patient at 1615. Patient reports throat symptoms have significantly improved and only dry throat. No difficulties breathing or swallowing noted. Assessed right cheek, no redness or hive noted. Patient reports her right cheek doesn't feel as tight as it did before. Patient sts Dr who she's working with will looked over her and helped direct her medication given as needed. She left work at 1740, prior to leaving denies any facial swelling, SOB, hives. On symptoms is fatigue. She has anaphalytic kit as home for home infusion for Crohn's therapy and for bee allergy. On 4/22-Called and spoke with patient and she denies any symptoms. She reports when she got home she ate dinner and went to bed. Woke up in the morning feeling great. Patient received her 1st covid vaccine (Pfizer, BioNTech lot EM9810) on 3/18/21 in right arm with no reactions. She did test positive for covid-19 on 3/26/21. She has recovered from covid-19 and returned to work on 4/4.

Immediately following IM injection of vaccine, patient reported feeling flushed and slight shortness of breath as needle was being removed. Patient denied progression of SOB, wheezing and sx resolved immediately. On auscultation, patient lungs were CTAB without w/r/r/c. No angioedema. Vitals: temp 98.8, HR 72, RR 22, BP 128./76 Patient reported all symptoms of feeling flushed and SOB resolved by 10:50 AM.

Redness at vaccine site on 4/16/21. Redness started spreading on 4/18/21, with pruritic rash across chest. Today developed rash extending onto neck, tightness in throat, and mild swelling of the lips.

shortly after receiving the vaccine, the patient reported shortness of breath, scratchy throat, and tingling of the face and lips for which she was administered an adult epipen and 50mg benadryl by mouth. Vital signs obtained simultaneously demonstrated normotension and oxygen saturation greater than 98%. Her symptoms improved, vital signs remained stable, and she was transferred to the local ED by EMS. At the ED, her symptoms did not recur and she was discharged from the ED. She followed up late in the afternoon in the base clinic and reported resolution of her previous symptoms with only a lingering headache.

My throat hurts a lot. I feel two balls so tight there. I feel my glands swollen. My head hurts constantly. My body hurts. This started 10 days after having the first dose of the vaccine. Take a COVID test and it came back negative.

Approximately five minutes after being vaccinated the patient described what she felt was a hot flash and then became dizzy with sweating, rapid breathing, and pale skin.

Received the first dose on 4/7/21 at 3:30 pm, no adverse affects. Received the second dose on 4/28/21 at 3:30pm, only a sore arm for the first 24 hours. At about 3:30pm on 4/29/21, began to feel a tightness in the chest, took my inhaler and it provided slight relief. At 3:30am on 4/29/21, throat began to swell so I went to the ER to get that checked out. They gave me Benadryl, a steroid shot, and some Pepcid for anti-inflammatory and provided prescriptions for when the medicines they administered wore off. From 5/1/21 until today, I have felt slight swelling in the throat and mouth and sinus areas, all manageable by prescriptions given. Today, 5/3/21, felt fatigue and headaches. There is still a bruise at the sight of injection, but no swelling there.

I previously tested positive for COVID on 11/4/20. I had fever, chills, feeling of being very cold, cough, headache, rigors, fatigue, nausea, dizziness and was slightly short of breath one night. I recovered within two or so weeks. I was not hospitalized. I recieved my first dose COVID Pfizer vaccination on Tuesday, 4/13/21 at 1:10PM. On 4/16/21, I woke up around 8:00AM with blurred vision. I took out my contacts three separate times because I was convinced I kept putting them in wrong. As I was staring at the computer, my vision was very blurry and distorted. That night, I went to dinner with my father, a few other family members and friends. I kept remarking how my vision was blurry.

Difficulty breathing Fatigue Muscle or body aches Headache New loss of taste or smell Sore throat Congestion or running nose

On 5-4-2021-Patient returned to the pharmacy approximately 5 hours after their vaccination. She was complaining of tightness in her chest and difficulty breathing. She was referred to the local emergency room. On 5-5-2021- I spoke to the patient she said she was just feeling tired today. The emergency room did an EKG and wanted to observe her for 8 hours. She did not stay for observation. She believes her EKG was ok.

Pt is a 28 y.o. female past medical history of asthma with albuterol and Symbicort use daily, eczema, food allergies. Received and tolerated first dose of Pfizer COVID-19 vaccination on 2/12. Report of allergic reaction after receiving her 2nd COVID-19 Pfizer vaccine on 3/11/2021. She felt like her throat closing up and developed a facial rash. She had immediate onset of nausea and dry heaving while feeling a sense of warmth was beginning in her feet and radiating up through her body. She received IM epinephrine and 50 mg Benadryl by EMS in the field was transported to the Emergency Department for further evaluation treatment. At the ED she reports that her symptoms have begun to resolve and denies any respiratory difficulty. An additional 20 mg Pepcid given in ED. Symptoms completely resolved on discharge and EpiPen prescription refilled. Follow-up with allergist recommended.

Extremely elevated heart rate (still elevated days after injection), vertigo, shortness of breath, headache, a sense of heaviness throughout the body, extreme fatigue (still days after injection), body aches and fever.

Pt c/o difficulty breathing, anxiety, felt like having heart palpitations. Lungs clear, VS WNL. Pt felt better after water and rest. Patient stable and released from vaccination site.

Shortness of breath 5 days after the vaccine that persisted 2 weeks, limiting the ability to talk, eat a full plate of food, or walk to the bathroom without stopping to catch my breath. Shortness of breath still comes and goes at this time currently in my daily life.

Full blown anxiety attack; Heart started to race, it felt like it want to come out of my chest.; Eyes start to go blurry; Sharp back pain; Shortness of breath; Blood pressure high; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0162), via an unspecified route of administration on 15Apr2021 12:00 in the right upper arm at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: ER8733) on 25Mar2021 in the right upper arm for COVID-19 immunisation. Patient experienced a full blown anxiety attack. Her heart started to race, it felt like it wanted to come out of her chest. Patient also felt that her eyes started to go blurry and she had like sharp back pain and they put her on the stretcher and that mainly she had like shortness of breath with the main thing that she asked the nurse that people tended to get anxiety since they had been given initial of dose and she said no. Because of that nurse thought that patient should call Pfizer to report because nurse said that might be something like a side effect and they put her on the stretcher right away. Patient was on the stretcher for 40 minutes. These happened on 15Apr2021 13:00, an hour after vaccination. Patient did not receive treatment for events. She was given a whole bunch of water because she had like anxiety, the heart was racing fast, patient was kept on checking the high blood pressure until it went to low. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

28 y/o female presents with c/o feeling dizzy, heaviness in the left arm in observation after receiving her second dose at 1635. Patient tolerated first dose without any adverse reaction. Symptoms then progressed to difficulty swallowing, throat swelling, hoarseness, full body rash. Patient was alert and oriented x 3. Patient denied difficulty breathing. EMS administered 0.3 mg IM Epinephrine (Right Deltoid) at 1711, 50 mg IV Benadryl at 1718. Blood Glucose was 116 at 1719. Patient was given IV fluids and IV Dexamethasone during transport to Hospital.

Felt burning in back of left hand in the first 15 minutes. Once released and able to drive off, began to feel 'off' on the 15 minute drive home. Hive-like reaction on skin, wheezing that required inhaler and overall terrible feeling. Did not abate until 10 PM that night.

Patient stated she was feeling dizzy and heart racing about 10 min after receiving the vaccination. Pt reports that she has a history of anxiety attack. Talked with patient for about 10 min and worked her through her breathing to decrease any potential anxiety attack. Pt started to state that she felt like she could no longer breathe and was having difficulty breathing. Pt's started to produce hives around her throat, her hands felt cold to touch and pt then passed out. At that point, Epipen was administered to patient and 911 was called. Pt woke up after Epipen was administered and said she was able to breathe again. EMS came to observe pt and took pt to Emergency Room.

Within two minutes of receiving the COVID vaccine my throat started to tighten up on the left side, similar to what I experience when I have an allergic reaction to food. It progressed and spread throughout my throat and a rash/hives developed on my left side neck and chest within 5 mn of the dose. Within those 5 minutes I took Benadryl (5 tablets) and decided since my throat was right and I had a skin rash to go to the ER. Did not take an epi (have them due to food allergies) since the vaccine site was 6 mn away from the nearest hospital.

Within 24 hours: Fever over 100°F, chills, vomiting (possibly with blood), coughing, runny nose, body aches, fatigue, menstrual cramping and discharge, dizziness, migraine After 36 hours until now (68 hours later): Shortness of breath, fatigue, body aches, migraine, severe menstrual cramping and discharge, dizziness, coughing

shortness of breath; asthma attack; hives; This is a spontaneous report from a non-contactable Pharmacist. A 28-years-old female (pregnant: unknown) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via intramuscularly on 28Jan2021 as single for covid-19 immunisation. Patient took first dose of BNT162B2 (Lot number: EL3246), via intramuscularly on 07Jan2021 (at age of 28-years-old) for covid-19 immunisation. Facility type of vaccine was hospital. The patient medical history was not reported. Concomitant medications included (Other medications in two weeks) hydrochlorothiazide. It was unknown that patient had other vaccine in four weeks. Adverse event start date was 28Jan2021. Adverse event 12 hours after her second COVID-19 vaccine, the patient experienced shortness of breath that seemed to be an asthma attack (which she hasn't had in 10 years). She used a short acting inhaler. Then she experienced hives 1 hour after shortness of breath which she treated with Benadryl. Covid prior vaccination was unknown, covid tested post vaccination was unknown. Patient received short acting inhaler, Benadryl as treatment for AE. She was asymptomatic by the morning and has continued to be stable since event. The outcome of event was recovered on an unknown date in Jan2021. No follow-up attempts are possible. No further information is expected.

Approximately 4.5 hours after injection my upper body around my ribs and back felt as if there was a band tightening. There was a lot of stress and pressure and inflammation in my upper body especially near the base of my heart. My heart beat was rapid and I was short of breath. The event lasted approximately 25 minutes.

Swelling of Throat- treated with benedryl for 2 days Shooting paid down right arm- has not gone away and still present. Extreme pain at site of injection- has not gone away.

Fever on 105 F, Headache, Pain in the local area of the injection, chest pain, heart over 125 beats for minute, pain in the two livers, breathe difficult, inflammation and pain on the neck ....trouble with swollen and speak , hard abdominal pain, diarrhea, dizziness.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: patient states her tongue and throat feel tingly similar to when she has reactions to peanuts, she states no difficulty breathing at this time.

Patient has history of vaccine/needle phobia and fainting after vaccine administration and was nervous at the time of covid19 vaccine administration. After discussion with the patient, patient decided she was willing to have immunization administered. About 10 seconds after administration, the patient began hyperventilating, turned pale and fainted. Patient was sitting down at the time of fainting and no injury was reported. Patient was administered 0.3mg epi-pen once about 10 seconds after passing out and 911 was called. After about 5 seconds after administration, patient regained consciousness and continued hyperventilating. about 30 seconds later, patient slowly began to breath normally. Emergency services came in shortly after and patient stated feeling "a little better." I (pharmacist) called pt about 3 hours after even and patient was home and described feeling pleasant. pt stated she did not required hospitalization and went home after EMS check up.

60 seconds after receiving first dose, patient reported symptoms of not being able to move both arms, nauseous, dizziness, black spots/blurry vision, hyperventilating patient was given EpiPen injection & 911 was called EMT and paramedics arrived & said it was most likely anxiety related & patient looked much better after being calmed down thru breathing techniques patient was feeling and looking better after 15-20 minutes and opted NOT to go to hospital.

Chest pain in the heart. Had a CRP test done on May 4th and it came back elevated at a 2.0 instead of under .8 Chest pain came with laying down, heavy breathing and getting going the first few hours of the day. Last for about 2 weeks.

Given the vaccination at 12:30pm on Sat. 5/22/2021 and on Sunday 5/23/2021 at 8:00 am, patient started having chest pain, shortness of breath, and severe right-sided headache. On 5/25/2021 patient had a loss of consciousness and is being evaluated in the Emergency Department

Pt began feeling bad with chest pain and fatigue, SOB after the vaccine. Per spouse woke up in the middle of the night and tried to get out of bed but fainted and possibly had a seizure, had foam coming out of her mouth. Was transported to the ER and released.

My arm was extremely sore starting at a few hours after I got the shot and lasted about 24 hours after that. I took ibuprofen for the pain. However, roughly 15 hours after the vaccine, my fever spiked high, I was shaking uncontrollably, I had several episodes of hyperventilating, I was nauseous, weak, clammy, off and on chills and hot flashes and had a small panic attack after feeling like I couldn?t breathe two different times. I had zero appetite for the following day and remained nauseous with a slight fever off and on for the following 18 hours or so.

facial hives, lasted 3 days. Rash on the arm, tachycardia (persisted 2 weeks plus), increased memory problems, increased fatigue, increased dyspnea (did have Covid infection 11/2020)

Head congestion; Left ear pain; Arm soreness; Chills; Blurred vision; Dehydration; Malaise; Sinus pain in left side; Dizziness/lightheaded; Left side of face swelling; Lips and tip of tongue numb; Itchy around injection site; Swollen throat; Left eye discomfort/swelling; Tension pain in left side of neck; This is a spontaneous report from a contactable Consumer, a patient. A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EL9266), via an unspecified route of administration in the Left arm on 20Feb2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID 19 immunisation. The patient's medical history included Asthma. The patients' concomitant medications were not reported. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. On 20Feb2021 the patient experienced arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck. The patient did not receive any treatment for the events. The clinical outcome for the events arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck was recovered. No follow-up attempts are needed. No further information is expected.

Patient complaint of shortness of breath and dizziness after receiving Covid 19 2nd dose. Felt as if her throat was constricting. Vital signs assessed and WNL. Patient stated symptoms were subsiding a few minutes after noticing and decreasing in severity. Patient was monitored for 45 minutes and displayed no signs of distress with vital signs remaining normal.

second shot; allergic reaction on left side (shot in left arm) - swelling of face, tingling fingers and toes, mild throat swelling, droopy eye; took Benadryl per recommendation of pharmacist side-effects occurred 30 mins post shot

Client requested to lay on stretcher for vaccine, provided. Almost immediately following vaccine, client closed eyes- briefly did not respond to name. Skin warm and dry, strong steady pulse. Responded to verbal stimuli, complained of throat tightening and wheezing. EMT called to client pod. vss. HR76, BP 109/74, sat 97 on room air. Client then closed eyes again, briefly did not respond - then opened eyes . vs's continued stable. As per EMT positive slight wheeze. Ambulance arrived and client transported to ER.

28 year old female administered Pfizer vaccine, 0.3 mL, EW0179 at 1610. At 1617 she reported feeling a tightness in her throat, accompanied by difficulty swallowing and agreed to be monitored more closely. She stated that she had not experienced this level of a throat sensation after the first Pfizer dose, but that this sensation was more similar to the throat swelling she experienced after exposure to shell fish, which was followed by anaphylaxis. She carries her own epi pen and diphenhydramine for such emergencies. She stated that she self administered diphenhydramine after her first immunization, which controlled the throat sensation at that time. She agreed to take a 50mg diphenhydramine at 1625. BP was approximately 152/107, 97% pulse ox on room air, HR 112. At 1635 no change in how her throat was feeling, or that it was any easier to swallow. She agreed to have EMT services called. 911 was called and the dispatch instructions were followed, including the administration of 0.3mg of epinephrine via an Mylan EpiPen (Mylan, Lot 0FM544, Exp 9/22) at 1642. Soon after, she stated she was feeling significantly better and breathing was easier. At 1645 EMT teams from arrived and assessed the situation; the patient agreed to be transported to for further evaluation.

having a heart attack might feel like; tightening around upper body especially around the base of heart; inflammation; heart beat became rapid; short of breath; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in left arm on 18May2021 04:15 PM (Lot Number: EW0165) at single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and migraines/psoriasis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine) via an unspecified route of administration in right arm on 27Apr2021 04:15 PM (Lot Number: EW0175) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tightening around upper body especially around the base of heart, accompanied by inflammation. Her heart beat became rapid and she was short of breath. The event start date and time was reported as 18May2021 07:30 PM. It was also reported this happened "4.5 hours after injection". The event lasted 25 minutes. The patient felt what she assumed having a heart attack might feel like. The events were reported as non-serious. The patient did not receive treatment. The outcome of event was resolved. The patient has not been tested for COVID-19 since the vaccination.

WITHIN 5 MINUTES FELT THROAT SLIGHTLY SWELL.; FELT BODY CHILLS FIRST; This is a spontaneous report received from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (At the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included ACID REDUCER PLUS ANTACID chewable tablet initiated on an unknown date for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to vaccination patient had not tested positive for COVID-19. Since the vaccination, patient has not tested positive for COVID-19. On 17March2021 at 13:15, patient felt body chills first and within 5 minutes felt throat slightly swell, patient felt her throat less swollen 10 minutes later but still felt it a "tad bit" for the following two and a half hour. Therapeutic measures were reported as unknown. The clinical outcome of the events chills and throat swelling were recovered in Mar2021 with sequelae. Information about lot/batch number cannot be obtained. No further information is expected.

Patient had a seizure episode within 15 minutes after receiving 2nd shot of Pfizer Covid-19 vaccine. Patient's mother started to scream suddenly after patient fell on the floor and started to seize. Patient did not have any ADR to the first dose of same vaccine, reported no history of seizures or health conditions. Pharmacist saw patient lying on the floor, eyes bulging and having difficulty breathing, asked manager to call 911 and administered EpiPen 0.3mg IM shot into the right upper thigh. Patient was able to breathe and talk within around 2 minutes. 911 arrived and took patient to the hospital for observation

I had my injection 5 minutes after, I fainted and began hyperventilating. Heart spiked to 160bpm, blood pressure 180/90, Temperature spiked to 38.9. Heart rate kept spiking on and off for hours I was transferred to hospital for monitoring and after and I was dizzy for 4 days still after vaccine.

Back breaking pain for three days straight Extreme stress (persists but getting better) Soreness and inability to raise arm (persists) Fever Vomiting Rash/skin irritation Inability to breathe deeply (persists but getting better) Lower back and abdomen pain Tired/lethargy (persists)

Chest pain - short of breath Inhaler - doesn?t help much Prednisone - didn?t help , came back beta blocker for HR

Shortness of breath, feelings of having a fast-beating, fluttering, and pounding heart (some sweating also).

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: Patient returned for 2nd dose of Pfizer and stated no issues with 1st dose. During her 15 min observation her mother said patient complained she felt like she would faint. She was sweating, extremely hot, lethargic and dizzy while she was sitting on chair. Mom agreed that I should call 911 and paramedics took vitals and transported her to ER. I followed up and mom said she was better but getting tests at ER.

1st day fine June 1 2021 Day 2 muscle aches joint pain malaise fever chills Day 3 nighttime/ morning of day 4 anaphylaxis Day 4 morning epi pen at urgent care/ tachycardia Day 5 tachycardia Day 6 tachycardia Day 7 tachycardia and migraine followed by numb right side arm / leg/ face Corticosteroids taken Day 9 visit ER FOR NUMBNESS to rule out stroke Corticosteroids end June 12 (tachycardia and shortness of breath continue since the symptoms first noticed) Night of 13th day anaphylaxis Urgent care june 14: prescribed beta blockers epi pens and corticosteroids Effects continuing today: Tachycardia (baseline prior to shot was 60 resting heart rate and now is in the 100+, going up 10 stairs causes it to hit 160, small movement triggers it- beta blockers help sometimes) Numbness on right side: face arm leg foot etc Chest pain, chest tightness, shortness of breath

Shortness of breath; Fatigue; Fever; Arm pain; Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in the left arm, on 17Mar2021 at 13:15 (age at vaccination was 28-year-old), as a single dose for COVID-19 immunisation. Medical history included obesity and allergic to dairy. Concomitant medications included tylenol (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) for an unknown indication received within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. 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 positive for COVID-19. On 18Mar2021 at 11:00, patient experienced dizziness, fatigue, fever, and arm pain and on 19Mar2021 experienced shortness of breath. No therapeutic measures were taken for the reported events. The clinical outcome for dizziness, fatigue, fever, arm pain and shortness of breath was not recovered. No follow-up attempts are needed. No further information is expected.

First dose of Pfizer - 03/06/2021 at a Coliseum. Second dose of Pfizer - 04/03/2021 at pharmacy. Presented to the ED at on 5/9/21 with fever to 39.6C, HR 120s, throat pain, myalgias, headache, improved with IVF, tylenol, ibuprofen. Re-presented to ED on 5/13/21 with fever 39.5C, HR 120s, chest pain, dyspnea on exertion limiting her ability to walk >2 blocks as well as the remainer of her prior symptoms, with troponin 1.95 and TTE with new pericardial effusion. No sick contacts. Admitted at hospital 5/13 - 5/16 for myopericarditis, improved with colchicine, ibuprofen, and fluids. Sx persistent at post-discharge clinic visit.

About one (1) hour following dose #1 - persistent coughing; frequency and intensity of symptoms slowly subsided through the date of dose #2 (6/13/21). About thirty (30) minutes following dose #2 - persistent coughing, congestion and wheezing/trouble breathing. Wheezing/trouble breathing subsided after about four (4) days; persistent coughing and congestion continues.

Right side chest pain and shoulder pain, shortness of breath and rapid heart rate. These effects seem to happen randomly and with varying degrees or intensity. Started experiencing effects 6/21 in the evening. Went to urgent care 6/24. Diagnosed at this time with heart murmur and tachyarrhythmia. Seeking referral to cardiologist.

my throat started to feel constricted; hives/rash developed on the left side of my neck, and across my chest; This is a spontaneous report from a contactable consumer ((the patient, reported for self). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8736, Expiration date: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 11May2021 17:15 (at the age of 28-year-old) as single for covid-19 immunisation. The patient Medical history included food allergy to Peanuts, soy, shellfish, fish, sesame, legumes, coconut, nuts, stone fruit; Drug allergy to penicillin; Anaphylaxis allergic reaction from an unspecified date an unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 17:15 within two minutes of getting the shot patient stated that her throat started to feel constricted, within five minutes of getting the shot "hives/rash developed on the left side of my neck, and across my chest." She stated that throat continued to get constricted. She had a history of Anaphylaxis allergic reactions to various food, so she had felt her throat tighten due to food before, but this was different. Patient had visited Doctor or other healthcare professional office/clinic. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken because of throat continued to feel tight as she took Benadryl on the ride to the (ER) Emergency room/department or urgent care. No epi was taken before arriving at the hospital. Patient received steroids and Antihistamines at the ER. The outcome of the events were unknown. Device Date : 12May2021 Information on Lot/Batch number was available. Additional information has been requested

GOT SUPER SICK AND COULD NOT WORK. THROWING UP, DIARRHEA, SUPER NAUSEOUS, CHILLS, FEVER, HEADACHES, BODY ACHES, SUPER TIGHT CHEST, TROUBLE BREATHING. FELT LIKE I WAS GOING TO DIE AND THERE WAS NOTHING I COULD DO BUT LAY THERE. IT LASTED FOR 2 DAYS, THE SECOND DAY WAS BETTER THAN THE FIRST DAY.

Swelling of throat/Felt like throat was swelling on drive home; Lump node swelling; Body aches; Tiredness; Throat feels tight; This is a spontaneous report from a contactable consumer (patient). A 28-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8727, 28-years-old at the time of vaccination), via an unspecified route of administration, administered in arm left on 18Mar2021 at 16:45 at unknown dose single for covid-19 immunisation. Medical history included urinary reflux, frequent urinary tract infection (UTI)/kidney infections, high blood pressure (BP) (managed through diet) and Penicillin allergy. Patient's concomitant medication included prenatal. Past drug event included Codeine resulted allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Covid was not tested post vaccination. On 18Mar2021 at 17:30 she experienced swelling of throat/felt like throat was swelling on drive home, lump node swelling, body aches, tiredness and throat feels tight. Events resulted in emergency room/department or urgent care. As treatment she received Steroid shot and high dose BENEDRYL. Reported swelling of throat was still able to breath fine. Lump node swelling, body aches, tiredness. Was waited 15 mins and left vaccination site. Felt like throat was swelling on drive home, stopped at a hospital. They gave her a Steroid shot and high dose BENEDRYL. Throat felt tight but better morning after. Seriousness was reported as non-serious by reporter. Outcome of the events was resolving. No follow up attempts are possible. No further information is expected.

Per Director of Nursing: patient stated that the day she got the vaccine she also got her allergy shot as she gets them 2 x a week. On Friday she woke up with fever, GI issues then her lips swelled and she got welts on them and she developed wheezing. She went to the ER on Friday, they gave her Benadryl , Prednisone and an antibiotic. On Sunday her lips were burning and swollen and burst open and started to bleed so she returned to the ER again. She states she is feeling better now but her lips are scabbed and dry. She stated that the ER doctor wasn?t sure if she may have had a reaction to the allergy shot in combination with the vaccine.

Patient allergies and Pfizer ingredient/component list discussed with patient prior to administration. She denied any known allergy to any vaccine components. Advised to stay in the waiting area for 15-30 min for monitoring. Vaccine was given at 1504, then at 1518 the patient started complaining of feeling itchy all over her body, having a hard time getting a full breath, and chest pain. She was assisted from the seated position to standing and then laid supine on the exam table. VSS, SpO2 98%, HR 84, BP 96/60. 50mg IM Benadryl given at 1525 to right deltoid. About 5 minutes later the patient reported relief of her full body itching but still complained of chest pain, having a hard time breathing, and also was dizzy and slight difficulty swallowing. No tongue swelling noted, patient was speaking in completed sentences and handling her own secretions. She has a history of POTS and stated that chest pain and dizziness was not uncommon for her. 911 called at 1530pm. VSS at 1537pm, BP 96/70, HR 106 regular, 98% Spo2 on RA,

I reacted to the first vaccine, the health department took me to the hospital. I was monitored immediately having trouble breathing, took Benadryl, used my inhaler but then after that I started having problems to allergens that were not a problem before. I ended up needing an epi pen, I started to have trigeminal episode where it started to have them everyday. I also had fibromyalgia every day, pain scale 7 out of 10 on VAS scale. I ended up going to the doctors where they tried different medications. I started getting heavy periods and my birth control medication I had been out for 7 years, stopped working. I have lost a lot of weight, about 40 pounds. I was having migraines pretty much every day. I also started to get on one side of my face, left side. Then the same started happening to my right leg. I started to have vision problems, where me the sides of my eyes would go black and cracks in my vision. I went to the neurologist, ophthalmologist and no one had been able to figure out what is wrong with me. I have not been able to work for months. I was pretty active before the vaccine, I worked with a cancer institute for kids, but now I could not perform my daily activities, got so sick all the time. I had to move back with my parents. I still have pain a lot of the time, I do not have Covid and my symptoms have been pretty horrible since receiving the vaccine. I've had blood panels done, eye exams, MRI of the brain and pap smears but the exams are all negative and can not find the reason to my symptoms. No spinal tap yet done. Also my asthma is not under control and I get winded when going up a flight of stairs. I do not have the lot# to provide today.

Allergic reaction of tightness of chest, short of breath, difficulty speaking right after shot. Recovered with benedryl Fever of 102 sustained for 36 hours even with medication. 1 migraine wed and 1 migraine Friday. After migraine on Friday I had a convulsive event. Then another then another while waiting for the ambulance and another while with them. One in the waiting room, one in trite etc. I had a total of 15 convulsive events in a day. 6 more the next day. Now just on rare occasions

4 days after the 2nd dose, I started having dizziness, heart rate increase and I almost passed out. I also started getting numbness in my right hand. I worked at the hospital and I was brought downstairs. I was given fluids and they did an EKG which detected tachycardia. I was discharged with instructions to follow up with PCP. The next couple of days, I felt tired and a couple of episodes of nausea. I decided to go back to work on 7/12/2021. At around 8PM I felt my heart rate increasing and I sat down and my co worker took me downstairs to the ER. I felt nausea and felt like I was going to pass out. I was given fluids and my tachycardia did not go down. My heart rate was as high as 120-150. I was admitted to the hospital for rapid heart rate. I was given Metoprolol to bring down my heart rate. Currently, I am still in the hospital. I still have tachycardia, fatigue, SOB and numbness in my right hand. I will be here another night to run more tests and more blood work.

On Friday night I had increased heart rate and couldn't catch my breath. The ambulance came and did an EKG where everything was normal. They took me to the ER. When I got there, they wheeled me out into the waiting area. While I was there, I was sitting there for about 2-3 hours. I noticed that my heart rate was not spiking anymore, and my breathing was better. I asked to be discharged without being seen. On 4/19, I went to pick up my daughter after a walk. When I got back, I was gasping for air and had chest pain. I went to the ER where they told me I had an elevated D dimer. They referred me to a cardiologist. They did all the CT scans and said they did not see anything, so they discharged me. On 4/14 I saw the cardiologist, who said he does not think it was due to pericardial effusion/pericarditis which I was diagnosed with after the birth of my daughter in June 2019. He had done an echo which was normal in October. I also saw my PCP where my blood pressure medication was changed to amlodipine and I was referred to a pulmonologist. I saw doctor who did a bunch of tests and did not find anything. He suggested I had costochondritis and put me on Toradol and an asthma pump. The asthma pump did not help. On 5/7, I had extreme chest pain where I could not move my arm. I went to the ER where they did a scan of my heart to check for fluid and a D dimer test. Since receiving the shot, I noticed my tonsils would swell up after eating. I had to stop eating and went on an ensure diet. I went to an allergist that said I was severely allergic to rice, a dog, but I was never allergic to anything before. I went back to the cardiologist where the PA said even though there is nothing wrong, maybe there is unseen myocarditis or pericarditis. The medication messed with my stomach. I went to check that everything was fine with my lungs where everything was deemed fine. On 5/27, I did a stress test which was fine. On 6/2, I had experienced shortness of breath again. I was unable to work normally and had to stop working. Doctor did tests for inflammatory diseases Mitochondrial M2 antibodies was in the middle range. This is inconclusive. I went to doctor who ran a lot of tests and found that Sedimentation rate was too high, Comprehensive metabolic rate was normal, CMV Igg: positive. He said perhaps I have long haul COVID. The antibody test showed I was positive for the vaccine antibodies but not the true COVID antibody. He suggested it could be an inflammatory issue. I saw an ENT for my throat who put me on antibiotics. The antibiotics helped but when I got off, I had another flare up. I was put on more antibiotics. On 6/29, I went to another cardiologist who did a contact MRI. He saw a swollen left atrium but said it was overall normal. I also saw a pulmonologist to notify them that the shortness of breath is still sometimes present. I saw a GI who did a test and found that I had erosive gastritis. I was taking metoprolol and tarivid. I still have stomach discomfort.

Woke up next morning in a cold sweat, had a fever, shakes, tremors, exhaustion, headache and nausea. Had difficulty breathing. Slept 17+hours and symptoms resolved over next 12-24hours.

Red flushing cheeks at time of shot; swollen glands in neck; extreme pain in front of neck; shortness of breath/painful breathing; burning lips; burning nose; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in left arm on 06Mar2021 at 00:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune diseases and allergies to sulfa drugs. The patient took unspecified medication within two weeks. 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. On 06Mar2021, the patient experienced red flushing cheeks at time of shot, swollen glands in neck, extreme pain in front of neck, shortness of breath, painful breathing, burning nose and lips. The adverse events resulted in a doctor or other healthcare professional office or clinic visit, and an emergency room or a department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with BENADRYL and ant-inflammatory medications. The clinical outcome of the event red flushing cheeks at time of shot, swollen glands in neck, extreme pain in front of neck, shortness of breath, painful breathing, burning nose and lips was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Diarrhea; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Lightheadedness; Weakness; Severe Headache; Left ear was hurting; Chest Tightness; chest feels funny; Throat Tingling and Tightness; Throat Tingling and Tightness; felt hot on her left side of her body then her complete body felt hot; felt like her entire body was on fire; gets really really hot inside and starts to sweat; Chills; disoriented really bad and confused and had a bit of a blurred mind; disoriented really bad and confused and had a bit of a blurred mind; Feels Very Off; Blood Sugar Level Dropped Below 60; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female consumer received first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in Arm Left on 21Apr2021 at 08:35 as single dose (at the age of 28-years-old) for covid-19 immunisation. Medical history included drug hypersensitivity penicillin and anything that is a cousin to penicillin. She did not have any prior vaccinations within 4 weeks. There were no concomitant medications. She stated that she took the vaccine at 8:30 by 8:45, she felt very lightheaded and she signaled the nurse, and she was brought into a room. She stated that she took the shot in her left arm. After the vaccine it was like she was disoriented and confused and had a bit of a blurred mind, like she felt confused. States she thought she would be up and ready after but they put her to lay down. Caller states she was disoriented really bad. She felt her left ear hurting and then tingling in the front of throat and her throat and chest began to get tight. She stated that as she was trying to drive home, she had to pull over and she felt like her entire body was on fire. She stated it was on and off. She gets really hot inside and starts to sweat and had cold chills and then it goes away and comes back. She stated she felt hot on her left side of her body then her complete body felt hot until 10:00 PM. She felt hot and weak to the point that couldn't drive this morning. She stated her blood sugar level had dropped to below 60. She stated that many of her side effects come and go, they don't last very long. She was treated with Tylenol. She stated that she was in observation under a tent after her vaccine. On 21Apr2021, in the morning she still feels hot and now had diarrhea, severe headache, her chest feels funny and she felt very off. She asked is it common to have diarrhea. She stated that her main concern is if she should take the second dose since she had this reaction with her first dose. The outcome of all the event was not recovered while the outcome of the events disoriented really bad and confused and had a bit of a blurred mind and left ear hurting was recovered. No follow-up attempts are possible. No further information is expected.

woke up with pain that shot up to the neck. the area was swollen and hot. which prompt patient to go to ER. The physician subsequently diagnosed patient with superficial arm blood clot. patient has a follow up visit to investigate if a presence of blood clot which is causing sob is related to the immunization

Injection site and surrounding arm felt like a rock; Dizziness; Overall achy; Mild wheezing; Chest tightness; Mild headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route in the right arm on 01Apr2021 at 12:30 (at an age of 28-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had medical history of asthma, anxiety, depression, ADHD (attention deficit hyperactivity disorder), peanut allergy and food allergy to legumes. The patient had known allergy to past drug VICODIN. Concomitant medications included birth control medications, montelukast (MANUFACTURER UNKNOWN), fluticasone propionate and salmeterol xinafoate (ADVAIR), esomeprazole (MANUFACTURER UNKNOWN) started on an unknown date for unknown indications. The patient did not receive any other vaccination within four weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 01Apr2021 at 15:00, the patient experienced fatigue, dizziness, overall achy, mild headache, mild wheezing and chest tightness. On 02Apr2021, the patient's injection site and surrounding arm felt like a rock. No treatment was given 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 for the events of injection site and surrounding arm felt like a rock, fatigue, dizziness, overall achy, mild headache, mild wheezing and chest tightness were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic to establish care several months after immunization. Reports symptoms consistent with a severe allergic reaction almost immediately after receiving vaccine: dyspnea and stridor. Patient was hospitalized, received intravenous fluids, epinephrine, and was discharged to home. Since then patient continues to experience dyspnea on exertion and activity level has not returned to pre-vaccination status.

the week following the vaccine i had extreme exhaustion and fatigue. On July 16th I started experiencing a fever going up to 104.4 this lasted for over a week. I had 2 negative rapid tests on the 19th. The morning of the 21st I started to experience a sore throat and a rash. I was again tested for covid as well as strep both came back negative. by the afternoon of the 22 the rash spread to over 95 percent of my body. I was admitted into the hospital that evening. while in the hospital i had numerous test for a variety of viral and bacterial illnesses, all came back negative. I started to also experience swelling in some of my extremities and around my heart. My longs also had a significant amount of fluid. I was advised during a ct scan that there was lymphoid swelling on the side I received the vaccine.

Intermittent runs of tachycardia accompanied with dyspnea and diaphoresis. Symptoms began approximately 6 hours after receiving vaccine and has persisted.

Approximately 5 hours after administration, I developed severe pleuritic chest pain and tachycardia that self resolved after about an hour. This was followed by about 2 days of fatigue and myalgias that interfered with my daily activities that also self resolved. Had a large tender reaction on my left bicep for about 5 days after the injection.

Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began 20 minutes after the injection. Lasted about 25 minutes. After this episode subsided, I continued to have persistent Dyspnea, chest pain, palpitations and heart racing. Was unable to speak in full sentences, exercise. Walking short distances caused extreme SOB. These symptoms lasted about a week.

Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.

palpitations; Shortness of breath; Heart rate was 160s; This is a spontaneous report from a contactable Physician. This 29-Year-old female physician reported that she received 1st dose of BNT162B2 on 30Dec2020 08:30 AM at right arm for COVID-19 immunisation. Medical history included allergies: Citrus and cinnamon- perioral contact dermatitis. Concomitant therapy included birth control- Mylan. The patient reported within 5 mins of vaccine administration, she experienced palpitations and shortness of breath. Heart rate was 160s on 30Dec2020. No rash or fever. Event onset time was reported as 30Dec2020 8:30. She needed to be taken to the emergency room. Treatment was received as Steroids epinephrine Benadryl. The outcome of the event was recovering. The events were reported as non-serious. Lot/Batch and Expiration date has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

30 minutes after injection of vaccine, I developed tightness in my throat (not severe). This persisted for approximately 1 hour. Later in the evening around 1830, I developed chills and body aches. When I woke up the next day, all symptoms were gone.

Had Throat and chest tightness, SOB, pruritis within 5 min of covid immunization. BP: 146/111, P 144; o2 99%, RR 16. She was given albuterol inhaler x 3, Epi-pen x 1, benadryl 25 mg with some iprovement. She was sent to ED. PMHx: tree nut allergy, Hashimoto's thyroiditis, hereditary hemochromatosis, PCOS; Taken to ED

Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot

Started as itching at the injection site approx 35 minutes after shot which led to generalized itching on left arm, chest, and back when another colleague examined my back and noted hives. Became slightly short of breath and felt my heart was racing. Took 25 mg of oral Benadryl and told to go to ED. In ED heart rate was 126 bpm and BP WAS 136/99. Monitored in the ED for a few hours with no further interventions. Heart rate improved to 102 bpm and blood pressure to 129/82.

Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began to start breathing rapidly and become short of breath. Also, red blotches started to develop around her neck. Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.

Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day. Went to sleep with no issues. Woke up at 2:00am uncontrollably shaking with chills/goosebumps, sweating with shortness of breath. Extreme headache and all over body soreness also at that time. This continued in waves for the next several hours. I finally slept for a short time and woke with continued headache and muscle/joint soreness. This was accompanied by dizziness, nausea and decreased appetite. This persisted throughout the entire next day following vaccination. The day after that was slightly better and the subsequent day I felt relatively back to normal. I checked for fever many times throughout the symptoms but was always afebrile.

12/22 vaccination 12/24 48 hour after started to have nasal drip, sore throat. 12/26/2020 low grade fever 12/28/2020 chest congestion; COVID 2nd test; negative sore throat, nasal drip x2 weeks

Estimated due date: 03/17/2021 On the day of the vaccine during observation I had tingling in my mouth, numbness in tongue and I just used my Benadryl and it eased the symptoms. But at night I started wheezing, had sweats and chills, did not check my temperature but I had pretty severe chills that night. In the morning I checked no fever, but still chills, severe cough and sore throat.. Headache and fatigue. All got worse more severe on Saturday and then I decided to go get tested for Covid on the Care Clinic. I had a known exposure to COVID before I got the vaccine around 01/04/21 - my husband who tested positive on the 6th) I tested positive. All symptoms continued (except the tingling on the mouth it stopped on the 8th) and I saw my OB-GYN on the 11th due to a low amniotic fluid - I had an ultrasound at the facility and was referred to MD and saw him on the 11th as well. Now I lost my sense of taste and smell. The chills have subsided a little bit and so the headache, but fatigue, congestion and cough are still there. I had increased intermittent shortness of breathe but could be the baby's position.

I am having chills since last night; Shortness and breathlessness last night; throat is super dry; don't have too much pain in my left arm right where I got the vaccine; Left clavicle that is swollen and painful to touch; Left clavicle that is swollen and painful to touch; Little bit fever; This is a spontaneous report from a contactable consumer reported for herself. A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiry date: Apr2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose to get vaccinated to prevent COVID. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) and hadn't taken Vitamins yesterday or day before. The patient got yesterday on 05Jan2021 the vaccine and thought that it was a side effect which she didn't have with the first vaccine. She had been having chills since last night 05Jan2021 and little bit of fever in Jan2021. She didn't have too much pain in her left arm right where she got the vaccine but her left clavicle that was swollen and painful to touch in Jan2021. The patient felt like she had a little bit of shortness and breathlessness last night 05Jan2021 but she was fine, her throat was super dry in Jan2021. For lot number, she stated "It is E. I am not sure what the next one is. It might be like a 21284." The patient had taken only pain killers she took two pain killers before she went to bed she took two pain killers when she woke in the middle of night and in morning. For Lab work, she just started feeling like between 12. The outcome of the events was unknown. Information on the lot/batch number has been requested.

I had a fever and chills at night and also a headache, I felt nauseous, vomiting and difficulty breathing. I could not sleep that night after I received my vaccine. I decided not to go the ER and slept it off I woke up much better next morning. I saw a Doctor a couple of days later because I had shortness of breathing and a high heart rate while I was at work. He just told me to take it slowly at work. No meds. I then started working part-time for some weeks and am being introduced again now to my regular scheduled.

Client was observed for 30 minutes. She walked out of the building then felt "funny" so returned, stating she felt her throat was starting to feel like it was closing.

Headache (first and second day post vaccine) Sore throat (first and second day post vaccine) Fever (first and second day post vaccine) Nausea (first day post vaccine) Vomiting (first day post vaccine) Chest tightness/ difficulty breathing (beginning on second day post vaccine)

29yo female patient reports feeling her throat tingling and closing sensation in her throat with a metallic taste and diaphoretic approximately 3 minutes after receiving vaccine. She did not report these sensations until about 15min after injection. EMS assist was immediately called and pt was brought into one of the patient rooms. She was given Epipen injection approx. 20min after injection and EMS arrived to transport patient down to ER within 1-2 minutes after Epipen administered. Patient was monitored in ER and recovered well

I was asleep I woke up coughing. Feeling like I swallowed my necklace( it felt like there was a string in my throat) and labored breathing. Rash developed all over body that is similar to the rash Kawasaki syndrome kids get. Was taken to emergency room where I was given iv steroids and epi. 10-15 mins after my breathing was back to baseline and throat felt better. I have never had any trouble breathing or any allergic reactions to anything in the past.

I experienced throat swelling itching and hives as a result of my covid vaccine. The vaccine was given 1/6, symptoms occurred 1/7 overnight.

Elevated temperature 99.9-100.2 Chills Diffuse body aches Elevated blood pressure (130/110) Tachycardia 120-130 at rest Shortness of breath

Second dose of COVID vaccine (Pfzier/BioNTech) received Friday morning around 8:00, I left work about an hour early that day due to rising nausea, migraine and fatigue. By the time I got to my car in the parking garage I had thrown up and was so dizzy that I called my boyfriend to come pick me up. When I got home I immediately laid down to take a nap. 3 hours later I woke up very sore and achy and still had a migraine. I remained in bed and later that night I spiked a fever as high as 101.8 fahrenheit. I had severe chills and the aches were so bad that my bones hurt all over and it felt like someone was stabbing me with a metal broom handle. Pain spiked to 8 on the pain scale and with the length of time I had this pain, it was one of the worst experiences of my life. The dizziness and fatigue caused me to need help to get out of bed to use the restroom. I took ibuprofen frequently and Nyquil at night to help relieve the effects without it doing little more than taking the edge off. Saturday night was the same as Friday night with no relief of symptoms. Fever remained around 100.9. Sunday night it dropped to 99.8 with chills, dizziness and fatigue still remaining but aches slightly lessening. Monday night I was still dizzy and weak but not nearly as in much pain and fever had subsided. Tuesday I started to feel more normal by the end of the night, just easily out of breath and off and on again headache.

Sharp, non-radiating chest pain at xiphoid process 10/10 pain worse with inspiration, better with exhalation, unable to lay down, lasting 1.5hours, finally resolved with tylenol and motrin. Two separate instances of this pain, one on 1/18/21 at 1600-1730, and one on 1/18/21 2230-0000. The second instance the pain was so severe, lead to nausea and one episode of emesis. Initially trialed treatment with antacids but that did nothing to improve the pain. Evaluation by MD on 1/19 at 1300 diagnosed with pleuritic pain secondary to inflammation. No prior history of this, no cardiac history, and no history of GERD. Other post vaccination symptoms included fever approx 10 hours following the vaccine, nausea, one episode of diarrhea, fatigue, body achs, dizziness, and chills, all of which resolved by 1/18 at 1100am.

P29 y/o f with no pmh, on OCP's, citrus allergy (contact dermatitis), non smoker, sent to ED with palpitations, sob approximately 5 mins after receiving COVID vaccine. Patient describes palpitations as heart beating fast also with tingling in her tongue. She was given epinephrine and symptoms improved, however restarted shortly after. She denies chest pain, rash, oral swelling, difficulty swallowing, coughing, nausea, vomiting, syncope. Treated with benadryl, dexamethasone, famotidine

I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking with management and felt faint and short of breath, continued to be tingly. Last night 1/19/21 I had a moment of not feeling well and my heart rate went from 60s to 120s with shortness of breath and nausea qnd tingling. This continued for about 30 minutes, I was debating going to the ED for the SOB. I then became really cold and had such bad shaking I couldn't hold anything for another 20 minutes. Today I continue to have some tingling. All of this on top of the expected side effects.

Patient developed lightheaded sensation and wheezing 10 minutes after vaccine. She was sent to the emergency room for close observation, given a single dose of steroids and diphenhydramine, and discharged home without further complication.

Began about 1.5-2 hrs after vaccine Hives, red rash all over face and body. Fever of 103 disoriented trouble breathing and speaking and remembering. Dizzy. Alternating high and low blood pressure. Chills. Body aches. Sore tenderness and warmth at injection site. Sluggish speach

Pfizer-BioNT Tech COVID-19 Vaccine EUA. Rash of bumps on the left arm where injection occurred as well as a rash on right side of neck some difficulty breathing. Albuterol and Benadryl were taken to address the reaction.

5 minutes after vaccination, became pale, diaphoretic and tachycardic (HR 150s). She reported that she felt like her throat was closing. No itching, rash, nausea, vomiting, wheezing, swelling. Epipen was administered to left lateral thigh. 3 minutes later, she reported that her throat felt better, overall felt better and heart rate decreased to 100. She was transported to our ED. She felt anxious and like her heart was racing. She was observed in the ED and slowly reported feeling better with complete resolution of symptoms within 2-3 hours. She did not require any further intervention. She was discharged from our ED with an Epipen and Epipen teaching.

Having a head arch, chest pains and shortness of breath pulmonary embolism and was tested for COVID-19 and tested positive.

Mild Shortness of breath for about 24hrs. Swollen lip from about 4:15pm into next morning until about 8:00 am. Sore throat for about 24 hrs. All treated with Benadryl from home.

Sore injection site at 10:00pm day of injection. Morning of day after chills, fever, sore throat, cough, short of breath. 48 hours later same symptoms but fever is worse. I?ve been alternating Tylenol and Advil Q 4 hours. Had a COVID test performed on 1/26/2021. Negative results morning of 1/27/2021. Currently extremely sore throat, cough, fever, short of breath.

1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness

Within 5 minutes of receiving Covid Vaccine (Pfizer ), second dose..... Employee complains of difficulty breathing, warm, sweaty, left arm pain, lips swelling, tachycardia (p=140-100). Team called and sent to ER.

Sxs started around 2 H post vaccination: fatigue followed by difficulty sleeping. The next day, fatigue, slight cough, stomach upset, and severe headache (before noon). After noon, nausea, diarrhea, cough, SOB, and fever (max 103); in addition to all previous Sxs. Sxs lasted through 48 H. In total, 1.5 days was missed from work. I have never felt this sick before.

fever; chills; severe headache; severe muscle and joint pain; chest tightness; mild nausea; lungs felt inflamed, making it difficult to take deep breaths; unable to sleep; severe muscle and joint pain; This is a spontaneous report from a contactable health care professional (patient). A 29-year-old female patient recived the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EK4176) via an unspecified route of administration on 12Jan2021 at 08:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL], manufacturer unknown), vitamin B12 (manufacturer unknown), vitamin c (manufacturer unknown), melatonin (manufacturer unknown), biotin (manufacturer unknown) and elderberry [sambucus nigra] (manufacturer unknown). The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EJ1685) on 22Dec2020 at 9:00 PM on the left arm. The patient did not receive other vaccines in four weeks. The patient reported that after her second dose, she began experiencing severe side effects around 5:00 pm the same day (about 7 hours after the dose was administered). These side effects were fever, chills, severe headache, severe muscle and joint pain, chest tightness, and mild nausea. She also added a difficult symptom to describe, but her lungs felt inflamed, making it difficult to take deep breaths. These symptoms lasted for 36 hours unabated, and she was unable to sleep, go to work, eat, or go about daily activities during this time. After 36 hours, the fever, chills, headache, and nausea subsided, but the muscle and joint pain and chest tightness persisted. It has been 50 hours since her second dose and the muscle and joint pain and chest tightness still persists, although its severity is reduced and it is not preventing her from work or daily activities. The patient did not receive any treatment for all the events. The outcome of the events severe muscle and joint pain and chest tightness was not recovered while the outcome of the other events was recovering.The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.

PMH: dx with Grave's disease in 2014, s/p thyroidectomy 2/2 thyroid cancer on 8/10/2020 (now on synthroid 150 mcg). 1/26 ED VISIT: P/w chest pain/SOB went to ED. Patient received the COVID vaccination 3 days prior (1/23). Was in NSH the morning of vaccine, then in the afternoon became tired. Then developed a H/A (frontal and right sided, that has resolved) and chills. p/w SS chest pain, radiating to the right shoulder and to the back. Worsened with deep inspiration and difficult to take a deep breath. Took tylenol at 8 pm yesterday (1/25) and advil at 1 pm yesterday (1/25). A/w DOE. Denies birth control use, n/v, abd pain, urinary symptoms, tobacco/etoh/drug use, recent travel, cough, le swelling, hx pe/dvt. Patient had imagining completed - no significant findings and discharged on percocet and ibuprofen. Patient represented to the ED on 2/2/2021: Over the last two days, patient has tender right shoulder pain radiating to neck and chest with ROM and strength limited by pain associated with nausea. Evaluate for rhabdo and myocarditis - negative. Patient seen by ortho (note unable to be obtained). 2/4 Telehealth visit: The patient reports still having a swollen lymph node under her left axillary area. She denies fever. Patient reports pain to her right shoulder. She presented to ortho who said it might be an infected cyst and attempted to drain it unsuccessfully. Patient mentions pain and tingling to her left breast. She notes right shoulder pain to the back of her neck that radiates down to her left arm. She notes a stabbing back pain and rib pain when she takes a deep breath. Patient given levofloxacin and gabapentin

Patient arrived to vaccine clinic for her 1st Pfizer vaccine. She received her vaccine at 1606. She was then walked out to the waiting room to wait her 15-20 minutes that is strongly recommended after receiving the vaccine. Approximately 5 minutes later, she alerted the reception staff that she was having some sort of reaction. I was then notified immediately and patient was brought back to a private exam area. Patient complained of chest tightness, numbness in fingers and a racing heartbeat. She also felt that she was having difficulty breathing. Vital signs at that time were 96.3 temperature, RR 36, blood pressure 170/100 and a heart rate of 174. Patient received (1) epipen and 911 was simultaneously notified. 2 liters of oxygen via nasal cannula were applied. Shortly after epipen was given and oxygen applied, patients heartrate decreased into the 130s. Oxygen remained stable at 99-100% on 2 liters nasal cannula. Ice pack applied to base of neck for comfort. EMS arrived and report given as patient will be taken to the emergency department for further evaluation.

Starting last Thursday January 28th ,I started to experience shortness of breath at rest. Friday January 29th I was experiencing constant chest tightness/discomfort. Breath started to catch with speaking, fatigue. On Saturday January 30th at work in teh hospital I moved a heavy patient, became short of breath that the patient heard it and inquired about it, and my heart rate went up into the 120s. After a hot shower on January 31st, my heart rate went into the 110s, shortness of breath experienced. Vital signs have all been normal, no fever, normal blood pressure, normal oxygen saturation. My heart rate only increased on Saturday and Sunday and have been fine since. Negative fro Covid on January 29th and Negative for COVID, flu A and B and RSV on Monday February first. Saw to PCP on Wednesday February 3rd and with my symptoms states it is mild myocarditis from the vaccine, to rest and take an NSAID daily for two weeks.

Patient first complained of her normal anxiety and was doing deep breathing exercise. Then she described chest tightness similar to when she had contrast dye. At that time EMT notified and brought to back area 1:18. Chest tightness and tightness in her throat, O2 sat 95%, HR 92, BP 141/89, EMT started an IV 1:23 Benadryl IV given 1:28, 12 Lead EKG for the chest tightness, HR 90- 94, O2 sat 94-95%, BP 142/92, 1:32 chest tightness improved, Now with a Headache 1:36 transport to ER via ambulance

trouble breathing; Patient experienced itching on legs arms and face along with hives; Patient experienced itching on legs arms and face along with hives; Headache getting severe by the minute; This is a spontaneous report from a contactable pharmacist. A 29-year-old female patient received 2nd dose of bnt162b2 (BNT162B2; lot number EN5318) on 25Jan2021 intramuscular at right arm for COVID-19 immunization. Medical history was not reported. The patient had no COVID prior to vaccination. Historical vaccine include BNT162B2 for COVID-19 immunization. The patient had no other vaccine in weeks, concomitant drugs was none. The patient experienced headache getting severe by the minute. Patient experienced itching on legs arms and face along with hives and trouble breathing. Event start date was 25Jan2021. One epinephrine was received. Patient was taken to the hospital. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events headache, dyspnea, urticaria and pruritus are possibly related to suspect vaccine BNT162B2 administration. 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.

On 2/5/21 patient received Pzifer COVID-19 dose #2 early afternoon at workplace clinic. On 2/9/21 patient reported beginning 2/5/21 early evening she began having overall body rash and body ache that progressed over the next few days to sore/swollen throat, voice loss, nausea, intermittent fever, loss of taste and smell, headache, and diarrhea. Tested COVID-19 negative 2/9/21, still having symptoms. Stated has not seen her healthcare provider but will contact for care.

Adverse event: Blurred vision, numbness left side head to shoulder, vomiting, chills, shortness of breath, severe headache, oral mycosis swelling Treatment: Benadryl Outcome: Sent to ER by facility MD, treated and observed at hospital for 1.5 hours released no negative outcome

Rash on right side of neck; Rash of bumps on the left arm where injection happened; Rash of bumps on the left arm where injection happened; Some difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 22Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies and migraine. Concomitant medication included ibuprofen, albuterol [salbutamol] and sumatriptan. The patient previously took clindamycin and experienced drug allergy. The patient experienced rash of bumps on the left arm where injection happened, rash on right side of neck some difficulty breathing on 22Jan2021 19:30. The patient received treatment Benadryl and albuterol to treat symptoms. The outcome of events was recovered in Jan2021. Information on the Lot/Batch number has been requested.

Approximately 4 minutes after receiving my vaccine I felt warmth down injected arm. Approximately 20 minutes post injection, I experienced a drop in my blood pressure, heaviness in my legs (like walking through cement), and ringing in my ears. At approximately 12:30-12:45pm I experienced mental fog (I couldn't remember how to turn off my windshield wipers), increased heart rate, rapid onset of feelings of panic, minor shortness of breath, neck/clavicle tightness on side of injection, and sweating. Between approximately 1:30pm and 2:30pm I continued to have extreme sweating, as well as: increased pulse, fatigue, dry throat, muscle weakness/shakiness, brain fog, and headache. At approximately 3:30 I hit my knee on the bed frame and felt like the wind had been knocked out of me and immediately had a severe drop in blood pressure that felt similar to a vasovagal event. I called the vaccine clinic and my symptoms were noted and I was told to seek help if my symptoms worsened or I felt like I was going to pass out. My symptoms have not worsened but I am still experiencing extreme sweating along with shivering, shakiness, blood pressure changes with movement (orthostatic hypotension), and fatigue - time is currently 5:50pm

Pt developed increased work of breathing about 10 min after injection. Used albuterol 8 times with little improvement. HR remained 74-88, BP122/73, 118/56. RR 40-50 O2 sat 99-100. Pt did not want EPI. Was given 50 mg of Benadryl without improvement. Pt denied CP, throat symptoms, nausea/vomiting, headache or dizziness. Monitored for 30 min in vaccine clinic without progression of symptoms. Pt declined emergency transport, so was taken via wheelchair to ER for further monitoring.

Right after vaccine had rough patch of skin 2 inches below vx site- may be reaction to glove. 26 hours after vx experienced extreme lethargy, chills, temp rise to 99.3, mild congestion/cough that continued until 2/13/2021. Was out of breath/lightheaded if holding anything over 10lbs. Sleeping or spending 12-24 hrs in bed at a time.

Shortness of breath, fatigue, body ache to left lower limb, fever 99.6F. Lasted approximately 8.5 hours.

Patient almost immediately stated she felt "tingly" on her toung along with the feeling of her throat swelling shut. Patient stated it felt much like it does when she has an allergic reaction to shellfish. 1 adult epinephrine pen was administered to patient intramuscular in thigh and patient was taken to hospital emergency department for workup and observation. In ED, symptoms had subsided, and patient reported feeling better. Patient was given IV diphenhydramine x one 25 mg dose (1751) and IV methylprednisolone x one 125 mg dose (1751). No additional doses of epinephrine were required.

PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 hours following first dose on 1/20/21. After second dose of vaccine, reported: itching, stridor, cough, nausea, vomiting, dizziness, tachycardia, acute change in mental status, temp102.5, DBP >100, tremors for 48 hours. Did not see doctor or other healthcare provider.

Difficulty breathing- received EpiPen dose, patient was able to breath normally again Shortly thereafter patient was witnessed to have seizure like activity, EMS was called and administered Ativan and Benadryl in route to ED

When I got up Monday morning, I noticed I had a enlarge lymph node, in the same arm where the vaccine was given. It was the size of a tennis ball. I went to the Doctor, she did a chest xray and blood work to rule out lymphoma. That came back negative and I have had some shortness of breath. This hasn't went away, has got smaller but still there, My PCP is keeping an eye on it.

Patient reported to COVID-19 Vaccine clinice on 02/21/2021 for first dose of Pfizer Covid-19 Vaccine. Patient received first dose, and described a "tightness/itchiness" in her throat, radiating up her jaw. Patient was able to take benadryl by mouth at 2:50pm. Itchiness and tightness in throat did not subside, so emergency services were called around 3:00pm. Ambulance arrived a few minutes later and patient was take via ambulance for emergency medical serices. No epi-pen was administered as of time of departure from clinic.

Lightheaded, short of breath, tightness across chest, unsteadiness in legs, cloudy brain. Went to ER with labs done (tryp 4.8). Discharged.

ended up in the ED later that day with a flare up of covid symptoms, I stated hurting all over as expected, but also got lightheaded, nauseated, sugar kept dropping, felt short of breath due to coughing, head started pounding, and got very weak.

Patient felt nervous, difficulty breathing and complained about swelling in the back of the throat within 15 minutes of administration. Her face was red and heart rate was elevated to 120bpm with blood pressure of 140/90mmhg.

29 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat and chest tightness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress and tongue swelling. PMH includes anxiety. Takes lexapro 10 mg for this. She is currently 21 weeks pregnant. Feels baby moving. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 0857 BP: 126/68 Pulse: 93 SpO2: 100% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway Eyes: Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious (slightly). Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)

Vaccine was administered at 10:55 am, was in observation for 15 minutes; s/s of mild throat constriction and chest pain began at 11:20. Benadryl 25mg IM given and observed for approx. 15 minutes. VS WNL and patient states symptoms were relieved. She returned to medical staff at approximately 4:30 and had no additional s/s.

Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with pounding heart rate, short of breath, cold forehead. Stood up and walked to next room, pulse continued to rise, ultimately plateauing around 160bpm. Called family doctor, was advised to apply pressure to one side of neck and monitor for the next half hour. Followed advice, sat down with knees bent, and did slow breathing. Pulse slowly decreased and returned to normal rate around half an hour later.

Patient with prior hx of anaphylaxis - required 30 min wait, ~ 25 mins into wait time - reporting slight swelling of lips, sensation of itchy throat/tightening, appearance of hives on arms. Patient alert and oriented, breathing comfortably. Advised will take to ED dept for further evaluation - patient refusing wheelchair - ambulatory. Walked to ED dept with NP, report given to ED, registration completed.

Patient presented for her first covid vaccine today. She received the immunization in her right deltoid at 1703, was seated in the 15 minute observation area. After about 10 minutes, she reported feeling dizzy. RN alerted EMS who brought her for closer evaluation. While in EMS care, patient developed rash and hives on her neck and arms, swelling in her lips and tongue, shortness of breath with oxygen saturations in the 80's. EMS started a 20g Left antecubital IV, administered 50 mg benadryl IM, 125 mg solumedrol IV, placed patient on supplemental oxygen at 2L nasal canula. After medication administration, patient's rash and hives began to resolve and she was able to speak clearly after medication. Patient was transported to hospital via ambulance for further evaluation. VAERS documented.

Drowsy, SOB, lightheadedness. Evaluated by EMS-Transported to Emergency room/department or urgent care.

Approximately 3 to 4 minutes after receiving vaccine, patient stated she was not feeling good and patient turned red and fainted. She was sitting in chair so mom stood behind her with an ice pack behind neck and holding patient head while dad stood in front of patient. Her body became limp and mom was shaking her body on right side in attempt to wake patient up. Her eyes opened but was still unresponsive and she was breathing heavily for 30-40 seconds. After placing patient on floor and elevating her legs, patient stated she felt better but still fills nauseated. Paramedics were called.

heart racing, throat feels like its closing, hard to breathe, generalized weakness. Evaluated by EMS-Cleared

noticed difficulty breathing and extreme pain on inhalation. went to the emergency room and was diagnosed with pleurisy

Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on left chest and shoulder with muscle pain. Left arm became numb, rash at injections site, migraine, numb lips and mouth. Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea. On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat. 1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.

Pt. received first dose Pfizer COVID vaccine at 1415 and shortly developed throat itching, swollen tongue, and swollen left lower eyelid. Baseline VS at 1418 was BP 126/82, RR 16, HR 122, O2sats 95% on RA. States throat felt tighter and epipen was administered to left thigh at 1419. She was examined Lungs CTA, no stridor, CV RRR and did not appear to be in distress with breathing. She was placed on oxygen at 2 liters. Code blue called at 1427. VS-BP 128/73, RR 18 HR 132 O2sats 99% on 2L post-epipen administration. States she felt better after epipen was administered and 2 puffs albuterol. Transported to local ER and discharged same evening.

" Heart rate went up and my lips, tongue and throat started swelling"" I took 3 Benadryl and had taken Allegra that morning. It seemed to work and the swelling went down. Bad back pain, arm pain headache, general muscle aches, fatigue and my grip strength is very weak"

Patient was administered the vaccine and ask to sit and wait 15 minutes for observation. within 10 minutes of sitting she stated that she wasn't feeling well and was having trouble breathing and swallowing. The pharmacist was notified and an epipen was administered.

29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.

1430: 29yo female with complaints of throat itching and tightness. Allergies: Latex, eggs, dairy, wheat Epi-pen has been used in the past. Patient given Benadryl 25mg Po by Physician on duty Patient symptoms resolved and patient discharged home with friends and boyfriend to watch over patient.

patient noted TDAP reaction (hives) in the past, after vaccine reported throat tightness and chest heaviness, EMS evaluation completed, given benadryl and alleviated and patient self drove himself home.

AFTER 15 MINUTE OBSERVATION, PT WAS UNABLE TO WALK MORE THAN 10-15 FT BEFORE NEEDING TO SIT BACK DOWN AT WHICH TIME SHE SLOWLY SLID OFF THE CJAIR AND ONTO THE FLOOR (GUIDED BY HER FRIEND WHO ACCOMAPANIED HER). SHE REMAINED LYING ON THE FLOOR UNTIL MEDICAL PERSONNEL ARRIVED. SHE APPREARED TO HAVE PASSED OUT, HAD VERY BRIEF CONVULSIONS/TREMORS BEFORE COMING TO, AT WHICH TIME SHE WAS ABLE TO REPSOND TO QUESTIONS AND ANSWER THEM. HER PULSE RATE SEEMED WITHIN NORMAL WITH SLIGHTLY ELEVATED RESPIRATORY RATE. MEDICAL PERSONNEL ASSISTED HER FROM THE FLOOR TO THE GURNEY. SHE WAS TAKEN TO THE AMBULANCE IN THE PARKING LOT FOR FURTHER EVALUATION. NO UPDATE ON HER STATUS WAS GIVEN TO US.

Itchy throat, redness around throat/chest, strider, difficulty breathing within 10 minutes of shot Taken to ER by ambulance Treatment: 2 doses epi, 50mg Benadryl PO, 25mg diphenhydramine IV, Salu Medrol IV, Pepcid IV, duoneb Next day (3/28) symptoms reoccurring at 9am. Returned to ER for treatment. Treatment same as previous day minus epi

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: itching of neck-Mild, Systemic: Shakiness-Mild

Client canceled second dose appointment. Reported tight throat within 4 hours and "itchy body welts" the next day.

2:50pm started with chest pressure and heaviness. 2:52pm shortness of breathe, honked and there was a delay of paramedics. Took 2 pumps of inhaler. Did not work. EMT loaded me on the stretcher out of my car in the ambulance. Gave albuterol mix in nebulizer. Went into full anaphylaxis on the way to ER. 4 epi in the arm did not help 2 benedrylmshits to the arm did not help. I was on 5L oxygen until the epi was mixed with albuterol to pen airways. Anaphylactic episodes continued every 5 hours for 2 days, then became every 12 hours, then 24 hours, then 12 hours. Steroids, Claritin, antacid, albuterol epi mix have helped managed episodes. Still currently in the hospital.

Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tachycardia-Mild

Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was discharged. Patient returned the same day at 15:40 cyanotic, altered, hypoxic and hypotensive. The patient was found to have profound metabolic acidosis, liver failure, renal failure. She went into cardiopulmonary arrest, was revived, rearrested and died. Patient was treated for possible sepsis, shock, liver failure.

13 minutes after receiving her vaccination, she reported feeling itchy nose in her throat as well as left swelling. She was taken to a private section of the arena monitored. She was given one tablet of fexofenadine 60 mg times one.

Patient is a 29 year old female patient who went to County Health ER on 3-1-2021 at 02:52AM with possible complex migraine, vision blurring, and transient aphasia. CT was (-), she needs an MRI and referral to neurology. 1) paresthesia of skin, 2) other migraine not intractable, without status migrainosus, 3) (receptive) aphasia Saturday night(2-27-21) laying in bed looking at her phone and all of a sudden experienced a headache, vision went blurry, thought her eyes were tired and she tried to go to sleep. Headache was in the front of her head. Went to sleep then woke up at midnight, 2 hours later, breathing was off, head was hurting and felt anxious, felt like she needed to pace. Her husband was asking her what she was doing but she could not understand what he was asking. Couldn't figure out what to tell him or how to tell him, she could only say "what?" She then lay down, shaking, hand and tongue went numb. Went to ER, by that point the numbness was gone and she could understand what they were saying. The ER doctor Gave her Cogentin that helped to calm her down. Her head was not hurting all of the time. Gets headaches but not usually migraines. Patient has not had COVID that she knows of, son was negative for COVID in November 2020, but he had COVID-like symptoms. No recent sickness, travelled the first week of February 2020. Denies any weight loss, night sweats, no falls, no rashes, no tripping over her feet, no urinary retention. Yesterday felt light headed and dizzy, felt that she had to focus her eyes a little longer. PE abnormalities on office exam 3-2-2020: Right side smile is more droopy than left. Right side, pt is unable to puff cheeks due to right facial muscles with decreased strength/tone. Right foot has decreased vibratory sense compared to left foot. Left foot slightly decreased vibratory sense, but very slight, right is much worse. Monofilament testing is good/normal in the hands and feet bilaterally. Point to point discrimination testing: 2 mm left hand 3 mm right hand Right foot 11 mm on bottom, 10 mm on top (abnormal) Left foot 12 mm on bottom, 11 mm on top(abnormal) strength 5/5 and reflexes normal 2+ in bilateral UEs and LEs. Mental status is normal. MRI and MRA of brain is advised. EEG study with Dr., neurology, referral made. Check tick borne illness panel, vitamin B, folate, thiamine. (ER labs were unrevealing.)

Difficulty breathing 10 minutes after injection. Cleared up with allergy medicine. Extreme exhaustion that has continued for 3 days.

injection site pain, tiredness, headache, muscle pain, chills, injection site redness/rash/itching, nausea, swollen lymph nodes (armpits/throat), inside of mouth cheeks/throat very sore, hard to breath, sharp/achy chest pain - sort like bronchitis without the phlegm, potentially high blood pressure but I have no way of measuring it. Have been taking benadryl 2 pills every 4-6 hours since around 15 minutes after dose one, took aleve since yesterday (April 5 2021). As of present (April 6 2021) still experiencing all of the above and feel unwell

There was a rash like on my arms and thighs roughly after 30 minutes. When I got home, I took Benadryl and Tylenol. After 30 minutes, I noticed that my rash started to go down. While at the same time, I started feeling abdominal pain and my throat closing. I started to feel fatigue and very sleepy.

pt signaled to ems and stated "are you two ready to work?" pt complaint of "throat closing up" pt was taken to evaluation room. pt vitals bp 145/95 hr 106, spo2 100$ ra rr 18 bgl 96 pt 4 lead ekg sinus tach. pt adminstred 12.5 mg children's Benadryl liquid oral. pt reevalutaed bp 130/85 hr 96 spo2 100% ra rr18. pt appeared stable. no visible airway obstruction noticed upon inspection. rescue transported to hospital.

In the 24 hours after getting the first dose of Pfizer I experienced shortness of breath and runny eyes and a scratchy throat

One half hour post injection I began feeling a tingling in my throat. It progressed to swelling, which made it more difficult to breathe. My lips swelled a bit and a white line formed on them. I took two 25 mg tablets of Benadryl. I began feeling better about an hour later. I also started my period the morning of the shot. The next morning, my period stopped.

Hives all over body about 80% of the entire body. Swollen face, tongue and throat felt compressed. Started exactly 24hours after shot and lasted 4 days. On the 2nd day of the symptoms is when my face and tongue became swollen and my throat felt like there was an arm around it.

29 yo Female reported after last vaccine hives that resolved next day with Benadryl and single brief dizziness described as insignificant before vaccine. Upon walking to the bathroom during the 30 minute wait time, escort noted patient appeared to be in need of assistance so he offered her a chair. Upon sitting, she slumped against him so he asked for medical assistance. EMS called. On the ground patient was unresponsive with shallow breathing; neck was hard to move but attributed to her large bun. Stethoscope used to hear breath sounds as nurse reported she was breathing but did not appear to be strong breaths. Pulse ox 96% or higher with BP appropriate, HR in 90s. She awoke to sternal rub, nurse asked her if she had difficulty breathing after noting her jaw was rigid and unable to open. Patient indicated yes to difficult breathing so epinephrine was given. ~ 30 seconds after epinephrine patient alert and breathing deeply, began to respond to questions. After reporting breathing was still moderately difficulty (a few minutes later), epinephrine second dose given. Patient transport via EMS.

ADMINISTERED PER PROTOCOL IM INJECTION ICD-10 Z23 CPT 91300: 30MCG/0.3ML INTO LEFT DELTOID AROUND 11:40 AM. Patient in vaccine room with pharmacist post injection for about 5 minutes then moved to waiting room and about 5 minutes later patient started experiencing shortness of breath and used 2 puffs of Proair HFA. She knocked on pharmacy door expressing shortness of breath. Pharmacist evaluated no swelling on body, no rash, no bleeding occurred at injection site. Patient was given 3 tablets of 25mg Diphenhydramine. Pharmacist also noticed her hands were really cold as she was attempting to help calm patient. Technician immediately dispatched EMS as patient was expressing increased difficulty in breathing. Patient blood pressure was assessed about every 3 minutes 1st reading 137/118 pulse 78; 2nd time 153/92 pulse 126; 3rd time 150/97 pulse 138. EMS showed up at showed up about 7 minutes later 12pm. Patient was escorted to the hospital by EMS for 24 hour observation.

In the evening of the 5th I felt like I had the flu (malaise, fatigue, chills, headache, nausea + mild arm pain). Went to bed early. Next day didn't feel well in the morning but continued daily responsibilities. By Tuesday the initial symptoms had gone. Felt almost normal in AM. By Tuesday evening I had a new throng of symptoms that were different than the initial ones. My left breast and underarm were extremely sore. I was having trouble breathing (it felt labored, and like I needed to focus to be able to breath, full breaths were impossible, never felt like I was getting enough oxygen), general feeling of just being very unwell, dizzy, weak, clumsy, exhaustion/fatigue, on-off headache, tingling in limbs, unusual heart rate fluctuation with activity and high sometimes when resting without effort, trouble concentrating, very shakey. I have been resting but it has continued. Lots of sleep and fluids.

there is clear liquid or mucus when she blows her nose and her nose is constantly running and she feels it in the back of her throat; her nose is constantly running and she feels it in the back of her throat; Tested positive for covid; Coughs up little specs of blood with dry cough; Fever; Feels a little weak at night sometimes; Light to mild cough; Losing her voice; Dry throat; Having problems breathing because of nose and throat; Loss of sense of taste and smell; Loss of sense of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6205; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm left on 16Mar2021 12:30 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced Dry throat, light to mild cough, Having problems breathing because of nose and throat, loss of sense of taste and smell, Losing her voice on 26Mar2021. The patient experienced fever, feels a little weak at night sometimes on 27Mar2021. The patient was tested positive for covid on 28Mar2021. She coughs up little specs of blood with dry cough on 28Mar2021. There was clear liquid or mucus when she blows her nose and her nose was constantly running and she felt it in the back of her throat. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Mar2021. Therapeutic measures included Nyquil were taken as a result of fever, feels a little weak at night sometimes, dry throat, light to mild cough. The outcome of events tested positive for COVID-19 was unknown, fever was recovered with sequelae, feels a little weak at night sometimes, light to mild cough, coughs up little specs of blood with dry cough, loss of sense of taste and smell, losing her voice was recovering while dry throat, having problems breathing because of nose and throat was not recovered. Information on Lot/Batch number was available. Additional information has been requested

passed out from exhaustion; Fever; was unable to stand unassisted.; writhing in pain/so much pain; in and out of consciousness/passed out; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; sweating profusely; couldn't support her own body without tipping over.; seizure; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; chills; extreme muscle pain; spasms; This is a spontaneous report from a non-contactable consumer (patient herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 13:15 (Batch/Lot Number: ER8737) as single dose, for COVID-19 immunisation. Medical history was reported as no. Patient did not have COVID-19 prior to vaccination. Patient did not receive other vaccines within 4 weeks prior to COVID-19 vaccine. Patient's concomitant medication includes omeprazole, ethinylestradiol, levonorgestrel (MARLISSA), venlafaxine and gabapentin from unspecified dates, received within 2 weeks of vaccination, for unspecified indication. Patient historically took first dose of Pfizer BNT162B2 (Lot number: EN6204) on 13Mar2021 at 11:00 AM on the left arm for COVID-19 immunisation. Patient previously took hydrocodone bitartrate, paracetamol (VICODIN) on an unspecified date and indication and had allergy. On 02Apr2021, around 10pm, patient began having chills and extreme muscle pain and spasms, and the lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain. By midnight (03Apr2021 00:00), patient had a fever and was unable to stand unassisted. She was writhing in pain and arching uncontrollably off the bed. She believed in hindsight that this was a seizure as she went in and out of consciousness and her tongue swelled up, making it hard to breathe and impossible to speak. She was sweating profusely, and had to drink water constantly. Her husband had to help her get to the bathroom because she couldn't support her own body without tipping over. The chills and fever alternated all night, and she finally passed out from exhaustion at 03Apr2021 at 7am. The next 2 days, she was in a cycle of fever and chills again, and the fever got so bad that she seized twice more on Saturday (03Apr2021). She had to take the day off work on Monday (05Apr2021) as she was still in so much pain that she could barely leave bed except to use the bathroom. Events were reported as life-threatening, immediate risk of death from the events. Patient was not hospitalized. Treatment for the adverse events were cool baths, naproxen (ALEVE) for fever and pain, and PEDIALYTE. COVID-19 was not tested post vaccination. Vaccination facility type was at a hospital. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

throat has been itching; having a hard time breathing; everything hurts and feels like she got hit by a truck; bad allergic reaction; throat started closing up; throat has felt swollen; wheezing; a rash on and off located around her throat and chest.; her symptoms began at the vaccination site; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EP8720), via an unspecified route of administration in left arm on 27Mar2021 11:00 (at the age of 29-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a pharmacy/drug store and vaccine was not administered at military facility. Medical history included asthma and pulmonary embolism, both ongoing. There were no family medical history relevant to the events. No AE(s) following prior vaccinations. No Prior Vaccinations (within 4 weeks). The patient had no investigation assessment. Concomitant medications included apixaban (ELIQUIS) from an unspecified start date and ongoing for pulmonary embolism and prednisone for asthma from 31Jan2021 and ongoing. The patient received the first dose of BNT162B2 on this past Saturday (on 27Mar2021) and she had a bad allergic reaction and she has been having allergic reaction symptoms since then, almost in anaphylactic shock, throat has felt swollen, she has been wheezing, a rash on and off located around her throat and chest and throat started closing up, all on 27Mar2021 at 11:08. The patient stated her symptoms began at the vaccination site and she was taken by ambulance to an emergency room for treatment. On 28Mar2021, another allergic reaction; wheezing and her throat started closing up and she had a rash around her neck. On 31Mar2021, the patient was having allergic reactions, throat has been itching, having a hard time breathing, and everything hurts and feels like she got hit by a truck. The patient had the shot on Saturday 27Mar2021 and within eight minutes she was almost in anaphylactic shock. The patient got that taken care of and the next day she went into another allergic reaction and now today she was still having allergic reactions. The patient considered the events as non-serious. The patient would like to know how long her symptoms would last. Called ambulance with treatments included 2 shots of Epi and IV steroids and diphenhydramine hydrochloride (BENADRYL) and nebulizer treatments. The patient had anaphylactic reactions with allergy shots. The events required emergency room visits on 27Mar2021 and on 28Mar2021. No physician office visit. The outcome was recovered for anaphylactic shock, rash and wheezing on 27Mar2021; unknown for vaccination site reaction and not recovered for the remaining events.

Patient received the vaccine at 9:30 am and complained about feeling anxious and shivering around 9:40 am. Her blood pressure was 174/95 mmHg. She also complained about chest tightness and breathing difficulty, so an EpiPen 0.3 mg auto-injector was administered into her left thigh at 9:45 am and EMS was contacted.

Client began to complain of feeling like her throat was swelling and opening. 50mg of Benadryl given. 4 min later client stated they were feeling better. Client's vitals remained stable. Released to personal car at 3:15pm

began with a thick throat and lips and face began to swell - left side was more swollen than the left, began taking Benadryl but it took almost 3 full days for it to go down.

48 hours after the vaccine my mouth began itching after eating. It happened during breakfast and lunch this day, and then the next morning at breakfast, which is when I became worried. My throat began feeling tight, felt like it had mucus in it and I needed to clear it. My mouth was itching and my tongue felt tingly. Four days after the vaccine my tongue started to swell so I called my doctor. I saw him the Tuesday, 3/2 after the vaccine and he said my thyroid was swollen and felt I was having an allergic reaction to the vaccine. He did an allergy panel and lab work for my thyroid, all tests came back within normal limits. He referred me to an allergist and said to take benadryl every six hours. A few days later my bottom lip started to swell and my tongue ached. I was also having intermittent chest pains for about five weeks. Then my lymph nodes in my throat started throbbing. I saw the allergist on 4/6 and he advised to cancel the second dose. He did lab work to check for autoimmune disorders and inflammation but tests came back normal. He advised on 4/19 to take allegra two times a day for three weeks and we will follow up. Ongoing symptoms are mouth itching after eating, tingling in throat, and itching on throat and neck, and on and off swelling of my bottom lip. I have also experienced lightheadedness and ocular migraines.

5 minutes after receiving the vaccine my arm started to become hot in the area of injection. Within seconds, my body temperature increased, my limbs started to tingle, and my forehead began dripping with sweat. I called the facility worker in the area and asked "Is it normal to get this hot and tingly?". As my body seemed to lose strength, she told me to put my head down and flagged down a paramedic. I was wheeled to the back (as symptoms were increasing), and was laid on a bed. They measured my vitals and provided me with water. I was so weak that I couldn't open my eyes and was told that I was clinically hyperventilating (I personally felt calm prior to laying on the bed). I was monitored for about 45 minutes until I was picked up by a family member. I returned home and slept for almost 18 hours straight, and could hardly move for almost 3 days (as I continued to sleep the following day).

shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare; shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare; overwhelming fatigue; This is a spontaneous report from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASP2021052927), license party for etanercept (ENBREL). This non-serious spontaneous report (USASP2021052927) was reported on 06/APR/2021 by a consumer and involves a 29 year old female patient who experienced had shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare [PT: hypersensitivity] while receiving Enbrel with Single Dose Prefilled Syringe and Aimovig with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis, migraine, and asthma. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Aimovig with Single Dose Prefilled Autoinjector on an unknown date in JUL/2018. The patient started taking Enbrel with Single Dose Prefilled Syringe on an unknown date in 2020. On 15/MAR/2021, the patient received her first Pfizer COVID-19 vaccination. On 25/MAR/2021, the patient took her latest Enbrel injection. On 27/MAR/2021, the patient took her latest Aimovig injection. On 28/MAR/2021, Sunday, the patient started experiencing shortness of breath (SOB) and chest pain which lead her to see her physician the following Monday. On 29/MAR/2021, the patient performed electrocardiogram (ECG) at the physician's office which was normal. On 29/MAR/2021, on Monday night, the patient went to the emergency room with a burning throat and SOB and the patient was diagnosed with an allergic reaction or possible asthma flare, and she was prescribed a prednisone taper which she did not take and baclofen. The patient had been taking the baclofen and using her Xopenex (levosalbutamol hydrochloride) rescue inhaler as needed for SOB. The patient also reported that the SOB and chest pain was getting better but still had issues. On an unknown date in 2021, the patient also reported that she had been experiencing overwhelming fatigue and was scheduled to receive her second Pfizer COVID-19 vaccination on 09/APR/2021. The outcome of the events hypersensitivity was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Syringe was reported as unknown for the events hypersensitivity. Action taken with Aimovig with Single Dose Prefilled Autoinjector was reported as unknown for the events hypersensitivity. The causal relationship between the events hypersensitivity, and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. The causal relationship between the events hypersensitivity and Aimovig with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up is not required.

Pt presents with right forearm rash, generalized itchiness, nausea, throat itch and feeling throat closing. Past med history: asthma managed with daily Benadryl, albuterol for rescue. Exam: generalized rash, diffuse redness around right forearm and left flank. lungs have bilateral wheezing. tachycardia. 9:23 IM epi given in right thigh 9:25 25mg Benadryl IM 9:30 nausea/vomiting resolved 9:40 pt taken to hospital for observation

Received vaccine 4/8/21. Presented to hospital 4/14 with worsening dyspnea and chest tightness. Found to have bilateral pulmonary embolism. Unclear if the vaccine is a true precipitant here but wanted to report.

After 20 mins (I had already arrived to my car) my throat started to feel tight, I could breathe normally but the sensation of tightening was happening accompanied by very warm rushing sensation in my neck and ears. I also experienced numbness near my neck. My heart rate also elevated significantly range between 88-106. (After the tightening sensation began I started to panic a little which certainly contributed to the heart rate elevation), The provider monitored me to make sure that no breathing issues were present and I took two chewable Benadryl. I stayed at the clinic until one hour had passed and returned home. The provider called me later to check on my status. I want to emphasize that i was not at all nervous or anxious about receiving the shot but I very stupidly had alcohol in my system.

Day 1 (1 hour after shot) - nausea, vomiting, fatigue, body shaking, general feeling unwell and needing to rest, injection site soreness. Day 2 (at night before bed) - some shortness of breath (not sure if due to anxiety), joint pains, muscle aches, injection site soreness, chills. Day 3 - abdominal spasming (contractions every couple of minutes) early morning to early evening 4pm, fatigue, waves of heat, throat closure sensation without issue eating/drinking/breathing, anxiety over symptoms. Day 4 - less symptoms during day, occasional feelings of not being able to take deep breath. Week and half after first vaccine - muscle twitching of legs only, achiness present before bed.

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

Site: Itching at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild

Within 30 minutes I felt tingling and numbness in my left arm, right arm, and face, shortly followed by tightness in my chest and throat, slight swelling of the tongue accompanied with a dizzy feeling and hugh blood pressure when usually good or normal. When administered benadryl the tightness and swelling subsided, but two hours later followed with heat and itchiness felt from head to toe almost inside the body. For 3-4 days nausea, dizziness, slight headache, feeling extremely hot in the core and itchiness came and went.

Patient experienced rapid heart rate, increased respiratory rate and dizziness. The patient was given oral water to treat shock, and was monitored for worsening condition or anaphylaxis. After 5 minutes the patient had completely recovered and was observed for another 15 minutes.

URI, bronchitis, bronchiolitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia, asthma exacerbation, COPD exacerbation

First day: vaccinated on Monday at noon Arm hurt Tired 12 hours later - Tuesday - fever, chills Fever all day Tuesday and body aches Went to bed Tuesday night with a 101.7 fever Broke fever at about 36 hours Wednesday - Woke up feeling pretty normal but had really sensitive teeth As the day persisted my lungs started hurting. It felt like I smoked 2 packs of cigarettes or was on the verge of an asthma attack. Thursday - teeth less sensitive, lungs hurt but nothing as bad as Wednesday At 8:00pm found a golf ball size swollen lymph node on my left side where I got the vaccine. Also have a few swollen lymph nodes in my throat Friday (today) - swollen lymph node still present and large, Still having difficulty breathing.

Approx 4-5 hours post vaccination pt started a systemic allergic reaction that has progressed to require steriods and she had two episodes of SOB and tongue swelling that have resolved but are worsening in severity.

Started having an allergic reaction around 3pm on 4/28/2021 hives and itching, then throat stated to swell. Went to er and they gave me Benadryl and steroids to stop the reaction. The next day I started to have the reaction again around 10am and had to go back to the er for treatment. I was given more steroids, Benadryl and also epinephrine due to the throat swelling.

Pt developed chest pain 30 mins after vaccination, associated with feeling of shortness of breath and persistent cough that has lasted for 7 days. She developed fever/chills/muscle aches 14 hours after vaccination that lasted for 1-2 days and then resolved. Pt referred from our health center to local ED for more thorough evaluation to r/o PE.

Puffy eyes; eye pain in lids. ? 12hrs Pain in chest. Pain inhaling to take deep breath. Strenuous activity makes chest hurt more. Pain in left side of neck. Swollen lymph nodes.

My entire body turned bright red within a minute of receiving the vaccine. My throat started to close, I immediately started sweating profusely. Store immediately administered 2 doses of Benadryl, followed by another 2, followed by another 4. Epinephrine was given to me to take home. I was put on prednisone and hydroxyzine.

Fever or Chills Cough Shortness of Breath Fatigue Headache Sore throat Congestion or running nose

Headache Congestion or running nose New loss of taste or smell Dx Cough ? Shortness of Breath FATIGUE FEVER

swollen bottom lip; tongue ached; chest pains; itching in mouth after eating; swelling and tingling tongue; swelling and tingling tongue; tight throat after eating; felt like mucus was in throat; enlarged thyroid; lightheadedness; ocular migraines; throbbing lymph nodes in throat; Discomfort in throat; skin itchy; This is a spontaneous report from a contactable consumer (patient). This 29-year-old female consumer (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot En 6506), on 24Feb2021 at 10:00 AM, in left arm, for COVID-19 immunisation. Medical history included benign thalaseemia, irritable bowel syndrome, ocular migraines, peanuts allergy, tree nuts allergy, penicillin allergy, amoxicillin allergy. Concomitant medications were none (no other medications in two weeks, no other vaccine in four weeks). Covid prior vaccination: no. On 26Feb2021 at 11:00, 48 hours post vaccine, the patient experienced itching in mouth after eating, swelling and tingling tongue, tight throat after eating, felt like mucus was in throat, enlarged thyroid. 2 weeks post vaccine, on an unspecified date in Mar2021, the patient experienced swollen bottom lip, tongue ached, chest pains. 4 weeks post vaccine, on an unspecified date in 2021, the patient experienced lightheadedness, ocular migraines, throbbing lymph nodes in throat. Discomfort in throat and skin itchy were also reported. The events resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. Allergist recommended antihistamines 2x per day. The patient had a negative nasal swab on 28Feb2021. The events had not yet resolved.

Shortness of breath/Shortness of breath on exertion; with chest pressure, on exertion; Headache with sinus congestion; Headache with sinus congestion; Body aches; Diagnosed with Covid-19 virus after taking both vaccines; Diagnosed with Covid-19 virus after taking both vaccines; Tachycardic; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: 31Mar2021) on 29Dec2020 20:00 (at the age of 29-years-old) then received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021) on 19Jan2021 09:00 (at the age of 29-years-old) both via an unspecified route of administration, administered in deltoid left as 0.3 mL, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included Factor V Leiden from Mar or Apr of 2017, while she was pregnant; migraine from 2011; exercise induced asthma from 2007 or 2008; all were ongoing. The patient's other family members have tested positive for Covid-19 last summer but specifies that they were not vaccinated. The patient was taking medications routinely prior to the event being reported which included Vyvanse at 20 mg by mouth once a day. She added that she does not take it every day because she works at night; and amitriptyline at 10 mg by mouth daily. On 20Apr2021, the patient was diagnosed with Covid-19 virus after taking both vaccines, tachycardic, loss of taste and smell; then at 3:00 am of 20Apr2021, the patient had body aches, headache with sinus congestion and cough. On 21Apr2021, the patient experienced fever. On 22Apr2021, the patient experienced shortness of breath, with chest pressure, on exertion. It was also reported that the patient's loss of taste and smell was worsened 21Apr2021 described as very noticeable. It was further reported as the patient got her first vaccine on 29Dec2020 and second vaccine on 19Jan2021 then she was diagnosed with Covid-19 on 20Apr2021. The patient stated that when she moves around, she gets short of breath and her heart rate elevates. She went to the emergency room. She had to go to the hospital because she was tachycardic described as when she came home from work, it felt like her chest was pounding; and had chest pressure from being short of breath. She was not admitted, she went to the emergency room, and was released. She cannot walk without getting short of breath. She called her primary care provider, who told her to go to the emergency room, because of her history with a clotting disorder, Factor V Leiden. The patient confirmed she has no history of having clots. Her heart rate baseline was 50 to 70 beats a minute. Shortness of breath on exertion. Loss of taste and smell started in the evening on the 20Apr2021 as her drink did not taste right, and the next day, the event was very noticeable, on the 21Apr2021. She had fever, and took Tylenol for her headache and reclarified, that it somewhat helped the headache. She also had body aches, headache with sinus congestion and cough; all on 20Apr2021 at 3:00 am. The events shortness of breath and tachycardia resulted in emergency room visit. The patient did receive additional therapies for COVID-19 which included albuterol started on 20Apr2021 as patient will take it when she was sick or has allergies; and Lovenox started on 20Apr2021 at 0.7 ml once a day, subcutaneous injection, due to her history of clotting condition. The patient underwent lab tests and procedures on 20Apr2021 which included rapid Covid-19 test: positive, no reference range provided; CBC, BMP, D-dimer: all results were normal, reference ranges not provided; Chest X-ray in emergency room: no infiltrates were noted. The events diagnosed with Covid-19 virus after taking both vaccines, tachycardic; shortness of breath, with chest pressure, on exertion; fever and headache with sinus congestion were all considered as medically significant by the reporter/patient. The outcome of the events body aches and cough was recovering while the rest of the events was not recovered. Relatedness of drug to reactions/events. Reactions assessed were diagnosed with Covid-19 virus after taking both vaccines, tachycardic, loss of taste and smell, fever, body aches, headache with sinus congestion and cough: Source of assessment was the primary source reporter and the method of assessment was global introspection then the drug results were unknown.; Sender's Comments: The association between the event lack of effect (COVID-19) and the other events with BNt162b2 can not be fully excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; Presented to hospital 14Apr2021 with dyspnea and found to have bilateral pulmonary Embolism.; This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular first dose on 08Apr2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient was presented to hospital on 14Apr2021 (also reported on 04Jan2021) with dyspnea and found to have bilateral pulmonary Embolism. The event caused hospitalization on 14Apr2021. The patient was treated with Anticoagulation. The patient underwent lab tests and procedures which included Nasal Swab: negative on 14Apr2021. The outcome of the events was recovered. Information on the lot/batch number has been requested.

Respiratory distress (SOB), chest pain 3/10 intermittent sternal. VS stabilized back to baseline and D/C'd to home. Documented allergy in HL.

Lip swelling; throat swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number er8723 /expiration date: not provided), via an unspecified route of administration, on 27Mar2021 at 17:30 (at the age of 29 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included asthma, Triaminic allergy and requip allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included trazodone and alprazolam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Apr2021, one week after vaccine was given, the patient experienced lip swelling and throat swelling which required a physician's office visit. The patient received treatment for the events lip swelling and throat swelling which included prednisolone injection. The outcome of the events lip swelling and throat swelling was recovering. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : same patient, different vaccine dose/event

Feel both my arms and my neck start to itch and burn; Feel both my arms and my neck start to itch and burn; My chest started feeling heavy; Trouble breathing; Wheezing; Was not able to speak very well; Inflamed throat; Not much movement in my lungs; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in right arm at age of 29-years, on 27Mar2021 14:30 (Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included allergies to pork and cow milk; she had asthma and paralysis. The patient was not pregnant at time of vaccination. Concomitant medication included amitriptyline and "nurtec odt" (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced both arms and her neck start to itch and burn. Then her chest started feeling heavy, then trouble breathing and wheezing. She was not able to speak very well, inflamed throat and not much movement in her lungs. She was sent to ICU. The adverse event result in hospitalization and "Doctor or other healthcare professional office/clinic visit". Adverse events started at 14:45 on 27Mar2021. She was hospitalized for 7 days. The treatment for events included Epi, steroids, dual nebulizer benedryl. The patient did not diagnose with COVID-19 prior to vaccination. She tested for COVID-19 with Nasal Swab since the vaccination on 27Mar2021 with outcome was negative. Events outcome was recovering. Information on the lot/batch number has been requested.

Coughing, chest and throat tightness, nausea, vomiting, dizziness, fatigue, muscle and joint soreness, sporadic tingling in fingers and toes, on-and-off low grade fever, and temperature regulation issues ; home care and rest as well as 1 virtual visit with MD ; outcome pending

Had experienced flu-like symptoms 24-48 hours after vaccination and had recovered by 72 hours. Approximately seven days after vaccination experienced severe chest pain with heavy pressure on the chest causing an urgent care visit. Chest X-ray was done and EKG performed at urgent care to rule out infection and serious cardiac events. Trouble breathing with pain worse while laying down. Symptoms improved three days after onset and improved about one week after onset.

I received the vaccine on 04/27/2021. I had a high resting heart rate (100+) with shortness of breath and went to the Emergency Department two days after receiving the vaccine (04/29/2021). They gave me fluids and monitored my heart rate until it came down into the 80s. However, since then, I have continued to have a high resting heart rate with occasional chest tightness and followed up with my primary care doctor who recommended seeing a cardiologist. On 05/09/2021, I also had a skin rash on my face, lips, arms, and hands (I think part of my chest/abdomen as well). I went to the Immediate Care Center and was prescribed hydroxyzine. With the medication, the rash went away within a few days.

Post vaccine patient reports breathing issues lasting approximately 1 month. These breathing issues resulted in multiple trips to the emergency department at which she received breathing treatments. Patient states that 5/24/2021 was the first day that she was well enough to speak on the phone to discuss her adverse effects.

I received the vaccine on 04/27/2021. I had a high resting heart rate (100+) with shortness of breath and went to the Emergency Department two days after receiving the vaccine (04/29/2021). They gave me fluids and monitored my heart rate until it came down into the 80s. However, since then, I have continued to have a high resting heart rate with occasional chest tightness and followed up with my primary care doctor who recommended seeing a cardiologist. On 05/09/2021, I also had a skin rash on my face, lips, arms, and hands (I think part of my chest/abdomen as well). I went to the Care Center and was prescribed hydroxyzine. With the medication, the rash went away within a few days.

at 4pm the same day my stomach was really hurting and I was really tired with severe diarrhea. I went to bed at 8pm and woke an hour later at 9pm with a high fever of 102.2 I was shivering, I was convulsing and hyperventilating so I was having trouble breathing. I was unable to take any medication because I wasn't fully alert at the time my husband got my to take chewable Tylenol my fever broke at about 2am. the next day I had a severe headache and muscle aches and bad back pain and still had diarrhea. It is not the 24th and my back is still hurting and my stomach hurts I'm still having diarrhea and am breathing like I ran a marathon.

within 15-30min of getting the vaccine the rashes and hives began to appear on my arms and shortly after my throat got tight and hard to breath. Went to the ER were they treated me. They determined it was anaphylaxis and prescribed an Epipen.

Pt came to desk stating felt like throat was "closing up and tongue swelling". Pt able to speak clearly, no audible wheezing or stridor noted, denies difficulty breathing. Taken immediately to ED, placed into room, nurse with pt and report given, Dr. with pt. No overt signs of anaphylaxis, but discharged with steroids, epi-pen, and benadryl and consulted on returning if new, worsening, or concerning symptoms arise

PT reported throat swelling sensation and difficulty to swallow associated with mild chest pressure approx 5 mins after vaccination. Pt denied nausea, sob, rash, voice coarseness. Upon assessment, no redness/edema to throat/tongue , airway patent. No rash observed Began to report improvement in sx approx 5 mins into oberservation period but still felt some difficulty swallowing. 50mg Benedryl given prophylactically at this time. Pt free of symptoms at time of discharge w/ boyfriend. d/c vitals : HR:92 RR:18 BP 120/80 SP02: 99%

super anxious; Breathing a little rapid; hives on her legs, arms, and neck that have been extremely itchy; Arm was a little itchy/itching/itchy arm was very mild; itchy arm was due to irritation from the band aid that was applied after her vaccination; This is a spontaneous report from a contactable consumer (parent). A 29-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 at 14:00 (Batch/Lot Number: EW0173) as 1ST DOSE, SINGLE for covid-19 immunization. Facility in which the vaccine was give was a 'mass vaccination site'. No other vaccines were given within 4 weeks. Medical history included cellulitis (at the Age: 3 or 4 years old, Treatment included antibiotics), generalized anxiety disorder from an unknown date and unknown if ongoing (diagnosed with generalized anxiety 10-12 years ago). No family history was provided as patient was adopted. Concomitant medication included multivitamin [MINERALS NOS;VITAMINS NOS] (Reported as Multi-Vitamin and vitamins) from an unspecified date and ongoing for general health and Lactaid (occasionally). The patient previously had a vaccine (unable to recall which vaccine caused the reaction event occurred at 3-4 years old) and experienced localized, big red circle around the injection area. The patient experienced hives on her legs, arms, and neck that have been extremely itchy on 09May2021, arm was a little itchy/itching/itchy arm was very mild on 02May2021, itchy arm was due to irritation from the band aid that was applied after her vaccination on 02May2021 breathing a little rapid on 10May2021 and super anxious on an unspecified date, Treatment was given for the events hives and itching. The clinical course was reported as follows the patients arm began to itch a couple hours after the patient received the first dose the Covid-19 vaccine on 02May2021. The patient thought the itchy arm was due to irritation from the band aid that was applied after her vaccination. She had some itching for a day or two after the vaccine was administered also stated itchy arm occurred on and off for one day. The patients arm was a little itchy, but other than that she did not have anything major on until around midnight on 09May2021. Patient woke up and had hives everywhere. Stated she had Hives on her legs, arms, and neck that have been extremely itchy. The hives come and go and she has taken Benadryl but there has been no improvement. The patient's primary care physician was contacted on 10May2021. The event resulted in a physician office visit. The physician noted the patients breathing was a little rapid. Patient thought her breathing was a little rapid because she was super anxious. Patient denied having any difficulty breathing. The patient reported she didn't drink anything new, didn't eat anything new, didn't have new hair or shower products, no new laundry detergent was being used. The physician stated that from the size and extent of the hives, the hives were probably from the Covid-19 vaccine. Caller reported her daughters hives have stayed pretty much the same. One hive will disappear and then another will appear on the patients body somewhere else. The hives are on her neck, arms and legs are very itchy and appear as big blotches. The patient took pictures of her hives and would show them to her doctor in the event they improved before the patient could be seen. Caller reported that the patient would be able to share the photos of her hives with Pfizer if requested. The patient is due to have her second dose of the Covid-19 vaccine. Caller stated the patient's physician leaned toward the patient not getting the second dose. Caller preferred to get more information from Pfizer prior to canceling the patient's second appointment. The clinical outcome of the event Hives and itching was ongoing, Breathing a little rapid was recovered on 10May2021 and the remaining events were unknown. follow-up attempts are needed. further information is requested.

severe shoulder pain, unable to move without sharp piercing pain, cannot lift or move whatsoever. Also had sharp chest pain and shortness of breath. Admitted to ER on 5/30/21 to hospital. Tested abnormal for D-Dimer, going to get CT scan and MRI.

Headache Light-headedness Hot/cold chills Sharp pains near lungs/pressure Heavier breathing Sluggish Felt like I was punched in the arm on first and second dose but worse the first time Achy body

trouble breathing; experiencing hives all over her body; swelling of the face; tightness of the throat; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date were not reported), dose 2 via an unknown route of administration on 20May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date of May2021, the patient experienced hives all over her body and swelling of the face. She also experienced tightness of the throat and trouble breathing. The patient was at local hospital, who haven't provided her proper care, stating that Pfizer has not told them how to treat those reactions. Reporter would like to know if any treatment or a hospital recommended. Outcome of events hives all over her body and swelling face was not recovered while the outcome of events tightness of the throat and trouble breathing was unknown. Information on Lot/Batch number was available. Additional information has been requested.

skin rash on both arms 5 minutes after vaccination, throat tightening sx's, globus sensation, headache and palpitations 5-15 minute after vaccine administration. 8 hours later, sensation of chest burning, throat burning and dyspnea; watery eyes and facial warmth. Associated facial erythema and eyes rolling in head X 5 minutes. Had alternating cold and warmth sensation - now still. Sx's continued - especially globus sensation. + abdominal pain continued for few days. One week later, patient with dyspnea. + eye dryness.

Woke up around 4:30 AM short of breath, feeling somewhat queasy, cold forehead. Checked pulse, heart was racing, around 120 BPM.; Woke up around 4:30 AM short of breath, feeling somewhat queasy, cold forehead. Checked pulse, heart was racing, around 120 BPM.; Woke up around 4:30 AM short of breath, feeling somewhat queasy, cold forehead. Checked pulse, heart was racing, around 120 BPM.; Woke up around 4:30 AM short of breath, feeling somewhat queasy, cold forehead. Checked pulse, heart was racing, around 120 BPM.; Stood up, walked to next room, heart rate increased to around 160, hands shaking, cold hands and forehead; Stood up, walked to next room, heart rate increased to around 160, hands shaking, cold hands and forehead; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6198, Expiration date was not reported), via an unspecified route of administration, administered in right arm on 05Mar2021 at 16:15 hours as 1st dose, single (at the age of 29-years-old) for covid-19 immunisation. Medical history included known allergies: avocado gives stomach aches, depression/anxiety and vitamin D supplements. Patient had no other vaccine in four weeks. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) at a dose of 50 mg/day taken for depression/anxiety; vitamin D not otherwise specified (NOS) taken for vitamin D supplements. On 06Mar2021, the patient woke up around 4:30 AM and experienced short of breath, feeling somewhat queasy, cold forehead. Checked pulse, heart was racing, around 120 BPM. Stood up, walked to next room, heart rate increased to around 160, hands shaking, cold hands and forehead. Called family doctor, given advice to apply pressure to one side of neck and keep an eye on it for half an hour. Did slow breathing and followed advice; heart returned to normal rate within half an hour. Patient received no treatment for all the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of all the events was recovered on 06Mar2021. No follow-up attempts are possible. No further information is expected.

shortness of breath; high heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in right arm on 04Mar2021 at 15:00 (at the age of 29-years-old) at 2nd dose, single for COVID-19 immunisation. The patient was not pregnant. Medical history was not reported. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications in two weeks included fluoxetine hydrochloride (PROZAC), propranolol. No other vaccine received in four weeks. The patient previously received the first dose of BNT162B2 on 11Feb2021 at 01:00 AM (at the age of 29-years-old) administered in the right arm for COVID-19 immunisation. The patient previously took codeine and experienced known allergies. The patient experienced high heart rate and shortness of breath on 04Mar2021 at 21:00. No treatment was received for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

After receiving vaccine, patient complained of nausea, vomiting,. Urticaria, tightening of throat, pruritis. EMS and MD responded, patient was given IM Benedryl by EMS, IV access was obtained, Albuterol was given via EMS and patient was transferred tou Hospital. Symptoms started at 12:05, left for transfer at 12:30 pm

This is a spontaneous report from a non-contactable consumer. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 17Apr2021 09:15 (Batch/Lot Number: EW0169) as 1ST DOSE, SINGLE (at the age of 29 years) for covid-19 immunisation. Medical history included gastritis from an unknown date and unknown if ongoing and covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hemorrhages for more than 1 month on 19Apr2021 with outcome of not recovered, allergies throughout the whole body on 19Apr2021 with outcome of not recovered, body pain on 19Apr2021 with outcome of not recovered, bad breathing on 19Apr2021 with outcome of not recovered and fever at night on 19Apr2021 with outcome of not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID 19 since the vaccination. No follow-up attempts are possible. No further information is expected.

Hives over 90% of body; swollen face; difficulty breathing; This is a spontaneous report from a contactable consumer (reported for herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the left arm, at age 29 years, on 21May2021 18:00 (Batch/Lot Number: EW0186) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing. Patient had no known allergies. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol;norethisterone acetate taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically took first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EW0179) at age 29 years on 30Apr2021 05:00 PM on the left arm for COVID-19 immunisation. On 21May2021 at 21:00, the patient experienced hives over 90% of body, swollen face and difficulty breathing. Patient was hospitalized in May2021 for 1 day. Patient was treated with dexamethasone 12mg for the events. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. The outcome of the events was recovering.

Within 15 minutes of vaccine there was tingling sensation in the mouth. Within 40 minutes of the vaccine there was tongue swelling, a metallic taste, and dry mouth. April 25, 2021 (10 a.m.) - Right half of face, right arm and right leg all went numb and tingly (Paresthesia). April 26, 2021 (evening) - slight shortness of breath, Dry mouth continued, sharp upper back pain April 28, 2021 (evening) - Shortness of breath, throat swelling, Dry mouth continued, sharp upper back pain. April 29th - Prescribed 40 mg of prednisone for 5 days (I felt good while on the prednisone), advair and albuterol May 4th - Symptoms returned after the prednisone dose was complete - On and off tingling/numbness of arms and right leg (Paresthesia), sharp pain in left calve and foot, shortness of breath, sharp back pain (upper), stomach pain (sharp), heart palpitations, dizzy, light headed. - These symptoms continue until present day (June 10, 2021). 21 Day dose of prednisone has been prescribed and a referral to a pulmonary doctor. June 10, 2021 - breath test came back abnormal indicating asthma -

suicidal thoughts; allergic reaction; a rash; throat swelling; erratic moods; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 29-year-old on an unspecified date at single dose for covid-19 immunisation. Medical history included allergies to Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included calcium; bifidobacterium lactis (PROBIOTIC); magnesium, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The allergic reaction included a rash and throat swelling. Psychological/neurological effects included suicidal thoughts and erratic moods. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were serious for being disability. Facility where the most recent COVID-19 vaccine was administered in Doctor's office/urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient received the medication for events. The outcome of events was not recovered. Follow-up attempts are needed. Further information is expected.

Swelling in face. Breathing issues for first couple days. That cleared up, but the chest pain has stayed with me from the day I started to have the reaction.

5/4-5/6: PRURITIC RASH DEVELOPED AT INJECTION SITE 5/7 - HIVES STARTED, TREATED WITH PREDISONE 50 mg qd x 5 days 5/8-5/10: HIVES, SWELLING ON UPPER & LOWER LIPS, SWELLING OF EYES 5/10 - HIVES, SWELLING OF EYES/MOUTH, SHORTNESS OF BREATH, TIGHTNESS AROUND CHEST; HIGH BLOOD PRESSUE,SWELLING IN POSTERIOR OROPHARYNX, SWELLING ON UPPER & LOWER LIPS, URTICARIA & MULTIPLE PAPULES ON BOTH ARMS, TORSO & BOTH LEGS -> WENT TO URGENT CARE WHERE WAS GIVEN AN EPIPEN THEN 911 CALLED &TAKEN TO THE HOSPITAL FOR FURTHER OBSERVATION OF ANAPHYLAXIS 5/11-5/15 - BRUISING; TAKING PREDISONE, BENADRYL, PEPCID AND CLARATIN. SYMPTOMS SUBSIDED DURING COURSE OF TREATMENT 5/26 - HIVES, SWELLING OF EYES/MOUTH, SHORTNESS OF BREATH, TIGHTNESS AROUND CHEST -> EPIPEN INJECTION ADMINISTERED 6/6 - HIVES AROUND ANKLE AREA AND SWOLLEN FEET/ANKLES 6/12 - WORST REACTION YET, HIVES, EYES SWOLLEN SHUT, SHORTNESS OF BREATH AND LIPS SWOLLEN -> EPIPEN INJECTION ADMINISTERED; LINGERING SIDE EFFECTS (SWOLLEN EYES, RASH HAVE NOT SUBSIDED COMPLETELY AS OF TODAY) - CONTINUING BANOPHREN AND CLARITIN TREATMENT DAILY

Pt. reports 15 minutes post vaccination experience double vision and tightness of the chest, causing it to be difficult to breath. This nurse was notified and vitals were 120/96, HR 110, O2 98. This nurse waited 5 minutes and took vitals again. They were - 120/88, HR 89, O2 99. After 15 additional minutes of patient resting on the cot, vitals were 118/20, HR81, and O2 99. Pt then began to be vomitous, experiencing increased chest tightness, and difficulty breathing. This nurse asked the pt if they would like to have EMS called and they obliged. Upon EMS arriving, pt vitals were stable and all tests done in the field came back WNL. Pt still wanted to be transferred to the nearest facility to be evaluated further. Pt. did state hx of elevated Red cell and was to follow up with PCP next week.

blood clot; high levels of d dimer in blood; very dizzy; can barely walk; migraine; fatigue; chills; temperature changes; pain in body switching from left to right and vice verse; chest pain; shallow breathing; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-years, via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunization, in hospital. Medical history was not reported. 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. The patient was not pregnant at time of vaccination. Concomitant medications included gabapentin, lorazepam (ATIVAN), norethisterone (NORETHINDRONE), omeprazole. The patient previously received all antibiotics except for doxycycline. The patient went to hospital to check for blood clot; high levels of d dimer in blood; very dizzy, can barely walk; migraine; fatigue; chills and temperature changes; pain in body switching from left to right and vice verse; chest pain and shallow breathing; serious side effects 1 week later. The events occurred on 27May2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, resulted in emergency room/department or urgent care. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained

6 hours after vaccine, pt reported that her LEFT arm was warm, had a red rash, and tender to palpation. Pt also stated that she felt as if her throat were closing.

After second dose, I had a fever, and continue to experience shortness of breath, chest tightness and heart palpitations as of June 18th.

Starting having tongue pain and swelling 2 days after second vaccine shot, felt like my throat was swelling up as well. Have been diagnosed with geographic tongue, which there is no cure for. Its been 3 weeks and my symptoms have not improved.

I had lymph node swelling under my left armpit & joint pain that began May 12 & resolved within a couple days. I am a competitive marathoner (currently training ) & run everyday & noticed shortness of breath/chest tightness & elevated heart rate when I was running, worse during hard workouts. I think that began around May 14. I am still having elevated heart rate and some shortness of breath during hard workouts. It has taken a day and a half, sometimes up to 2 days, for chest tightness to go away, but it comes back every time I do a hard workout.

appear blood clot in my lungs; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14May2021 (Batch/Lot Number: EW0172) (at the age of 29-years-old) as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8731) on 23Apr2021 (at the age of 29-years-old) in the left arm for COVID-19 immunisation. On 15May2021, patient reported appearance of blood clot in her lungs. The event resulted in Emergency room/department or urgent care. The patient was given Eliquis as treatment for the event. The event was assessed as non-serious. Outcome of event was unknown. Since the vaccination, patient has been tested for COVID-19.

Difficulty breathing and swallowing, was informed this was a normal reaction. I was given a Benadryl and sent home. Missed period, hair loss, hormonal, insomnia , and exercise asthma attacks. Checked for pregnancy and blood tests and nothing different or shown up as wrong except for diabetes. Was told to wait again and follow up with obgyn to see if my period would begin. It has still not begun and have scheduled a follow up. I am still losing hair in clumps and hormonal. I wa a given an inhaler for the asthma attacks.

The first dose caused mild soreness and some discomfort which I thought was anxiety, since it disappeared after the waiting period. Almost immediately after the second dose, I began to have discomfort in my chest and to feel woozy. I thought it was anxiety. I left the pharmacy and began to have chest pains, difficulty breathing, and shortness of breath. I called the CDC Vaccine hotline to ask for advice about the reactions, and I was told my reactions were normal, and people have the same kind all the time. I took a Benadryl and went to sleep. It has been two weeks. If I become excitable or exert myself, my chest begins to hurt and it can be difficult to breathe. I have never had asthma, and I have always been active. It might be getting worse since it can feel like heartburn even if I'm not even doing anything.

felt like dry lips; Dry mouth; Really thirsty; top lip was swollen; lips, tip of nose, and throat feel tingly now; felt tingly and dry underneath my lip; throat feel tingly; soreness on my arm; tightness on my chest with difficulty breathing; tightness on my chest with difficulty breathing; my mind was foggy.; it was hard for me to walk and I was incredibly tired; massive headache on my forehead; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other medications within 2 weeks of vaccination. On 20Mar2021 at 10:00 approx. 20 seconds after the vaccine, the patient experienced massive headache on her forehead, shortly after that felt like a huge load was pushing her back into her seat. The patient wasn't able to keep conversations and her mind was foggy. It was hard for her to walk and she was incredibly tired. She slept most of the afternoon. At night before going to bed (at 21:00), she had a tightness on her chest with difficulty breathing and this was on Saturday. On 21Mar2021 (Sunday), all she had was soreness on her arm. On 23Mar2021 (Tuesday), she woke up around 4:10 with a dry mouth and what felt like dry lips. She was really thirsty and grabbed a cup of water and used the restroom. When she was washing my hands, she saw her face and noticed the top lip was swollen. It was so big that it overlapped her bottom lip. She felt tingly and dry underneath the lip. The patient continued to drink water and the swelling decreased not completely but it did go down. On 23Mar2021 at 09:07, the swelling decreased. The patient reported that the lips, tip of nose, and throat felt tingly now. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, swollen lips, tingling lips, tingling and tingling throat. The clinical outcome of the event swollen lips was recovering while that of forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, tingling lips, tingling and tingling throat was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

At vaccine site I experienced an acute event of shortness of breathe, tunnel/blurred vision, heart palpitations, increased heart rate, brain fog. Had 9 episodes since then. Three days after I had an ER visit, no diagnosis. Given EpiPen and muscle relaxers. Occasional chest pain, tightness in chest and neck. difficult to sallow. Very short winded, shortness of breathe. Currently on heart monitor.

Experienced fatigue and diarrhea 2 days after receiving vaccine. Continued to experience diarrhea symptoms for 7 days (intermittently for a month after). Experienced dizziness, shortness of breath and chest pain on April 26, 13 days after receiving vaccine. Went to ER, EKG was clear. Blood work showed elevated D-dimer levels and CT scan of the chest was done with no abnormalities found. Experienced dizziness, shortness of breath and chest pain 3 times after ER visit. Echo and heart monitor was ordered by cardiologist, a month later. Findings showed irregular heartbeat and trace pericardial effusion.

While in observation @ 1125 c/o of not able to breath, headache and chest discomfort right side. Placed in WC back to med eval. VS taken 166/101, sat 99%RA, HR 106 and respiration 20. Mask removed and fluids offered. Anxious and holding her chest. Pt speaks Spanish interpreter line used for translation. EKG done by EMS . VS monitored, friend speaks no English for support. Resting in chair VS repeated after no further headache and decrease in chest pressure. BP 146/101. Pt history of DM and asthma. Lung sounds clear, inhaler present and not needed. Pt declines any further work up or transport to hospital. Reviewed with pt need to call PMD regarding events with post vaccine and to discuss 2nd dose with PMD. Pt to bring someone to drive with 2nd dose and her inhaler with her. Verbalized understanding to call 911 for any difficulty breathing, hives or continued chest pressure. Discharged ambulatory @ 1205 with friend with no further chest pressure or headache. RS, NP

presents for evaluation of tightness in her throat beginning approximately 20 minutes prior to arrival. The patient states that approximately an hour ago she had her 1st COVID vaccine. ED medications- famotidine (PEPCID) tablet 20 mg (20 mg Oral Given 5/7/21 1120)

This morning 19Jun at about 6:35 am I woke up with chest pains that feel like burning; accelerated heartbeat; shortness of breath; on Thursday morning 17Jun I woke up with a 101degree fever at 5:20; body aches; chills; extreme fatigue; nausea; headache; This is a spontaneous report from a contactable consumer. A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, batch/lot number: unknown), via an unspecified route of administration on 16Jun2021 3:15 PM as unknown dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had no known allergies. Historical vaccine included first dose of BNT162b2 on 22May2021 at 02:30 AM on left arm for covid-19 immunization. Patient did not have covid prior to vaccination. Patient was not tested for covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient provided privacy policy consent. On Thursday morning 17Jun patient woke up with a 101degree fever at 5:20 along with body aches, chills, extreme fatigue, shortness of breath, nausea, and headache. On 18Jun she woke up with a continuing headache, slight fever of 99.6, fatigue, and shortness of breath. On 19Jun at about 6:35 am she woke up with chest pains that feel like burning, along with shortness of breath, accelerated heartbeat, and fatigue. Patient reported that this was awful. The outcome of events was recovering. Follow-up attempts are needed; information about lot/batch number has been requested.

The first day, I noticed a lot of saliva passing through my throat and then it went away. I also noticed a lot of exhaustion days later and throughout the whole month. After my second dose, I noticed I started having edema. I struggled with that for about a month. Then I ended up being diagnosed with nephrotic syndrome, minimal change disease and acute kidney injury. The cause was pretty much unknown. I don't have a history or kidney disease or anything like that.

Approx 10 minutes after vaccine administration patient became very clammy and stated "everything went black" she stated her throat was becoming tight. She was very pale. I text the MD on site to come to vaccine area. Vital signs recorded, HR 82, BP 112/78, O2 saturation 98%, she was afebrile. Dr. arrived and examined the patient. At 1042 he ordered Benadryl 25mg, IM and Methylprednisolone 62.5 mg IM. Benadryl 25mg IM was administered at 10:43 and Methylprednisolone 62.5mg IM administered at 10:49. The patient symptoms began to improve. Vital signs were repeated several times and remained stable. The patient was monitored until 13:10. She ate lunch and ambulated to the bathroom. She stated she was fine and was discharged in a stable condition.

itchy body welts; welts; tight throat; This is a spontaneous report from a contactable healthcare professional, nurse. A 29-years-old-non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via intramuscular route of administration in the left arm on 09Mar2021 at 14:45 (at the age of 29-years-old) as a single dose for Covid-19 immunisation. The patient medical history and Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 18:45, within 4 hours of first dose, the patient experienced tight throat. On the next day, 10Mar2021, the patient experienced itchy body welts. It was reported that the patient cancelled her 2nd dose after experiencing these events. No therapeutic measures were received 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 events tight throat, itchy body and welts were recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

pain in elbow of right arm; Pain in fingers/knuckles of right arm; Anxiety level increased; Heart rate went to 101; blood pressure skyrocketed to 142/88; Throat started closing; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number UNKNOWN) via an unspecified route of administration in the right arm on 25Mar2021 at 14:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received codeine (MANUFACTURER UNKNOW) for unspecified indication on unknown date and she experienced drug allergy to it. Concomitant medications included ethinylestradiol; norgestimate (SPRINTEX), bifidobacterium bifidum; bifidobacterium lactis; bifidobacterium longum; cactobacillus acidophilus; cactobacillus rhamnosus (PROBIOTIC) and colecalciferol (VITAMIN D3), all were for unspecified indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19 on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Mar2021 at 15:15, the patient experienced pain in elbow and fingers/knuckles of right arm. After about 20-25 min throat started closing, anxiety level increased. Heart rate was 101 and blood pressure skyrocketed to 142/88. The patient underwent COVID-19 antigen test on 25Mar2021 and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. The therapeutic measures included treatment with benadryl for all the event from an unknown date. The clinical outcome of pain in elbow and fingers, anxiety, heart rate increased, blood pressure increased and throat constriction was recovering at the time of report. No follow-up attempts are possible; information about lot number cannot be obtained.

Co-worker reports "On 07/09/21 woke up with a fever, chills, muscle aches, fatigue. On 7/10/21 woke with no fever but minor aches, pain and fatigue. was doing light chores and suddenly had severe chest pain and shortness of breath. Felt like she couldn't "catch" her breath and someone was squeezing her lungs and heart. Went to bed and continued to hurt throughout the night 7/11/21. continued to have shortness of breath and intermittent but severe pain. On 07/12/21 spoke with cardiologist and had a stress test and echocardiogram sue to pain (normal). As of 07/20/21 continues to have intermittent chest pain but less severe compared to when it first started. Struggles with shortness of breath very quickly when taking stairs that she did not have previous to vaccine."

Lymph nodes were swollen for the past 5 days; Vision was blurry and light was bothering her; Heart racing; Hard to breathe; She got a fever of 100.1; Chills; Tired even after getting a full 8 hours sleep/refused to get off the couch for the past seven days; Joint pain in her knees back and shoulders; She was vomiting three times since she got the injection; Headache, like an extreme migraine/headache is worse; She couldn't eat and refused to get of the couch for the past seven days; Heart Racing; Feels like an anxiety attack; Last night she could feel her heartbeat in her feet and hands; She says it feels like there is an elephant on her shoulders; refused to get of the couch for the past seven days; her blood pressure and he is guessing it was about 152/90; tenderness at injection site; Vision was blurry and light was bothering her; swelling and redness at the injection site; swelling and redness at the injection site; This is a spontaneous report from a contactable consumer reported for 29-years-old female patient (reporter's fiancé). This consumer reported different events for two patients. This is 2 of 2 reports. A 29-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, (Batch/Lot number: not reported; Expiration date: UNKNOWN) in left arm via an unknown route of administration, administered in the left arm on 29Apr2021 09:30 (at the age of 29-years-old) as dose 2, single for COVID-19 immunisation. (Reason for no lot number: of Pfizer COVID 19 vaccine: Other: Caller does not have vaccination card; no lot number). Medical history included thyroid disorder on 2013 (From eight years ago). No prior vaccinations were done within 4 weeks. And they think Patient needs glasses, because she has problems seeing at night. All of this all happened before the vaccine. Checked for COVID19 twice JUN2020 through JAN2021 and this was negative. The patient's concomitant medications were not reported. Family History: none. The patient previously received the first dose of bnt162b2 (BNT162B2, solution for injection, (Batch/Lot number: not reported) in left arm via an unknown route of administration on 22 days prior on 07Apr2021 at 09:30am in left arm as dose 1, single for covid-19 immunisation and experienced fever of 100.3F within 12 hours of having the vaccine the first time, unwell causing blurred vision, nausea from extreme headache comparative to a massive migraine, muscle pains and chills, fast heartbeat then the nigh, heart rate is 128 bpm-132 bpm, dizziness and weakness that lasted for 5 days. It was reported that after the second dose patient had everything on 29Apr2021. The reporter clarified that first she (patient) thought she had a cold, so he looked at her and found swollen lymph nodes; she got a fever of 100.1; chills; tired even after getting a full 8 hours sleep; tenderness at injection site; joint pain in her knees back and shoulders. She took that day of the vaccination off. She was vomiting three times since she got the injection, and again today at work. She complained of a headache, like an extreme migraine, like a hammer hitting her head and it is getting worse everyday. She noticed her vision was blurry and light was bothering her. She couldn't eat and refused to get of the couch for the past seven days. He took her blood pressure and he is guessing it was about 152/90. At night she feels her heart racing; she can't relax, it feels like an anxiety attack and she never has that. Mentioned, last night she could feel her heartbeat in her feet and hands; she says it is hard to breathe. Adds she just texted him hour ago she was going to talk to her direct boss, because she threw up today at work and she still has the headache; and she says it feels like there is an elephant on her shoulders it is hard to breathe. Today she has no fever and her heart rate was fine at 65 beats per minute. But nothing has changed. All of her symptoms are persisting and the headache is worse. Adds at night her heart rate was 130 beats per minute just laying in bed. The adverse events did not require a visit to the Emergency Room/ Physician Office. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative in Jun2020, sars cov-2 test negative in Jan2021; Blood pressure 152/90 (units not reported); body temperature was 100.1 on on 29Apr2021; Heart rate (65 beats per minute/ 130 beats per minute). Clinical outcome of the event Fever recovered on an unspecified date in April 2021; outcome of the event Vaccination site swelling was unknown; outcome of the other events had not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

woken up in the middle of the night with heart racing and felt like i couldn't breathe. after a few minutes my heart rate went back to normal and difficulty breathing subsided to shortness of breath that lasted 6 more days. 20 days later heart still feels a little weird and shortness of breath returns for a moment, slight tightness of chest persists but very minor symptoms.

face started hives; Chest started getting tight; heart rate started elevating; face started burning; started wheezing; started coughing; begging to not breath; Weird taste in mouth; itching all over; whole body was sore; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162B2 (Lot Number: Ewd171), dose 1 via an unspecified route of administration, administered in arm right on 10Jul2021 11:00 at the age of 29-year-old as single dose for covid-19 immunisation. Medical history included asthma. No known allergies. The patient's concomitant medications were none. The patient experienced adverse events on 10Jul2021 at 11:30. Reported Event: Weird taste in mouth, face started hives, chest started getting tight, heart rate started elevating, face started burning. The patient started wheezing then she started coughing she begging to not breath. The patient grabbed her inhaler and took the first pump it did not work, she took another pump it did not work, she took 2 more no luck, 2 more some luck, ambulance assisted. Hour later her whole body was broken out, her chest tight itching all over bumps everywhere, she was wheezing, her whole body was sore and she did not feel good. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 08Jul2021. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Shortness of breath (3pm-8 pm), chest pain 3pm-8 pm), Headache (3pm- next morning), lightheadedness (3 pm-8 pm) Treatment: emergency room visit and observation for 4+ hours, Benadryl, EKG, chest X-ray, 650 mg Tylenol Outcomes: improvement of all symptoms for the most part, some recurrence next day, but resolved after that.

the sensation of swelling of posterior tongue and lower pharynx swelling like an allergic reaction but tongue not visibly swollen about 30 minutes after administration of 1st dose. Took oral anti-histamine, and symptoms resolved after 1 hour.

Extreme dizziness; flu like symptoms; trouble breathing; rash on right side of body; This is a spontaneous report from a contactable consumer. This 29-year-old non-pregnant female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, batch number; unknown as obscured by other product labelling, NDC number, UPC number, expiry date; unknown) via an unspecified route of administration on 17Mar2021 at 13: 00 (1:00 pm) (age at vaccination 29-year-old) at right arm as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Past vaccine included first dose of BNT162B2, lot number; unknown on an unspecified date for covid-19 immunisation. Past drug event included known allergies to Sulfa drugs. 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. Patient's concomitant medication included Sertraline, Omeprazole for unknown indication. It was reported that, Patient experienced extreme dizziness and trouble breathing, flu like symptoms and rash on right side of body on 18Mar2021 at 12:00 am. AE resulted in none of the above. When probed for the concern, Reported that patiient received her second dose of Pfizer vaccine (unspecified vaccine) yesterday (17Mar2021) and she knew that flu like symptoms were common but she developed rash on the right part of her body. she received my dose in her right arm and she didn't know are these symptoms or not, she wanted want to know that right part of her body rash or was something concerning or it's common. When probed for event start date, consumer stated she got the shot at 1 ‘o' Clock yesterday afternoon and I woke up at 12 am this morning with symptoms (18Mar2021). When probed for the vaccination facility name, consumer stated, no, Idea it was at clinic. As consumer abruptly hung up the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and further probing could not be done. Hence, limited information was available over the call and appropriate response could not be provided. It was unknown if the treatment was received for the adverse event. The patient has not been tested for COVID-19. The outcome of events was not recovered. Reporter seriousness for the events was unspecified. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

numbness in my hands has progressed to my feet and arms, and my fingers are beginning to hurt; difficulty breathing; stabbing pain in chest/burning and sore sensation in the middle of chest; issues of breathing whenever she exercised; I couldn't breathe because my chest was too tight; woke up with tingling and pain in my arm; woke up with tingling and pain in my arm/my fingers are beginning to hurt; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 11Jun2021 13:00 (at the age of 29 years) (Batch/Lot Number: Ew0172) as a single dose for COVID-19 immunization. Medical history included epilepsy and allergies: steroids. Concomitant medications included zonisamide (ZONEGRAN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE); both reported as other medications in two weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Patient previously took prednisone and experienced allergies. Patient is not pregnant at the time of vaccination. No other vaccine in four weeks. During the second shot, patient had difficulty breathing and stabbing pain in her chest as soon as she left the Pharmacy and began walking around. Patient called the CDC hotline, and they said that was a normal reaction. Patient took a Benadryl and slept off the pain and generalized side effects. From the next two weeks, patient began to have issues of breathing whenever she exercised. She would get stabbing pains in her chest if she moved too quickly or bent over. It felt like there was a burning and sore sensation in the middle of her chest. She could not breathe because her chest was too tight, so she would have to lay down and rest for a while until she caught her breath. When she woke up with tingling and pain in her arm, she checked into the ER. She was referred to a cardiologist for further testing. The numbness in her hands has progressed to her feet and arms, and her fingers are beginning to hurt. Adverse event start date was reported as 11Jun2021 13:15. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: Covid Test-ER) on 30Jun2021 with result unknown. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient has not recovered from the events. AE treatment: Zyrtec and observe if gets worse.

Within 10-15 minutes experienced full body pruritus, worse on the upper extremities and chest. Experienced throat tightness sensation 24 hours after vaccination that resolved 1 hour after taking more loratadine. Also experienced extreme right arm soreness 24 hours after injection, which lasted for about 3 days.

Sudden onset cough, shortness of breath, and wheezing. A fever of 100.6 was noted but unsure as to when that occurred as I did not have chills. Feber has subsided. Cough, shortness of breath and intermittent wheezing remain as well as some chest pressure, sore throat, headache and chills. Coughing fits are bad enough to cause urinary incontinence but I did give birth 4 months ago so this may not be significant. No signs of allergic reactive such as redness, urticaria or swelling.

12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermittent 1500- chest tightness, palpitations lasting 20-30 minutes 1900- feet b/l ice cold, muscle aches, chills, lasting 8 hrs 12/29/2020- upon awakening-fatigue, SOB 6 hrs, intermittent paresthesia persist left foot, left cheek, new onset teeth pain (lasts less than 1 minute) left sided headache (1-5 min) left sided back pain at SI joint 12/30- tingling sensation persist, fatigue is gone. Chills- 1-3 min duartion, intermittent. left ear pain, left headache, "pings " of left cheek, tingling back pain persists (left) 12/31/2020 noted mild left facial weakness-, left eye brow rise, unilateral wrinkle forehead, smile reduced left sided tingling persists with intermittent headache, ear pain, teeth pain sought care of PCP tx of early onset bells palsy with steroid taper + PPI Began prednisone 40 mg PO 1/1/2021 left sided back pain persists

Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital. Since then, I lost feeling in my hands and feet, numbness and tingling. I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.

30YO F ICU nurse obesity (BMI 35) COVID 19 on Dec 2 symptoms, Dec 3 tested positive for COVID-19. never hospitalized, outpatient only. 12/12 completed isolation 12/21 received vaccine 12/7 developed Fever chills diarrhea SOB cough Urgent care visit. RLL consolidation on CXR given doxycycline 100 mg po bid worse, fever 40 targetoid lesions to LE (started before doxy) WBC 22K tachycardic tachypneic admitted requiring 2-4L oxygen CT angio without clot, diffuse ground glass and RML dense infiltrate DDimer 7.8 LDH 599 CRP 41 procal 0.67 ferritin 500 Viral respiratory PCR negative Sputum cx with oral flora (pending) COVID ag testing neg COVID PCR 1/3 targets positive (called as indeterminate).

When patient presented to get immunization she reported previous mild reaction of hives with flu immunization. She reported prior to receiving her flu immunization she would take 50mg diphenhydramine. We had her take 50mg diphenhydramine & then wait 30 minutes prior to receiving the first COVID-19 dose. After receiving the vaccine we had her stay in the room directly in front of us for 30 minutes so we could monitor her. It was noted she seemed to be having difficulty breathing & at that point we administered the first epinephrine 0.3mg dose. She reported feeling better & her color got better. We continued to closely monitor her & in approximately 7 to 8 minutes her breathing became labored again. A second epinephrine 0.3mg dose was administered & we called to have her transported to the hospital.

palpitations; shortness of breath; ears burning; This is a spontaneous report from a contactable physician. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced palpitations on 04Jan2021 08:00, shortness of breath on 04Jan2021 08:00, ears burning on 04Jan2021 08:00. All events were nonserious. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. the patient has not been tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. The outcome of the events was resolved in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

shortness of breath/progressed until I went to urgent care; I started to really bad cough and then it actually got worse and worse; I was so weak like I am breastfeeding, I couldn't even hold my baby; extreme fatigue; I couldn't stay awake for more than a few hours at a time; Headache; lung problem; This is a spontaneous report from a contactable physician (the patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EH9899, via an unspecified route of administration on 16Dec2020 13:00 at single dose for COVID-19 immunisation. Medical history included history of reaction to mango (like face swelling and just a rash) and then gluten intolerant: if she eat it she doesn't have difficulty breathing. She never had problems with asthma in the past. The patient previously took BENADRYL for shortened like when she had a reaction with mango many years ago. In the past the patient had problems with cold and problems having bad cough that linger but she never needed Albuterol or steroids before. The patient had flu vaccine a month before, administered in deltoid left. The patient's concomitant medications were not reported. The patient experienced extreme fatigue on 19Dec2020 with outcome of recovering, shortness of breath/progressed until she went to urgent care on 21Dec2020 with outcome of recovering, She started to really bad cough and then it actually got worse and worse on 21Dec2020 with outcome of recovering, She was so weak like she was breastfeeding/She couldn't even hold her baby on 19Dec2020 with outcome of recovered on 20Dec2020, She couldn't stay awake for more than a few hours at a time on Dec2020 with outcome of unknown, headache on Dec2020 with outcome of unknown, lung problems on Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included chest x-ray: normal on unspecified date; SARS-COV-2 test: negative on 23Dec2020. The vaccine was administered at Hospital Facility. The patient was treated with steroids (20mg for 5 days) and an albuterol inhaler (2 puff every 4 hour). The events required visit to Emergency Room. The events were non serious.

light headed, sore throat, swollen throat, body and muscle aches and fatigue, encouraged to seek medical attention.

Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately after injection. Benadryl was given and EMT advised going to the hospital for observation. Heart rate and bp returned to normal a few hours later. Still feel dizzy and lightheaded when standing. Was informed that it was a vasovagal reaction. Arm is also very sorry at injection sight. Left arm where injection was placed it still tingling in hand, right hand feels normal.

3-5 mins after receiving, developed tachycardia, shortness of breath, dizziness, and nausea. Improved within 2-3 mins, cleared within 5-10 mins. No further reaction.

20 minutes after dose pt experienced some chest tightness, trouble breathing, and headache. Patient was still talking so gave her 50mg Benadryl and ice water, had her sit down and continue drinking water for another 30 minutes. 30 minutes after Benadryl was given patient's symptoms subsided.

Tachycardia and throat and chest tightening with second dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in left deltoid. Called RRT. Patient took diphenhydramine 25 mg PO, and taken to ED for monitoring. ECG normal. Given 1 L NS and vitals monitored for 2 hours. Symptoms resolved and patient discharged in stable condition.

At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral forearms and bilateral hip area. I felt itchy all over. When I stood up, I felt palpitations and started to feel as if I was going to pass out. I sat down and I started to tremor and felt like it was hard to catch my breath. I took an antihistamine and took a puff of albuterol. I felt a lot better. At 10 AM in the morning, the hives have improved but i still feel some pruritus.

within 15': flushed, nauseated, throat swelling. dizzy., tachycardia Transferred to ED: treated with Benadryl. solumedrol. sx resolved. Observed for 4 hrs. d/cd to home

throat began swelling up; hives; This is a spontaneous report from a contactable other HCP. A 30-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from 06Jan2021 to 06Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: PCN. The patient's concomitant medications were not reported. On 06Jan2021, the patient stated that his throat began swelling up and also had breaking out into hives. The patient underwent lab tests and procedures which included nasal swab (COVID test): negative on 19Dec2020. Therapeutic measures were taken as a result of pharyngeal swelling and hives included Benadryl. Outcome of the events was not recovered. Information on the Lot/batch number has been requested.

20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure and warmth (coming in waves) up towards my chest, lasting 1-2 seconds and occurring about every 5 minutes . Was able to withstand feeling until it became difficult to breath. Lips and face turned white and blue, fainted. Felt extremely nausea when awake. Called 911. Vitals were normal apart from BP was very high 130/100's. EKG was NSR. Blood sugar taken was normal around 113. After 1 hour of event, I took a shower and drank water. I felt the wave one more time before trying to fall asleep. Then stopped. Woke up fine.

chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after receiving the vaccine employee reported mild chest pressure/pain, hoarse voice, SOB, light-headedness, and scratchy throat. (She was given the vaccine in the ED because of a history of anaphylaxis with taking antibiotics). Her physical examination and vital signs were normal. No evidence of swelling to lips, tongue or throat. No treatment was required. Employee was observed for 4 hours and discharged to home. She was diagnosed with a minor allergic reaction.

Severe headache, fever of 103.9, tachycardia, lymphadenopathy, body aches, chills, fatigue, and shortness of breath. Advised to go to Urgent Care on 1/14/2021. Was given fluids and toradol and told to continue to monitor and treat symptoms at home.

not feeling good (felt like crap); dizziness (really dizzy); weakness; shortness of breath (short of breath); arm feeling weak (arm felt weak); This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140, expiration date 31Mar2021) via an unspecified route of administration on 08Jan2021 at a single dose in the left arm as Covid-19 vaccine due to being a front line worker. Medical history included ongoing pre-diabetic from 2015. There were no concomitant medications. The patient received the vaccine today on 08Jan2021. Within 15 minutes (also reported as 15 minutes after the vaccine), she experienced not feeling good (felt like crap), dizziness (really dizzy), weakness, shortness of breath (short of breath), and arm feeling weak (arm felt weak) on the side where the injection was received. It's the weirdest thing, she never had issues with vaccines before. She was asking if this was normal. The outcome of the events was unknown. The nurse reported that the events were related to the suspect product.

I experienced SOB, feeling of hot ,dizzy, lightheaded and tachycardiac and hypotensive, shivering and generalized body aches.

Within 5 mins of injection tingling between shoulder blades and face, came in waves. Within 20 mins of the injection throat tightness, dysphagia. 50mg Benadryl PO, 20mg Pepcid PO, 2 puffs of Albuterol. Throat tightness resolved within the following 30 mins. The next day body aches, itching of arms, and swelling in the left axilla (same side as injection). 48 hours after injection rash and itching on the upper back, chest, and both arms resolved with 50mg Benadryl.

Started with itchy mouth and itchy soft palate. Progressed to itchy throat. Gave 50mg of Benedryl with no relief, progressed to difficulty breathing, and increased throat itching. Gave EPI pen and sent to ER

The patient received her first dose of the Pfizer vaccine on 12/26/2020. Following the second dose of the Pfizer vaccine, the patient became lightheaded, dizzy, and wheezed 20-30 minutes after the injection. 25 mg Benadryl administered, along with Epi-Pen. The patient was transported to the ED.

1 hour after receipt of booster vaccine, developed pruritis and difficulty breathing, throat tightness; Stridor evident in the ED, hypotension requiring epinephrine injections and eventual infusion.

Passed out; Chest tightness; Dizziness; Trouble breathing; Itching throat; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at site of left arm at 17:15 on 11Jan2021 at single dose for COVID-19 immunization. Medical history included migraine and seizure. Concomitant medication included lamotrigine (LAMICTAL) and zonisamide (ZONEGRAN). Both received within two weeks of vaccination. The patient experienced passed out, chest tightness, dizziness, trouble breathing, and itching throat, all at 17:30 on 11Jan2021. No other vaccines received in four weeks. Facility type vaccine was in hospital. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received salbutamol (ALBUTEROL), steroids, diphenhydramine hydrochloride (BENADRYL), lansoprazole (PREVACID) and IV fluids for treatment. No covid prior vaccination. No covid tested post vaccination. No known allergies. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Patient immediately on administration became flushed, reported metallic taste in her mouth, thickening of her throat, and light headedness. VS, O2 6l/min via NC and EPI 0.3mg/0.3ml IM injection given and patient transferred to ED.

Shortness of breath - began with exertion but continued at rest for the rest of the day and into the next.

Patient c/o metallic taste, chest tightness, SOB, difficulty breathing, and difficulty swallowing. Also had a mild erythematous rash. Symptoms began < 5 minutes after vaccination. Epi Pen was administered and code team took patient to the emergency room. In the emergency room the patient was treated with benadryl (50mg PO once), prednisone (60mg PO once), famotidine (20mg PO once)and monitored for 4 hours. Symptoms improved and patient was discharged home safely.

Nasal congestion, uvular edema/erythema, stridor. Received 2 doses of epi followed by oral benadryl 50 mg and 32 mg methylprednisolone; albuterol. Needed an additional 2 doses of epinephrine. Monitored for 3 hours.

Hives on face, slightly short of breath, anxious. Had taken 50 mg Benadryl OTC before going to Urgent Care, reported feeling better once there. Denied wheezing or any other symptoms. Prescribed 20 mg Prednisone, two per day for 3 days to take if needed but no indication of needed

I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.

Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; Shortness of breath Chest Heavy Lightheaded; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date not reported), intramuscular on 14Jan2021 10:15 at single dose on the right arm for COVID-19 immunization. Medical history included chronic pain and known allergies to sulfa. The patient's concomitant medications were not reported. The patient experienced shortness of breath, chest heavy, lightheaded on 15Jan2021 at 10:00. The patient has not recovered from the events at the time of the report. The patient was not pregnant, has no prior COVID vaccination and was not tested for COVID post vaccination.

pain in side like with asthma attack, still fine, breathing, going to continue monitoring. chest pain began to resolve. followed up with patient at about 7:15, pt still symptomatic. asthma inhaler helped.

Received 1st dose Pfizer COVID vaccine at 8:36am. At 9:43 am patient complained of chest tightness and shortness of breath. Facial redness and tension. Complained of facial tingling and cheeks feeling "tingly". Administered 1 epi-pen to right thigh at9:00am. Continued to complain of chest pain, throat tightness, and facial tingling and numbness. Administered 2nd epi-pen at9:04am and 911 called. Patient transported to ER.

patient had vaccine and more than 15 minutes later after she left the clinic she came back with c/o sob, tingling in hands and throat. Had previously felt the throat tingling when she had covid-19 virus. Patient reported anxiety and was tachycardia and hypertensive. sat in clinic for additional thirty minutes and vitals normalized and no further complaints.

Employee stated that approx. 1hrs after, she felt mild chest tightness and wheezing.. Has a hx of asthma- Used Albuterol 1 puff and Benadryl. Denies sob. Called Nurse number and Followed up with doctor1 hr later. Prescribed Qvar.

Received initial COVID vaccine at about 1200 today. About ten minutes later started to feeling burning CP, SOB, feeling of tongue swelling, and had a loose stool. Now feeling lightheaded. Was feeling fine prior to the immunization. Anxiety. Anaphylaxis. 30 yo female known hx of allergic reaction/atopy to vaccines presented with anaphylaxis approx 10 minutes after the covid-19 Pfizer vaccine.

anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.

Vaccine started at 4. Roughly 5 minutes after, I raised my hand in the waiting for for the male nurse to come over due to symptoms of dizziness, loss of consciousness, ?blacking out?, and confusion. The male nurse came over and started seeing signs of profuse sweating as water began dripping from all over my body. 5 minutes after that I started heaving and gasping for air unaroused next to the nurse as he took my blood pressure. Blood pressure dropped to 85/76. I started breathing heavy, sweating uncontrollably and couldn?t talk or stand. I remained hardly alert and almost passed out due to weakness.

Anaphylaxis; persistent throat swelling; nasopharynx/oropharynx edema; difficulty breathing; difficulty swallowing; choking sensation; This is a spontaneous report from a contactable Physician. A 30-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The relevant medical history included known allergies: sulfa from an unspecified date. Concomitant medications were not reported. The patient experienced anaphylaxis: followed by persistent throat swelling, nasopharynx, oropharynx edema causing recurrent difficulty breathing, choking sensation and difficulty swallowing on 14Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient underwent lab test included Covid which showed negative on an unspecified date post vaccination. The outcome of the events was unknown.; Sender's Comments: Based on a close chronological association a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Complain of Left side of throat "a little swollen". Medicated with Zyrtec 10 mg po, ,Prednisone 40 mg po, , Pepcid 20 mg po. Monitored for approximately 1.5 hours. felt better, advised to follow up with primary care physician as needed.

She reports with a few minutes she felt light headed, dizzy and mentally disconnected. Symptoms included feeling nonspecific discomfort, hot, cold, palpitations, nausea. She states her chest cavity felt strange and can best describe it as internal burning. She states breathing was strange, and was 'almost' SOB. She felt palpitations. They seated her in a chair for 15 minutes and observed her for 35-45 minutes. Her VS were normal. She denies pruritis, urticaria, flushing, sweating, cough, wheeze, oral/facial/throat/tongue swelling, red/watery eyes. She went home and continued to feel uncomfortable and restless. She had one emesis. She took a Tylenol pm at 19:00 and slept until about midnight. She reports the restlessness and discomfort stopped, but she then felt flulike symptoms (malaise, myalgias) for the next 3 days. She noted onset of edema at the injection site day 1, but no erythema or dermatitis.

Itching, difficulty breathing, tachycardia IV established Sat of 99%, tachy in 120's Patient was given 25 mg IV Benadryl, 20 mg Pepcid IV, and 125 mg IV Solumedrol Patient with ongoing difficulty breathing over following 5-10 minutes 911 called. Report given. Patient stable at time of departure.

With in two minutes of injection I started having very rapid heart beat and heaviness in my chest. By four minutes I had throat swelling and pressure and slight difficulty breathing. I did not seek medical attention while at the clinic. Once home I took two Benadryl and contacted my primary provider for advice. She advised that because of my history of anaphylactic reactions to medications and the throat swelling I experienced to not receive the second shot. She suggested I take Benadryl and seek emergent medical attention if my symptoms worsened. Symptoms continued for several hours. I administered two more pills of Benadryl following the package instructions. The symptoms tapered over time. For days I was wheezy and my asthma was not controlled. I also had small runny nose and flared up my vocal cord dysfunction and asthma symptoms. With in a week and a half I was able to run again with out experiencing breathing difficulty that is abnormal. My breathing is still not 100% but I can not confirm that it is a result of the shot or my asthma not being completely stable.

Fatigue; Chills and Sweats; Chills and Sweats; Fever (102); Headache; Muscle aches; Weakness; Cough; Out of Breath; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient receives the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose at left arm on 27Jan2021 14:30 at 30 years for covid-19 immunisation, administered at hospital. Medical history included bladder cancer. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications within 2 weeks of vaccination. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # E1L9L31) at single dose at left arm on 04Jan2021 for covid-19 immunisation. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 01:00 the patient experienced fatigue, chills and sweats, fever (102), headache, muscle aches, weakness, cough, out of breath. The patient underwent lab tests and procedures which included body temperature: 102 on 28Jan2021. No treatment received for the adverse events. Since the vaccination, has the patient been not tested for COVID-19. The outcome of events was recovering. Case was reported as non serious. No follow-up attempts are possible. No further information is expected.

Per patient/employee: 5-6 minutes after her dose was administered, she felt her throat tightened, she was monitored in the clinic initially then taken to the ED. Treatment was fluids via IV. Patient/employee then followed up with her PCP & allergist; it was determined at that time that she should not receive her second dose.

She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction to her first dose of the Pfizer Covid vaccine with acute hives within 15 minutes on 12/26. She had hives on her neck, arms chest, headache arm pain and mild dizziness. Symptoms resolved with Benadryl She received her second dose of the Covid vaccine 12/26 with immediate symptoms within 30 minutes of respiratory symptoms, shortness of breath, hives, dizziness, fainting with treatment of epinephrine on site at the Vaccine Site by ambulance to the ER. She reports she was hypoxic with O2 sat 70 to 75%. Went to hospital and received 3 doses of epinephrine, IV Benadryl, IV fluids, Pepcid, and 7 days of prednisone. 1/26: c/o chest tightness had video visit with primarily MD, continued diphenhydramine and refer to allergy. She does have a history of vaccine reaction in the past to Gardasiln (contains polysorbate 80) given at age 16 with delayed hives 24 hours later. Allergist assessment: Covid vaccine 19 mRNA anaphylaxis with 2nd dose and acute hives with 1st dose of Pfizer vaccine S/p repeated doses of epipen With ongoing asthma, dizziness, light headed , nausea and fast heart rate 1.5 weeks after anaphylaxis but normotensive With prior history of delayed hives with gardisil --may be sensitive to polysorbate 80 in both vaccines. Added COVID vaccine to allergy list

Within 5 minutes, she developed itching in the right arm (opposite from injection site), itching on back, redness on the right arm, dyspnea, "out of body experience," "sense of impending doom," chest tightness. Then, the nurse who observed her transported her to a bed to be evaluated. stated that she was tachycardic, short of breath and had erythema on both arms. An IV was placed 10 minutes later and 9-1-1 was called. She was given Pepcid, Benadryl and Solu-Medrol at the clinic before arriving to the emergency room. She was given Epinephrine approximately 1 hour after the reaction occurred as well as IV benadryl. She was sent home with prednisone.

Patient received vaccination and was monitored for adverse events after approximately 20 minutes patient presented with tingling in lips, tightness in throat and wheezing. Patient self administered 25 mg diphenhydramine orally and was given Dexamethasone 4mg IM left deltoid as per standing orders and onsite provider orders.

Dizziness progressed to shortness of breath and chest pain; benadryl given x 1; Epi when the patient complained of throat tightness and difficulty. EMS transfer to hospital

Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of breath from simply walking around swelling of the glands and consul in the neck and throat

After 5 minutes receiving the 2nd dose of Covid 19 vaccine, both eye pupils of patient got smaller. Patient informed that she had the same reaction when receiving the first dose but she ignored it. Patient expressed that she was tired and had mild difficulty breathing. I provided 2 tablets of Benadryl 25 mg (Total 50 mg). Patient recovered from the adverse condition after resting for 30 minutes.

Patient is currently pregnant and her estimated delivery date is 7/17/21. At 1140 BP 98/67, P 98, R 28, O2 97% and pt c/o feeling faint, nurse observed pt as pale and hyperventilating. At 1145 Np 100/65, P 83, R 20, O2 100% pt states she feels lightheaded. At 1150 BP 98/65, P 82, R 20, O2 99%, pt states she still feels lightheaded. At 1200 BP 107/62, P 84, R 21, O2 98%, pt states she feels "better". At 1210 BP 100/65, P 81, R 20, O2 99%, pt states she is no dizzy. At 1215 BP 103/66, P 85, R 20, O2 99%, pt states she is "feeling good". At 1235 pt was discharged home.

Difficulty breathing, felt like throat was closing, epi and Benadryl given by EMS, transported offsite to nearest ER.

Patient reported being flushed; slightly short of breath; and a severe headache. EMS was called at the patient's request and she was examined by them. She later saw her primary care provider that day and they reported she is fine.

Participant was anxious, staff attempted to calm her, however, then she stated, "it feels like my throat is closing." Epi Pen 0.3 mg. administered IM. EMS called - upon arrival participant continued to complain of tightness in throat - transported to hospital

Mild anaphylaxis about 20 minutes after dose. Abrupt painful tightening of the throat, no real difficulty breathing. My face felt "buzzy" but didn't swell and I did not have significant itching. I have had similar reactions in the past to cleaning products and pesticides and usually take a benadryl, though I do carry an epipen and had one with me at the time. Instead of going back in the convention center for medical attention I took a benadryl and waited in the parking garage for about an hour and felt the throat restriction ease a bit. About 10 hours later around 8pm the tightness came back suddenly over about 10 minutes and I took another benadryl. The next morning around 7am I had one more round of tightening and took one more benadryl, and it stopped after that. I told my doctor about it a few days later.

Patient with history of food allergy with throat tightness/sore throat symptoms at baseline (only required epi pen once due to exercising after food). Developed similar symptoms 5 minutes after Pfizer dose 1 lot# EN6205. Initially became more tachypnea with "ball stuck in throat" but improved after observation for 45 min. Exam with no wheeze/stridor. VS with BP 131/60-- >129/84 O2 sat 100% throughout.

Patient told nurse that after her 1st shot she had an itchy throat so she pre-medicated with Benadryl at 8:20. Pt. was sent for 30 minute observation period. At 0840, pt. started complaining of throat itching, SOA and heart racing. It was hard to get words out. Denied trouble swallowing. Respirations fast and shallow. This lasted less than 2 minutes, denied CP. After 2 minutes, pt. started feeling better. Pt. encouraged to be assisted to ED for monitoring. Pt. stated feeling better and refused to go to ED. At 0900, pt. stated feeling much better and ready to check out. Pt. instructed to go to ED if worsening symptoms or new concerning symptoms. Pt. verbalized understanding.

Throat felt tight about 30 min after injection. Got extremely tired and cold. I could breathe but it hurt to swallow. Stomach was burning a bit right under right rib cage. Head started to hurt at about the 1 hour mark. Lost all color in face - white as ghost. Fell asleep for 2 hours and woke up with color and much better. Throat was just scratchy. next morning throat was still scratchy but much better.

Due to extensive history of allergies and concerns she was pre-medicated 30 minutes prior to vaccination with 25 mg of Benadryl. At 1209 she started getting anxious and having tingling on her tongue. She progressed to nausea, throat tightness, shaking and then chest pain. EMS was called to transport to the ED

I have been having shortness of breath since the a few days after vaccination. Have been in Urgent Care twice and the ER once. They dismiss it as asthma because of my history but no asthma medication works plus it feela different. My regular Dr. said it was the vaccine.

I am currently 22 weeks pregnant with expected date of delivery July 16th 2021. I was diagnosed with epilepsy in January of 2017. In 2019 i began using lamictal and had zero problems with the anti -seizure medication. One week after my second dose of vaccine i developed a significant rash and experienced extreme difficulty breathing. After seeing a dermatologist and getting a biopsy i was told that i had DRESS syndrome which is very uncommon given i had already been on lamictal for such a long period of time. I have been prescribed a topical steroid as well as 40mg prednisone and am titrating off the lamictal to the keppra (1500mg).

Patient waited in pharmacy for 15 minutes after receiving vaccine and was fine. Approximately 30 minutes after administration she began experiencing throat tightness described by the patient to feel like an anaphylactic reaction. She immediately took oral Benadryl and returned to normal.

Pt had itchy throat, tight throat, sense of doom at 30 min obs mark. Was given EPI and transferred to local ED. Had rebound anaphylaxis days later (3 days after) resulting in 2nd ED trip.

Pt read through the list of questions and stated "I am short of breath at baseline, I am chronically anemic and tired, and I get sick for like 2 weeks after my flu shot." She denies having a flu shot over the last few years. Discussed at length the risks/benefits of vaccine and potential side effects, expected time frame and duration expected. Pt stated she had Lupus and consented to her first dose. Pt also stated she had an anaphylactic history to PCN, Amoxicillin, and Sulfa. Therefore she was instructed to stay for 30 minutes observation. Approximately 10 minutes post vaccine, pt stated she was "really hot and tired, like she couldn't keep her eyes open." She was given an ice pack and water. She denied any difficulty breathing, throat irritation, dizziness, or vision changes. She initially stated she did not think she could drive home and requested a work note so she did not have to return back to work. Requested pt have someone pick her up and she refused and stated "she was fine to drive." Of note, pt carried on an entire conversation for the one hour she was observed in the lobby here Hospital, laughing and acting appropriately. She denied the need to be seen at Urgent Care by a Provider for her c/o tiredness. Upon re-evaluation prior to d/c patient, she was asked by this RN, "do you feel you are able to drive home safely?" She responded with "I don't know, I still feel very tired and having trouble keeping my eyes open and I have not walked around." Explained to pt that if she was not able to drive home safely she needed to go to Urgent Care here for further monitoring and pt was lead to registration.

Pfizer-BioNTech COVID-19 Vaccine EUA headache first day, immediate itching and redness and lump at injection site, nausea and shortness of breath, tenderness on injection site, arm soreness it is now day 9 since my 1st shot, and everything else has gone away except for the redness, itchiness, and the lump size which has progressively gotten worse not cleared up in 7 to 10 days

I had an allergic reaction to the Pfizer vaccine. After 10-15 minutes from receiving the vaccine, my face got itchy but it was mild so I left after 25 minutes of waiting. Over the next hour the itching got more noticeable (no rash) and my throat felt slightly swollen, although I had no difficulty breathing or talking. I called a pharmacy that advised I take Benadryl, which helped. The next morning my face was still itching and it felt like there was a lump in my throat. I went to urgent care and received a steroid shot and prescription for Atarax, although the pharmacy was closed, so I just ended up taking more Benadryl. Today, 2 days after the vaccine, my face no longer itches and my throat feels normal. Just feel moderately fatigued, although I think that is a normal side effect.

30 yo female with PMHx severe anaphylactic food allergies (peanuts, beans, shellfish), who presented for her firstdose of Pfizer COVID vaccine today. She was otherwise in her USH, received her vaccine at 2:45 PM. About 15 minutes later, began having chest pressure and SOB. Chest pressure, substernal, 8/10, w/o radiation, nonpleuritic, nonpositional, not exertional. +SOB "like I'm trying to catch my breath". No wheezing, tachypnea, tongue/throat itching/closing, runny nose, N/V, abd pain, diarrhea, hives. No LH, palp, diaphoresis. Prev h/o food allergies with severe hives, SOB, troat closing. Usually takes Benadryl with resolution. No h/o epipen use. Does not have her own epipen. Had lunch at 1 PM, does not think it she was exposed to any known allergens. On initial evauation: VS: T 98.6F, BP 140s/90s, HR 120s, RR, SaO2 99% RA. Gen: WDWN, NAD. HEENT: NCAT, sclera anicteric and w/o injection, MMM OP clear. Neck: supple, good ROM. CV: tachy, reg rhythm, S1, S2. No m/r/g. Pulm: CTAB. No wheezes or crackles. No stridor. Abd: S, NT, ND. NABS. No rebound or guarding. Extr: no c/c/e. Skin: no rashes Neuro: A&Ox3. No focal deficits. Pt given Benadryl 50 mg po x1 with improvement in chest pressure in about 20 minutes, but no change in SOB. No further sxs. Repeat VS: 133/91, HR 93, R 20, SaO2 99%, RA 125/85, HR 80sR 20, SaO2 97% RA. As sxs persisted, EMS activated.

pt had severe anxiety attack after receiving the vaccine. pt was very tense and not breathing with eyes rolled back into her head. mother stated she had had an attack at the hospital giving blood before bc of severe fear of needles. 911 was called and she was taken to the hospital

When I first got the vaccine I had a flush reaction (felt like I had an IV and they had just flushed the IV). I felt dizzy. It went away quickly. 5 mins later I had diarrhea. I was also feeling post nasal drip, itchy throat, my chest had a burning sensation from the inject arm towards the middle of my chest. Throat was closing and tongue and lips were swelling. Entire body was itchy.

Hives, itchiness, swollen and itchy tongue/lips, mild wheezing. I took zyrtec before I noticed symptoms beginning, which probably helped. The next day, as the zyrtec started to wear off, my tongue/lips began to feel itchy and mildly swollen again. I called my doctor but did not go to the hospital

the patient felt shortness of breath and chest tightness. The issue resolved after removing mask for 30 minutes.

I had shortness of breath and that was treated with an inhaler for wheezing. I got a headache - the worst headache ever - never had a headache like that before - and I went to the hospital for the headache and they did a COVID test at Urgent Care and it was positive result. I came home and slept. I quarantined for 14 days. After the 14 days, and to present, I have fatigue and I had a jerkiness in my head and my doctor (Dr - Video call) is treating that with a stimulant - Modafinil. Still am fighting the fatigue. I got flu shot about a month before this vaccine but do not know for sure what brand it was or the exact date.

Heartbeat 15-20 bpm higher than my normal; Chest tightness; Difficulty breathing; Dizziness; Injection site pain; Headache; Tiredness/ Extreme exhaustion; Muscle pain; Joint pain; Fever; Feeling unwell; Swollen lymph nodes; This is a spontaneous report received from a contactable consumer (patient). A 30-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9261), via an unspecified route of administration on Arm Left on 25Jan2021 18:30 as single dose for COVID-19 immunisation in hospital. Medical history included seasonal allergy and Known allergies. Concomitant medications included unspecified medications received within two weeks. The patient did not receive other vaccines within four weeks. The patient not had COVID prior vaccination. The patient was not tested for COVID post vaccination. On 25Jan2021 22:30, the patient was totally fine for 4 hours. After 4 hours she started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hours mark (on 26Jan2021), she started having a heartbeat 15-20 bpm higher than her normal, chest tightness, difficulty breathing, and dizziness. She was now 3.5 days post vaccine dose 1 and still having all of the symptoms in her last sentence plus extreme exhaustion, muscle pain, and fever. The events result in doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a for all the events. The outcome of the events was reported as not recovered.

Patient came in this evening from visit with her doctor with a prednisone dospak, 6 day... loratadine tabs and a albuterol inhaler. Stated her right side of her face went numb and her right eye began to swell. also stated her skin was blotchy all over and later in the evening (3/31) had very labored breathing.

Lightheaded and dizzy for 24 hours after shot. Entire left arm in pain 24 hours after shot, as well as migraine headache and debilitating body aches. 48 hours after shot felt fatigue and brain fog. Then from 03/29 to 04/01 felt inflammation in rib cage that made it hard hard breathe and move. The last part was very similar to "Covid Relapses" I have had since getting sick in March 2020.

However at 2pm symptoms came back as before along with chest tightness and hives.; However at 2pm symptoms came back as before along with chest tightness and hives.; after 5 mins felt tightness in my throat; felt skin tightness; followed by itchy face, eyes and stomach; developed a cough; This is a spontaneous report from a contactable consumer. A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included arthritis reactive from Aug2020 , thyroid cancer from Aug2020. Concomitant medications included lansoprazole (LANSOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; etodolac (ETODOLAC) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELECOXIB) taken for an unspecified indication, start and stop date were not reported. The patient after 5 mins felt tightness in her throat, felt skin tightness, followed by itchy face, eyes and stomach, developed a cough on 19Mar2021 with outcome of recovering , however at 2pm symptoms came back as before along with chest tightness and hives on 19Mar2021 14:00 with outcome of recovering. All the reported events were considered serious because Impotant Medical Events. Course of the event. Adverse event: after 5 mins felt tightness in the throat, then felt skin tightness, followed by itchy face, eyes and stomach, and developed a cough. At 1200 the patient was given 25mg of Benadryl, and then another dose at 12:30. This improved symptoms and the patient was starting to consider going home. However at 2pm symptoms came back as before along with chest tightness and hives. she was given another 25mg of Beandryl and an ambulance was called. In the hospital they gave epinephrine, famotidine and methylprednisolone, which helped almost immediately. After a few hours she was discharged home. Follow up information has been requested. Lot number already obtained.

Patient presented in obs area after receiving 2nd dose, started complaining of left arm injection site numbness that radiated down to left hand, also complained of tongue numbness, vitals: 156/101 right arm, HR 91, SpO2 98% room air, respiratory rate 22, 0/10 pain. Pt began feeling worse, assessed lung sounds, expiratory wheezing noted, pt had home dose inhaler on hand, self-administered 2 puffs of albuterol HFA inhaler, states relief, pt did not complained of respiratory distress at any time. EMS left with patient at 1140 to local hospital, pt alert, oriented and cooperative at all times. Left alert and oriented, in no apparent distress. No epi or benadryl administered.

Cough that lasted two weeks mostly at night not able to sleep because I could not breath. Prescribed steroids and cough medicine.

Difficulty swallowing, swollen throat, dizzy, rapid heart rate, high blood pressure within 5 mins of receiving vaccine. Nurse gave Allegra for throat. Throat swollen after 24 hours lost vaccine

throat itching and tightness; throat itching and tightness; This is a spontaneous report from a contactable other healthcare professional. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscular on 06Mar2021 at 14:30 (batch/lot number: EN6204) as a single dose for COVID-19 immunization. Medical history included allergies to latex, eggs, dairy and wheat. The patient's concomitant medications were not reported. The patient previously took epinephrine (EPIPEN) (has been used in the past). Facility type vaccine was public health clinic/veterans administration facility. It was unknown if other vaccine in four weeks and unknown if other medications in two weeks. It was unknown if the patient had Covid prior to vaccination and unknown if Covid tested post vaccination. The patient experienced throat itching and tightness on 06Mar2021 at 14:30. The patient was hospitalized for throat itching and tightness from 06Mar2021 to Mar2021. Patient was given Benadryl 25 mg per oral (PO) by physician on duty. Patient's symptoms resolved and patient was discharged home with friends and boyfriend to watch over patient. The outcome of the events was recovered on Mar2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a plausible temporal association, a causal association between the reported events of throat itching and tightness cannot be excluded as the events followed the single dose of COVID-19 immunization.

10 minutes after injection, experienced sudden dizziness, nausea in the back of the throat, mild wheezing. Oral benadryl resolved acute symptoms within 20 minutes. Mild wheezing continued for 48 hours after injection. Severe fatigue and headache began about an hour after injection and resolved with home care after about 48 hours.

I couldn't get like enough oxygen; I ran a fever of 101; this triggered my asthma I just didn't have an attack.; short of breath; dizziness; extreme shakiness throughout my whole body; This is a spontaneous report from a contactable consumer. A 30-years-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 13:15 (Batch/Lot Number: EL9264) as single dose for covid-19 immunisation. Medical history included asthma and allergies to sulfa drugs and wheat/gluten. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL), ibuprofen (IBUPROFEN) and guaifenesin (MUCINEX). On 17Feb2021 19:00 the patient had an asthma, not all of the time to where she needs her inhaler for a lot of events. But this triggered her asthma she just did not have an attack. She was short of breath, had dizziness, and felt like she could not get like enough oxygen in it was hard to explain. Her inhaler did help this, she had this occurrence 3 times the first day of the vaccine. The same night (17Feb2021) she started having extreme shakiness throughout whole body and it had not stopped since even in her face. She took a video if that helps as well. But, even right now two days later she still having full body tremors 24-7. She ran a fever of 101 the day after off and on all day but she no longer have been feverish the third day at all, the tremors remain. The patient underwent lab tests and procedures which included body temperature: 101, oxygen saturation: couldn't get like enough oxygen on. Therapeutic measures were taken as a result of asthma, dyspnoea, dizziness and oxygen saturation decreased. No treatment received for pyrexia and tremor. Outcome of the event asthma, dyspnoea, and dizziness was recovered on unknown date. Tremor and oxygen saturation decreased was not recovered, pyrexia was recovered on unspecified date in Feb2021.

Pt complain of SOB, no apparent distress noted. Speaking in full sentences. Pt stated had a rough year and was anxiuos. itals obtained and patient refused transport.

Patient notified observing RN of increased "itchy throat" and throat closure s/p vaccination. Hx of anaphylactic reactions. Patient able to ambulate to triage room. Antihistamine provided by pharmacist. Pt able to tolerated water and thins. VSS. 129/84 HR 67, O2 saturation 99%. Patient observed for 30minutes and reported resolved symptoms. Patient ambulated to exit without any issues.

Within less than an hour receiving the vaccime, I started feeling sharp stabbing pain on my right side below my breast. It was for a short period at first then stopped. However, in the middle of the night I was in so much pain that got worse when I take deep breaths. I also experienced shortness of breath and difficulty breathing especially when I make efforts like walking up stairs. On the afternoon of Friday April 9th, I went to Health center to get checked after reporting my symptoms. The doctor said that it could be an inflammation of the lungs so recommended rest and taking Ibuprofen to help with the pain and if symptoms persist, I go get checked again. I felt slightly better on Saturday but from Sunday evening, the pain came back and got worse Monday night. I couldn't sleep on my back or sides, heavy breathing, shortness of breath I felt all night. I went to the hospital physician ordered different X-rays that came back negative. Her diagnosis is that I have inflammation of the lungs but not sure what the cause is. She prescribed predniSONE.

Patient received Pfizer shot at 9:42am and walked up to the observation area, upon sitting she complained of dizziness and before the observing nurse finished wrapping the blood pressure cuff she became short of breath and then lost consciousness. she was transported to the hospital by EMS

Six minutes after administration of the clients second dose of BioNTech Pfizer vaccine she began to have difficulty breathing and audible wheezing. She reported GI upset, headache, feeling dizzy, and impending doom. She self-administered puffs from her albuterol inhaler. Pulse ox remained above 97% , pulse 113, BP- 160/100. EMS was activated. Epi 0.5mg administered into left deltoid at 12:25 pm. Transferred client from chair to floor without difficulty. Continued to experience respiratory distress and became diaphoretic. Administered second dose epinephrine 0.5mg to left vastus lateralis at 12:30pm. Fire and Rescue arrived at 12:33pm. Transferred client to ED via ambulance.

Hoarse voice, itchy throat, tight chest, trouble breathing, difficulty swallowing, throat closing (happened sequentially in that order)

1hr after vaccine: lightheaded + had presyncope when moving around, stretching, or moving from sitting to standing. Injection site sore from arm to shoulder and into neck, unable to lift arm for 3 days. 3hrs after vaccine: developed shortness of breath that is only getting better after day 6, Needed to use asthma inhaler several times. Prior to vaccine, had not needed inhaler for many months. Day after vaccine: developed severe migraine, vomited. Had persistent brain fog and made mistakes at work, didn?t start to get better until day 6 post-vaccine. Brain fog and shortness or breath have not fully resolved but do seem better today and more transient rather than constant (day 6 post vaccine). Side effects persisted far longer than expected, and were more severe than my peers, so I feel like it is notable.

Fever, Dizzy, Fatigue, Swollen Left Arm, Vaccination site hot to touch and visibly swollen and red. left Arm, left armpit, left torso lymph swollen. painful to lower left arm fully, panful to raise/ use left arm. Soar throat, labored breathing,

Being observed for 30 min due to allergy history. Pt stated she felt like her throat was tight and closing., right at her 30 min time. EMS responded and took control of scene. No wheezing, moving good air, o2 was 96% on room air. Other VS stable. Kept an additional 10min, VS remained the same and pt calmed down and stated she felt better.

Swelling on right side of face; right eye swelled shut; labored breathing; red splotches on face and arm; extreme fatigue and fog; extreme fatigue and fog; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 16:45 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with Covid-19 prior vaccination, and has not been tested for Covid-19 since vaccination. Patient was not pregnant at time of vaccination. Concomitant medications reported included bupropion hydrochloride (WELLBUTRIN XL) for unspecified indication, start and stop date not reported. On 31Mar2021 17:30, patient experienced swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm, and extreme fatigue and fog. Therapeutic measures were taken as a result of swelling on right side of face, right eye swelled shut, labored breathing, red splotches on face and arm and extreme fatigue and fog. The adverse events resulted on emergency room/department or urgent care. Patient received steroids, inhaler and allergy medicine. Outcome of the event labored breathing and extreme fatigue and fog (feeling abnormal) recovered on unspecified date, while others were recovering. The vaccine was administered in a Pharmacy or Drug Store. Follow up attempts are needed. Information on lot/batch number was requested.

Mild itching in face, chest, abdomen, and arms; scratching sensation in throat; mild feeling of throat tightness; patient states this feels like the onset of previous mild allergic reactions

Patient is a 30 y.o. female Patient received Covid vaccine at immunization site. During 15 minutes post-monitoring period: Please see additional note below regarding counseling points, monitoring, and interventions done. COVID-19 Vaccine Adverse Reaction Reaction due to: First dose of vaccine Symptoms: Difficulty swallowing, Throat tightness, Dizziness/Lightheadedness, Shortness of breath, Lip and/or tongue swelling How long after administration did the symptoms start?: Immediately (within 15 minutes) Interventions: Additional monitoring, Education provided regarding symptoms and home care, Other (comment) (pt used her own epi pen with improvement, given 50mg oral diphenhydramine) If reassessed, patient's condition: Improved (improved with epi pen) Disposition: Education and follow-up phone number (given follow-up precautions) Pt experienced throat and tongue swelling 10-12 minutes after Pfizer COVID19 vaccine that improved with the use of her own epinephrine pen. Symptoms rapidly improved. Pt was given 50mg oral diphenhydramine. BP 136/86 hr 93, SaO2 100%. Was counseled on when to seek emergency medical attention. I advised pt to be evaluated by allergy specialist prior to her second dose and pt says she already has one via facility. Has her fiance to drive her home. 30 min observation with periodic vitals. 11:40a BP 120/76 11:45a BP 126/70 HR 86, SaO2 99%

PATIENT DEVELOPED LOWER EXTREMETY SWELLING 3 DAYS POST VACCINATION, JOINT PAIN, MOSTLY IN RIGHT KNEE, GENERALIZED MYALGIAS, SHORTNESS OF BREATH, CALF PAIN RIGHT MORE THAN LEFT, LOW GRADE FEVER WHICH NOW RESOLVED, EXTREME GENERALIZED WEAKNESS AND FATIGUE.

Increased heart rate with walking, increased respiratory rate with walking in the morning. This progressed to throughout the day over the next week. Hospitalized for these symptoms, sweating, and dizziness on 03/25/21-03/27/21. High lactate levels were also present. Multiple tests for cardiac workup have been negative except for high heart rate and respiratory rate with sitting, standing, and walking but these will return to normal within a few minutes. Oxygen saturation has also been dropping as low as 74% for a few minutes after lying back down. Diagnosis of POTS was made but continued work up in progress for oxygen saturation dropping.

Fatigue and chills since the day after vaccination. Tight chest and shortness of breath by on and off since 4/9, about 3x/week. Ringing and echo in ears started occurring 4/18 or so, about 2x/ day

passed out/stared to black out; got really hot; had trouble breathing; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 30 years). Medical history included anxiety, depression. Concomitant medications included trazodone; phentermine (ADIPEX [PHENTERMINE]); omeprazole; citalopram; alprazolam (XANAX). The patient previously took Imitrex and experienced allergies. On 08Apr2020 (13:00), the patient stated that she felt fine and was texting. Then all of a sudden she got really hot, had trouble breathing, and stared to black out. She was blacking out. She could hear someone asking if she was okay and if she needed help. She dropped all her things and passed out. The patient was not pregnant. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date.

fever 104 Fahrenheit; Severe swelling of right armpit lymph node accompanied by severe pain; Severe swelling of right armpit lymph node accompanied by severe pain; Severe swelling in right breast; Severe headache; Pain in chest when breathing; Pain in chest when breathing; This is a spontaneous report received from a contactable consumer (reported for herself). A 30-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 12:00 (Lot Number: EW0162) (Age at vaccination: 30 Years) as single dose for covid-19 immunisation. Medical history included Intracranial hypertension, sulfonamide allergy. The patient's concomitant medications were not reported. The patient previous received the first dose of bnt162b2 (lot number: EN6204) in Arm right on 17Mar2021 10:00 (Age at vaccination: 30 Years) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 08Apr2021 03:00, the patient experienced Severe swelling of right armpit lymph node accompanied by severe pain, Severe swelling in right breast, Severe headache and fever 104 Fahrenheit, Pain in chest when breathing. No treatment received for the adverse events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

I began to experience wheezing in my chest about 12 hours after vaccine . After 14 hours, I took claritin-d and singulair to help my breathing. Within 15 hours, my eyes were red and began to ache and swell. After 22 hours, my eyeslids (upper and bottom) were swollen , teary, and had crust around the eyelids. I also experienced a headache so I took some tylenol. Headache has mostly subsided but my eyes are still achy and swollen.

She first noticed a sensation of swelling in the middle of her throat. She says that the sensation has stayed about the same. She reports feeling a sensation of spinning/motion. She says that her symptoms have mildly improved over time. She denies dyspnea, chest pain, stomach discomfort, feeling nauseated, rash/itchiness.

Fever of 101 for 12 hours Skin sensitivity: painful to touch, constant needles Shortness of breath Difficulty to move without getting winded Muscle aches all over except for at injection site for 5 days Three weeks later: I am still feeling needles in my back, I still have shortness of breath, anxiety, period like spotting before period is due, sudden chills, and stiffness in muscles that was not there prior to vaccine.

This is a spontaneous report from a contactable consumer (patient). This is the second of two reports of the same patient receiving the second dose of BNT162B2. A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 17Mar2021 (Lot Number: EN6201) as single dose (at the age of 30) for covid-19 immunization. Medical history included ongoing asthma (diagnosed about 10 years ago), Basedow's disease from 01Mar2021 and ongoing, hypersensitivity, hyperthyroidism, anxiety. First dose of BNT162B2 was given on 22Feb2021 and she felt sick to her stomach, nausea, had no energy, 160 heart rate atrial fibrillation, hand tremors, shortness of breath, she felt exhausted, low grade fever, thyroid storm, felt tired, shaking, flu symptoms. Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for allergy from 2020 to 24Feb2021, guaifenesin (MUCINEX) taken for hypersensitivity from Dec2020 to 20Feb2021. When she got the second vaccine, her heart rate was high again. She did have a thyroid storm the day after the second dose (18Mar2021) and she was in the emergency room again since her heart rate was so high. It was reported that the vaccine did cause her thyroid storm. She knows vaccinations have to do with the immune systems, and if she has an autoimmune disease, she is thinking it may have come from it. States two doctors are certain that it triggered an immune response and wanted her to report this. She could barely stand up or talk, she was so short of breath and is guessing that was from her heart. She had normal flu like symptoms from the vaccine but does not think it was related to her thyroid. She has always had little cold symptoms after getting a vaccination. First night she felt very exhausted, tired. She had a low grade fever that Tylenol took care of and it went away within a day. She felt run down and it was vaccination related. The second day (19Mar2021) she had really bad hand tremors that moved into her body. She thought the shaking was from the vaccination and she took a video of it. She did not really have any other symptoms yet, then started to get really fatigued. She went to ER and her heart was really elevated. Each time she went to the doctor or the ER, her heart rate would be 20 beats faster then 20 beats faster again. The outcome of her heart rate was high again / heart elevated/her heart rate would be 20 beats faster then 20 beats faster again, short of breath was recovering. The outcome of guessing that was from her heart, exhausted/tired/ felt run down/ really fatigued was not recovered. The outcome of the other events was unknown.

I started getting short of breath about an hour after the vaccine and it has been progressively getting worse since that time.

Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted in chair, when trying to lay down on floor she awoke and was very sweaty, dizzy and disoriented. NP came to check blood pressure and oxygen levels, very low, 911 called and ambulance took her to ER to assess

Within 15 minutes of the vaccination, I felt something traveling first to my left arm where I received the vaccine, then to the chest then to my right arm then to my torso. I became extremely tired and lost a lot of strength, especially in my arms. It took significantly more energy than usual to lift up my arms. It became a little hard to breathe (I did have three masks on for precaution, so I took off one.) then I briefly felt tension/stress in my heart. These symptoms went away in less than 30 min. I had a really sore arm, which lasted me a few days afterwards. It was painful to raise that arm above the shoulder for three days or so. I was very tired for the next 2 or 3 days. Then 9 days after the injection, I woke up in middle of the night with pain in the front side of my left armpit, the part that connects to my chest. It felt swollen. It lasted 2-3 days. I saw a small red patch next to the injection site. The pain came back yesterday. Every time my left upper arm touches my torso, it hurts. In general, I am feeling fatigue and under the weather.

Today's Visit: COVID-19 Pfizer, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (CVX=208)5/2/2021, 4/11/2021 patient received both of her vaccines at clinic Had fatigue and left arm soreness after the first vaccine but this resolved after a few days Within 8 hours, however, of receiving the second vaccine patient had chills, diaphoresis, tactile temperature and a very sore left arm. Severe headache and dizziness. Could not get out of bed for two days. Poor appetite. Was able to maintain her hydration. Beginning on Tuesday had a very painful throat with dysphagia. Had some breathing. Seen last night at clinic due to pain and breathing difficulties.Maalox/pepcid and albuterol/decadron.

Patient received the 1st Pfizer vaccine on Friday 4/9 at 3:15 pm; by 7:00 pm she started having symptoms. By 10 pm she was at the ER with trouble breathing, swelling in the hands, dizziness, fatigue/malaise, and headache. She left the ER before receiving treatment. The next day the patient went to an urgent care where she received a prednisone shot, prescriptions for 3 days of oral prednisone and an EpiPen, and was advised not to get the 2nd vaccine dose. On 4/19, the patient reported that she was still having breathing issues and headaches, and she was prescribed an albuterol inhaler. On 5/3, the patient reported improvement but that she was still experiencing shortness of breath with activity such as walking up stairs; Flovent HFA was prescribed. Heart failure, pulmonary embolism, and anemia were ruled out.

Patient reported being unable to breathe approximately 10 minutes after receiving the vaccine and requested epipen to be administered but then later changed her mind and wanted to wait for EMTs. Signs and symptoms mimicked those of an anxiety attack and paramedics also concluded it was an anxiety attack

Patient came in to our hospital outpatient pharmacy to receive the second dose of Pfizer COVID-19 vaccine. Patient reported history of asthma and an anaphylactic aspirin allergy during initial pre-vaccine questionnaire. Dose given 3:36PM and patient told to wait inside pharmacy due to history of allergic reactions. Patient began having itching and rashes behind ear. Was given water and 50mg diphenhydramine orally when rash appeared. Patient's breathing became labored and patients husband gave her the patients albuterol inhaler. She took two puffs and was laid down on the floor on a mat when breathing did not improve. ED/EMS was contacted. Patient began having ineffective breaths and 1 dose of generic EpiPen (NDC 49502-0102-02 exp 05/22) was given. Breathing quickly improved. ED physicians arrived minutes following EpiPen dose and patient was taken to ED for further evaluation and treatment.

Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); This is the spontaneous report received from a contactable other health professional. This other HCP (patient) reported for herself that a 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) at the age of 30-years, via an unspecified route of administration in left arm on 19Mar2021 13:00 at single dose for COVID-19 immunization, in hospital. Medical history included PTSD, anorexia, chronic migraines, bradycardia. Patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included propranolol, atorvastatin (LIPITOR), prazosin, alprazolam (XANAX). On 19Mar2021 13:15, the patient experienced allergic reaction-characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling). After medical treatment, hives continued for 3-4 days. The events result in doctor or other healthcare professional office/clinic visit. The patient received high dose diphenhydramine hydrochloride (BENADRYL) and epinephrine (EPIPEN). Outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Allergic reaction, Anaphylactic reaction. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

When I received the 2nd dose of the vaccine, I was 26 weeks and 3 days pregnant. My estimated due date is 07/10/2021. I received the vaccine mid-morning on 4-6-2021. The following day (4-7-2021), I experienced arm soreness, fatigue, muscle aches, and chills. Those symptoms were subsiding by the evening of 4-7-2021. Early in the morning of 4-8-2021, I was wakened from sleep because my heart felt like it was beating too fast and too hard. This experience was most intense when lying on my left side, and at its most intense, I felt like I couldn't quite catch my breath. Sitting upright seemed to slow my heart rate. Walking caused it to increase again, and I felt more winded than usual walking short distances. I contacted my OB-GYN when her office opened on 4-8-2021 and told her what I'd been experiencing, and she instructed me to go to the hospital to be evaluated. I was admitted and monitored in Labor and Delivery continuously all day. My heart rate was elevated. My fetus's heart rate was normal. I had an EKG which was normal. I had labs done (CBC, metabolic, thyroid, progesterone), and all were normal. I was not found to be dehydrated, but I was given a liter of fluids IV as a precaution. Over the course of the day, my heart rate returned to normal, and I was discharged.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: She received the pfizer vaccine on the left arm. Patient complained of itchy throat and swelling so nurse who gave shot provided water. Started sweating and called 911. Patient was alert and responsive and was monitored until the paramedics arrived. She was visibly sweating and shaking but otherwise responsive. Did not mention throat closing worsening. Was monitored by the nurse who gave and pharmacist.

hard to hear at times; horrible pain from head to toe; couldn't see anything; couldn't breathe at all; face turned green; fever; aching in her legs; extreme exhaustion; blacking out; diarrhea; sweating; unable to talk; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 12:00 (Batch/Lot Number: EW0150) as 1st dose, single, at the age of 30-years-old for COVID-19 immunization. The patient had no medical/family history and concomitant medications. The patient went to go get her second shot of Pfizer covid vaccine but they wouldn't give it to her based on her reactions to the first dose. They said there was a chance of anaphylaxis reaction to the second shot. The patient reported blacking out, diarrhea, sweating and unable to talk. She consulted with her healthcare professional regarding whether to get the second shot and they didn't know. She asked if her reactions were normal. She doesn't know what to do whether to get a second shot given her reaction. It was mentioned that the patient was hard to hear at times. She got the vaccine on 06Apr2021 around noon and she was fine until around 3:30 am. She woke up in horrible pain from head to toe, she thought maybe she just needed to pee, she didn't know what was going on. She stood up and she blacked out like she was about to faint. She couldn't see anything, like it was completely black. She got to bathroom and she couldn't breathe at all, she couldn't talk. She thought she needs to go to the hospital, but she couldn't talk. Her face turned green, she had diarrhea, she was like dripping wet. At this point, she could sort of breathe. She felt like she was being held under water, still dripping sweat. She has recovered completely from these symptoms. The severity of symptoms was so severe she doesn't know if she had a fever at the same time, it was hard to tell. With the breathing part, she was so freaked out by that, so it's hard to know for sure, maybe yes. She may have had a low fever. She had a fever that night to the point where she was dripping on the floor. She has aching in her legs. She went to the doctor thinking she had Lyme disease, which she doesn't. Since that vaccine, she's had very, somewhat severe leg aches and extreme exhaustion like all the time. she can hardly go to work sometimes. Everybody has days they are tired, but this was different. She had to come home at 2pm and lay down for like five hours. She stated it was persisting. She had a blood test recently and everything came back perfect on 26Apr2021. She thought she had Lyme disease because of all the symptoms she was having, and it all came back negative. She didn't exactly get turned away. They said they didn't feel comfortable giving her the second dose of vaccine. The patient stated if a nurse tells her they don't feel comfortable, she wouldn't feel comfortable until she speaks to Pfizer. The nurse told her she had to go to an allergist and rheumatologist. The nurse said the same thing, the nurse told her that she should have gone to the hospital, but she wasn't thinking at that moment. She was just at a loss of what to do. That day at the hospital, they were scared with the second vaccine that she could go into anaphylaxis and she's not sure what to do. The patient had no other vaccines administered on the same date of Pfizer suspect and no other vaccinations within 4 weeks. The event hard to hear at times started on an unknown date while other events started on 07Apr2021 and ended the same day. The outcome of the events aching in her legs and exhaustion was not recovered, hard to hear at times was unknown while for other events was recovered. The events "she blacked out, like she was about to faint" was assessed as serious medically significant. No follow-up attempts are needed. No further information expected.

About a week after my second dose I developed fever and flu like symptoms. I took 2 covid tests and they came out negative. My flu like symptoms worsened and persisted for several weeks. On 04/21/2021 my neck began to hurt and swell, mostly on my right side. The following day the pain worsened to the point of calling out of work and seeking help at an urgent care. At this point, the lymph nodes in my neck appeared to swell on both sides. Swallowing became difficult and I struggled to eat mashed potatoes. In the following days my neck began swelling more and it became difficult to drink water. The pain level rose to a 7 out of 10 and my throat was so swollen that when I tried to drink water or protien shakes part of them would go up my nose and down the wrong pipe in my throat. It became difficult to talk and my lymph nodes seemed extra swollen. I went to an emergency room in but the doctor was unsure of any treatment and sent me home to rest. I declined lab tests. I had sever chills, sweating and fever. On 04/30 My symptoms began to improve and on 05/02/2021 I was able to eat again. At this point I'd lost 13 pounds and was weak.

Non-severe allergic reaction Onset of small red hives within minutes, followed by itchy throat about 10 minutes later. Resolved with Benadryl administered on site. Wheezing 2 hours later (possibly a panic attack due to stress over the situation, and not related). Resolved quickly.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Pt. received vaccine around 1930. She stated on 5/12/21 that she did not sit down for the full 15 minutes and left after approximately 5 to 10 minutes. She stated she began to have chest tightness and difficulty breathing. She was brought to an ambulatory care room by pharmacy technician and laid down. I observed her for approximately 10 minutes and took her blood pressure (124/83, pulse 90). She stated that she was able to breathe okay, but her chest was still tight. No known harm.

Patient called nurse over and complained of SOB. Paramedics called to patients side. Heart rate 146. Unable to obtain blood pressure. Patient given oral Benedryl and IM epinephrine by paramedics. Patient transferred to Hospital via ambulance.

Arm pain that radiated down arm and up shoulder and neck and fatigue started a few hours after shot. Later in the evening I felt very tired and body aches. Frequent urination. That night I got sweats and chills and more intense body aches. The following day symptoms got worse, even more chills, lots of sweating requiring changing clothes multiple times a day, frequent urination, dehydration, fever, severe body aches and weakness, severe nausea. It was difficult to get out of bed and walk. Low appetite. Cough and slight difficulty breathing. These symptoms continued at same rate for 48 hrs and started to get better then, fever went away but symptoms continued for at least 72 hours. Lingering cough continued past 2 weeks. When symptoms were most severe, I considered going to urgent care or ER but lacked ability to do so by myself.

Patient reported chest pain and shortness of breath and a feeling of malaise 2 minutes after her initial COVID - 19 vaccine. She took her albuterol inhaler and after about 30 minutes her breathing returned to normal. Allergy was caught and noted on 5/14 when the patient came to Expo for their second dose. She is considering coming back next week, once she would be eligible for the Johnson and Johnson vaccine.

Tech administer vaccine (1st dose). After approximately 5 minutes, the patient stated she felt light headed, dizzy and had trouble breathing. Checked her blood pressure (Check #1 156/127 Check #2 148/93) Admnistered Benadryl with patient consent. She stated her face felt numb and she continued to decline. Pharmacist called 911 and technician prepped EpiPen explained to patient and administered at 4:59 pm. Patient was turned over to the paramedics and transported.

Chest tightness; Dizzy; Breathing difficult; Throat tightness; Hives on vaccinated arm; This is a spontaneous report from contactable consumer, the patient. A 30-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: EN6201), via an unspecified route of administration in the left arm on 13Mar2021 at 10:45 am as a single dose for COVID-19 immunisation. The patient's medical history included ovarian cysts and irritable bowel syndrome (IBS). The patient was allergic to Gluten, dairy, bees, methocarbamol (manufacturer unknown), Dilaudid(manufacturer unknown). The concomitant medication included birth control contraceptives (Manufacturer unknown), Gastrozyme (Manufacturer unknown), Beta TCP (Manufacturer unknown), Phosphatidyl choline (Manufacturer unknown) for an unknown indication. On 13Mar2021, at 11:00 am the patient experienced dizzy (after 15 minutes of vaccination), hives on the vaccinated arm (after another 15 minutes), chest and throat tightness (after 30 minutes as per reported). The patient experienced breathing difficulties on 16Mar2021 at unknown time. Therapeutic measure were taken as a result of dizzy, hives on the vaccinated arm, chest and throat tightness, breathing difficulties treated with Benadryl, Pepcid, prednisone.The clinical outcomes of the dizzy, hives on vaccination arm, breathing difficulty, chest and throat tightness were not recovered. No follow-up attempts are needed. No further information is expected.

About 20+ blood spots on my arms, left shoulder, chest, left thigh, and legs.; Shortness of breath; Dizzy; Feel weird in my heart, like it felt cold/numb sometimes and hot sometimes; Feel weird in my heart, like it felt cold/numb sometimes and hot sometimes; Pain on my upper left back; Cough; Chest tightness; Rash on my forearms (not itchy); Joint pain; Muscle pain; This is a spontaneous report received from contactable consumer (patient). A 30-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 23Apr2021 10:30 (at the age of 30-years-old) as 1st dose, single for covid-19 immunization. Medical history included cold sores and allergies with mango, peach, and mold. The patient's concomitant medications were not reported. The patient previously took penicillin and erythromycin and experienced drug allergy in both. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within an hour after getting the first dose on 23Apr2021 at 11:00 AM, the patient felt dizzy and saw rash on her forearms (not itchy); then she started to feel weird in her heart, like it felt cold/numb sometimes and hot sometimes; it also developed into pain on her upper left back. At the same time, her heart beat also became fast (90-100/min). These symptoms lasted about another 3 days, and then she started to cough and had chest tightness and shortness of breath. The difficulty of breathing worsened within 2 days, so she took some Benadryl and it helped a bit. Then she noticed that there were about 20+ blood spots on her arms, left shoulder, chest, left thigh, and legs. All the events occurred on 23Apr2021 at 11:00 AM. She had muscle pain and joint pain in the next 3 to 4 days (in Apr2021), then the rash on her forearms disappeared. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.

The day after my second Pfizer shot i felt overwhelmed and shortness of breath. I felt like i was going to faint. I got hot. I went to work the next day and felt similar symptoms of a panic attack while at work which us what i thought it was. My stress levels seemed normal so i wasnt sure why i felt anxious all of a sudden. But then i felt the tightening of the chest and shortness of breath daily ever since. Everyone keeps telling me its because of my anxiety but it just came out of nowhere and doesnt seem right at all. I started researching it and saw the article from the CDC regarding myocarditis being linked to the covid shot and i strongly without a doubt believe that is what's really going on with me currently. I am going to try and go to Urgent care either tomorrow or Friday to speak with someone.

Day after vaccine, experienced elevated heart rate, pain at injection site, fatigue, and dizziness which passed over 3 days. Developed itchy skin and elevated heart rate again about 7 days after vaccination. Itchy skin subsided after 3-4 days but elevated heart rate has been getting worse since day of vaccination. Normal heart rate was 60-70 pre-vaccination, but since vaccination has been 85+ at all times even when at rest. Heart rate randomly spikes to 100-120 when resting and remains there for hours which is causing dizziness and disabling me. I am always short of breath even at rest. I experience disturbing heart palpitations. Every time I stand my heart rate spikes to 120-140+, I get dizzy and very short of breath, and cannot walk for long without having to sit down again. I was diagnosed with POTS about 3 years ago, but it had been in remission for about 2 years. These symptoms are similar to my POTS, so I believe the vaccination has caused my POTS to come out of remission or possibly caused heart inflammation. It is now over 2 weeks since vaccination and all my other side effects have cleared, but my elevated heart rate continues to worsen. I called 911 and was seen by paramedics on 6/1/2021 due to heart rate randomly spiking to 140 and refusing to go down for hours, causing me to feel faint. I declined hospital transport as heart rate went down to 110 after paramedics arrived.

Hard to swallow like lump in throat, throat tightness/swelling feeling.; Hard to swallow like lump in throat, throat tightness/swelling feeling.; Hard to swallow like lump in throat, throat tightness/swelling feeling.; slight rapid breathing; Hives on chest; This is a spontaneous report from a contactable Consumer or other non HCP (patient, self-reporting). A 30-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: En6203 and expiration dates were not reported), via an unspecified route of administration in Arm Left on 01Mar2021at 17:00 as first dose, single for COVID-19 immunisation. The patient was 30 years old, non-pregnant at the time of vaccination. Medical history included Known allergies: Tree nuts. Concomitant medications included Welbutrin, vyvanse, vitamin c, vitamin d, shilajit. 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 patient was not tested for COVID-19 since the vaccination. On 01Mar2021 17:30 the patient experienced Hard to swallow like lump in throat, throat tightness/swelling feeling. Hives on chest, slight rapid breathing. The patient was treated with benedryl. Therapeutic measures were taken as a result of Hard to swallow like lump in throat, throat tightness/swelling feeling. Hives on chest, slight rapid breathing. Facility type vaccine: School or Student Health Clinic. The Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was resolved. No follow up attempts are possible. No further information is expected.

Injection site burned when administered; Felt dizzy and light headed; Heart raced and started sweating; Heart raced and started sweating; Throat felt swelled at base; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot Number: EN6204) as a single dose, via an unspecified route of administration in the left arm on 18Mar2021 at 09:00 for COVID-19 immunisation (at the age of 30 years old). The patient had no medical history. The patients concomitant medication included LOLOESTRIN for birth control. 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. The patient experienced injection site burned when administered after 4minutes, dizzy and lightheaded, Heart raced and started sweating, throat felt swollen at base on 18Mar2021 at 09:00. The patient was treated with BENADRYL for the event. At the time of report, the clinical outcome of the events injection site burned, dizziness, heart racing, sweating and throat swelling were recovered. No follow-up attempts are needed. No further information is expected.

Tingling/ heaviness in hands and feet, dizziness, fatigue, and shortness of breath. Symptoms began Monday May 24th at night and have persisted until present day. I visited urgent care and was ordered examination. A comprehensive metabolic panel (CMP) and a complete blood count (CBC) has been done. Both exams are normal. Further examination is in progress as per general doctors request. I believe the aforementioned symptoms are due to the vaccination.

Chills, heavy breathing, and sweating 2 and 3rd day post vaccine back pain started 05/25 pm for about a week constant headache & migraine (started 05/26/2021 - 05/31/2021) neck pain started (05/29/21 - ended 06/04/2021) intermittent ringing in ears (5 days after- 5/29/2021- 6/2/2021)

Constant pain in arm. Over 10 days, pain radiated outward from injection site. Pain spanned chest, and entered chest cavity. I experienced shortness of breath for about 3 days while walking normally and going up and down stairs. Pain dissipated by the end of day 10. During these 10 days, pain radiated up my neck and at one point the right side of my cheek and upper lip went numb for about 2 minutes. Then starting on around June 6th, pain in abdomen started. Symptoms of current experience includes: nausea, diarrhea, abdominal pain in lower right, upper left, and back on left side. Pain is mild to moderate, comes and goes. Feeling of fullness and pressure in abdomen constantly, even before eating for the first time of the day. Very fatigued. Menstrual cycle is late. Pregnancy test is negative. Dr. performed a battery of tests - urinalysis, blood, and COVID-19 nasal swab. CT scan of abdomen scheduled for Monday June 14 with Oral Contrast. IV Contrast allergy.

Patient felt throat "closing up" within 15 minutes of vaccination. Had had similar reaction to Tdap vaccine in April. Patient refused transport to ER; she said she would go to the ER with her boyfriend after leaving the vaccination clinic. O2 sats were stable throughout her time in the clinic.

SHORTNESS OF BREATH, IRREGULAR MENSTRUAL CYCLE, LEFT AXILLARY LYMPH NODE SWELLING, HEADACHE, ARM PAIN AND SWELLING.

Dizziness, light headedness, nausea, diarrhea, heaviness on right side of body, breathing issue exacerbated. I started feeling symptoms on Tuesday night and it progressed on Wednesday and I went to the ER

client complained of lightheadedness . feeling like she "couldnt breathe." Also states feeling numbness to left arm that radiates to chest and up to neck Client reports history of panic attacks. Seen by NP: Vitals obtained : o2sat at 157pm o2sat 98% HR 88, 207pm o2sat 99% HR 87, 221pm o2sat 99% and HR 81. Client left site after over 30 mins in observation, reported feeling better her sister at her side.

Day one- Started in research covid vaccine clinic?shortly after shot maybe 5-7 minutes - 1. At 4:50pm felt dizzy, 2.started to tingly in left hand and made nurse aware 3. She checked if I could push her back. Lost motor function of whole left side and feeling 4. At 5pm Was rushed to ER there? They thought I was having a stroke or had one 5. Did Code stroke 6. Added an ivy during stroke and I couldn?t feel it and became light sensitive. 7. Shortly after CAT scan came back- no stroke 8. 5:30pm Moved to ER? was given large ivy dose of anti- histamine, anti nausea and I couldn?t move my whole left side and feel anything. My legs and arms felt dead. I would try but nothing happen. The drew several labs. 9. At 6:30pm did X-ray- everything was fine 10. At 7pm was admitted into hospital to stay overnight 11. At 8:00pm Did a movement test-no improvement and still had massive headache and sensitive to light Day 2 - Did eating test and eating was normal. I could finally feel my left side of lips and face- passed, PT- failed. Couldn?t walk. Feeling of legs slowly coming back. They did this test where I couldn?t push them away. Got an MRI- everything normal, they thought I was having a code- struggled at breathing, was out on oxygen, blood presume dropped, did blood cultures and X-ray, ekeg, They finally realized kept having these inflammatory responses where my blood pressure went from normal to drop then my body would get super red and hot to the touch. My injection site would swell and sometimes I struggled breathing so oxygen was provided. They put me on more antihistamines and Pepcid. MRI was clear, continued to have massive headache , In the evening I started to feel if you would pinch my arm or leg, but I couldn?t tell if you put hot or cold up against it. Day 3- The lab person came to grab blood and I could finally feel the ivy and blood. Also could get up move around finally. I finally could feel my legs and most of my arm. I still couldn?t tell if it was a light touch or hot/cold. Finally realized 4/11 at 7pm. Was told not to lift over 10 lbs and to follow up with primary Day 4- would get winded going up and down stairs, still struggled with hot and cold feeling on legs, would have inflammatory responses but could control them Day 5- met with primary care- nurse. She put on bendryll and Pepcid multiple times a day. I continued to have inflammatory responses Day 6- after talking to her medical group they decide to put me on steroids. By day 2-3 I was feeling normal still weak. Less inflammatory responses and injection site still very swollen Day 10- finally no more adverse symptoms

Dose 1, 7:05pm June 3, 2021: - Tight throat / minor swelling and elevated heart rate within 5 minutes of vaccination, lasting for about an hour - Moderate level of dizziness / lightheadedness (needed to sit down and stay sitting) beginning 1 hour after vaccination, lasting for about 3 hours. - On waking the next morning, body aches and somewhat intense exhaustion lasting for half the day. - On waking the next morning, pain and tenderness at injection site (left arm) and pain lifting or moving arm. (steadily improving over 2 to 3 days) Dose 2, 6:50pm June 24, 2021: - Tight throat immediately following vaccination, lasting about an hour (but somewhat less so than after first dose) - Pain and tenderness at injection site the same evening of vaccination (continuing for a day or two, less pain than after first dose) - Within 48 hours: Flare up of shingles symptoms from virus case end of Jan - Feb 2021 (with no other such occurrences of symptoms happening after resolution of the virus). Symptom 1: Allodynia under left armpit/upper arm (along the same path it manifested previously) lasting around 48 hours in total and lessening over this time. Symptom 2: itching on chest along the same path the rash manifested previously.

104.7 fever, shortness of breath, delirious, fatigue, body aches, sweats and chills. Fever, body ache, delirious, sweats and chills lasted several days. Shortness of breath, body ache, fatigue was more than 2 weeks and I had to miss work and go out on FMLA

chest pain/SOB; chest pain/SOB; large pericardial effusion; hemodynamic instability; started exploring Lupus; joint pain; low WBC; This is a spontaneous report from a contactable pharmacist (patient). A 31 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 07Jan2021 (Lot Number: EL1283) at the age of 30 years old, as single dose for covid-19 immunisation. Medical history included sulfa products cause rash, anxiety, migraine. Concomitant medications included sumatriptan succinate (IMITREX); ibuprofen (MOTRIN); paracetamol (TYLENOL), OTC vitamin B complex supplement, OTC iron supplement. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Dec2020 (Lot Number: EK9899) at the age of 30 years old, as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient came to the ER on 14Jun2021 for chest pain/SOB, CT scan found large pericardial effusion, had to undergo emergency pericardiocentesis due to hemodynamic instability and hospitalized from 14Jun2021 and until 17Jun2021. Labs on fluid ruled our infectious or cancer origin. The patient had no prior medical history aside from anxiety and migraines, although the patient had recently started exploring Lupus but not confirmed. The patient have biomarkers consistent with Lupus, minor and infrequent joint pain, and chronically low WBC but WBC is unaffected by plaquenil (plaquenil started after vaccine) and no trademark rash. Events started from 06Jun2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment pericardiocentesis, prednisone, ibuprofen, colchicine, Nexium was received. The outcome of the events was Recovered with lasting effects/ Recovered with Sequel. Follow-up attempts are possible. Further information is expected.; Sender's Comments: Based on known safety profile and lack of close temporal association the reported events are assessed as intercurrent medical conditions and unrelated to BNT162B2. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Shortness of breath lasting over 1 week; Migraine/Severe Headache; Migraine/Severe Headache; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Left Arm on 09Apr2021 18:00, at the age of 30-years-old, (Lot Number: EP7534) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included endometriosis, seasonal allergy, and migraine. Concomitant medication included norethindrone; gabapentin; loratadine (CLARITINE); ibuprofen, all were taken for unspecified indication, start and stop date were not reported. Historical vaccine includes dose 1 of BNT162B2 administered on 19Mar2021, 05:45 PM on left arm (No reaction on previous exposure to vaccine). The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 13Apr2021, the patient experienced migraine/severe headache, shortness of breath lasting over 1 week. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.

Headache, shortness of breath, burning sensation in chest, joint pain, fatigue, brain fog, trouble sleeping. Began one day after first dose and still present 12 days later.

shortness of breath; tightness in the chest; swollen throat; heaviness on chest; when she eats something the heaviness on her chest gets worse; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9265, Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 14Apr2021 at 10:30 AM (at the age of 30 years), as a single dose for covid-19 immunisation. The patient medical history included ongoing asthma. She has had asthma since she was about 7 years old. Concomitant medications included salbutamol sulfate (VENTOLIN HFA) taken for asthma from an unspecified start date and ongoing. There was no History of all previous immunization with the Pfizer vaccine considered as suspect.There was no additional Vaccines administered on same date with the Pfizer vaccine considered as suspect. There was no prior vaccinations within 4 weeks. There was no AEs following prior vaccinations. On 14Apr2021, about an hour later, the patient had developed shortness of breath, tightness in the chest, swollen throat, heaviness on chest, when she eats something the heaviness on her chest gets worse and she still has to gasp for breath. She is calling to ask if she should get her second Covid 19 vaccine. She went to an Immediate Care and to the emergency room. She received medication for her asthma. She does have a history of asthma. She received a nebulizer with albuterol and a steroid inhaler called budesonide. She feels like she has to take in a deep breath to breath when she eats something. She also received something for her chest to calm her chest down from being cramped up and inflamed. She received Prednisone 20 mg, take 2 tablets for 2 days, then take 1 tablet for 2 days then take half a tablet for 2 days. The Prednisone was prescribed at the Immediate Care on 17Apr2021 and the emergency department prescribed it again on 21Apr2021 with the same directions. She was not admitted to the hospital, she was discharged from the emergency room. The patient underwent lab tests and procedures which included blood test: unknown results on 21Apr2021, chest x-ray: unknown results on 17Apr2021, chest x-ray: unknown results on 21Apr2021, electrocardiogram: unknown results on 21Apr2021. The outcome of event shortness of breath, tightness in the chest was unknown and Swollen throat, heaviness on chest, when she eats something the heaviness on her chest gets worse was reported as not recovered. No follow-up attempts are possible. No further information is expected.

Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe

Developed numbness and tingling in right upper extremity on 3/13/21. Was seen in the ER on 3/14/21, they thought it could have been an electrolyte imbalance so they checked bloodwork, but it was normal. Then over the course of several days, the numbness and tingling spread to left upper extremity and bilateral lower extremities. Developed difficulty with fine motor coordination in both hands as well as difficulty walking. Was seen by PCP who ordered more labs including inflammatory markers and vitamin D and B12 levels. Inflammatory markers were normal. Vitamin D and B 12 levels were mildly low, but not enough to cause symptoms. Was then referred to a neurologist. Had an MRI of brain and cervical spine to rule out stroke or MS, was normal except for a mild bulging disc at C5-C6. The symptoms of numbness, tingling, difficult fine motor coordination of hands/fingers, and trouble walking resolved on it's own after 2 weeks. Then for several weeks after that, there was noticeably more muscle twitches in all four extremities which have since resolved.

The day of the vaccine, anaphylaxis (difficulty breathing, accelerated heartbeat, fever, chills, confusion). From then and ongoing for the last six months, severe daily heart pains and very weak immune system.

Patient came in yesterday 7/21/21 at around 3pm to get the second Pfizer shot. During the consultation, patient was asked about side effects she had experienced after the first shot. Patient claims that approximately a day after the vaccine was administered, her chest started hurting, she experienced shortness of breath, difficulty breathing, fever at 100 and sore arm. We advised patient to seek a physician to evaluate whether patient should be getting the second CV19 Pfizer shot.

patient is 2.5 weeks post-op and has multiple (10-12) large pulmonary opacities concerning for organizing pneumonia (has no infectious symptoms, just developed back pain and mild difficulty taking deep breaths)

The symptoms started with having a hard time breathing going jus down the stairs or to the car being short distances. As the week went on it suddenly got worse as now I am coughing profusely with a hard time breathing as if I am gasping for air. I have noticed it gets worst when the weather is rainy and dewy like, but when it is sunny and no storm like weather it seems to be better. Recently the as the weather changes my symptoms have gotten worst again. I cough so much that I vomit and now when I eat food I can not eat food with out coughing and it feels as if my throat is closing when I eat so I do not eat a lot of food. I did not have this issue before the vaccine and after I got the vaccine now I am having all of these issues.

FOLLOW-UP TO A PREVIOUSLY SUBMITTED VAERS REPORT 0949661-1 Notes per Medical Records and patient history: On 15 Jan 2021, went to ER - Chest pain, tingling of right arm, nausea, elevated BP and heart rate. One hour after vaccine receipt on 14 Jan, experienced 30-45 min episode of right-sided chest pain with radiation to right arm. Later that afternoon, similar episode of chest pain. Awoke in middle of night with similar episode. Episode today more severe and associated with lightheadedness and near syncope. No leg swelling or rashes. PHYSICAL EXAM: WNL. Released in stable condition with instructions to follow-up with PCM. Per patient - EKG was reported as normal. Vital signs were normal except BP 140/84 (higher than usual for patient). No labs done. Anxiety considered a factor. 18 Jan 2021, ER visit - Several intermittent episodes of chest pain since 14 Jan. Now, more midsternal and lasting longer; non-exertional and non-positional. No SOB; no diaphoresis. No fever/chills, myalgias, cough, sore throat, nausea/vomiting/diarrhea. Initial BP 157/90. PHYSICAL EXAM: WNL. CXR and ECG normal. Treated with Toradol. Cardiology consulted and recommended obtaining a Troponin, D-dimer, and CRP, and trial of Colchicine and Naprosyn, and to schedule a stress echo. DX: Chest pain, unspecified 26 Feb 2021, ER visit - Chest pain intermittently x 7 weeks, with increase in pain for past several hours. Pain described as tightness across bottom of lungs and upper abdomen. Seen by Cardiology with no evidence of ischemia or pericarditis. Took colchicine x 3 days with no relief. Since Cardiology work-up, pain decreased to 1/10 intensity. While having dinner tonight, felt sudden onset of stabbing pain in mid-sternal region. Also noted onset of associated shortness of breath. Current chest pain is localized to mid-sternal region; exacerbated with deep breaths and somewhat alleviated with lying down. Pain now is 6/10 after taking naproxen prior to ER arrival. Also reports new onset frequent headaches and nausea. Had brain MRI yesterday and is awaiting Rheumatology evaluation for possible autoimmune disease. BP 143/81. PHYSICAL EXAM: WNL. Treated with GI cocktail (felt worse after). Had bedside ultrasound (normal gall bladder; no gall stones). ECG normal/no changes. Troponin - negative. CBC, CMP, Lipase unremarkable. Possibly inflammatory/chest wall pain. Continued Naproxen recommended. 3 Mar 2021, Rheumatology consult - Acute onset of syndrome characterized by chest pain with some radiation to the right side and intermittently to the right shoulder, episodic, moderate to intense, partially responsive to naproxen. Malaise, fatigue, especially in the morning; decreased exercise tolerance due to lower energy. Also reports recent frequent, intermittent headaches - bilateral temporal. No history of chronic headaches. Episodes interspersed "good days" without chest pain but with persistent malaise, fatigue, decreased tolerance to exercise. Decreased tolerance to exercise is not so much dyspnea on exertion but fatigue and feeling spent after half a workout of what she was able to do before. No hair loss, rashes, sicca syndrome, oral ulcers, pleuritic chest pain, GI changes, inflammatory arthritis, muscle weakness or neurological complaints. PHYSICAL EXAM: WNL 17 Feb 2021- ANA 1:40 speckled. Negative ANCA, complement components C3, C4, urinalysis, SPEP ASSESSMENT/PLAN: Onset about 2 hours after the 1st dose of Pfizer Covid 19 vaccine in very healthy individual, physically fit, helicopter pilot. Unremarkable physical exam, laboratory tests and recent stress echo. Negative MRI of brain. Doubt a systemic autoimmune disorder. Discussed prevalence of low titer ANA in general population and relatively low predictive power of test. Recent studies of the vaccine have reported some patients with complaints of pain and findings of enlarged lymph nodes,; she has no findings to suspect myocarditis. Aortitis cannot be ruled out. The onset 2 hours after the 1st dose of the vaccine in a previously very healthy individual suggests some form of reaction. Pericarditis has not been found on echocardiogram. I wonder if a cardiac MRI with and without gadolinium may be useful. Alternatively, a CT scan of the chest with contrast may be useful. Specific autoantibodies were ordered. Recommended another trial of colchicine 0.6 mg daily x 2 or 3 weeks along with Naprosyn 500 mg 1 to 2 times daily. 23 Mar 2021, Rheum follow-up - ASSESSMENT/PLAN: Unusual, new onset, episodic chest pain, short lived, associated with malaise and decreased tolerance to exercise. Naprosyn, when used, helps for the day...Discussed the option of observing and treat symptomatically and continue to do studies or consultations as needed or to intervene, on an empirical basis with short course of prednisone assuming some unresolved inflammatory process. ( 20 mg in the morning x 4 days, 15 mg x 4 days, 10 mg x 4 days, and 5 mg x 4days). Ordered CRP, CBC, SPEP, ESR. 26 Apr 2021, Pulmonary (video) - referred for evaluation of atypical chest pain and exertional dyspnea. 30-year-old CG helicopter pilot who describes being in very good general health until clinical episode began in Jan. She is a runner and was training for marathon at baseline...2 hours after her 1st dose of COVID vaccination, she felt rapid onset chest tightness, more on right side. Right arm felt numb; seen in emergent care...Symptoms include right sided chest heaviness and pain, now migrating to left side. Can be stabbing pain in nature. No prior similar symptoms. Denies asthma as kid. One pneumonia in second grade. Never smoker; no second hand smoke. Helicopter pilot, some jet fuel exposure, flies for Coast Guard. Has not had second dose of COVID vaccine. From onset to now, initial improvement, some fatigue early on, 2-3 weeks later fatigue on plateau, then headaches, pain on both sides of chest, prednisone given and fatigue improved, headaches went away but then came back, milder, short term in nature. Chest pain has increased to constant as weight in bottom of chest. Was big runner before, training for marathon, now down to running a mile, exertional chest pain and heaviness, stabbing pain usually low down sometimes right of sternum. Takes few hours to subside. Treatment included a prednisone taper, made chest symptoms worse but made fatigue and headaches better. Colchicine led to no improvement. Currently on Naprosyn and Tylenol for pain. CLINICAL IMPRESSION: Never smoker, good baseline health, runner. 4 months ongoing R>L chest pain, onset within 2 hours of 1st COVID vaccine. Fatigue, improved on steroids. Headaches, improved on steroids. Exertional dyspnea, persistent. Normal tests include chest radiograph, ESR, CRP, ECG, Stress test and reportedly CT, but not see by this provider; ANA 1:80 likely not clinically consequential. PLAN: Obtain outside CT scan; D-dimer and BMP; if positive, consider CT angiogram to r/o PE. PFT and exercise oximetry, COVID screen before test. Continue Tylenol/Naprosyn as need. Follow-up after testing complete. DISCUSSION: Explained story and normalcy of tests not suggestive of pneumonia, coronary syndrome, asthma, and apparently without underlying collagen vascular disease. Sterile pleurisy seems to fit her scenario better if there is a lung pathology present, but if severe enough to cause symptoms this profound for this long, surprising no lab markers for inflammation are positive. PE can cause dyspnea and chest pain and not show up on x-ray or on noncontrast CT, which was what she reports having had. Would be extremely unusual to cause pain this far out from onset, and hard to explain increase in symptoms with prednisone use. For dyspnea, recommend PFTs first, and for possible clot, review outside CT initially, but in absence of clear answer, move forward with d-dimer check and if positive, then anticipate CT-angiogram to at least exclude dangerous processes. COVID-induced inflammation does not currently have a confirmatory test, although the timing of symptoms onset just after vaccine is noted. Follow-up after above testing. 21 Apr 2021, T-CON: Review of initial symptom onset - Experienced chest tightness within 2 hours of vaccine receipt. The next day, she did not wake up with chest tightness, but later that day while at work, she experienced chest tightness and right arm numbness. She went to the local clinic, who had her go to the ER; at the ER, they thought she was most likely having a panic attack. She reports having brief episodes of chest tightness on 15 - 17 Jan. On Monday, 18 Jan, the chest tightness lasted about 5 hours. She went to the ER and at that time, was told her ECG was abnormal. She was then referred to Cardiology; reports having normal stress test and imaging. Then toward the end of the month, she experienced increased fatigue (sleeping x 12-15 hours/day). She also started having severe headaches. During her evaluation, it was noted that she had a positive ANA, so she was referred to Rheumatology; told she did not have evidence of an autoimmune disease, but her symptoms were c/w post-COVID "long haulers". UPDATE AS OF 15 JUL 2021: Symptoms are about the same. Experiencing constant chest pain that occasionally gets worse. Severe headaches 2-3X/week.; no pattern in symptoms; they seem to come on spontaneously without a trigger. Initial Neurologist evaluation last week. No specific diagnosis, but assessed as borderline chronic migraines; will follow up later in the summer if the migraines continue. Between the Neurologist and PCM, initiated prescriptions - Riboflavin 400 mg/day, Magnesium oxide 250 mg 2x/day and Petadolex 75 mg 2x/day. Had first virtual appointment with Internal Medicine on 15 Jun; scheduled for a physical on 19Aug. Applied for the Clinic but appointment pending (told it would be in about 8 weeks.)

it constricted her breathing/couldn't breath; Costochondritis/there was inflammation her ribs; bruising; has been having on and off rashes on her chest; waking up in the middle of the night; had a flare up and it got really red and itchy; had a flare up and it got really red and itchy/Then Randomly her Ear is on fire, its bright red; sore arm/arm soreness; punch inflammation inflammatory reaction; Redness in chest; Swollen lymph nodes; ear on fire and is bright red; bad chest pain; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 07:00 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included prednisone (PREDNISONE) 10mg, 3 times a day for first 2 days; 2 10mg tablets for twice a day for next 2 days. States that after doctor stopped the Prednisone, she was put on Cyclobenzaprine and Hydroxyzine. States that she was just given these today. On an unspecified date, the patient experienced sore arm/arm soreness, punch inflammation inflammatory reaction, redness in chest, swollen lymph nodes, it constricted her breathing/couldn't breath, costochondritis/there was inflammation her ribs, bruising, has been having on and off rashes on her chest, waking up in the middle of the night, had a flare up and it got really red and itchy, had a flare up and it got really red and itchy/then randomly her ear is on fire, its bright red, her ear is on fire, its bright red on 01Apr2021 and bad chest pain on 25Mar2021. Sore arm, Thursday punch inflammation inflammatory reaction. Redness in chest. Swollen lymph nodes. Twice to HCP, tried prednisone. Asking for recommendation on second dose. Potential duplicate AE. States she has been having some really weird side effects. States that it has been 9 days since the first shot. States that in the first couple of days, she just had arm soreness. On the third day, started having really bad chest pain, almost like someone was punching her in the chest. States that it constricted her breathing. Went to the ER and they said she had Costochondritis, stating there was inflammation her ribs. States that under her arm is really hurting and there is bruising under her sternum. States that she has been having on and off rashes on her chest. States that she went to her primary doctor twice, including today. States that her doctor told her to call Pfizer to see if she should be getting the second dose of the vaccine, or if she should get the Moderna vaccine. States that her doctor stated it may have been an allergic reaction to the vaccine. Chest pain and arm pain: States that she got the shot on 23Mar2021 and the chest pain started on 25Mar2021. States that it started up on top of the front of the arm and down around the arm. Was more severe in the side that she got the vaccine. States that the other arm is hurting a bit, but mostly in the same arm. States that it is still hurting now. Treatment was given Ibuprofen in the ER and was given a prescription for 800mg Ibuprofen prescription. States that she went to the doctor on Monday and was given Prednisone. States that she went again today because of more things happening, she was waking up in the middle of the night, her chest was pounding and she couldn't breath and that went away but then she would get rashes and that would go away. States that she has always had these since this happened. States that there is redness on her chest, mostly from inflammation. A few days ago, had a flare up and it got really red and itchy. States that it goes away in an hour. States that this occurs randomly. Then Randomly her Ear is on fire, its bright red and then goes away for an hour. States that this started today. She is not sure if this is from the Prednisone because it occurred shortly after taking it. The patient underwent lab tests and procedures which included chest x-ray: normal, electrocardiogram: normal. Therapeutic measures were taken as a result of sore arm/arm soreness, punch inflammation inflammatory reaction, bad chest pain. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.

I keep getting chills; I get hot; I have a headache; My arms I cant move its really sore and pain goes to my breast; My arms I cant move its really sore and pain goes to my breast; I was experiencing tightening in my breast; I felt terrible today; Earlier this morning I had trouble breathing and but it hasn't came back again I am not sure about 20 minutes; This is a spontaneous report from a contactable consumer reporting for herself. This report was not related to a study or programme. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0182; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 30-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history, investigation assessment included none. Concomitant medications included ibuprofen (IBUPROFEN); elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) taken for an unspecified indication, start and stop date were not reported. Patient stated she was taking both medications. The patient previously took first dose of BNT162B2 on 26Apr2021 for covid-19 immunisation in left arm. Patient stated that lot number for first one was EW0170, and she think it was 00 and not sure. Patient stated that there was no expiration date on there. The patient experienced keep getting chills, get hot, had a headache, arms cant move its really sore and pain goes to breast, was experiencing tightening in breast on unspecified date; earlier this morning had trouble breathing and but it hasn't came back again, not sure about 20 minutes, felt terrible today on 18May2021. Patient reported that she had second shot the day before this report and just getting, wanted to know the side effects that are possible because she felt terrible on the day of this report and wanted to think it was necessary for her to go to the hospital because she heard that you could get a side effect like lost it off because it was her second day as whatever as she did not know if it was true. Patient asked they usually what we put the shot you get a side effect that will last a day and patient asked if that was true. Patient reported that she keeps getting chills, get hot. Had a headache. Her arms cannot move it was really sore and pain goes to her breast. earlier on the morning of this report, she had trouble breathing and, but it hadn't come back again it was just for about 20 minutes. Patient thought it went away that morning her side effects came back again. Patient was just curious on when she should go to the hospital, or should she wait on it. Patient stated that she was experiencing tightening in her breast. Consumer was informed about Pfizer Medical Information Department. It was reported that due to poor internet connectivity issue voice did not get through and hence patient disconnected the call. Clinical outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Patient called hospital call center. Pt stated pt got 2nd covid vaccine Pfizer yesterday at her local pharmacy. Pt said pt feels left throat swelling, left eye and left collar bone swelling and pain(socre 7/10) when pt touches on left collar bone swelling area, body aches and sinus headache. Pt advised by to go to ED

Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing)/ Left and right neck pain; Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing); Arm Pain at injection site; Arm Pain at injection site; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: EK5730), intramuscularly on 22Dec2020 09:45 at single dose on left arm for COVID-19 immunization in hospital. Medical history included gastrooesophageal reflux disease (reported as GERD). No true allergies; unable to take NSAIDs or eat bananas or avocados 2/2 GERD. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain at injection site on Day 1 (22Dec2020); chest, back and left neck pain (chest and back pain worse with breathing) on Day 2 (23Dec2020); left and right neck pain on Day 3, resolved on Day 4. No treatment received for the adverse events. The events outcome was resolved on 25Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. No follow-up attempts are possible. No further information is expected.

Received Pfizer COVID 19 vaccine on 1/3/21. While waiting 15 minutes in observation patient report tightness to her throat. Was taken to ER

48 hours post vaccine I started having sore throat, cough, fever for the next three days. Later I got tested positive. 5 days after vaccine I was experiencing SOB but all symptoms were gone after 10 days post injection. Not sure if I was exposed to people with covid prior to receiving the vaccine. I also do work with covid patients at work

Heart palpitations, tachycardia, PVCs and shortness of breath, fatigue, weakness started on Monday (1/4), worsened over next 2 days. Saw primary doctor on 1/7 who called paramedics to take me to the ER due to EKG results and increased work of breathing. ER doctor suspects mild guillain-barre reaction, I will be following up with cardiology and pulmonology as soon as possible as they were unable to determine exact cause or fix the issues.

All the covid symptoms - sore throat fever, headache; shortness of breath; no taste; fatigue; tested positive on the 23rd for Covid. 2nd dose: 1/6/2021 (received in right arm) - in am; adverse events started in the pm of the 6th: (6 Pm) - fever, chill, sweats, headache - all night into the following day for the headache; took tylenol LATE IN EVENING for fever and so no fever when I woke up 7th - took last night (7th) - still had chills and headache. (day two still) - HAS BEEN TAKING TYLENOL FOR24 HOURS BECAUSE HEADACHE IS BAD IF IT COMES ON day two - symptoms are better now; military - so was coming off covid protocol - so it complicated going back to work.

within 5 minutes of the vaccine administration patient had numbness/tingling of her lips, tongue, and face. She was given Benadryl, which she states improved her symptoms and she was able to sleep. This morning (day after vaccine) she states that her tingling feeling has returned to her face, lips and tongue and she feels a globus sensation and constriction within her throat. She has taken a benadryl this morning with no improvement. Patient was recommended to seek care in the ER.

2:45 pm - 10 minutes after receiving vaccine pt reports throat tightness and sensation of lump in throat, and rash to face and chest 2:50 Pm pt evaluated by EMS and transported to Hospital pt reports is 10 weeks pregnant

Developed a "scratchy throat approximately 20 minutes post vaccination. Symptoms worsened and she developed shortness of breath. Required evaluation and treatment in the Emergency Department. Received Benadryl, dexamethaxone, famotidine and solumedrol. Second COVID vaccine, no reaction with the first vaccine. ED provider notes below: This patient presented due to concern for allergic reaction to COVID-19 vaccine and was seen by myself immediately upon arrival. When in triage the triage nurse noted her oxygen saturation was 81% so she was placed on 2 L nasal cannula and brought directly back to her room. When placed in the room she was hooked up to the monitor and her oxygen saturation was 100% and I took her off of the nasal cannula and her oxygen saturation remained in the upper 90s. She had no stridor and respirations were nonlabored. She was speaking without difficulty and had no vocal changes. She did not appear to be in any acute distress. Her posterior oropharynx was widely patent and she had no uvula or tongue swelling or lip swelling. She did have some blotchiness to the upper chest area but no hives. Abdomen was soft and nontender. Pulse was regular. Blood pressure was stable. She was nontoxic in appearance. An IV was established and the patient was given Decadron and Benadryl for initial treatment.

Woke in middle of night (2am approx. 12hrs post vax) with palpitations, HR 120s, SOB, fever 100.8, sweats, chills, body/joint aches. Palpitations and SOB persisted for approx 4hrs, off and on. Fever 100.2 and body aches persisted until approx. 5pm the day after 2nd vax (approx 27hrs).

The patient experienced dyspnea and chest tightness several minutes after receiving the shot. She did not notify anyone, and after her 15 minute wait, she went home. Her respiratory symptoms worsened despite taking a dose of diphenhydramine. At the urging of her family, she went to the ER four hours later, where she was evaluated. No treatment was done, and she was told that she was having a mild reaction. Her symptoms resolved after several hours.

Side effects: headache, joint pain, muscle aches, fever, dizziness, nausea, shortness of breath, fatigue

After my first dose, the only symptom I had was soreness at the injection site lasting 1 day. 12 hours after my second vaccine, I developed muscle aches and chills that were gone the following morning when I woke up. 3 days after receiving my second dose, I developed hives and swelling on my entire body that progressed over 2 days. I also started to have some swelling in my throat by 4 days after the second dose and ended up going to immediate care for a steroid injection which began to provide relief by the next morning.

Pt developed post COVID vaccine side effects at 1000. Pt received COVID vaccine at 0932 by LVN. Pt complained of a numb throat, and said, "I cant seem to swallow my saliva well." This writer did an immediate assessment of patient's throat with flashlight, and no swelling, abnormal discharge, or discoloration noted. Pulse-ox that was available on hand was used on pt, and sats were 96% and HR 78. MA on site was asked to grab a complete VS machine for somewhere stat, for there was none on site. This writer reassured pt was going to be okay and to breathe normally, for assessed pt was breathing fast. This writer called every doctor listed on the "Contact List for COVID Vaccine Clinic," but there was no response. This writer then called Urgent Care and Minor Injury Clinic, but the doctors were busy with patients. Asked MAs from those areas to have a doctor call immediately for a patient here was symptomatic. Once VS got here, VS were taken, and pt was assessed again. Pt said there was no more numbness in her throat, but tongue was feeling itchy, and her body temp went from hot to cold. Intitial VS: Temp: 98.3 BP: 122/80 HR: 77 O2: 99% RR: 18 Dr from Urgent Care finally called. Background story given, and she ordered Diphenhydramine Cap 25mg (Benadryl) which this writer had on hand in the emergency kit. Order was on computer, but could not acknowledge or scan, so order detail was printed, and pt and I signed form together. Benadryl given at 1025. Dr also suggested that ID doctor be called. At 1030, I got a hold of Dr., gave her a background story, and she advised that the pt stay for another 30 mins to be observed and she would come see the pt. Dr. arrived at 1100, assessed the patient, and ordered Cetrizine Tab 10mg (Zyrtec) to give to pt, which Dr. had to get from another department. There was no Zyrtec available in emergency kit. Again, order was on computer, but could not acknowledge or scan, so order detail was printed, and pt and I signed form together. Zyrtec given at 1128. An additional Zrytec Tab 10mg was given at same time at 1128 "for home use" per Dr and per her order. VS set #2 taken at 1133 Temp: 98.1 BP: 133/94 HR: 63 O2: 100% RR: 16 Dr suggested that she schedule an appt to see an allergist and to get an allergy test done prior to the next dose of the COVID vaccine. Patient was feeling a lot better and more at ease. Pt left comfortably with no symptoms at 1200.

1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting 15 min. 1630: Woke up. Felt more tired than usual. 1900: Arrived at work. Felt fatigue and sore arm. 2000: Felt sore arm, fatigue, and mild HA. Drank coffee and this helped with fatigue and HA. 2100: Mild nausea starts. Still have sore arm. Less fatigue, no HA. Still able to eat with the nausea. 2200: Developed chills. I was putting up curtains in an isolation room and had to pause halfway through due to being short of breath as if I'd done something strenuous. I then was short of breath again walking specimens to lab, which is unusual for me. Walking samples to lab involves walking 400 ft and going up and down 1 flight of stairs. 2300: Coworkers keep asking me why I'm always out of breath. They are concerned. Chills are worse now and I go from feeling normal to feeling cold. My hands are like ice and I am gripping my arms to keep warm. I walk 2 samples to lab and each time I am dizzy on the way back. By the 2nd time I have to hold the wall to keep balance. I can no longer hide the side effects and a coworker offers me 650mg Tylenol. I gladly accept. I measure my spO2 and it is 97%. 1/13 0530: I am almost back to normal other than feeling fatigued. 0815: I get home and go to bed. My feet are ice cold so I have to wear socks, but my hands feel normal temperature. I feel like my blanket isn't warm enough. 1330: I wake up and feel absolutely miserable. I am going between having chills to having a hot flash. I can't seem to will myself to leave bed. I'm pretty sure I have a fever, which I haven't had in over 10 years. My mouth is completely dry. 1400: I manage to roll out of bed and take my temperature, which is 101.3F. I feel an overall malaise and keep getting periodic hot flashes, but manage to make it downstairs and I mix 1 liquid IV electrolyte packet w/ 24fl oz. water. I drank the whole thing. I also cooked myself some dumplings and 1 waffle w/ maple syrup due to feeling much hungrier than usual. 1430: I take 1000mg Extra Strength Tylenol after eating. 1830: I feel almost normal except for significant fatigue and go to bed. 1/14 0430: I wake up and feel completely normal. No fatigue. Go about my day as normal. 1545: Suddenly I feel lightheadedness and mild HA. Have trouble with inattention (ex. not following w/ conversation or forgetting what people just said, or listening but not registering, or can't find the words to respond or answers to a question.). I take my Vitals: 117/95, spO2 85%, HR 63. I then try taking a couple deep breaths and spO2 increases to 98% and lightheadedness and HA go away. Then a few minutes later lightheadedness and HA begin again and spO2 is 80-90%. Then I take 2 deep breaths and spO2 is 98% and HA and dizziness improves. This repeats several times and I grow concerned. My hands are cold and the pulse oximeter is $30 from Amazon. However, I used the pulse ox on my mother and she was 97% consistently every time without fail. I also used pulse ox on myself when perfectly healthy and same thing it was 98%+ every time. This is why I was now worried. 1630: I take Tylenol since this seems to have helped with any and every symptom I've had so far and book an Urgent Care appointment. 1700: I get up to take a shower and feel extremely dizzy to the point where I'm worried I might fall. I stumble into the bathroom holding the wall. I take spO2 and it is 87%. 1800: I show up to Urgent Care and after the shower I feel my hands are warm now. At Urgent Care they are using pulse oximeters and I am spO2 99% and HR 64. So they chalk it up to my crappy Amazon pulse ox and they tell me to hang in there. Perhaps if I had not taken a shower before going there it may have been a different story? Hard to say now. Also the Tylenol may have started to work by then. 2200: I am still inattentive, spacey, lightheaded, and fatigued. I then fell asleep on the couch without realizing. 1/15 0230: I wake up and feel fatigued with brain fog, but no more lightheadedness. 0630: I go back to bed because I'm too sleepy.

flu like symptoms, shortness of breath, chest pain with deep inspiration, fatigue, malaise, body aches

Approximately 15-20 minutes post-injection I started to feel lightheaded, dizzy, shaky and increased heart rate. This was swiftly followed by a feeling of tightness in my throat, shortness of breath, and coughing. In addition I had a moderate to severe headache. The hospitals rapid response team was called and I was brought to the emergency department on-site. I was given a racemic epinephrine and albuterol neb treatment which resolved upper airway stridor and cough. I received PO Benadryl, Pepcid, and Prednisone. A EKG was completed. I was observed in the emergency department for about 2 hours until discharge. I was discharged with prescriptions for an Epi-Pen, Prednisone, and Pepcid. The diagnosis on my after visit summary was: Allergic Reaction. I was unable to finish my scheduled shift as an RN.

Fever (max 102 degrees Fahrenheit) after 12 hours of the vaccine, lasting for approximately 18 hours total. Accompanied by chills, malaise, myalgias. Continues with mild tiredness and shortness of breath on exertion over the next few days. COVID-19 test done on 1/13/2021 due to severity of symptoms, was negative. 3 days later (1/15/2021) left calf pain with mild edema, subsequently diagnosed (1/20/2021) as a left posterior tibialis complete vein occlusion (DVT). Chest CT done to rule out pulmonary emboli. Anticoagulation prescribed (xarelto).

Approximately 10 to 15 minutes post injection she started feeling hot, then patient began to become flushed . I gave her oral benadryl 50 mg and 40 mg of famotidine oral. The difficulty in breathing did not lessen. She began to use her accessory muscles. Her O2 sats were 99% via finger pulse oximeter. Breathing became increasingly labored. An Epi pen 0.3 mg was administered. An ambulance was called. Her breathing became less labored, she was transported to the hospital via ambulance to be checked out.

Fever; difficulty breathing; fast heartbeat; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 12:30 at single dose on the left arm for COVID-19 immunization. Medical history included allergies: PCN. Concomitant medications included galcanezumab (EMGALITY) received in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 09Jan2021 18:00, the patient experienced fever, difficulty breathing, fast heartbeat. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Information about Lot/batch number has been requested.