Pfizer

CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.

I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.

Asthma exacerbation; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: ek5730), via an unspecified route of administration at the left arm on 18Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history includes adult onset asthma, seasonal allergies, anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included atomoxetine hydrochloride (STRATTERA), vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol and levonorgestrel (SEASONIQUE). The patient experienced asthma exacerbation following vaccination that started 2 hours after (18Dec2020, 3PM) and worsened 1 day later. The pulmonologist advised to nebulize the patient with albuterol due to shortness of breath tightness and clear secretions despite MDI. The patient had to restart controller Symbicort (still with 3x day albuterol on 23Dec2020) and seen at an urgent care. Oral steroids were prescribed (Medrol dose pack). The patient was not hospitalized for the event but the resulted in Emergency room/department or urgent care visit. The event was reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has been tested for Flu and COVID (Nasal Swab, PCR) Testing on 23Dec2020 and results were negative. The outcome of the event was recovering.

Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2

12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.

About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.

Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.

Patient became anxious, felt her throat closing and pressure in her chest. Pulse rate increased. Rash noted initially on arms, chest, and back. Palms of hand became very red. Shortly after, she became hoarse, and hives were noted on chest and neck.

Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with rapid onset of dyspnea. Epinephrine Injection, USP Auto-Injector 0.3 mg administered. Code blue called. This occured in hospital setting, emergency department responded to vaccination clinic. Oxygen therapy, Methlyprednisolone 125 mg IV push, Diphenhydramine 50 mg IV push.

Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.

Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.

Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.

After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.

Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness

Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.

This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.

lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine administered. about 1 hour later had wheezing and chest tightness lasting about 4 hours

0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal

shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years). Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.

Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."

lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.

Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events. The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes. Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing. She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops. Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up". She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms. While being transported to the ED an additional 0.3 mg dose of epinephrine was administered. The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose. The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.

EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization. The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020. There were no concomitant medications. The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath. The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose. Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks. The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.

15 minutes after receiving the second dose of vaccine, she felt light-headed and short of breath. She received Epinephrine 0.3 mg IM, solumedrol, and Benadryl. She remained hemodynamically stable.

Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.

Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.

Patient stated she had chest heaviness and SOB the evening after receiving the vaccine. She saw her PCP and got a steroid shot and took Benadryl on 1/15. On 1/17 she came to the ER with complaints of cough and chest heaviness thought to be caused by the vaccine. She was treated for underlying pneumonia with azithromycin 500mg PO, cefdinir 300mg PO, and a one time dose of methylprednisolone 125mg IM.

During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.

1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen pressure in lungs, antibiotic has provided some relief to lungs but pain continues, feels lungs are fatigue and worked. 20 days swollen throat has continued, and small rashes with no itch come and go on eyelid, chin, shoulder.

Within a few minutes I felt like my throat was getting tight, constricted, and maybe even the description would be inflamed. I was still able to breathe okay and swallow with only some restriction so I didnt say anything. I felt a little foggy and shaky as well for about another 2 hours and then was fine.

Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat

Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area and met with the nurse, to show her direction of where to wait for recovery. client informed her, "I think I'm having an allergic reaction." Nurse asked her to describe what symptoms she is having. Client stated that she had an itchy throat, she felt that she couldn't breathe, and her heart was racing. Nurse activated RRT. At 10:00, Nurse responded to scene with the Kit containing the AED, oxygen, and emergency medication. Vitals taken: P: 102, RR: 18, Manual BP: 120/80, Oxygen: 100% RA, no pain. Upon assessment, stethoscope used, clear lungs sounds, normal heart sounds. Client AAO x4, speaking in full sentences, no SOB noted. Skin color normal, capillary refill <3 seconds. Lip color normal. Nurse noted that client's lymph nodes were swollen. Throughout event, client spoke with no SOB and in clear sentences. EMS arrived to scene at 10:09 am. Vitals: HR: 99, 100% RA, 146/98. At this point, client is reporting feeling much better, head-to-toe assessment appears normal. She refused transport via ambulance to the hospital. EMS left scene at 10:20 am. Client was instructed to wait for 30 more minutes for monitoring. Client left scene at 10:30 am with client feeling better. Lymph nodes are no longer swollen, client continues to speak in full sentences with no SOB noted. Skin and lip color normal. Client AA0x4. Client instructed that if she is needing medical attention, feeling SOB, etc., to call 911 or go to the nearest hospital.

Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.

I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.

Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.

Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, tachycardia, dyspnea at 12:00pm 1/24/2020 Improvement with ibuprofen and acetaminophen. Resolved by 1/25/2021

Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date. The following information on the batch/lot number has been requested.

Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of throat "fuzzy", heart rate 140/min for 20 minutes. Her breathing was as if she was "trying to catch my breath" which lasted 5 minutes. At 1pm she experienced fatigue, chills, had fog, and weakness which lasted or approximately 18 hours. She felt much better 48 hours later.

approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also had intermittent itching and chills. Rapid Response team notified and she was observed for an additional 30 minutes with improvement in symptoms. She was dismissed at 1000 to home

patient developed itching and rash on chest and neck with some throat tightness. RRT called and she was transferred to the ER

My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I had bronchitis two weeks prior next day cough wheezing completely gone and my lungs feel great I can breathe again with no mucus I have swollen lymph nodes but not to bad little headache but overall feeling ok just tired and some dizziness at times.

Throat itchy, felt like right side of throat swelling, dizzy, skin hot. Seen by doctor in vaccine clinic who held me for one hour. Took Benadryl which helped reduce throat itching and feeling of swelling in throat.

Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.

Patient reported coughing and shortness of breath 1 hour after Covid vaccine.Pulse Ox 99%, lungs clear, P 88, cough noted. Patient given 25mg oral Benadryl. Coughing subsided

Pt received first dose and stated feeling throat swelling. Monitors with vitals and called Allergy. BP WNL, Tachycardic to 106. No signs of facial edema, no difficulty breathing or swallowing, Allergy recommended to give 10mg of Zyrtec. Afterward developed tingling in mouth. Observed total of 1hr. No progression of symptoms and allowed to go home.

after the vaccine, I started to feel Body aches, chills, nausea, gum pain, I felt fine prior to the vaccine, I went to an Express Care they did a Covid 19 test, result was negative, I had a video visit with my doctor because I developed cough, chest tightness and shortness of breath, they did a 2nd Covid 19 test result was negative, The cough become persistent and the cough caused pain in my chest and back, The Doctor prescribed guaifenesin with codeine, albuterol and something for my gums. the cough and pain in chest was worsen and the Doctor gave me the zpack, I was out of work for 10 days. they said I had an acute URI

Patient felt flushed and experienced shortness of breath (history of anxiety, panic attacks). Drank water and felt better in 10 minutes.

Covid 19 vaccination provided by patients work (unknown manufacturer) via phone visit pt reports starting Saturday positive swelling in face, hands and feet, reports improvement in swelling at this time. Positive full body aches, fever, significant fatigue and shortness of breath

Elevated heart rate immediately after vaccine; shortness of breath with 90 minutes that's persisted on and off for 5 days so far; This is a spontaneous report from a non-contactable healthcare professional reporting on behalf of the patient. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration), intramuscular in left arm on 15Jan2021 at 09:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma. The patient has no known allergies to medications, food, or other products. Concomitant medications included antibiotics, prenatal vitamins, and probiotics. On 15Jan2021, the patient experienced elevated heart rate immediately after vaccine and shortness of breath with 90 minutes that's persisted on and off for 5 days so far. The patient received albuterol for the event. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID post vaccination. The patient recovered from the events with sequelae. The events were assessed as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.

A few days after the vaccination I begin having mild symptoms as if I had COVID so I went and got tested on 12/24 and was positive for covid. I was experiencing SOB so I had a virtual Urgent Care and was prescribed a weeks worth of Deckadron and antibiotic and all symptoms cleared up. I also experienced extended abdominal distenstion for an extended period of time.

felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.

5 Mins into the vaccine I started to feel a sensation to my tongue. 40Mins into the vaccine my heartrate as high 120-150 I started to get really dizzy, I had shortness of breath I felt like I was getting ready to faint . I started having getting cotton mouth(Dry mouth). 8 hours post vaccine I started the heart rate went down but I started feeling like I had something in my throat . the bumps on the back on my tongue was swollen. I took Zyrtec and Pepcid Blood pressure was high Glucose was high

red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient

Immediately after receiving vaccination, patient experienced tremors, tachycardia, shortness of breath. Within 30 minutes she had nausea, emesis and a strange feeling in her mouth/throat. Patient was monitored and did not require EpiPen. She was given Benadryl. She was recommended to not have a second injection due to immediate allergic reaction. She did

approx. 10 min post vaccine pt started to have elevated heart rate, dizziness, tingling in hands and feeling like her throat was "tight" and more difficult to swallow

Symptoms started with blurred vision within 30 minutes had full double vision , dysarthria and aphasia . Went to sleep, woke up 1 hour later bc I felt like I couldn?t breath. My arms and legs were very heavy felt close to paralyzed. I was able to move but movement was very ataxic and labored. Next morning the limb heaviness was gone, double vision was gone but had blurry vision for approx three days. Still having word finding difficulty, but mild.

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

40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.

Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.

Immediately after given vaccine - feeling of lump in throat. Unable to swallow, shortness of breath, rapid heart beat, flush feeling, intense shaking (especially in legs), pain in chest, lightheadedness, dizziness (ruled anxiety) and was monitored for 40 minutes. Was given orange juice and water and allowed to remove mask to catch breath. Almost everyday since this event, the same event keeps repeating it self (almost daily for 3 weeks). I am unable to control these episodes. Emergency department (ED) has been called and I have gone to see my nurse practitioner. Been trying to make an appointment with my doctor for this week. I have lost 5 pounds (down to 105 lbs. so I can't afford to loose more weight) since this first happened and I have also lost my appetite and unable to function normally.

Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: nothing Face swelling/redness/shortness of breath: Benadryl

lip and tongue swelling, subjective throat swelling, pruritis epi 0.5 mg IM, benadryl 50 mg IV, solu-medrol 60 mg IV, pepcid 20 mg IV

Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.

General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat

shortness of breath, chest tightness, throat fullness within 5 minutes of administration. With CPAP support (I use this at night for my autoimmune disease), I did not require intervention. Lasted 24 hours.

At approximately 0924 client reported feeling light headed and nauseated. She was hyperventilating and very anxious. She quickly became pale and fainted. At 0925 she was awoken using a cold pack to her face and chest. Her vital signs were taken and stable. She continued to feel anxious, her nausea went away. She still felt dizzy and her fingers were tingling, at approximately 0934 she felt it difficult to swallow and like something was "swollen/tight" in her throat. Lungs were clear, she was swallowing normally. At 0940 she felt her neck still "swollen", upon assessment her submandibular nodes were enlarged to palpation. Benadryl 25 mg orally x1 was given at 0945, vital signs remained stable. She began to feel better at approximately 10:00 am, she recovered and was able to ambulate. A co-worker took her home at 10:51 am.

Pt stated she currenty has a post nasal drip and she feels like her throat swelling comes and goes. Pt stated she just got very nervous and wanted to be checked out. Pt seen by EMS on site BP: 158/88, P:100, O2:99% on RA. Pt declined to go to hospital. EMS educated pt on signs and symtoms to report and go to the hospital. RN

Patient checked in for vaccine at 10:52am. During screening process, patient identified as needing additional monitoring (30 minutes) after vaccine administration. Patient received vaccine at approximately 11:00am, at which time she left vaccination site to observation site. Approximately 15 miniutes post vaccine administration, patient self-reported feeling of lightheadedness to RN at site. Doctor was informed and called over to assess patient, at which time he diverted patient to the 30 minute observation area and placed on Stryker bed.. During this period, patient continued to feel worsening of pre-syncopal type dizziness and developed parasthesias to bilateral arms and legs. VS at 11:35 am - BP 131/95; HR 82; RR 18; O2 sat 98%. Patient also endorsed some nausea, but did not vomit; negative abdominal pain. Patient did not present with any difficulty breathing, edema, urticaria, pruritis, or globus sensation. VS at 11:50am - BP 115/77; HR 72; RR 18; O2 sat 98%; patient seemed to be relatively comfortable. Clinically ,patient seemed to be improving, parasthesias resolving. Approximately 12:05pm, patient with complaint of increase dizziness, brief episode of chest pain, worsening parasthesias and exihibiting some difficulty breathing. VS at 12:07pm - BP 160/60; HR 90 12:10pm: EpiPen 0.3 mg adminstered to R thigh IM and 911 called. VS post Epi - BP 156/82; HR 151 EMS arrived at 12:15pm EMS started IV but had to wait for transfer due to social situation (2 children with patient). 12:39 pm, patient transported to Medical Center, with children, via EMS. Doctor spoke with ER physician. Patient was discharged at approximately 4:00pm after evaluated by ER physician.

About 9 hours after vaccine, developed body aches and rigors, low grade temp to ~100. Fatigued, so went to bed and took ibuprofen. Continued to have significant body aches and rigors. While lying in bed, developed nausea. I got up to go to the bathroom and woke up on the bathroom floor after a syncopal episode. I returned to bed bed and still felt very lightheaded and laid down. I had another brief syncopal episode while lying down. I felt short of breath and had chest tightness when I woke up. This was around 11pm. I was evaluated in the ED, where I continued to have body aches and rigors. I developed fever to 101 and was given Advil and Tylenol as well as IVF. Symptoms finally resolved. Had COVID test (which was negative), CBC, chemistries, EKG, chest x-ray, all of which were negative/normal. Continued to feel significantly fatigued for an additional 48 hours.

Fast onset of Tiredness occurred at 11:00pm until 11:00am.. Sore arm at injection site lasted for 4 days. Trouble breathing, felt like a weight on my chest and it was difficult to speak lasted for 90 minutes.

High blood pressure, tachycardia, difficulty breathing air, mental confusion, dizziness, nausea, asthenia, numbness arms hands and legs, couldn't move arms, flushing facial on neck and arms, hyporexia.. applied hydrocortisone and medication to reduce blood pressure.. I was hospitalized for 3 hours and they sent me home.. reoccurance 12 hours later but with greater intensity and I was hospitalized again.. I am the patient and I am a medical doctor..

Patient reported "my throat is closing up", then devoped generalized pruritis, more tightening and dyspnea. Epinephrine 0.3IM and EMS called. She refused transport. She called her primary care office who also urged her to go to ER 15 minutes later symptoms recurred along with anxiety EMS administered Epi IM, benedryl and solumedrol IV. She then refused transport again and departed. 10:22 - 114/81 P-111 02 98% 10:31 137/70, 102, 99% 10:40 130/80, 106. 98%

heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia; Anemic; lightheaded, foggy, kind of disconnected; lightheaded, foggy, kind of disconnected; chest got tight; hard time of breathing; chills and body aches; chills and body aches; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on Left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. It was reported that she was sick in October, she was exposed to COVID, but tested negative, she got sick. She got the vaccine on 21Jan2021, she started having about 4 hours after, chills and body aches, which is normal, then her heart started pounding out of chest, her chest got tight and she had a hard time of breathing. It lasted a couple minutes, the pounding of her heart, but it slowed down, it was fast but not as bad, and she took some Benadryl and after a half hour things settled down, her breathing went back to normal. She contacted her doctor who said to let him know if it happened again, and the next day (22Jan2021) she was kind of out of it, lightheaded, foggy, kind of disconnected, almost like a hangover feeling, just yucky and ran down, Saturday she was feeling a little better, then had 2 more episodes of heart pounding and continued shortness of breath. She ended up in the ER with tachycardia on23Jan2021. She is still having problems. In ER, they found out she was anemic on 23Jan2021.On 23Jan2021 they did bloodwork that day, she had an X-ray and EKG. EKG showed fast rate, normal rhythm, appeared to be no damage to heart. Her blood pressure was high and X-ray of lungs was clear, she had another X-ray this morning, since she developed a cough on 30Jan2021, a barky cough, is coughing up phlegm, Cough started on Saturday, this past Saturday, and is ongoing and worsening, it turned into a cough with a whistle into a barky cough, they are thinking it is connected to asthma response. She is supposed to have pulmonary function tests on the 19th and on the 15th, and endoscope and colonoscope due to anemia to ensure no bleed anywhere. They did another X-ray (on 04Feb2021) this morning and it was clear. They only thing they found is she is anemic, and her doctor is wondering if it is underlying asthma or long haul COVID or a combination of anemia and the shot kicked up stuff. It was reported that she had some asthma like symptoms, which were fully resolving, but kicked back up again since the shot. The events were considered as non-serious. The outcome of the event was chills and body aches was recovered, outcome of the event cough was not recovered and outcome of other events was unknown.

I began to feel very itchy all over my body within 30-60 minutes, I felt swollen in my hand, feet, tongue, my mouth and throat felt itchy, the itching got so bad that i had hives in some places such as my forearm and legs and skin just felt like it was on fire, I had issues breathing and felt as though someone was sitting on my chest, i have been shortness of breath since and have trouble catching my breath.. This was all that same night. The next day I had the same issues adding the sore arm of the injection site and feeling very tired all day. the next day from there am I am feeling better but am still experiencing shortness of breath, I am using my inhaler, I am still itchy but not as severe as the first night or next day. The arm tenderness has gone unless you touch the injection site and am no longer feeling over tired.

Within 2 to 3 minutes after the shot, I experienced swelling in my throat. My glands were sore. I was monitored for 30 minutes by the nurse and as the symptoms were not getting worse she suggested I drive home and take Benadryl. It was a 45 minute drive. Halfway home (about one hour after my shot) I started experiencing itching, swollen tongue, swollen lips. I took 62.5 mg of Children?s Benadryl and met up with my husband and he drove me to the ER, arriving at about 10;15. After being there about 15 minutes some of my symptoms started going away. At about 11 a rash appeared on my chest. The ER doctors gave me Pepcid 10 mg around 1130 or so. They just charge me and recommended I follow up with my allergy doctor.

Throat irritation like it was closing. HR elevated to 120-130. Clear airway with no wheezing, no stridor. Gave 25 mg Benadryl IM but then patient started coughing. Again checked airway, clear with normal lung sounds however with elevated heart rate, persistent coughing, called 911.

summons to vehicle for c/o. " slight throat tightness" She reports is most likely. R/T Anxiety. Resolved with removal of mask, fresh air & emotional support. BP 118/76 - P 55; 16 Resp unablored. Symptom resolved within 3 mins. time.

On the fourth day I began feeling a headache and weakness. On 5th day my symptoms increased to nausea , vomiting, headache, dizziness, weakness, fatigue, diarrhea, trouble breathing, rapid heart beat. These symptoms persisted for a few days. Then came on again on March 21, 2021. I have visited urgent care center and have tested negative for covid. I have been prescribed pain for headaches and nausea. My symptoms continue and persist as of now. I have missed work due to reactions.

Pfizer bio N Tech covid 19 Started with a slight cough then my throat felt like I couldn't swallow right. Then went to a persistent cough and got hard to swallow chest was tight. Went to the er and was given an epi in and 5 other meds through the iv. Also given a breathing treatment. They diagnosed me with an allergic reaction.

1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - First dose epinephrine administered with patient supply 1:45PM - Second dose epinephrine administered with patient supply 1:50PM - Third dose epinephrine administered with patient supply, EMS arrived, nasal cannula oxygen started 1:55PM - Fourth (PARTIAL... EMS did not remove locking mechanism, not certain how much patient received) dose epinephrine administered with store supply by EMS 2:00PM - Transported by EMS to Emergency Dept.

Throat stated to felt tight, lightheaded. Pt had COVID November 2020. More swollen under chin area and lymph nodes. Patient states her mouth feels dry.

Patient was brought to hospital. She complained of her throat being itchy and having a cough. In route her throat started to close and they administered Epi and IV Benadryl.

Worse asthma than usual for several hours, but not so bad that I had to use my rescue inhaler. At noon I had severe pain the entire length of my right arm, and I felt drowsy so I fell asleep for several hours and the pain in my arm was moderate and restricted to injection sight when I woke up. I went to bed at 10 pm and woke up at 1 am with diarrhea. I spent the the next hour having a few diarrhea bowel movements. On 3/20 my right arm was still in moderate pain and injection site was swollen and red. At 8 am I woke up with a headache and so I went back to bed. By afternoon I had the chills and went to bed for another nap and when I woke up the chills were gone. On 3/21 my right arm still had moderate pain. On 3/22 I had another bout of diarrhea for one bowel movement, and my arm pain was still moderate. On 3/23 the swelling and redness at the injection site went away but the area is still slightly tender to the touch on 3/25. On 3/25 at 1 am I was in bed trying to sleep, but I kept having intense dizzy spells that lasted 3-4 hours.

03.15.2021 1:40 vaccinated 1:55 left site, returned home ~3:00 began itch around waistband. Aleve for back. 3:30-4:00 symptoms undeniable: itch on neck, face, trunk, lips tingle/swell, lump in throat. Hoarse. No hives. 4:00 Claritin 4:30 talk to Dr take vitals (Sp02 100%, heartbeat normal, BP 131/79, pulse 67, temp normal) 5:15 Benadryl 5:30 itch spreads to whole body, including legs 6:30 talk to Dr Symptoms steady now. 7:30 fall asleep from Benadryl 8:30 wake up for dinner 9:30 laying in bed, breathing becomes shallow. O2 and bpm still normal. 10:00 Talk to Dr. Advises ER if vitals outside of norm. Report to PCP in am. 11:00 breathing normalizes. Sp02 and bpm normal, BP 122/82, pulse 70. Aleve before bed. midnight-1:00 fall asleep 03.16.2021 7:20 Wake up. Water, Wellbutrin, Aleve. Read in bed about an hour until fall back asleep. 11:15 Wake up. Headache. Sp02, bpm, temp, normal. Stay in bed. 12:25 Send report to Dr. 12:30 Get out of bed for first time; coffee, bathroom. Back to bed. 1:10 Spoke with triage nurse. Concern is that lips are still swollen at almost 24 hours. Recommends urgent care for steroids if increased lip/face or respiratory symptoms. Can take Claritin an hour early. 2:30 Get out of bed and shower. Warm to wash, cool to rinse. Got dressed, moved around. Increased itching, skin mottled; still no hives. Aleve. 3:00 Claritin, call from Dr nurse. 3:30 Heat up late lunch, continue to move around the house, answer work questions. 4:30 Upticked symptoms not abating, still mottled skin, lips more swollen. Harder to swallow and dry cough starts, worse when talking. Take vitals: Sp02 and bpm normal, BP 107/83, pulse 73 5:00 Leave for urgent care; BP there 159/71, pulse 79, temp normal. No steroids. Referral to allergy/immunology. Prescription H2 inhibitor, switch to Zyrtec in am. 6:40 Pepcid. Back in bed. 11:30 Benadryl, Aleve. 12:40 Sp02, bpm normal 1:15 Fall asleep 03.17.2021 8:55 Wake up. Water, Wellbutrin, Aleve. 9:30 Sp02, bpm normal. Get up for Pepcid, Zyrtec, bathroom then back in bed. 11:20-11:40 Dozed off, woken up by heart symptoms. Palpitations, panic feeling. Sp02, bpm normal 12:45 Dr called. Allowed to switch back to Claritin tomorrow. Recommends Benadryl more often. Allergy: 504.842.6742 Dr 3:00 Aleve. BP 117/80 pulse 75 4:15 Benadryl 8:20 Hoarse again 9:20 Pepcid. Itching increasing as Benadryl wears off. 10:20 Benadryl 10:30 BP 103/77, pulse 73. Sp02, bpm normal, PI 2.5% 11:45 Aleve 12:00 itching increasing as move around/get ready for bed 1:15 Fall asleep 12.18.2021 6:30 Benadryl. Tired, itch still present (improving), headache. Fell back asleep 7:30. 8:55 Water, Wellbutrin, Aleve, Claritin, Pepcid. Fell back asleep until 11:30 11:45 Sp02, bpm normal, PI 8.0 2:00 Finished shower, didn't worsen itch. 2:45 Aleve 6:00 Been "on" for work about 4 hours. Exhausted. Nauseated. Verge of collapse. Most itching is face/scalp and clothing seams. Lips almost normal though. 8:00 Meds definitely wearing off; face/lips symptoms increasing again. 8:30 Benadryl. Throat symptoms. Swollen lymph nodes. 9:15 Pepcid. Slight cough returned. 10:30 BP 120/85, pulse 80 (was just moving around quickly), Aleve. Itching better, throat/lymph nodes painful 12:45 Benadryl. Ibuprofen. Neck muscles hurt too. 1:15-1:30 fall asleep 03.19.2021 9:00 Water, Wellbutrin, Aleve. Throat still swollen. Itch primarily face/head, back of thighs. 9:15 Pepcid, Claritin. Sp02 normal, bpm low (51-53 back in bed), PI 4.1 3:15 Aleve. Lump in throat still impacts swallowing. Eating makes me hoarse. Neck muscles hurt. 11:00 Pepcid 12:15:Benadryl, Aleve. BP 109/76, pulse 69 2:30 fall asleep 03.20.2021 10:00 Water, Wellbutrin, Aleve. Lips swollen again. 10:15 Pepcid, Claritin 11:25 Symptoms: itching better, mostly gone from body (remains on head). Headache. Throat/neck improved. Lips still swollen. Sp02, bpm normal. PI 10.2% 6:00 Aleve. Itching only head/face. Throat/neck still symptomatic. 11:30 Aleve, Pepcid. Sp02 normal, bpm 70s. 12:15 Benadryl 1:20 Throat sore but no lump. Lymph nodes returning to normal. Still some itch head/face/neck. 1:45-2:00 fall asleep 03.21.2021 7:00 Claritin, back to sleep 11:00 Aleve, Pepcid, Wellbutrin. 5:00 Aleve 11:10 Pepcid, Benadryl. Mild itching. No lump. Throat still slightly sore. BP 113/77, pulse 69 12:20 Aleve 1:15-1:30 fall asleep 03.22.2021 9:45 Water, Wellbutrin, Aleve, Claritin, Pepcid 5:50 Aleve 10:00 Pepcid 12:15 Aleve. Minimal, occasional itching. Lips almost normal. Sp02 normal, bpm 70s 03.23.2021 9:45 Water, Wellbutrin, Aleve, Claritin, last Pepcid

Patient states she had a bad asthma attack, She became dizzy and heart rate was very elevated along with shortness of breath. She then came in and was treated, she is responding well to the steroids.

Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea. Given epinephrine, Benadryl and Zofram

Waves of various symptoms onset about 4 hours post vaccine. Exhaustion, headache, lung pain, achy, hot/cold flashes, arm pain?hot & not able to move it much

Anaphylaxis 40 y.o. female with multiple environmental allergies, migraines, asthma, mild OSA, and anxiety presents to the emergency department from the vaccine clinic with syncope and allergic reaction.She says shortly after getting her COVID-19 vaccine, she felt lightheaded, had near syncope. Per bystanders at the clinic, she had a brief episode of unresponsiveness and then spontaneously returned. She was conversant with multiple members of the code and rapid response team at the bedside. Did initially have some labored breathing but significantly improved. She had no vomiting but had mild nausea also significant improvement. In the field, IV was established and 125 mg of Solu-Medrol was administered. She was also given 1 IM dose of epinephrine. Her symptoms resolved she is at her baseline. Medically stable for discharge. Discharge home with short course of steroid, H2 blocker and Benadryl as needed. Advised patient to follow-up with PCP post discharge. Resume other home medicationS as listed. Of note, the patient had a similar reaction with influenza vaccine.

Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.

sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.

Patient received vaccine and within 5 minutes began feeling itchy all over and reported shortness of breath and reported throat was beginning to feel tight. Epi-Pen administered per RN at 1046. BP was 100/62 HR 70 bpm, oxygen saturation 99%. Nasal canula applied at 1048 due to decreasing oxygen saturation. Oxygen saturation promptly returned to 100%. Stat team called and responded, patient taken to ED at 1055 with resolving symptoms, decreased anxiety, and no shortness of breath with an oxygen saturation of 100%.

pt c/o wheezing, dyspnea, and flushing. She utilized her albuterol inhaler and took benadryl 50mg PO and improved within 10 minutes or so.- pt with hx of asthma, seasonal allergies and eczema

According to the patient, she experienced severe red and hot rash and hive all over her body. She had discomfort breathing and had to go to ER for treatment. She is currently taking loratadine and Benadryl to help treat the rash.

Coughing began about 20 minutes after shot was given. Wheezing began appx 5 minutes later at which point an Epi injection was provided. The Epi injection relieved symptoms. Transportation to ER via ambulance and subsequent monitoring and provided 4x puffs of albuterol inhaler. No further reaction was evident.

Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and EMT Called/Transported to Hospital Emergency Department.

2:33 pt coughing and states SOB. Taken to Triage 2. Pt used albuterol inhaler. Repeated dose as pt did not hold in and exhaled immediately. 2:43 pt states slightly dizzy. Dr. at beside with EMTs. BP 115/63 HR 97, 96% RA 2:51 BP 132/72 HR 85, 98% RA Pt states she is feeling better and ready to leave. Meeting friend. Stable for DC. Pt provided instructions when to return to ER or call 911. pt verbalized understanding and agreed. Pt also told if this becomes annual immunization she needs to notify her MD of previous experiences. Pt agreed.

Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling. Treated at home with 50 mg Benadryl every 6 hours, Pepcid, and Predinsonl (steroid pack).

Patient described a swollen tongue and senation in back of throat sensation. Onsite EMS was called vitals BP 128/60. Patient recovered and went home.

10 mins after injection, developed tingling in mouth and lips, tightening in throat, blotchy chest and neck. arrived to obs, 1830 bp 140/69 hr 95 rr 18 sats 96%, feeling hot. water and apple juice given, started feeling relief and blotchy neck and chest improving. 1838 bp 112/66 hr 97 rr 18 sats 95% on ra. 1847 bp 118/67 hr 67 rr 20 sats 99% on ra, blotchty areas resolved, and facial/mouth tingling resolved as well as throat tightness. escorted to exit with no further issues. instructed on benadryl once home.

Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.

After receiving vaccine, pt reported she began to feel as though her throat was closing up. Denies SOB, no wheezing noted upon auscultation. Pt given water before transfer to med obs #1. Pt arrived swallowing water without difficulty, but reported, "throat hurts" without further elaboration on quality of discomfort. VS at 0950: BP 154/83, HR 85, RR 17, O2 sat 99% on RA. VS at 1005: BP 152/99, rechecked BP 136/91, HR 87, RR 18, O2 sat 99% on RA. VS at 1015: BP 149/99, HR 86, RR 18, O2 sat 99% on RA. Pt recovered without further complaints. VSS at time of discharge to home. No s/s of distress noted at time of discharge. Pt escorted to exit.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: patient states night after recieving vaccine had sob and chest tightness \"like someone sitting on chest\" patient said harsh symptoms lasted 1.5 days but slowly felt better some lingering sob but patient does have astha. Almost went to ER but severity of symptoms she felt didnt prompt it yet but she was close to that feeling. Directed patient to consult with her pcp before second dose.

Flushed face and chest pressure at 09:34. Patient brought her own childrens oral Benadryl and took 40 mL as instructed by her doctor . At )9:53, patient stated her throat was getting tight and her tongue swelling so she received a epipen.

5 hours after injection - rapid heart rate increasing to 118bpm, dropping to 70bpm, increasing again to 120 bpm. Chest and lower throat tightness was felt. Continued this way for 2 hours. No other symptoms.

Patient developed temporal headache 5 minutes post vaccination, along with slight dizziness, dry mouth, and inability to catch a deep breath. Patient laid down to rest, had vitals checked. Patient was moved to a sitting position after 10 minutes, and stated that she felt better. She was given some water and monitored for another 10 minutes. Vital signs were rechecked and she was released.

SYMPTOMS BEGAN 40-45 MIN. POST VACCINATION AFTER LEAVING FACILITY. CLIENT REPORTS NUMBNESS/TINGLING BEGINNING IN LEFT ARM , PROGRESSING DOWN ENTIRE LEFT SIDE, UP RIGHT SIDE TO LEFT SIDE OF FACE AND HEAD, THEN DOWN RIGHT SIDE OF ENTIRE BODY , PROGRESS UP TRUNK. DIFFICULTY SWALLOWING DEVELOPED- "THROAT FELT SWOLLEN" NO DIFFICULTY BREATHING. NO HIVES OR OTHER RASH NOTED. NUMBNESS/TINGLING CONTINUES TODAY. THROAT SWELLING SLIGHTLY IMPROVED, CAN SWALLOW VERY SMALL BITES OF SOLIDS, AND LIQUIDS. LAST EVENING HAD CONTACTED PCP WHO ADVISED BENADRYL, WHICH SHE TOOK A DOSE 4/14/21 EVENING, AND AGAIN 4/15/2021 12:00PM. ONLY OTHER SYMPTONS VOICED IS MILD SITE TENDERNESS.

Patient is a 40 y.o. female who received the Pfizer lot # EW0158 on 4/15/2021. The patient experienced the following reaction(s) during the immediate of observation: 2:25pm Patient vaccinated. 2:46pm Patient c/o left sided "throat tightness and heaviness." Patient was treated/managed as follows: Patient alert and verbal. Denies shortness of breath or difficulty breathing. VS BP 100/60, HR 70, RR 18, O2 sat 99% on room air. Patient reports arthritis to area and receiving PT two days ago. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 2:59pm O2 sat 99% on room air. Patient reports feeling better. Escorted to car by son and RN.

Within a couple minutes of getting the shot, I could feel that my body was reacting. I started itching around my shoulder and chest area on the same side the shot was administered. Then my scalp and face stated itching. I decided to take two children's benadryl chewables (25 mg total) that I had in my purse. I notified the person watching us and he sent a supervisor to talk to me. I stayed about 45 minutes. They kept checking on me. I was itching all over and we all agreed that I needed more Benadryl but also that I shouldn't drive home after taking the full adult dose. I decided to go home and then take some more Benadryl once I got home. My throat was starting to get tight, but it wasn't awful. I took another 25 mg of Benadryl when I got home, for a total of 50 mg. After about 15 minutes, the itching went away. I had to lie down about 30 minutes later when the Benadryl made me sleepy. I didn't have any more serious issues after that.

Patient experienced back and abdominal pain, nausea 6 hours after the vaccination. As of 4-16-21 (8 days after the vaccination), patient still experienced chest / heart / abdominal pain, nausea and shortness of breath. Pain scale from 1-10, patient said she has level 6. Per patient, she is going to ER.

Within 15 minutes after vaccination "flushed with noted erythema of face/ant chest with complaints of itchiness of face/chest, with tachypnea, wheezing and reported sensation of throat swelling w/ shortness of breath."

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

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Severe

Approximately 3 to 4 minutes after receiving my first vaccine, I had a hot feeling travel from my toes up to my head. I then became dizzy and felt very faint. The tip of my tongue also became numb. I was too embarrassed to alert the hospital worker. The sensation lasted about a minute. However, the last 2 1/2 days I have been having a fast heart rate after doing minimal activities. I feel very winded by the slightest task. I did go to a clinic today to get my vitals checked. They were fine- but I still continue to feel like my heart rate spikes when I do something as minimal as emptying the dishwasher. It?s very scary and uncomfortable and makes me fearful of taking the second shot.

About 5 minutes after shot, while seated quietly, sudden onset of coughing and difficulty breathing. This is typical of my acute asthma symptoms. It worsened from a few coughs to uncontrollable coughing over about 2 minutes. Took two puffs of albuterol inhaler, coughing and breathing difficulty resolved over another 5 minutes. No further asthma symptoms in week since vaccination. It's unclear if the asthma attack was related to the vaccine. But I often go months without needing to use an inhaler, so timing is suspicious. My usual asthma triggers are environmental allergens (dust, cats), food (hazelnuts), or viral infection. I had been sick with a cold, but with no lingering asthma symptoms for 4 days prior to the vaccine. I also had more typical moderate side effect symptoms the next day (fatigue, sore arm, muscle aches).

pain in the midsternal region and in an area of the left side of her chest. Constant pain, unable to describe. she gets intermittent sharp/stabbing, burning pains in her chest. She has shortness of breath described as difficulty taking in a deep breath. She feels more fatigued than normal. She also complains of whole body tingling and feels like she's having "an out of body experience."

At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness. VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor. Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021. Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.

hives in throat (20 min post vaccine) 20 min-4 hours post vaccine shortness of breath body itching throat feeling constricted Sore throat continues as of today

Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports throat tightness, mild pain with swallowing (but able to swallow), flushing, and blotchy skin on forehead, cheeks, and neck after vaccination. Vital signs: blood pressure 146/93 mmHg (repeat 136/100 mmHg), pulse 74 beats per minute, oxygen saturation 98% on room air. Patient denies chest pain and shortness of breath. Administered oral diphenhydramine and left vaccination clinic stable with symptom improvement and drinking fluids without difficulty.

-LIMP ARM WITHIN 30 MINUTES OF VACCINATION -LEFT ARM, NECK, AND FACE SWELLING WITHING AN HOUR OF RECEIVING VACCINE - LASTED FOR 6 DAYS -UNABLE TO MOVE LEFT ARM, RAISE IT, OR LIFT ANYTHING FOR THE PAST 18 DAYS -UNABLE TO GRASP OBJECTS WITH LEFT ARM FOR THE PAST 18 DAYS -UNABLE TO SLEEP ON LEFT SIDE - CAUSES EXTREME PAIN -TINGLING AND NERVE SHOOTING PAIN ON LEFT ARM FROM FINGERS TO NECK, FRONT AND BACK CHEST LEFT SIDE -MUSCULAR NODULE DEVELOPED ON LEFT SHOULDER UP TO MY KNECK - CAUSING SEVERE EAR PAIN -EXTREME FATIGUE - LETHARGIC FOR THE PAST 18 DAYS -SEVERE JOINT/PAINT THROUGH OUT ENTIRE BODY -LOST OF TASTE -NIGHTSWEATS FOR PAST 18 DAYS -FEVERS RANGING BETWEEN 99.0 - 103 F FOR PAST 18 DAYS -NAUSE FOR PAST 18 DAYS -LOST OF APPETITE -DIARRHEA AND LOOSE STOOLS FOR THE PAST 8 DAYS (NO BLOOD) -BRAIN FEELS FOGGY ALL THE TIME - FEELING AS IN A DAZE FOR PAST 18 DAYS -SHORTNESS OF BREATH - JUST FROM WALKING OR MOVING AROUND -SKIN IS SUPER SENSITIVE AND ITCHY -UNABLE TO DRIVE BECAUSE OF THE FATIGUE AND UNABLE TO USE LEFT ARM. -UNABLE TO WORK - RELYING ON OTHERS TO TAKE CARE OF ME.

Patient received first dose of COVID vaccine today, appointment time 1430, received first dose vaccine at 1433. After receiving vaccine, patient sat in observation area and reported her voice "going away" sharing that with other allergies her voice often softens and she has a hard time communicating. No signs of shortness of breath, respirations even and not labored, oxygen sat at 100%, pulse 102, BP 112/66. Face flushed. Administered 1ml of benadryl IM, 50 mg total. Patient still expressing difficulties verbalizing and now stating a small feeling of tightness in her throat, face continued to be flushed. Administered epi pen to left thigh. Called 911. BP 110/60, 109, 100%. Gave report to ED RN and to paramedic responding. Patient then transferred to ED with paramedic assist. At time of transfer, patient reporting improvement with ability to communicate via voice, face less flushed and improved tightness in her throat.

throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.

Asthma like symptoms: Shortness of breath, dry cough, lung irritation, chest tightness, reduced exercise tolerance. Levalbuterol inhaler sometimes helped, but not consistently. After about a week, I saw my primary care physician (assuming it was seasonal allergies). I began taking Singulair. A few days later, I added Zyrtec, and had a chest x-ray. Over the next few days I started to improve and was feeling better by 2 weeks post vaccination. I received my second dose (Pfizer EU0120, left arm, same location) on 4/19/2021. The day after, I felt feverish and tired as expected and slept most of the day. On the 20th, the same respiratory symptoms as described above reappeared at their previous intensity. At the advice of my doctor, I am continuing the Singulair and Zyrtec, and monitoring symptoms. I have not yet recovered. Note: I have no previous history of asthma

From 10pm on Monday 5 April until the morning of Wednesday 7 April (approximately 33 hours) I had a severe reaction to the second dose of the vaccine. The night of 5 April I had extreme chills, uncontrollable teeth chattering, and freezing sweats. I had sharp shooting pains in my feet, legs, hands, and arms that lasted 24 hours. I also had sharp shooting pains in the back of my head and then it began in my ears. When moving my head for the next full day I experienced extremely sharp pain in one or the other ear. Sometimes the pain returned in my arms. I had tightness in my chest, shallow breathing, and extreme fatigue but also could not sleep due to the pains and the sharp ear pains when turning my head. I had a fever from 100-101 degrees from the first night and still had 101 at 10pm on 6 April (24 hours later). That night I took a Motrin due to the sharp ear pains. (The first night I had only taken Tylenol.) Throughout the second night, I woke up many times drenched in sweat and upon waking up on the following morning, my fever had broken. Throughout day 3 (Wednesday 6 April), I still had tightness in my chest, shallow breathing, and periodic sharp ear pain when moving my head but my fatigue, chills, and fever had subsided.

anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.

At approximately 1655 hours a 40 y/o WF c/o to Np a that she was having difficult breathing and feeling sweaty. NP immediately evaluated patient with assistant for the EMs. Benadryl 50mg ordered, Iv NS started and call 911. At approximately 1724 hours ambulance arrived and evaluated patient. After evaluation client was transported to hospital @1730 hours

Within 3-5 minutes of receiving the vaccine, patient starting complaining of difficulty breathing that quickly progressed to the inability to speak. Patient noted to have some airway inflammation and very large adenoids. Within another minute she started to lose consciousness. Epinephrine 0.3 mg IM was administered via EpiPen alonge with Diphenhydramine 50 mg IM. Patient responded within 1 minute and improved to the point of speaking freely, drinking water, and reporting full recovery. Patient was moved to the Emergency Department for additional monitoring and treatment where she received methylprednisolone and famotidine. Patient was discharged home later that day. Patient reports full recovery and willingness to receive the booster dose. A second dose, using Janssen vaccine is planned. Patient also now reports that she had a previous similar reaction to receiving a Vitamin B12 injection.

Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back. Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.

weird feeling, itchy all over mostly arms. increased phelgm with throat / tongue/ swelling; anxious.

Per pt, she received a covid-19 pfizer vaccine at middle school on 4/14/21. Pt c/o fever(104F) and slight pain in lower lungs. Had a UC visit with MD on 4/16/21 during which symptoms had resolved. Pt advised to follow-up or go to ED if symptoms return..

Full body aches and pain in both the joints and muscles. Headache, fatigue, easily out of breath. These started the day after and went away the next day. Day after injection saw blood in urine. Has not gone away.

Shallow breathing, 9am-1pm Fever of 102, 9am-3am (next day) Chills/sweating 9pm day of shot- 3am today Headache whole time since shot Body aches whole tome

general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Physician reported for a consumer (patient). A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiry date was not reported) intramuscular at left arm on 25Feb2021 at 09:30 am (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Medical history included HTN. The patient had known allergies to Penicillin and vancomycin. Concomitant medication patient received within 2 weeks of vaccination included duloxetine (DULOXETINE), gabapentin (NEURONTIN), verapamil (VERAPAMIL) and naproxen (NAPROXEN). The patient received shot and shortly after on 25Feb2021 at 09:45 am, the patient felt general itchiness and throat tightening and dizziness. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Epinephrine x2 steroids, Benadryl, famotidine now sxs improved. The reporter evaluated the patient in the emergency room. The outcome of all the events was recovering.

Headache stomach issues and arm pain Thursday chest pain and shortness of breathe went to the er had blood clots

About 5 minutes after the shot I felt pain in the area where they put the shot. About 15 minutes later I started to feel disoriented, lightheaded and felt like I was going to lose consciousness and I felt my heart racing. When they took my blood pressure it was 148/80. Then I started to have difficulty breathing. They took me to the ER in the same facility but the symptoms had resolved I believe because I drank plenty of water while I had the symptoms.

I received my shot at approximately 12:25. Within 5 minutes of my shot I started to feel a bit light headed, hot, having difficulty breathing with my mask on (so I pulled my mask down which helped) and then my heart started racing! After grabbing the attention of the nurses, drinking some water and doing some calming breathing exercises my heart rate went down but not to resting. Upon further investigation through my Apple Watch Heart App, my heart rate had spiked to 141 within those first 5-7 mins of the vaccine. Monitoring myself closely over the next couple of days, my heart rate would have little spikes randomly. I?d be sitting (should be at resting heart rate of 65-70) and I?d spike into the 90?s or 80?s for a few moments then return. The first day it happened about every 20-30 minutes for 3 hours, then tapered off to once every hour or so then the next day every hour or two. By Monday April 26th I felt completely normal and have had no other concerns at this time.

blood clots in left lung which turned into an infarction; blood clots in left lung which turned into an infarction; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration, administered on the left arm on 15Jan2021 (at the age of 40-year-old) at a single dose for COVID-19 immunisation. Medical history included lupus. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). The patient had blood clots in left lung which turned into an infarction on 22Feb2021. The event resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 3 days. Therapeutic measures were taken as a result of the events which included blood thinners and anti-inflammatory meds. COVID test post vaccination on 03Mar2021 Nasal Swab: Negative. Patient was not pregnant. 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. Outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely fo rBNT162B2 since there is no plausible mechanism implicating the subject drug to the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Severe flu like symptoms. Body hurts to even touch from head to toes, uncontrollable shaking/shivering, freezing hold or suffocating hot, eyeballs keep loosing focus, feeling like I'm having a anxiety or panic attack, short of breath. First day I felt fine, next day I woke up feeling like I was hit by a car and second day after I'm feeling all the symptoms listed above on a scale of 1-10 I'm at a 10 for discomfort

PATIENT HAD SHORTNESS OF BREATH FOR THE PAST 2-3 WEEKS DIAGNOSED WITH PULMONARY EMBOLISM AND PLEURAL EFFUSION

Pt received 2nd dose of Pfizer CIOVID-19 vaccine today, 5/12/2021 and within 5 minutes reports lip and face swelling and throat tightness. Pt denied any reactions from 1st dose of Pfizer COVID-19 vaccine, but report she has idiopathic anaphylaxis, an autoimmune disorder, chronic hives, asthma and she has anaphylactic episodes about once a month. Pt given 2 epi pen autoinjections in thigh in office prior to EMS arrival. Pt was transported in stable condition to Hospital ER via EMS for further evaluation and monitoring.

I walked down a very short flight of stairs to take laundry out of the dryer. My heart started racing and I began to sweat uncontrollably. My hands and feet became clammy. I became very hot and thirsty and distressed. My hands and feet were very clammy and I had to sit down and take deep breaths. I drank two water bottles of water and poured some on me to cool off. My breathing was compromised and I was taking gulps of air. I became slower in movement and responses and too disoriented to drive. I asked my boyfriend to give me a ride to the ER. I went through intake and was later given an EKG, IV for bloodwork and Chest X-ray. Symptoms: Nausea, palpitations, heart racing, muscle aches, chills, sudden sweating, clammy hands and feet, extreme thirst, difficulty breathing, slowed responses, slowed speech, burning tingling from top of neck down to left arm.

Patient initially experience dizziness, increased heart rate, and rapid breathing, then patient temporarily loss consciousness for less than 30 seconds. One dose of Epipen was immediately given. After giving patient the epipen, she remain lying down on the floor for a few minutes until she is capable of sitting up on a chair. She was fine after a few minutes, but the patient stayed at the pharmacy for at least another 20 minutes for monitoring. She left after she felt no other symptoms.

difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phone; feels like she is coming down with a respiratory illness; nausea; vomiting; cough; sweating; headache; body pain, achy and uncomfortable; body pain, achy and uncomfortable; overall feeling badly; cognition was not there; Problems with breathing; aspirating; sleepiness; fatigue; stomach pain; her nerve response is strong/affected; swelling in hands and feet; had arm soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the left arm, on 23Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing neuropathy (few years ago, at least since 2015 or 2016), seizures or epilepsy (had focal/absence seizures since a kid; not on any seizure medication, do have a neurologist), hard time with her vision, cancer from an unspecified date to an unspecified date (cancer as a teenager but has been cancer-free for a very long time), and glaucoma. The patient had a family history of cancer and heart problem. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN) taken for glaucoma from Apr2021 and ongoing and gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER8730), intramuscularly in the left arm, on 02Apr2021 for COVID-19 immunisation and experienced not very many side effects with first dose, not enough to be a problem; influenza vaccine (MANUFACTURER UNKNOWN) in 2021 (maybe) for immunisation; and polio vaccine (MANUFACTURER UNKNOWN) as a child for immunisation and experienced severe pain in her legs and she had trouble walking because of pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced difficulty walking and difficulty with speech / slurred speech on 23Apr2021, which required hospitalization from Apr2021 to 26Apr2021. The patient also experienced body pain, achy and uncomfortable, overall feeling badly, cognition was not there, and problems with breathing on 23Apr2021; sweating and headache on 26Apr2021; vomiting and cough on 27Apr2021; feels like she is coming down with a respiratory illness and nausea on 28Apr2021; sleepiness, fatigue, stomach pain, her nerve response is strong/affected, swelling in hands and feet, aspirating, and had arm soreness in Apr2021; and fingers are going numb holding the phone on 29Apr2021. The clinical course was reported as follows: The patient stated that she works in healthcare support and she is a first responder; she identifies as a person with a disability (unspecified). She stated that she did not have very many side effects with first dose, not enough to be a problem. By dinnertime, closer to 18:00-19:00 on 23Apr2021, she started experiencing difficulty walking and with her speech. She was concerned about having a stroke but that she is active and generally healthy. This was unusual for her and she started feeling pain through her body and overall feeling like crap. She did not expect the neurological stuff. By the end of the night on 23Apr2021, she realized she was not feeling good and went to the hospital either that night on 23Apr2021 or early the next day on 24Apr2021 and was admitted to the hospital. The patient stated that her cognition was not there, and her speech was kind of slurry, she felt like everything was slowing, and did not feel like herself. She could not get up unassisted, could not get up out of the bed, chair, or go to bathroom, and still requires the use of a walker and bedside commode, but now with the walker and assistance caller can make it to the bathroom. She also had problems with breathing, but she had a negative COVID-19 PCR test in Apr2021 both arriving to and leaving from the hospital; she did not believe them to be COVID-19 symptoms. At the hospital they did an x-ray or computerized tomography (CT) scan and a magnetic resonance imaging (MRI) on her brain in Apr2021 with unknown results. They gave her 3 or 4 intravenous (IV) unspecified medications and she had her complete blood count (CBC) labs done in Apr2021 with unknown results. There was an issue with her lungs, and she is currently waiting for her doctor to read report to see if there is an issue there. The patient stated that she never experienced anything like this after a vaccine. She cannot even get up and move around it is pretty serious. Caller states that at first when she had the symptoms, she thought she was going to wait it out, maybe her immune system is overresponding, give it a chance to resolve. She reported that she could not stand up, legs were shaking and that she had pain that was from her breasts down; felt like a ton of bricks. The patient stated that she is cognitively alert now, speaking normal. There are times it goes in waves where she feels like she can walk with walker but then a few hours later that is not the case. On Tuesday, 27Apr2021 night, the patient had a light dinner but then she was vomiting. Caller states that the pain was throughout her body and felt like someone lighting firecrackers. The patient initially stated 28Apr2021 was when the cough started, but later clarified she first noticed it on 27Apr2021, but at that time she was vomiting and thought it was due to that. However, the next day 28Apr2021, she still had this cough and that the cough was getting worse. She felt like she has a respiratory issue and has been coughing. She was not able to stay awake, even without taking any medications. She does take medications regularly but did not take the medications those days and not having medications would not cause sleepiness. She thought the doctor gave her sedative, but they did not. She states she had fatigue to the point where she was dead asleep, and nurse would come in to take vitals or do whatever and she would wake up suddenly with someone in front of her. She was sitting up with the nurse trying to read the discharge instructions and she fell asleep sitting up. She also complained of stomach pain. The patient had not been to work and not been having to use her brain and talking like she would for 8+ hours a day. She stated that the cough hurts, it feels like somebody is lighting firecrackers in her body. It also feels like this when she sneezes; the nerve response is strong. She reported that it is not a constant hacking cough, not really a dry cough; the cough is in-between productive and dry cough and cough is a bit better now and worse towards the evening. She still has swelling in her feet and hands. It looks like it has gone down a bit. She has a history of neuropathy and that her fingers are going numb holding the phone now. She got the shot in her left arm and those fingers are going numb. She was so tired and feels like did not get enough sleep. The fatigue had a slight improvement. She is more awake than when she was in the hospital. However, it depends as the day goes on, she is wiped out and has to go lay down. She stated that her nerve response is affected, and she had a difficult time with the neuro exam in Apr2021 with unknown results in the hospital. She was having an issue with her arms. She can't say anything about whether it affected her vision because she already has a hard time with her vision. She stated that she was throwing up pretty bad; the pain was really severe through her whole body while vomiting. After the vomiting stopped, the coughing got worse and she was coughing a little bit before the vomiting, but during the vomiting it was to the point she felt like she was drowning. She reported that she was vomiting through her nose and aspirating. After her MRI she started to get a really bad headache. Then when the nurse was coming to read the discharge information, she started to get sweats. She is not menopausal so she cannot blame the sweating on menopause, as reported. The patient also had arm soreness, but does not care about that long as it does not leave any scars. This was not a big deal for her at all. This started shortly after getting the vaccine. She waited for the observation time and no sensation out of the normal, then later towards the night started feeling like having really bad mensural cramps, like an achy feeling where have to go lie down. Then her lower half started to get worse. Her arms were affected and difficult time with the neuro testing. The patient stated she is now on the road to recovery. The clinical outcome of difficulty walking, difficulty with speech / slurred speech, body pain, achy and uncomfortable, nausea, sleepiness, fatigue, and stomach pain was recovering and of overall feeling badly, cognition was not there, problems with breathing, sweating, headache, vomiting, cough, feels like she is coming down with a respiratory illness, her nerve response is strong/affected, swelling in hands and feet, aspirating, had arm soreness, and fingers are going numb holding the phone was unknown.

high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation. Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.

- Swelling of the throat. - Trouble breathing. -Confused. Emergency Room: 4/17/2021 6:52:00 PM Hospital - Attending Physician: Medications Given in the ED: 4/17 8:21 pm EPINEPHrine 0.3 mg IM 4/17 8:22 pm methylPREDNISolone 125 mg IV Push 4/17 8:22 pm famotidine 20 mg IV Push After receiving this emergency care I felt I could breathe again but had many palpitations. New prescriptions provided at the time of service New Prescriptions: BENADRYL 25 MG ORAL CAPSULE 1 CAP BY MOUTH 2 TIMES A DAY; AS NEEDED FOR FOR ITCHING FOR 3 DAYS; Dispense: 6 CAP(S); Refills: 0; Prescription FAMOTIDINE 20 MG ORAL TABLET 1 TAB BY MOUTH 2 TIMES A DAY FOR 3 DAYS; Dispense: 6 TAB(S); Refills: 0; Prescription Electronically Submitted to PREDNISONE 50 MG ORAL TABLET 1 TAB BY MOUTH ONCE A DAY FOR 3 DAYS; Dispense: 3 TAB(S); Refills: 0; Prescription Electronically Submitted to The treatment gave me palpitations and exhausted me. It took me 4 weeks to recover my full mobility but it is still difficult to move, lift weights or perform at work and in daily life as before the vaccine. I feel a lot of fatigue after this experience.

tightening in her throat area; hard to swallow; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at 40 years old) (Batch/Lot Number: EN6205) as 1st dose, single for covid-19 immunisation. Medical history included allergy to shellfish from an unknown date. The patient had no concomitant medications. After first shot, patient felt tightening in her throat area for a short period where it was kind of hard to swallow and she took a Benadryl and it went away. The outcome of the events was recovered. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Administered Vaccines. No AE(s) required a visit to Emergency Room or Physician Office. No Prior Vaccinations (within 4 weeks). No AEs following prior vaccinations.

Throat tightening & pain with swallowing, itching, irritable/aggitated, hot. Purposefully tried to avoid EPI this time. Took oral hydroxyzine and decade in. Waited 1hr in observation. No changes, willing to send me home.Developed vomiting & diarrhea in the night, still itchy, throat still hurts.

Tightening in her throat area; Hard to swallow; Felt tightening in her throat area/hard to swallow/after the second dose it came on later and lasted longer and was more intense; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EB8737; Expiration date was not reported) on the left arm on 09Apr2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). Medical history included shellfish allergy. The patient had no concomitant medications. The patient had previously receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205; Expiration date was not reported) on the left arm on 19Mar2021 (when the patient was 40 years old) for COVID-19 immunization, and had felt tightening in her throat area and hard to swallow. On 09Apr2021, after the second dose of vaccination, the patient also had felt tightening in her throat area and hard to swallow; but it came on later and lasted longer, and was more intense. The events were reported to be serious (medically signficant). The patient had received diphenhydramine (BENADRYL) as treatment for the events. The outcome of the events was recovered on 09Apr2021. Information on lot/batch number was available. Additional information has been requested.

about 1 hour after receiving vaccine had swelling in throat resolved on own in 15 minutes. then 7 hours later returned with difficulty swallowing and breathing. started wheezing, felt light headed and dizzy, took epi injection.

Two weeks after the first Pfizer shot, I experienced labored breathing, congestion, fluid around my heart and left side numbness and stabbing head pain.

Patient felt throat closing, she had a very hard time breathing. She was dizzy, almost couldn't stand, she was coughing non stop (barking cough).

shortness of breath 5 minutes later; Coughing after 20 minutes; Wheezing; This is a spontaneous report received from a contactable consumer or other non hcp. A 40-yearsold non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: er8733), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (at the age of 40-year-old) 04:15 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history included asthma, familial medullary thyroid cancer, migraine. The patient had allergies to Penicillin, Cephalosporins, Azithromycin, Pineapple, Cinnamon, various grasses & trees. Concomitant medication included levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONINE SODIUM), fexofenadine hydrochloride (ALLEGRA) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. The patient experienced coughing after 20 minutes, wheezing and shortness of breath 5 minutes later on 23Mar2021. Patient received treatment for the events with Epi injection. 4x puffs of albuterol inhaler. No further reaction. The outcome of events was recovering. Follow-up (13May2021): Follow-up attempts completed. No further information expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient stated prior to vaccine that she had itching and throat tightness after her first Pfizer vaccine from Pharmacy. It was resolved by PO Benadryl. Patient took 25 mg Benadryl PO prior to receiving 2nd Pfizer vaccine. After vaccine, patient reported throat tightness, mouth tingling, and shortness of breath. Epipen 0.3mg SubQ was administered. Patient taken to ER. Given methylprednisolone 125mg x 1 before discharge from ED with prednisone prescription.

breathing difficulties/shortness of breath that worsens with any activity; soreness/body aches; slight fever; intense headache; Dry cough; feel dizzy; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration in left arm on 12May2021 13:45 at age of 40-year-old at single dose for COVID-19 immunisation. Medical history included ongoing asthma, chronic migraine, known allergies: sulfa drugs, COVID-19 in Mar2020 (COVID test positive in Mar2021, confirmed by antibodies in May2020). Concomitant medications included nortriptyline, tizanidine, propranolol (PROPANOLOL) and zolpidem (ZOLPIDEM), all taken for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 21Apr2021 13:45 at age of 40-year-old for COVID-19 immunisation. The patient had injection site pain with the first dose that cleared within a day. The second dose was when things became complicated. She had soreness, body aches, slight fever, and an intense headache as expected, but also, she experienced the same breathing difficulties she had when she had COVID. Dry cough and shortness of breath that worsens with any activity. She had preexisting asthma. It is not as bad as the shortness of breath she had with COVID, but it was similar (and different than her asthma symptoms - she didn't feel chest tightness, but she feel dizzy as if she was not getting oxygen when she move). She hadn't seen her primary care provider because it's not so bad that she needs medical attention, but she did want to report the adverse event since it's not a symptom she was warned about. The events onset date was reported as 13May2021 16:00. Treatment for the event (breathing difficulties/shortness of breath that worsens with any activity) included used albuterol rescue inhaler. The patient had not test COVID post vaccination. The outcome of the events was not recovered. The report considered non-serious. Information on lot/batch number has been requested.

I had the typical sore arm after the short for approximately 72 hours. The worst of it, the first 24. I did get some intense diarrhea as well for a few days but as I'm near my period, I haven't any idea if it's due to that. On the 27th of May in the evening, I noticed my lymph nodes visibly swollen out of nowhere by my clavicle and they were incredibly painful to palpate. Upon going to the ER they noted that my lymph nodes in my throat were also swollen but not painful. This being a new thing to me, I called the nurse line who advised me to go to the ER. The ER said I didn't have cancer (not helpful) and would not talk about any side effects. I got a Covid test (negative). They sent me home and told me if I have issues breathing or anything, to return. 5/28 I started developing some nausea, congestion, headache, and fatigue, and I have lacked appetite all day. Around 6 pm I developed, so far, one hive on my abdomen.

Onset of severe nausea followed by difficulty breathing, uncontrollable incessant dry heaving and coughing, spasms, full body shaking, full body tremors, inability to speak, seizure like reaction, dizziness, tingling in tongue,

On 5/28/2021 I started to develop shortness of breath. It continued to worsen and I went to the hospital on 5/30/2021 and it was discovered that I had a pulmonary embolism and after additional ultrasounds 3 DVT blood clots in my right leg.

April 15- second Covid shot April 22 - first big vertigo spell. Deafness then ringing in right ear April 23 - mild ringing in both ears and thumping, pressure in head May 4th - very noticeable ticking in right ear May 9th - felt sick, off, hard to take a deep breath, pounding head, fullness in ears, ringing, emotional May 11th - ENT visit. Ears clear, hearing fine May 18th - May 23- off and on headaches, difficulty breathing May 24th - Headache that didn?t go away with medicine. Fullness in ear. Nausea May 25th - Sleepless night, stiff neck, very full head. Medicine providing no relief(Excedrin, Sudafed, Flexeril) can feel fast heartbeat, ringing, and pulsation in ears, stiff jaw May 26-28 - light head congestion May 29- headache returns May 30- head congested even after Sudafed. Ears feel ?wet? hard to take a deep breath, lots of yawning. Flushed face and blotchiness on neck. May 31 - Difficulty breathing, ringing in both ears

I woke up on the 4/13/2021 with hives all over my body I did not know what it was I had no pain at injection site I felt fine I went about my business the next day I felt like there were ants crawling under my skin by Thursday the feeling of heat kept rising in my skin i would look and it would be hives the following the bloody noses began every three days i get nose bleeds. the hives has gotten worse I am now taking 6 Benadryl's a day just to avoid itching my skin off I went to medical facility where i received 2 steroid injections. The dr does not know what to do, I had to go to the hospital to cauterize the inside of my nose they could not figure out the cause. I had a stroke back in Oct and I thought maybe something was going on but the Dr said it was not associated. Ever since I received the shot I have not been the same. Right before the hives appear, it feels like the stinging burning feeling right after someone slaps your skin. This lasts for 30 seconds. My skin is dark but my skin turns red with the hives. They gave me Zofran for the nausea, they also gave me a nose pincher thing that I use when I have nosebleeds. Also, I thought it was allergies but I have congestion that have no diagnosis. It is hard to breathe. I feel like I have Covid but I do not. The doctors say I have insomnia, I have headaches due to the congestion. I also feel tired. I have dizziness that feels like I am on a merry go round that I can't get off. Walking up stairs exhausts me which is unusual because I am a physically fit individual. I have had to take a lot of days off from work due to these side effects. Taking as many Benadryl's as I do causes drowsiness and I am a single mother of 4, I cannot be drowsy.

wheezing; stridor; breathing difficulties; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 16Apr2021 09:30 (Lot Number: EW0169) at the age of 40-year-old, as 2nd dose, single for covid-19 immunisation. Medical history included asthma (Was diagnosed with this when the caller was 2 years old, 38 years ago), familial medullary thyroid cancer (The caller was diagnosed with this 30 years ago). Historical vaccine included first dose of bnt162b2 (lot: ER8733, Route of administration: left arm, appointment time was 1615) on 23Mar2021 and the patient had breathing difficulties, wheezing and coughing. Concomitant medication included salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. The patient had breathing difficulties after the second dose Pfizer Covid 19 Vaccine: After receiving the second dose Pfizer Covid 19 Vaccine the patient stated roughly the same thing that happened after the first dose Pfizer Covid 19 Vaccine occurred, but it occurred a lot faster. The patient clarified she had breathing difficulties after the second dose Pfizer Covid 19 Vaccine. She had stridor and wheezing and was also injected with an epi pen in the ambulance and they put the patient on other drugs. The breathing difficulties began 15 minutes after the patient received the second dose Pfizer Covid 19 Vaccine. The patient stated the breathing difficulties were not ongoing now. The breathing difficulties subsided mostly, patient not 100% certain, but after the patient was given Benadryl in the ambulance. The patient started to feel better and was given O2 and albuterol through a mask. The patient stated the effects after receiving the second dose Pfizer Covid 19 Vaccine were much worse. The patient was not 100% certain this has gone away. The patient was using her inhaler significantly more often after this occurred. The patient was discharged from the emergency room on both occasions. The outcome of breathing difficulties was recovered, of wheezing and stridor was unknown.

violently vomiting; nauseous; losing weight; my labs are a mess; losing hair; short of breath; dizzy; I have never felt so awful for so long.; can barely eat; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 16Mar2021 09:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included Lupus, Postural orthostatic tachycardia syndrome (POTS), depression, Axial Spondyloarthritis, Degenerative Disc Disease. Concomitant medications included unspecified medications, the patient was on quite a few, she didn't fit. The patient's known allergies Ambient, augmentin, doxycycline (not anaphylaxis). No other vaccine in four weeks. Vaccine 16Mar2021, day after she started violently vomiting. She had vomited al-most every day since, she was nauseous 24/7, she can barely eat so she was losing weight and her labs were a mess, she had to get IV Iron yesterday (19May2021), and she had a ton other GI tests coming up. She was losing hair, I'm getting barely any nutrients. She was now short of breath and dizzy too. She had never felt so awful for so long. Adverse event start date was 17Mar2021. Adverse event start time was 07:00 AM. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included intravenous Iron, tried different medicine, lots of appts. No covid prior vaccination. No covid tested post vaccination. The adverse events did not result in death, did not cause/prolong hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. All events considered as serious due to being medically significant. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Neuropathy initially in right arm, then subsided after two days. Neuropathy/tingling of fingers and toes returned with increasing sensation on May 21, 2021. On friday May 28, 2021 lips are now tingling and more feeling of full body tingling and weakness followed by close to fainting spells. Sunday night worst headache of life, followed by chills, almost fainted, went to ER and all tests normal. Neuropathy has not left. Sent home with no answers. Wednesday June 2, 2021 tingling of hands, feet and lips more extreme followed by moments of shortness of breath and fainting. Went back to ER all vitals normal. Two days later I have missed two days of work because my body is so weak and the nreopathy remains. Please help. I cannot continue to live with these symptoms. I had zero health issues leading up to this and all of the dr's are stumped.

6 days after second covid vaccine developed bronchospasm, body aches, difficulty breathing, short of breath, diarrhea, pleuritic chest pain

Chest pain, from time to time difficulty breathing , from time to time pain the heart area every 30 sec.

Pt reported difficulty breathing, swelling of face and throat, dizziness and weakness, pain, swelling and redness at injection site, sore throat, swollen lymph nodes, pain/tightness in chest, shortness of breath, headache, body aches, muscle aches, upset stomach, nausea, brain fog, fatigue, dizziness, and vertigo for six days after vaccination.

In march, I had a prescription to take Macrobid as a preventative for a UTI. I had taken it in the past with no problems. I took it on Saturday evening and in the morning I had a really bad cough, shortness of breath, body aches, fever. I had to call in sick to work, The next day on Monday, I felt completely better, I felt like I hadn't been sick at all. I took Macrobid again on the 16th of march and the same thing happened, I woke up the next morning on the 17th with shortness of breath and body aches this time was worse than the first. By the 18th I felt mostly back to normal. I was tested for Covid which came back negative on the 18th. My doctors said over the phone could have been an acute reaction to the Macrobid.

severe chest tightness, pain, and shortness of breath lasting 6 weeks this has gradually improved over time but did not occur in conjunction with any other illness or respirator condition.

Asthma; Oxygen was 89; Shortness of breath/breathing difficulties; Ribs hurt; Felt like she was coming down with the flu; Head and sinus congestion; Head and sinus congestion; Throat was on fire, it hurt so bad; Throat was on fire, it hurt so bad; Seizure; Kind of achy/achy feeling; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 22May2021 10:45 (at the age of 40 years old) as 1st dose, single for COVID-19 immunization, at a pharmacy. Medical history included epilepsy from an unknown date and unknown if ongoing (seizure free for two years; diagnosed in 2009 or 2010). Concomitant medications were not reported. On 23May2021, the patient was having breathing difficulties and had to go the emergency room (ER). The patient reported she went to the ER Monday, 24May2021 and was released 11 hours later. She also stated that on Sunday morning on 23May2021, she woke up at 0400 AM and her throat was on fire, it hurt so bad. This was Sunday at 0400, and her husband heard her, and they walked around the house, she had her hands over head, like when running and her ribs hurt. She raised her arms, and tried to take deep breaths, and it was working, to breathe, but it felt like she couldn't breathe, she couldn't catch her breath. She stated she went to work and in 1.5 hours came home, she called the pharmacy and said she can't breathe, then she was told this is not normal. She was told to go to the hospital, and she went and stated that her oxygen was 89 and then it shot up to 92 with standing and raising her arms up over her head, and they did 6 breathing treatments and 3 doses of steroids in her IV and oxygen and she went up to 98. She was sent home with a diagnosis of asthma with albuterol inhaler and nebulizer machine, treatments and said that she all of a sudden has asthma. She then added she had a seizure Sunday morning of 23May2021. She also felt like she was coming down with the flu. On 22May2021, Saturday night, she was kind of achy, then on Sunday, 23May2021, she felt like she was coming down with flu, she had head and sinus congestion, the achy feeling, all that was fine, it was the breathing that scares her. The patient was not hospitalized due to the events. The outcome of the event seizure was unknown and for other events was recovering.

Went on a walk on 6/8/21. Had high heart rate about 178 BPM) the entire time. After the walk, I could not breath well, the chest hurt, and I lost consciousness. Went to the ER.

Shortly after the shot (on the same day as the shot), I had some expected side effects, including arm soreness, headache and fatigue. Toward the evening, I began experiencing aches throughout my body, pins and needles, and mild chest pain. The next day, my right lower leg and foot became numb (felt like it was "asleep"). The leg/foot numbness persisted (on and off) for over a week, and kept me awake at nights because it was so unusual and couldn't be shaken off. Over the next week, I also developed stiff joints on my hands, fingers and feet, as well as various pains in those areas. Exactly one week after the vaccine, my chest pain became much more severe and localized to my heart. It felt like my heart was being squeezed. I felt some shortness of breath as well, so I used a finger pulse oximeter to take my oxygen. My oxygen reading was normal, but my heart rate reading did not stabilize (it kept changing from 90's to 60's). My headache was also much more severe and I could not do much for the next two days except rest. After 3 days, the chest pain went away. However, I still have pins and needles and joint pain/stiffness that comes and goes. Summary: Arm soreness: Started on the day of the vaccine and lasted about 4 days, then came back briefly exactly one week later. Headaches: Started on the day of the vaccine and lasted for over a week. Fatigue: Started on the day of the vaccine and lasted for over a week. Body aches: Started the evening of the vaccine and lasted over a week Pins and needles: Started the evening of the vaccine and lasted over a week (still ongoing) Chest pain: Started the evening of the vaccine and became very severe (with irregular heart rate) one week after the vaccine Numbness: Started the day after the vaccine and lasted over a week (still ongoing) Stiff and painful joints: Started the day after the vaccine and lasted over a week (still ongoing)

Racing heart. Elevated resting heart rate (up to 100 bpm). Sharp chest pain. Shortness of breath. Feels like unable to get enough oxygen & heart hurts.

I have had an increase heart rate, chest pressure (especially when laying down), night sweats, and shortness of breath, swollen throat) since receiving that second vaccine. I have gone to urgent care and also a PCP, who have not diagnosed anything, yet. Everyone thinks it is my anxiety.

Heavy chested; Shortness of breath/ it's uncomfortable to breathe a little bit with the chest; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE), dose 2 at vaccination age of 40-year-old via an unspecified route of administration in the left arm on 08Apr2021 13:30-14:00 (Lot Number: ER8737; Expiration Date: Jul2021) as 2nd dose, single dose for covid-19 immunization. The patient medical history and family history were none. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE) in the left arm on 18Mar2021 at 09:00 (lot number: EP7534) at vaccination age of 40-year-old as 1st dose, single dose for covid-19 immunization. The patient's concomitant medications were not reported. The patient did not receive other vaccine on the same day with the Pfizer Covid-19 vaccine. The patient did not receive other vaccinations within four weeks prior to the administration of the Pfizer Covid-19 vaccine. The patient mentioned that she got her second vaccine on 08Apr2021 and by that Sunday (11Apr2021), that past weekend, she began to feel heavy chested and since that date it has been off and on with heavy chest and a little bit of shortness of breath. The patient reported that she went to the doctor today (27May2021) for it, they did an x-ray of her heart an EKG and some blood work and she is just waiting for all that to come back (pending results). She reported further that heavy chested lasted a few days then it subsided, it does not necessarily go all the way away. She stated she randomly gets heavy chested and short of breath, she cannot pinpoint why or how, it just happens. She finally made a doctor's appointment because she has the worst case of it Monday (25May2021) and Tuesday (26May2021) and it was not going away. Her chest was so tight and heavy, and she was having shortness of breath. It usually subsides within the day and the following day, she will feel better but on Monday and on Tuesday, it was persistent and she had no relief until Wednesday and even then, it was not 100% relieved. She confirmed that the shortness of breath started around the same time. The patient mentioned that it is uncomfortable to breathe a little bit with the chest. The reporter states it's not all the time, but it did worsen Monday and Tuesday. The patient confirms both the heavy chested and shortness of breath have worsened. The adverse events did not result an emergence room visit but she was close since she did not want to go in there because there is COVID patients there. The adverse events though resulted in a physician office visit. The patient underwent lab tests and procedures which included blood work, x-ray of heart and EKG performed on 27May2021 with pending results. The outcome of the events was not recovered. The following information on the batch/lot number has been requested.

Subsequent progressive iron deficiency anemia with SOB and profound exhaustion - Ferritin levels plummeted to 3; iron, Hgb, HCT, MCHC, etc all low (especially iron). Required EGD/colon to rule out GI bleeding (normal) and subsequent Injectafer infusions x 2. Appt in July to repeat labs. O going February 2021- current

Tachycardia; Fever; Migraine; Fatigue; not feeling well; shortness of breath; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (at the age of 40 years old, not pregnant at the time of vaccination) (Lot Number: EL3249) as single dose for covid-19 immunisation. Medical history included migraine, attention deficit hyperactivity disorder (ADHD), irritable bowel syndrome (IBS-C), Gluten intolerance, Gulten allergy. Concomitant medications received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ibuprofen; topiramate (TOPAMAX); linaclotide (LINZESS). The patient previously received the first dose of BNT162B2 (Pfizer, lot number: EJ686) in Left arm on 01Jan2021 (at the age of 40 years old) for Covid-19 immunization. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021, the patient experienced Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Beta blocker, labs, holter monitor, ekg, echo, str. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test Nasal Swab post vaccination with the result of Negative. The events were non-serious per the reporter. The outcome of the events was Recovered with lasting effects.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the events of Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia cannot be excluded. The case will be reassessed once more 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.

April 21st: 10:30am: got 1st vaccine shot of Pfizer 11:15am: started getting blurry vision in left eye 2:00pm: started getting dizziness, tightness in chest, slight difficulty breathing, pressure in chest and lightheadness April 29th: started getting ringing in the ears (tinnitus) May 3rd: started getting rapid, fast heartbeat that wouldn't slow down. Continued all night so had to go to the ER at midnight Feelings of lightheadness lasted 1 week. Now almost 2 months later, I am still having dizziness and tinnitus. These two issues have interfered with day to day activities

Patient began feeling faint approximately 6 minutes after the shot. She was allowed to rest on the ground of the pharmacy for approximately 15 minutes post shot. Her breathing was shallow, but her heart rate was increased rapidly. She did not allow us to call emergency services. She did not lose consciousness.

1720 Patient complaint of tightness in throat after receiving vaccination Pfizer. Send to observation clinic and assessed patient. Benadryl 50 mg by mouth given times one. 911 called and report given. 1745 Sent to Emergency Department.

Developed a swollen lymph node under right arm.; itchy throat; Started with itchy nose; cough; nausea; headache; Temp 99.5.; heavy chest; hard breathing; Body aches occurred overnight; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL22613), via an unspecified route of administration in the right arm on 18Mar2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression/anxiety, and heart burn. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURE UNKNOWN), fluoxetine (MANUFACTURE UNKNOWN), norgestimate and ethinyl estradiol (TRI-LO SPRINTEC) and omeprazole (OMEPRA), all for unknown indications from unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration in the right arm on 25Feb2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 16:00, the patient experienced itchy nose and throat that developed into cough, nausea, and headache. Temp 99.5 and developed into heavy chest and hard breathing. Body aches occurred overnight and into the morning of 19Mar2021. Coughing, nausea, and body aches continued, and developed a swollen lymph node under right arm. The patient did not receive treatment for the reported adverse events. The clinical outcome of itchy nose, itchy throat, headache, temperature 99.5, heavy chest, hard breathing, swollen lymph node under right arm were recovering, and body aches, nausea, cough was not recovered. No follow up attempts are needed. No further information is expected.

Tired; Feeling ill/Not feeling well; My lips became tingly; Throat got swollen; Nausea; Tightness; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198 and Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 09:40 as dose 1, single for covid-19 immunisation. Medical history included eczema (I had little bit of eczema but it is not bad.) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced throat got swollen, nausea on 05Mar2021 and tired, not feeling well and feeling ill on an unspecified date, tightness and my lips became tingly on 05Mar2021 at 09:45. The reporter stated, she had the first Pfizer shot on 05Mar2021 and within 5 minutes his throat got a bit swollen, her breathing was fine able to eat and drink with no problem and then at 9:45am within an hour her lips became tingly about 12:30PM she took some Motrin, and symptoms went away. Took Motrin the first time and then it happened again about 6 hours later that evening and took Benadryl and Motrin (treatment) and it gone away. She had the first shot at 9:40 AM and then at 12:30 took Motrin and that helped his throat and the lip at 18:00 both symptoms came back again and took Benadryl and Motrin and that help and 06Mar2021 and 07Mar2021 had regular symptoms feeling ill, not really unwell no more sore throat. That evening about 6pm -7pm my throat began to feel tight and her lips tingly at the same time, took Benadryl and Motrin, it went away, on March 6 and 7th had regular usual side effects, nausea, tired, and overall not feeling well and no other reactions. Consumer stated, That was the first shot. Didn't get the second shot. She took Benadryl and Motrin as a treatment for event. Therapeutic measures were taken as a result of event tightness, my lips became tingly. The outcome of the event were recovered on an unspecified date and rest of the event were unknown. Information on the lot/batch number has been requested.

Heart palpitations, irregular heart beat, chest pain, chest tightness, difficulty breathing- Went to ER after symptoms persisted into 6/10/21, tests obtained- no treatment given. Subsided 6/10/21 evening time

Felt faint and body shaking immediately, after that sat during 15 min observation period. Had some more body shaking and feeling faint. Thought it was a normal vaccine reaction. Went to the car w/daughter after observation period. As she was leaving the parking garage she started having palpitations, was holding her chest, starting "doing breathing techniques." Throat then "dried out," drank water, then after a while it was hard to drink the water. Daughter told her that her face was swollen. Pulled the car over, had daughter call family to come and help, daughter drove her to a pharmacy where they purchased Benadryl. Patient took the Benadryl. Family arrived, then swelling subsided. Then when they got home she had vomiting and diarrhea. All symptoms lasted about 5 hrs. Vomiting and diarrhea continued into 2nd day, then after that everything completely resolved. Next day she called the VA to report what happened, she was advised to have come back in. Symptoms: palpitations, throat and face swelling vaccine administration time: 11:00am symptoms started: 11:01am symptoms ended: next day at 6pm

Heart started racing/palpating, glanced at clock- 12:23PM roughly 30 minutes after getting the vaccine. less than a minute later I lost my hearing in both ears, throat started to close and started to wheeze/gasp for air. Started to pull over to right shoulder of hwy and call EMS 12:25 could not breathe at all and began to panic having small child in back seat. dialed EMS but cannot breathe at all. 12:26 blowing cold ac in my face and finally caught a small breath. Slowly felt throat loosen a little and began gasping for air. 12:28 sweating profusely, able to breathe, still cannot hear anything out of left ear, regained hearing in right ear. Chest is tight and hurts, severe headache, lump in throat feeling. 12:30 I decide against 911 and drive home. Stayed in bed with family home. Still no hearing in left ear, chest pain, tightness in chest, heart palpitations.

Shortness of breath and chest pain 10 hrs after vaccination. Chest pain and shortness of breath worsened over the next 2 days. Went to ER on July 5th. Blood work,EKG and chest X-ray done. Sent home with 800mg IBU

9 hours later I had fatigue, body aches, headache and nausea. Lasting less than 24 hours. Then about 5 days through 14 days after the shot I had chest pain when lying in bed early in the morning made worse by breathing. That chest pain occurred 3 mornings during that time period.

Sudden extreme tachycardia up to 161 with hot/flushing feeling over my entire body and both arms experienced paresthesia, had some shortness of breath - tachycardia remained between 100-125 with the hot/flushed feeling for about 6 hours and had mild tachycardia for 2 days after the initial spike. Went to the ER and waited to be seen for hours; over the next days to a month I followed up with my PCP, Cardiology, had ECHO, stress test, and 3 week heart monitor done. I experienced elevated HR and SOB with minor activties for 1-2 months after the initial injection and occurrence.

notified RN that Pt was in the triage room and she needed help. Patient ID x 2, on assessment, Pt stated her throat feels dried up and she cannot breath appropriately. V/S was done and Pt's BP was 116/69, Pulse 81, R 22, Oxygen saturation 100%. Pt stated she had just recently gotten her second shot of the COVID-19 vaccine, Pfizer. She stated she had a rxn to the first dose. Pt was placed on 2liters of oxygen and Provider was informed. Provider ordered Solumedrol and benadryl. Medications were given at 0835am IM. Pt was continued to be monitored. BP at 0840 was 113/58, oxygen 100%, pulse 79, R 20. Pt was informed she is having a rxn to the vaccine and would be monitored before she could go home. After 0910, Pt's BP was taken manually and BP was 110/72, Pulse 78, R 18, and Oxygen saturation 100%. Pt was observed for about an hour before been discharged. Provider asked RN to schedule Pt for a telehealth appointment for tomorrow. Pt was scheduled for the appointment. Pt stated she feels much more better and alright and she can breath well. Pt's husband at bedside. Patient aware and verbalized understanding of all instructions and patient to return PRN to the clinic.

Staff notified RN that Pt was in the triage room and she needed help. Patient ID x 2, on assessment, Pt stated her throat feels dried up and she cannot breath appropriately. V/S was done and Pt's BP was 116/69, Pulse 81, R 22, Oxygen saturation 100%. Pt stated she had just recently gotten her second shot of the COVID-19 vaccine, Pfizer. She stated she had a rxn to the first dose. Pt was placed on 2liters of oxygen and Provider was informed. Provider, NP ordered Solumedrol and benadryl. Medications were given at 0835am IM. Pt was continued to be monitored. BP at 0840 was 113/58, oxygen 100%, pulse 79, R 20. Pt was informed she is having a rxn to the vaccine and would be monitored before she could go home. After 0910, Pt's BP was taken manually and BP was 110/72, Pulse 78, R 18, and Oxygen saturation 100%. Pt was observed for about an hour before been discharged. Provider asked RN to schedule Pt for a telehealth appointment for tomorrow. Pt was scheduled for the appointment. Pt stated she feels much more better and alright and she can breath well. Pt's husband at bedside. Patient aware and verbalized understanding of all instructions and patient to return PRN to the clinic. BSN, RN/PHN

was given the COVID-19 vaccine at 1130am on 7/9/21, within 10 minutes after giving the vaccine she began to feel dizzy, nauseated, had a lump in her throat, was complaining of chest pain and a "weird" feeling in her left arm. Her initial vital signs were concerning for pulse oximetry on 88% on room air with a normal blood pressure 130/93. Given her nausea, throat tightness, and decreased SpO2 she was given IM epinephrine 0.3mg at 1144am. Her blood glucose was 96. Her vital signs were cycled every 5minutes and blood pressure remained normal., and SpO2 improved to 100%. EMS was called and arrived at 12pm, EKG was normal, and she was transported to the emergency department for further treatment.

Fever, body aches, chills, nausea, vomiting, headache, cough for 2 days following vaccine starting 6 hours after injection. Chest pain, shortness of breath and coughing (still ongoing at time of filling out this form)

very dizzy/light headed; heart palpitations; felt like a knot in throat and could not take deep breaths; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er 8727), via an unspecified route of administration in the right arm on 24Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ibuprofen (ADVIL) for unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en 6205) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and buckwheat on unknown date and experienced anaphylaxis. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 18:30, after receiving second dose of vaccine 24 hours later, the patient experienced heart palpitations, got very dizzy and light headed, and felt like a knot in throat and could not take deep breaths. Since then, patient was feeling lightheaded and dizzy and it wont go away. The events resulted in doctor or other healthcare professional office/clinic visit twice and its been 5 days and events did not subside. The clinical outcome of event dizzy, heart palpitation and difficulty breathing was not recovered. No follow-up attempts are needed. No further information is expected.

Patient recieved her second dose of the Pfizer vaccine at noted facility . During her drive home her heart began racing and she was sweating and gasping for air because she could not breathe. There was a mini ER nearby and she ran inside for help. They called an ambulance transported me to ER. At ER my BP was ~175/105. I had a headache, chest pain, sweating and anxiety and felt generally unwell. They administered IV benadryl and ativan.

Chills, sweats, nausea, headache, chest pain with deep inspiration, contacted 1 week after vaccination. Continued for another week, contacted clinic. Recommended ER, patient did not go. Reached out to her cardiologist who ordered labs and chest xray. CMP, CBC and Chest xray all normal on 4/12/21. Reached out after she returned from vacation and reported lingering cough. Rx'd Cheratussin and Albuterol inhaler. Patient was recommended respiratory clinic, instead she made her own appt to go to ENT. Patient had also reported worsening GERD symptoms- upset stomach and throat clearing- referred to her GI specialist who manages her GERD/Hiatal hernia. ENT saw patient on 4/30/21- dx'd with cough, reactive airway, GERD, globus sensation. Rx'd- Advair- 2 puffs BID, Nasal saline spray, Allegra 180 mg- daily, continue Protonix and referred back to GI. Called 5/5- reported mid right back pain that woke her up on Saturday AM (4 days prior). Recommend ER due to pain awakening her and also to follow up with her GI MD. She reports her GI ordered an Ultrasound but couldn't see her until August. Went to ER on 5/5 with dx of right sided thoracic pain. Sent home with no Rx, recommend NSAIDs, ice/heat, lidocaine patches. Patient reached out on 5/18 to discuss US results- informed there was mild splenomegaly. Continued with cough, upset stomach, back pain. PCP received US results on 5/24. Patient recommended to come in to see PCP for further management. Saw PCP on 6/2/21- Labs ordered today are ANA screen, BNP, CRP, CMP, COVID IgG, UA macro/mirco and culture, CMV antibody, EBV panel, D-Dimer, CBC, hepatitis panel, HIV, LDH, lipase, Quantiferon, TSH, RF and ESR. Referred to respiratory clinic- informed patient it was Pertussis- placed on Azithromycin. PCP switched RX to Levaquin. Healthline reached out to patient for elevated D-Dimer- patient refused ER. 6/9/21- CT- renal infarct, splenic infarct 6/10/21- Admitted. Bacterial endocarditis, renal and splenic infarct, ended with open heart surgery, valve replaced, replaced pacemaker

I was initially getting mild pain on my left rib, on and off pain, increasing pain with the days, went from to left rib to my back. I went to see a doctor when I got a very strong pain (#10), I could not walk, got tired and was very difficult for me to breathe; the pain was going and off. I went to see the doctor and they did scan but doctor did not find anything and just gave me a prescription of Gabapentin 3 times a day.

7/8/21: Around 4:30pm became flushed and hot. 30 minutes later minor wheezing followed by itching on neck and upper back. Took 2 Benedryl and symptoms resolved. 7/10/21: Began experiencing tightness in chest, difficulty taking a deep breath. Asthma hasn't been this bad in well over a decade. Albuterol provided only short term relief. Benedryl provided more relieve and for longer period but symptoms persisted. 7/14/21: Met with doctor. Switched from Allegra to Zyrtec. Added Qvar on top of Symbicort. Will have checkin in a few days. If there's no improvement, the plan is to start prednisone.

Full body rash, legs, arms, stomach and back.; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8732) via an unspecified route of administration in the left arm on 25Mar2021 at 14:30 (at the age of vaccination 40-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma, GERD, gastritis. The patient previously had drug allergy while taking amoxicillin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and advil (MANUFACTURER UNKNOWN). Concomitant medications included famotidine (PEPCID), paracetamol (TYLENOL), vitamin D (MANUFACTURER UNKNOWN), prenatal vitamins (MANUFACTURER UNKNOWN) since an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 17:30, the patient experienced full body rash on legs, arms, stomach and back and shortness of breath. The patient had received BENADRYL (MANUFACTURER UNKNOWN), CLARITIN (MANUFACTURER UNKNOWN) as treatment for the events. The adverse events resulted in emergency room/department or urgent care. The clinical outcome for the events rash and shortness of breath were recovered with lasting effects at the time of report. No follow-up attempts are needed. No further information is expected.

chest started hurting; Fatigue; he couldn't move her mouth; her hands got real tight feeling; blood pressure and heart rate was up/Elevated BP; couldn't breath; fast heart rate/heart rate and it was 140-145; bad dizziness/Lightheadedness; She had a pins and needles sensation in her fingers; her hands and mouth were frozen; her hands and mouth were frozen; fever of 100 degree F/Temperature elevation; headache; tired; anxiety attack; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9263), via an intramuscular route, administered in Arm Right on 09Feb2021 at 13:20 (at the age of 40-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient's historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL1283), via intramuscular route, administered in Arm Right on 19Jan2021 (at the age of 40-year-old) as single dose for covid-19 immunization. It was not provided that the patient was received any vaccine 4 weeks prior vaccination. On 09Feb2021 the patient experienced fast heart rate/heart rate and it was 140-145, bad dizziness/light-headedness, she had a pins and needles sensation in her fingers, her hands and mouth were frozen, her hands and mouth were frozen, fever of 100-degree F/Temperature elevation, headache, tired, blood pressure and heart rate was up/Elevated BP, couldn't breathe, Fatigue, he couldn't move her mouth, her hands got real tight feeling and on Feb2021 anxiety attack and on 12Feb2021 chest started hurting. She mentioned that she received the 2nd dose of the vaccine last Tuesday and experienced a fast heart rate, really bad dizziness within 5 minutes. She had a pins and needles sensation in her fingers and her hands and mouth were frozen. She went to the EMS and her symptoms were addressed. She went home but experienced it again and went to the walking clinic with a fever of 100-degree F. Her doctor said that it may be related to the vaccine. On Wednesday she said that she had a headache and was tired. On Thursday she said that she may had an anxiety attack with a heart rate of 145. Blood work was done, and it said that there was no evidence of clotting. The EKG revealed that her heart rate won't drop, and it was hurting her chest and her heart as it was beating fast. She has been prescribed with anxiety medications. She was asking if this was a common side effect because her doctors don't know. She reported she had her second COVID-19 Vaccine dose on 09Feb2021 at 1:20PM, and she has had side effects ever since. She said the side effects have her scared. She said she still has a rapid heart rate in the 90s. Reporter Type: Patient Reported 5 minutes after receiving her second COVID-19 Vaccine dose she got lightheaded and dizzy. She said she told one of the staff at the COVID-19 Vaccine facility that she thought she was dizzy and didn't feel right. She said she was moved to a private room at the COVID-19 Vaccine site. She said the staff put things on her chest and stomach and checked her blood pressure. She said the staff told her that her blood pressure and heart rate was up. She said she doesn't remember what her blood pressure or heart rate was at the time. She said a staff member taking care of her asked her if she was nervous. She said she told the staff member she had nothing to be anxious about. She said she told the staff member that she knows what the common COVID-19 Vaccine side effects are, and that she had gotten over any fear of needles a long time ago. She said she was fine before she got her second COVID-19 Vaccine shot. She said 5 minutes after getting the second COVID-19 Vaccine shot, she gets dizzy and lightheaded out of nowhere. She said her mother had died of breast cancer in Dec2020, and she had a Xanax prescription from during that time. She said she took a 1/2 of Xanax to see if the Xanax would help her blood pressure and heart rate. She said after a half hour had gone by, she got a pins and needles feeling down her arms. She said her blood pressure and heart rate were still up, and she could feel her heart beating in her chest. She said while she was still being attended to by the COVID-19 Vaccine facility staff member, and EMS person came in, and said 3 more people were down from that vaccine lot. She said the staff member asked if he could move her to another area outside of the private room she was in, and he told her he would have 2 cops keep an eye on her. She said she spoke to the 2 cops for a while, and then she called her director at work. She said she then called her husband, and her husband told her if she was feeling well enough to drive home. She said while she was driving home, her hands got real tight feeling, she couldn't move her mouth, her heart was hurting because her heart was beating so fast, and she couldn't breathe. She said she had to pull her car over, and have her husband get her. She said she went to the walk-in clinic at her work, and when her temperature was checked, it was 100 degrees. She said the doctor at the walk-in clinic told her she was having a reaction to the COVID-19 Vaccine. She said she got a headache that evening, and her breathing, blood pressure, and heart rate hadn't dropped. She said the next day she still had a headache, but she didn't want to take off from work. She said everyone she works with whom got the COVID-19 Vaccine had a fever, body aches, and a headache, and took off the next day from work. She said she had an episode at work that afternoon where she couldn't breathe, and her chest started hurting. She said someone checked her blood pressure, and heart rate and it was 140-145. She said she went to her doctor yesterday, and he did and EKG and told her she had an elevated heart rate. She said her doctor drew blood to check for blood clots and to check for something in her blood vessels in her heart. She said her doctor told her it may be anxiety, and for her to take a Xanax. She said her doctor said he wants to see how she was in the next week and see if anything changes. She said her heart rate today has been between 90-95. She said her heart was beating so fast that it was making her chest hurt. She said she told her doctor the EMS staff member that checked on her after she got lightheaded and dizzy at the COVID-19 Vaccine facility told her he had the same thing happen to him. She said there seems to be a difference of opinion between the walk-in clinic doctor, and her doctor. She said the walk-in clinic doctor was saying she was having a reaction to the COVID-19 Vaccine, and her doctor was saying it was anxiety, and for her to wait a week. She said she doesn't want any damage to her heart. She said her doctor told her no one has died from getting the COVID-19 Vaccine. Thinks she was experiencing a side effect to the COVID- 19 Vaccine. She said her other colleagues from work had some of the same side effects after getting the COVID-19 Vaccine. She, her doctor, said the COVID-19 Vaccine side effects only last 48 hours. She said Dr. was only telling her that because that was what was said about the COVID-19 Vaccine. She said was a younger doctor and doesn't know anything about the COVID-19 Vaccine. Reported she doesn't want to wake up and have to go to the emergency room because there was something wrong with her heart caused by the COVID-19 Vaccine. Treatment: Reported her doctor gave her allergy pills, clarified as Cetirizine. She said the Cetirizine was dispensed in a pharmacy bottle and she did not have the NDC, Lot, and Expiration Date. Reported her doctor also prescribed Naproxen 500mg for her headache. She said she did not have the Naproxen NDC, Lot, and Expiration Date. She said she did not take any of the Naproxen 500mg prescription. She said the doctor had given her a shot of Toradol when she was at the doctor's office. She did not have the Toradol NDC, Lot, and Expiration Date. Caller didn't have Xanax NDC, Lot, and Expiration Date to provide during call. Reported she doesn't take any medication unless she has to. Reported her doctor doesn't know why her heart rate was up. She said she was scared that she might have damage to her heart. Caller stated she had to pick up her daughter. Reported no one has any idea what was going on with her. She said her blood pressure didn't go up today, and she has been checking her heart rate. She said yesterday morning her heart rate was up there and then her heart rate subsided. She said she doesn't want any damage to her heart. Caller stated at the COVID-19 Vaccine administering site told her he thought he was going to die after he got his COVID-19 Vaccine. No further details provided. Reported her symptoms improved from yesterday, but she still has a headache. She said she has fatigue that started on 09Feb2021 and has stayed the same since that time. She said her heart rate today has been between 90-95. She said her heart was beating so fast that it was making her chest hurt. The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure was up on unspecified date, blood test: no evidence of clotting on unspecified date, body temperature: 100-degree Fahrenheit on unspecified date, electrocardiogram: elevated heart rate on 11Feb2021, heart rate: 145 on unspecified date, heart rate: 140-145 on 11Feb2021 and heart rate: 90-95 on 12Feb2021. Patient not visited to emergency room for the events, visited to physician's office. Therapeutic measures were taken as a result of the events. The outcome of the events headache and fatigue was not recovered all others were recovering. Follow-up attempts completed. No further information expected.

About a week after the vaccine, I woke up in the middle of the night with severe dizziness. I almost fell over when i tried to walk to the bathroom. The dizziness has lasted this week. On top of that, I have experienced shortness of breath the past few days. I am currently having both the dizziness and SOB and hoping it will end soon.

Chest pain 3 times after second Pfizer vaccine but one was more severe. Very strong chest pain, felt like a fist in my chest very tight and like something squeezing my heart- dizzy- had to stop making dinner and sit down. Was out of breath.

Racing heart; Dizziness; Headache; Hives; Mild throat swelling; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot m100003243928, first dose) solution for injection intramuscular in the left arm on 29Mar2021 at 10:15 (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: shellfish, soy, nuts, sunflower seeds, sesame, mustard, bananas, apricots, peaches; and COVID-19 on an unknown date. Concomitant medications included salbutamol sulfate (PROAIR DIGIHALER) and over the counter allergy medication. Lab test on an unknown date included COVID-19 was positive. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Mar2021 at 10:30, the patient experienced racing heart, dizziness, headache, hives, mild throat swelling. Treatment for the events racing heart, dizziness, headache, hives, mild throat swelling included diphenhydramine (BENADRYL), epinephrine (EPIPEN), and inhaler. The outcome of the events racing heart, dizziness, headache, hives, mild throat swelling was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

pt complained of tighness in throat after 2nd dose of Pfizer. Felt better in 10 min after removing mask. VS stable, 90% on RA. Exam negative. May have been a panic attack rather than a vaccine reaction. Discharged to home with po benedryl. No meds given at blitz.

This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration on 30Apr2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously received penicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 07:00, the patient experienced headache, backache, chest pain (sharp pain in chest), and difficulty breathing deeply. The clinical outcome of the events headache, backache, chest pain (sharp pain in chest), and difficulty breathing deeply were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Effect On Ears - Evening of 3/13 tinnitus became louder and came in waves. - Tinnitus increased over the next couple of days to louder, constant, high-pitched buzzing, louder than TV and sound machine. - Feeling of fullness/pressure in/around ears. - Pain/discomfort in/around ear. - Sensitive to loud and high-pitched sounds, incl. kids, TV, music, dishes, loud talking. - Occasional popping in ears. - Occasional itching in ears. - Multiple sounds in ears (buzzing, tone), some times sound travels. - Tinnitus aggravated with exercise, hot showers, long exposure to sound (for example, low music, ocean waves, driving). Allergy shots cause flare ups with multiple symptoms (none of this happened prior to vaccine). - All symptoms above are new. Prior to vaccine I had a low baseline T that was easily ignored and only heard when silent. - Most symptoms eased after 10 - 12 weeks, but tinnitus (louder than pre-vaccine tinnitus) continues, as well as flare ups of all ear symptoms. Other Side Effects - GI: Significant loss of appetite, weight loss, stomach cramping, nausea, spit out food because of off taste, loose stool / diarrhea. All improved after 3 weeks. - Tremors / Shaking. Improved after 3 weeks. - Intense anxiety/depression began 3/14, including tightness in chest, difficulty breathing at times, increased heart rate, sleep disturbances, troubled thoughts. Eased after several weeks. Emotional upset from situation continues but at more appropriate level. - Pain/pressure (all over or shooting) in head and face, some times on one side of face, temples, forehead, base of neck. Eased after 1-2 months. - Prickly & numb sensations on face, similar sensation in toes and fingers a few times. Eased after 1-2 months. - Head fog. Eased after 1-2 months. - Fatigue. 3/26 Took walk and felt as though recovering from flu (heaviness in chest), unable to work out for 2 weeks, resumed since with less frequency & more modifications (continues like this). - 1-2 days after vaccine sore arm, aggravated arthritis and interstitial cystitis. - Other misc things experienced during the first 2-3 months post vaccine: neck and back pain, vision issues (trouble focusing, not as clear, floaters), hair loss (hair dresser noticed 3/23), increased pain in legs/veins, leg cramps.

1104 -Vaccine administer IM in L arm. 1110- PT states to complain of having something in her throat. Denies having any SOB, chest tightness, itching, and no hoarseness. 1115- PT is clearing her throat more and states that she feels like she has to keep clearing her throat more and started to have Hoarseness denies having SOB but states that she is having a harder time breathing when positioning her head in certain ways. 1118- Minimal facial swelling noted clearing throat more often pt continues to talk to staff. Denies having SOB or chest tightness. Doctor notified of pt's symptoms and instructed to give Epi-Pen NOW. Epi-PEn(Lot #0FM407 exp: 02/2022) administered to Left Thigh by LPN. Pt tolerated and continues to talk to staff. 1120- Doctor in Room evaluating patient. Doctor instructed to continue monitoring in room for the remainder of 30 minute wait and advised patient that she could return back to work since pt works in the hospital. PT voiced understanding. Pt continues to deny SOB and chest tightness. 1125- PT states that she can tell her throat is starting to feel better states that she doesn't feel like she has to continue clearing throat. Continues to communicate with staff and continues denying any SOB. 1130- PT continues to states that feels like she is improving. Facial swelling has gone down. Continues to communicate and denies having and SOB and chest tightness. 1135- PT's 30 minute wait is up and Pt continues communicating with staff. Denies SOB states that she feels somewhat better. Informed patient that she could continue to be monitored by immunizations RN but pt denies and verbalized that ''Dr. said I could go back to work''. Informed patient that if symptoms do not improve and if she starts to have SOB, difficulty swallowing, swelling in throat or tongue to seek immediate attention at the ER. Pt verbalized understanding and ambulated out of area.

Ten days after vaccination, I developed sudden symptoms of insomnia, chest tightness, shortness of breath, and extreme fatigue. These improved somewhat over the following two months at which time I took my second vaccine and had a massive relapse with the same symptoms. Now, 6 months out, I am still dealing with life-altering extreme fatigue, insomnia, breathing abnormalities, and heart rate abnormalities.

Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine COVID tests on days 9, 10, and 13 all negative

12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.

Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.

Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.

Patient reported having a swollen epiglottis on the date of the vaccination that did not resolve until the following date.

slight shortness of breath all lasting over 1 week; Extreme chills; extreme fatigue and tiredness; whole body muscle aches; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (batch/lot number and expiration date not provided, not available/provided to reporter at the time of report completion), via an unspecified route of administration, at arm left, first dose on 23Dec2020 09:15, at single dose, for COVID-19 immunization. No relevant medical history. No known allergies to medications, food, or other products. There were no concomitant medications. 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 was not diagnosed with COVID-19. The patient experienced extreme chills, extreme fatigue and tiredness, whole body muscle aches, slight shortness of breath all lasting over 1 week, all from 23Dec2020 16:15. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (test type: Nasal Swab, test name: rapid test): negative, on both 27Dec2020 and 30Dec2020. The outcome of the events was not recovered. Information about Batch/Lot number has been requested.

Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.

Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction

Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.

Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.

About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated. At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.

Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days after vaccine

On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/20, the shortness of breath worsened, developed muscle aches, headache and fatigue continues, blood pressure became elevated. Was seen in the Emergency Room. On 1/11/20 was evaluated by Primary Care Provider. Blood pressure medications were increased and taken off work until stable.

Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but definitely uncomfortable) over next few hours. Finally tried 2 puffs of my son?s albuterol about 5 hrs post vaccine and felt relief within 20?30 minutes. The next day I had more expected side effects: headache, myalgias, chills and fatigue. No recurrence of the chest symptoms.

Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her throat is closing. Patient has some inspiratory stridor. She was moved to a room and given intramuscular epinephrine, diphenhydramine, famotidine, and methylprednisolone.

2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little worse after shot. Patient noted walk in cold air on way to vaccine apt seemed to trigger it.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain

developed a scratchy throat at 2100 and by 2130 felt like throat was tightening. Went to ER and received Benedryl 50 mg IV, Solu medrol IV and protonix IVPB.

SkinRash, CoughWheeze, Rash, UrticariaPruritus, throat swelling not characterized by anaphylaxis Narrative: Report one hour following Vac #2, she felt a difficulty in swallowing. She did not go to ER, took benadryl x 4 days and used albuterol inhaler for the wheezing.

severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). 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 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharmacist. A 41-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284) via intramuscular route of administration on left arm at a single dose for COVID-19 immunization at a nursing home. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced shortness of breath, anxious, and chest heaviness on 07Jan2021 11:00. The events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Treatment and outcome of the events were unknown. The patient had not been tested for COVID-19 since the vaccination.

1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.

Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days

Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out of bed for the entire day, severe headaches through the entire day Day 2: fever of 101, shortness of breath, severe headache, entire left arm in pain

became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED, discharged home

~15 minutes post vaccination, reported feeling sensation on right side of throat. Tightness, burning, swollen ("like strep throat, raw") 1515: Dose of 50mg capsule of diphenhydramine PO Can swallow without difficulties Denies troubles breathing 15:25: Notes some improvement in symptoms, denies worsening VS: 148/98

About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.

Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.

COVID positive 11/27/20. Oxygen saturation dropped to 90% with exertion and 94% resting. Also had chest pain and sinus tachycardia. Received first COVID vaccine 12/18/20.Developed continuous vomiting 1.5 hours later then muscle aches and cramps as the day went on. Symptoms were gone later the next day except site soreness. Developed SOB and wheezing on 12/24/20. Went to ER - no treatment. Called her pulmonologist and increased diltiazem for the weekend. Called cardiologist 12/28/20 and was put on Corlanor. Took care of acute issues, but still had some SOB and palpitations.

tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I developed labored breathing around the same time as the lightheadedness. I was evaluated in the emergency room and diagnosed with a vasovagal event. The evening of the vaccine, I developed mild body aches, especially in the legs. The morning after the vaccine, I developed headache ,nausea and vomited once.

Shot 1- shaky, weak, increased heart rate, mild swelling of mouth tongue and throat - resolved in a day Shot 2 a shaky, weak, increased heart rate and blood pressure, moderate swelling of face, tongue, throat, intermittent dizziness and Left eye blurriest, left facial decreased sensation and pain from mouth to ear, pain behind Left eye - symptoms wax and wane throughout the day

Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)

Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.

Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.

Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed

22 hours after the second dose started to have an allergic reaction, hives all over back and chest and neck. Took benedryl and pepcid at home OTC. The next morning woke up with hives, flushed feeling, and chest/throat tightening. Went to the ER was administered iv medications. Went home. 4 Hours later started again with chest and throat tightening and swelling of the eyes. Kept having break through reactions when medications were wearing off. The ER md that I saw called in some home medications that I started taking. Pepcid and Prednisone. 7 days later still having to take benedryl and pepcid due to eye itchiness and swelling.

5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.

The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".

Patient reported tightness in throat and swollen glands after injection. Rapid response called. Returned to work with a follow up check by rapid response.

pt c/o tightness feeling in throat. denies SOb. VS taken and stable, pt observed x 30 minutes. vs repeated WNL. Pt d/c home with return precautions. pt states understanding

Pt received COVID vaccine (2nd dose) at 0857. Pt reported after twenty-five minutes that it was "difficult to take a deep breath". RN and EMT took VS. VSS. Clear lung sounds. RN told pt to remain for an additional 15 min of observation. Patient stable and able to leave on her own at the end of 15 min observation.

Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my shirt. Hives went up from my chest to my neck and eventually to my face. About 30 mins after hives started, my breathing became labored. I took 3 Benadryl and was preparing to give my self an EpiPen injection. Benadryl was enough to slowly bring everything back to normal. This began around 6:00 pm, Benadryl was taken around 6:45, by 9:00pm I was completely normal for bed.

Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patient had her own personal Benadryl on hand and administer 50 mg orally to self. Pt was watched for 20 minutes by EMT following administration- she reported her throat continued to feel scratchy. Patient was driven and advised to go to emergency room. hospital was contacted per EMT and informed that patient was in route to hospital following a reaction to COVID-19 vaccine.

Tightening of throat, facial swelling, and ear pressure 15 minutes post injection. Treatment given-epi 3mg via epi pen. Outcome- called 911 and medics took over

Sharp pain at bridge of nose that became a tightening across entire face and forehead, rapid heartbeat, nausea, numbness in lips, sinuses pushing on roof of mouth, difficulty swallowing for about 15 minutes about a half hour after taking vaccine. Then about 6 hours same symptoms but without rapid heartbeat, swallowing issues were worse, took Benadryl, after about an hour symptoms lessened and I fell asleep. Next morning roughly 13 hours later would randomly have tightness in face and under chin. Lasted off and on all day.

This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.

Shortness of breath, difficulty breathing, hard time catching my breath, can?t take a full or deep breath, lightheaded and dizzy

Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.

heart was racing; increased respiratory rate; tingling in the tongue; full/swollen feeling in the tongue; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot/batch number and expiry date unknown), intramuscular on12Jan2021 07:30 at single dose in the left arm for COVID-19 immunization. Medical history included PCN allergies from an unknown date. There were no concomitant medications. On 12Jan2021 07:45 about 15 minutes after the injection, the patient felt like heart was racing, increased respiratory rate and tingling in the tongue. Heart rate and respiratory rate quickly returned to normal but the tingling and full/swollen feeling in the tongue continued for about 1.5 hours post injection. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. The vaccine was given in the Hospital. The outcome of the event "heart was racing" and "increased respiratory rate" was recovered on Jan2021 while outcome of the other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.

headache runny nose Nausea severe muscle aches fever 102 degrees chills muscle fatigue shortness of breath cough congestion

Shortness of breath with activity; night sweats; right jaw pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), intramuscular in the right arm on 09Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included thyroid cancer. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath with activity, night sweats, and right jaw pain on 11Jan2021. Right jaw pain resulted in physician office visit. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious.

Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within normal limits. Patient stabilized and left for home.

All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite

PATIENT FELT TONGUE SWELLING AND THROAT SWELLING. NEW ONSET HEADACHE. ADMINISTERED DIPHENHYDRAMINE 10ML. PATIENT SENT TO ED.

It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.

"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.

At the 8 to 10 minute mark: Could not stop coughing Lips burning and itching At about 20 minute mark: Still coughing Swollen mouth Lips burning and itchy - took Flovent inhaler and drank water About 45 minutes Same and worse , nurse gave me 25 mg of Benadryl After about 20 minutes coughing reduces, Swelling reduces but still itchy in moisture Still swollen at about 30 minutes of the Benadryl and the nurse gave me another dose of Benadryl. Symptoms started to get somewhat better I was very tired from the Benadryl Next day my mouth was still swollen Next day chest was very very tight and took inhaler constantly Third day after vaccine had an asthma attack, hadn?t had an asthma attack since I was in middle school. Dr prescribed prednisone and to take Zyrtec along with my inhaler I cannot return to exercise until 10 days after the start of prednisone

Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient medical history reported no current heath issue like no "acute" (not clarified) current she got but she had got "bulging" (not clarified) disc and "effects" in the past, no "aplasia" (not clarified) nothing, no and she was "marina" (not clarified)." There were no concomitant medications. The reporter reported a patient that had an allergic reaction to the Pfizer Covid vaccine. Nurse stated that when she was "admitted" (not clarified) she was in the ER being monitored she got "admitted" (not clarified) first day today 7:45 not clarified (15Jan2021). The patient experienced allergic reaction, included "Throat swelling, tightness, difficulty swallowing." The reporter gave the patient "Api" (not clarified) 0.3 milligram and then also she had "Dimedrol" (not clarified) 125 and then she had CAPCID 20mg IV "piggy back" (not clarified). She had Benadryl 50 milligrams." The outcome of the events was unknown. Information on the batch number and lot number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (pregnant: no) received first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm on 17Jan2021 12:00 at single dose for covid-19 immunization. Medical history included occasional migraines from an unknown date and unknown if ongoing. Concomitant medication included fluoxetine hydrochloride (PROZAC), ethinylestradiol, norgestimate (TRI LO MARZIA). The patient experienced lightheadedness, labored breathing on 17Jan2021 12:00, mild body aches on 17Jan2021, nausea, severe headache, vomited all on 18Jan2021 10:00. The event resulted in a visit to emergency room/department or urgent care. Treatment diphenhydramine hydrochloride (BENADRYL) 2mg was introduced. The patient developed lightheadedness within 2 minutes of receiving the COVID 19 vaccination. She did not faint. She was seen and evaluated in the emergency room. She developed labored breathing as well. She developed mild body aches the evening of the vaccine. The morning after the vaccine- around 10 am, She developed nausea, severe headache and vomited once. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Not Known allergies.

Patient reported to vaccine clinic to receive second dose of Pfizer Covid vaccine. First dose received on 1/12/2021 without any problems or reaction. Patient reported history of anaphylaxis to shellfish so she was asked to wait 30 minutes post vaccination for observation. Around 15-20 minutes after receiving vaccination, it was noted patient was rubbing her throat. RN at vaccine clinic asked patient if she was ok and she reported she was fine, she thinks it is in her head. RN noted she continued to rub her throat and asked her to describe what it felt like. Patient felt sensation of tickle in her throat and asked for water. Patient also noticed began to itch all over. Patient provided water and 25 mg PO Benadryl. Patient noted it felt like her throat was starting to close and her tongue felt it might be swelling. Epinephrine 0.3 mg IM was administered at 12:07 and patient arrived in ER at 12:08. Patient received another dose of IV benadryl and famotidine and kept for observation. She was discharged home after a couple of hours.

About 10 minutes after receiving COVID vaccine, patient reported that her throat got tight and she became dizzy. Vital signs stable. Patient was administered 12.5mg PO Benadryl and symptoms subsided. Patient was able to be discharged home and asked to contact allergist for further recommendations

Pt. C/O Throat tightening soon after receiving the vaccine, denied difficulty breathing, no impairment of her airway, complaint improved with swallowing water. She also developed an itchy rash (very faint) on left arm. which resolved over about 10 minutes.

Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxis

A few minutes after taking vaccine i felt my throat tighten like it was closing up and I was very dizzy

Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination. Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not. However, PCP felt pt should go ahead and take the second dose. Pt's baseline HR is around 66. HR taken - 73. Patient said it felt like pins on her tongue. Drank one bottle of water, denied SOB or throat issues. HR monitored for another 30 minutes and returned to baseline. Patient had another bottle of water and tinglyness dissipated. Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.

1350 Feeling anxious and weird, HX seizures as a child, 1413 Zyrtec given laid down Semi Fowlers position 1444 Report feeling nasal congestion throat swelling has improved. Vitals 124/84, P-79 SPO 97 % Exited and in stable condition.

patient reported swelling of left side of face and we administered Benadryl 25mg at 12:10pm then patients other side of face started swelling. She felt like her throat was closing so we administered 1 dose of EpiPen 0.3mg at 12:30pm and called 911. EMS arrived on site 15 minutes later and took patient to ER.

I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.

Client received her first dose of the Pfizer vaccine. She stated that she was allergic to alcohol and bleach. During her 30minute post-vaccination wait time, she complained of tightness in her chest and attributed it to the smell of alcohol (from the alcohol pads) in the cafeteria. She was evaluated by Nurses, the EMT Personnel working at the POD. She wanted to know if she could use her inhaler, since she was asthmatic. She used her inhaler, stated she felt fine and was observed for another 15 minutes, during which period she denied any symptoms.

a lot of body aches; headache; some shortness of breath; This is a spontaneous report from a contactable Other Health Professional (HCP) reported for herself. A 41-year-old female patient (pregnant: no) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 18Jan2021 at 12:15 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 41 years old on 28Dec2020 for COVID-19 immunisation (first dose, via intramuscular, administration time=10:00 AM, vaccine location=Left arm). After the second vaccine starting about 10 hours after it was given, the patient had a lot of body aches, headache, and some shortness of breath on 19Jan2021. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No other medications in two weeks. The outcome of the events was recovered on an unspecified date. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021067674 maternal, infant cases;US-PFIZER INC-2021068772 maternal, infant cases

Fever, sore throat, swollen lymph nodes in throat, clavicle, armpits and breasts, fatigue, chest tightness, some shortness of breath, rapid heart rate upon moving

heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.

Felt a slight flu-ish the following day. 4 days after, I had Aches, headache, severe sneezing, congestion that was painful coughing and difficulty breathing. Right Leg aches.

Hard to breath right chest but took inhaler and was better. Hives took 50 mg of Benadryl at sight then after one hour went to primary Dr to get checked out. Was told to take 25-50 mg of Benadryl every two hours and Pepcid 20 mg one tablet 2 time daily, itchy burning eyes use eye drops, come and go since 01/29/2021. I get really tired and upset stomach also 2/09/2021

Within 45 minutes experienced throat tightness, shortness of breathe. Less than 4 hours later, experienced diarrhea and abdominal pain. Less than two months later, my right shoulder dislocated and am now having issues with range of motion, pain and weakness.

Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe

Patient sat in our waiting area for 15 minutes and no obvious signs/symptoms of reaction to vaccine were reported or noted. Per patient, after she left our office, at 12:20 pm, she experienced "chest tightness, racing heart rate, could not feel her tongue and throat was tight." She went home, took Benadryl (25 mg) and she was "ok" after that - symptoms subsided. She followed up with her primary care provider, who advised her not to receive the second vaccination due to this adverse reaction. Patient informed our office, of her adverse reaction on 2/15/21 - we are reporting today because she was able to provide more information regarding the event.

Went to get the vaccine, sat down and received it in her left arm, and while waiting for the 15 minutes and after 10 minutes she stood up and coughed, a nurse came to her and asked if she could help her, she grabbed her throat and told her she could not breathe. She gave her an Epi-pen shot in her right thigh and then she put oxygenation on her finger, around 5 minutes later they took her to the ER. She felt fine immediately after the. The nurse then gave her an IV but they did not give her any medicine. She also had her BP monitored and checked her vitals signs, and a doctor talked to her and kept her for an hour for monitoring, and then released from the ER.

Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Tightness in the chest, throat, ears, and head with a feeling of dizziness started on the 4th day after receiving the vaccine. Feeling extremely fatigued and difficulty breathing. Falling asleep whenever and wherever. Rashes all over the body including the face that come and go. Burning pain and a feeling of flushing when the rash develops. Waking up in the nights with the rashes and itchiness that is unbearable. Experiencing difficulties staying focused and complete a single task. Off from work for a week now due to continuous dizziness.

Itching, stinging rash on arms, bump above injection site with swelling on left arm, throat thickening but not closure

got Shot about 8:30; immediately after getting the shot, I had the same feeling as my breath being taken away and the taste (just like after getting an IV cleaned with saline). Nurses told me to sit up front to be observed and waited 30 minutes. After the 30 minutes, I began getting very warm (went outside to get fresh air); went to vehicle, took mask off face, was still feeling very hot, Face was bright red, lips were very red (looked like I had on makeup and I didn't have any on). Took 4 children's Benadryl (dissolvable). Went back to work. redness started to go away. Throughout the morning, I continued having the feeling of breath being taken away and the taste. It wasn't as bad, so I didn't worry. My lips were not too swollen, face was still swollen. I have had MANY reactions to food allergies and didn't wanna "cause" a scene. By 1:30, I was in a meeting trying to talk and my tongue started to feel thick and it was harder to talk. I took 2 adult Benadryl's and tried to work some more to keep my mind off of the reaction. I ended up being very tired and laid down. I slept till about 5pm and seemed okay after. Nothing else was done. My muscle was sore, no other symptoms.

itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat

Client c/o hot flashes on and off; tingling sensation L finger; slight difficulty of breathing; slight dizziness and states " feels like having anxiety."

After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I awoke to sudden onset face swelling on my right side, severe and sudden sneezing and stuffiness, and a severe asthma attack. We called 911, and in the meantime I took 2 Benadryl and used my rescue inhaler. My breathing was assessed as diminished by the paramedics, and I was taken to the hospital. I was given oxygen and prednisone, and monitored. About 2 hours later I was released.

Immediate reaction, took over care, flushed and itchy progressed to facial swelling and difficult of breathing and was given EPI IM and Benadryl IV, transported Hospital.

pt stated that soon after she received the covid vax she felt like the back of her neck was on fire. She was flushed and itching. When she scratched her skin it would turn into a hive. Her eyes were swollen and looked bruised. She tried to eat a cracker but was not able to swallow. She became nauseous and winded. She went to the ER. Her entire back was red and inflamed. They administered Benadryl. Pt was released and to FU w/ PCP. That night she had some chills and fatigue. When she got up today 3/2/2021 she was super itchy, not able to swallow food and had diarrhea for two hours . She had a virtual appt w/ doctor and was referred to see her PCP. She made an appt w/ PCP. Her Dr. wrote her a RX for prednisone. Told her to take Benadryl as well and to stay off work for a couple of days.

1150AM Swelling throat feels she cant breathe, she refuses Epi pen says it may anxiety 1203 pm Given Benadryl 25mg po vitals stable 1213 Given Benadryl 25mg po, rest in supine position. 1230 feels more relaxed swelling in throat still a little scratchy. 1300 scratchy/swelling resolved. 1320 Sat up on exam table feels fine. ER precautions given, Exited in stable condition.

Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.

S: 41 yo female c/o B/L arm redness from upper arm to finger tips, dizziness, mild throat tightness and facial flushing after 16:10 after Pfizer vaccine that was given at 16:10. First dose of vaccine. No SOB. O: Pt flushed, arms reddened and feeling uneasy. B/P 130/100, Pulse 98. RA STATS 99%. RR 16. Lungs CTA. Benadryl 25 mg PO at 16:29, water and reassurance. B/P at 16:41 126/82, Pulse 94, SATS 100%, Lungs clear, B/L arms normal color. Hands remained chapped and reddened (too much hand washing per patient). A: Mild allergic reaction to Pfizer vaccine, first dose. P: 16:56, patient improved, refused further care, refusal form signed and instructions given for post care and worsening symptoms. Pt discharged to home via W/C to care. Instructed to F/U as noted.

face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.

Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness. onset within 30 minutes of vaccines. taken to Urgent care, received epinephrine injection, then transferred by ambulance to Hospital ER. given IV diphenhydramine and IV decadron. chest pain. normal ECG and troponin. They did not check tryptase.

heart rate suddenly increased; throat felt tight; felt very warm in the head and neck like was flushed; felt very warm in the head and neck like was flushed; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL9265) via an unspecified route of administration in the left arm on 30Jan2021 10:30 am at a single dose as Covid vaccine. Medical history included known allergies to penicillin- anaphylaxis. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Approximately 5 minutes after injection, heart rate suddenly increased and throat felt tight, and felt very warm in the head and neck like was flushed on 30Jan2021 10:45 am. It passed after a minute or two, then happened again around five times within the hour after injection. No treatment was provided for the events. The patient had no Covid prior to vaccination and has not had Covid tested positive post vaccination. The outcome of the events was recovered on Jan2021.

About 10 minutes after her vaccine she started feeling throat thickness and was able to swallow so she received 50mg of Benadryl PO. About 10 minutes later she said that she thought it was helping. About 20 minutes after the benadryl she started having dizziness/lightheadedness, visual field narrowing, worsening throat swelling with frequent throat clearing, and tingling in her hands, epinephrine pen given L thigh. After 5 minutes without improvement Epinephrine pen given R thigh. No rash/hives noted. Vitals were stable the entire time with SpO2 of 100%, RR 18-22, HR 84-98, BP 100-138/60-86.

Flushing feeling in face 7 minutes after vaccine was administered, then over the next 7-8 minutes there was an increasing feeling of throat tightness. It started on the right side of throat, then the left a few minutes later. Eventually a feeling of pressure behind eardrums and a little trouble swallowing. Epi was given approximately 20 minutes after vaccine was administered, then a dose of Benadryl. Paramedics were called, transported to ED for observation for 4 hours. Symptom of tightness in throat improved within minutes of Epi, returned after a few hours with less severity. That feeling took a few days to completely subside.

A few hours after the vaccine the pt became short of breath and wheezy, shortly after became itchy. She used her albuterol inhaler, took Benadryl and went to sleep. Today her itching returned today and she devolved a rash and hives. She came to the ER, was treated with Benadryl, Pepcid, methylprednisolone, and IM epinephrine, and IV fluids. Her symptoms resolved in the ER and she was observed x2 hours, and discharged with a prescription for oral steroids.

o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient states she got her COVID vaccine today and rapidly started feeling SOB, dizzy and feeling tired. Per EMS, patient did receive one IM of Epi. o Time Seen 02-17-2021 11:49 o Historian patient o Objective Statement 41-year-old female brought to the emergency room by EMS for allergic reaction. Patient says just prior to arrival she received first dose of her Covid vaccination. She said she was waiting after she received her vaccination when she began to have difficulty breathing, lightheadedness and nausea. She was given a IM dose of epinephrine and sent to the emergency department for further evaluation. In the emergency department, she says difficulty breathing has improved. She said she is now having some chest pain. She says pain is across the anterior chest, pressure-like. She said she also feels nauseous. Headache, throat tightening, rash, pruritus, abdominal pain, vomiting, diarrhea, dysuria, paresthesias or focal weakness. She has never had an allergic reaction before. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough. Positive for chest tightness and shortness of breath. Cardiovascular: Positive for chest pain. Negative for leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. There is no pharyngeal erythema or edema, uvula midline no stridor, patient handling secretions with no difficulty NECK: Supple, non-tender; no meningismus LUNGS: Patient in mild respiratory distress, tachypneic, lungs CTA. Normal air movement. HEART: Tachycardic with regular rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1250: On reevaluation, patient resting comfortably in the room. She said she is feeling much better. She is no longer having any difficulty breathing. Chest pain has resolved. Her vital signs have normalized. She is no longer tachycardic. CBC shows a mild leukocytosis. CMP does show hypokalemia. On her EKG she does appear to have some U waves. EKG shows sinus tachycardia, no ischemic changes. Chest x-ray unremarkable. Potassium was repleted. On arrival, patient was given Benadryl, Solu-Medrol, Pepcid. She was given epinephrine at the vaccination site so no additional epinephrine was given here and at this point I do not feel she needs an additional dose. We will continue to monitor the patient in the ED. 1520: On reevaluation, patient is resting comfortably in the room. Her vital signs remained stable. She is not having any symptoms. No chest pain or shortness of breath. We will discharge the patient home. We will give her prescription for an EpiPen. Discussed warnings indications to return to ED. Told patient she should contact her primary care provider to discuss whether or not she should receive the second dose. Patient understands and agrees with the plan.

Skin became hot, burning, difficulty swallowing, difficulty breathing, anxiety, dizziness, light headed. Took benadryl po 50 mg. Was seen at ER. Received albuterol neb, steroids IV, and prevacid PO. Sent home with po steroids and benadryl. S/S improved after treatment.

Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021

I was 32 minutes past receiving the vaccine when my face felt hot. I looked in the mirror and saw that it was. After about thirty more seconds I had trouble breathing and eventually could barely breathe. My face was puffy and my eyes started to close. I received IV Benadryl and two other medications which I can't remember.

Heavy sweating, nausea, numbness in hands, dizziness, shortness of breath, fatigue. Lasted for about 10 minutes. Still feeling very fatigued.

Patient verbalized to vaccinator she was feeling shortness of breath immediately after receiving 1st dose of Pfizer vaccination. Patient became diaphoretic. Vital signs monitored, EMS activated by site lead, patient remained safe, husband contacted and came into facility to retrieve patients belongings. EMS arrived and assessed patients vitals. Patient transferred to Hospital for further evaluation. Vital signs upon transfer B/P 134/75, HR 76, O2 saturation 100%

2 minutes after injection, right arm went numb, heart racing at 120 bpm. High blood pressure. Then irregular heart beat, rash on neck and chest. Nurses administered 50 mg Benadryl. 10 minutes later, heart racing again and inability to catch my breath. Dizzy and light headed. Irregular heart beat. Pulse ox was ok throughout. Total time of nurses observing these symptoms was 45 minutes. Two days later, still light headed and dizzy.

Patient complained of nausea and lightheadedness about 15 minutes after receiving the vaccine. She denied itching, hives, swelling of tongue or throat. Did not feel faint. Approximately 30-40 minutes later she had improvement of nausea and lightheadedness but felt some swelling on left side of throat. Physical exam still WNL. She declined paramedics. She wanted to leave and was felt to be stable. Did not become syncopal on standing. She is "7 belted mixed martial artist." Planned to return home and possibly take Benadryl. Left at approximately 3:50pm

1124 PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY. THEN C/O FEELING NAUSEATED WITH DRY HEAVES, PRESSURE IN RT. EAR AND HEADACHE: 1145. 1150 LOWERED TO THE GROUND, STATING SHE COULD NOT BREATHE. EMS CALLED. EPI VIA IM (PEN) ATTEMPTED X3, 3RD DOSE SUCCESSFUL. EMS ARRIVED SHORTLY AFTERWARDS.

1/13 vaccination About 6 hours later, I started to feel hot, feverish, to feel really sick. I didn't think much about it. I went to work, thought was a sinus infection. Went home, and felt horrible. 1/14 didn't feel great but went to beach for my birthday. It went downhill from there. I got really really sick really fast. 1/17 rapid test; positive. *still very fatigue, hard to describe the feeling. I get winded really easy. **it really did affect me; 'put me in a dark place' / the mental part is really worse then the body part.

Patient felt faint nearly immediately after but said she wasn't having problems breathing. She was told to breath deeply and she quickly started feeling "a little better" so she was helped to a chair with arm rests in the room. She said she had an orange in her bag, so she started eating her orange. Just a minute later she said she was going to pass out, so the pharmacist caught her. He held her up in the chair and tried to revive her for a few moments but noticed that the blood was draining from her face and her lips were turning blue so yelled for one of his technicians to call 911 and the other to grab an epi pen. He then lowered her to the floor in case he needed to begin to resuscitate while the technician brought him the epipen. While lowering her she urinated on herself. As the pharmacist went to check her vitals before administering the epipen and beginning cpr if necessary the patient suddenly gasped once and her eyes opened widely, but not continue to breath. Upon inspection in her mouth there was a piece of orange near the bottom of the throat. The pharmacist asked if she was choking and she did not response at all, but did not start visibly breathing either. So the pharmacist swiped the piece of orange out quickly, in case it was either previously lodged or patient would have to be resuscitated. She did not seem to enjoy this and this seemed to wake her up and she quietly gasped not choking. She started to quickly improve and admitted that she was feeling better, and had passed out before after getting blood drawn but never after a shot so didn't mention this. While this was happening a police office was going through the drive through so the technician called him in for assistance and he arrived around this time. He asked her a few questions like "what's her name, who's president, how many quarters are in a dollar" which she was able to answer. She said she was mostly embarrassed and was feeling much better. She sat up in the chair again about the time the emts came in. The checked her out, but she didn't want to go to the Emergency Room. She was driven home by her father. I called her later around 6 pm that night and she said she was feeling totally fine and I advised her to please call her PCP and discuss this incident with him or her.

Patient received her covid vaccine at 9:50am. She was in the observation area. She stated she couldn't breathe at 9:55am. She showed no signs of any breathing difficulty. Patient reported a past history of anaphylaxis to bee stings. At 9:57am 50mg of Benadryl was given. 9:58 am she reported she was sweaty, had blurred vision, and was hot. At 10:05, patient said she started to feel better. We asked that she wait the full 30 minutes. By 10:20am, she was feeling fine and the symptoms had resolved.

Within an hour of receving the vaccine, I became dizzy, had face tingling and arm tingling and felt mentally foggy. As the day progressed, I felt a fullness in my throat and fatigue. Over the next week, the dizziness became worse, I experienced intense headaches and shortness of breath for several days. I had difficulty sleeping and vivid dreams. I have had thyroiditis twice in my life after giving birth to my 2 children with similar dizziness and throat fullness. I decided to contact my doctors and had my thyroid levels checked. My TSH was abnormal and my doctor thinks I could be having another episode of thyroiditis. My menstrual cycle arrived a week early. Following this, I continued to have dizziness, throat fullness, and intense headaches. I developed sore breasts and breast discharge as well as in increase in frequency of urination. I decided to postpone the second shot until I was feeling better as past episodes of thryoiditis took about 2 months to resolve. My next menstrual period was a week late, also accompanied by mood swings, breast tenderness and intense headaches. SIx weeks later, I continue to experience occasional dizziness and throat fullness and increased urination. Prior to the vaccine, I was feeling fine and it seems like the vaccine triggered some kind of hormone/endocrine response in my body. I have not had reactions to any vaccines prior to this. I am quite hesitant to receive the second vaccine and am wondering if I should wait a period of time and try something different such as the Johnson and Johnson one. I? not quite sure what in the Pfizer vaccine ( perhaps the mRNA?) could have triggered this reaction in my thyroid and endocrine system. and would appreciate guidance on what to do next as I would like to be fully protected from COVID-19 but do not want to endure these unusual side effects.

1/10 vaccination I was in the 15 min observation, my throat tightened up. I thought anxiety. I left and feeling never went away. Wheezing, coughing. Dr. informed me I had exercise induced asthma. called pcp 10 days later when symptoms not going away 02/2021 ENT; allergic reaction. Inhalers, antihistamines. No skin reaction tests. Suggested to get 2nd vaccine. *still having tightness in throat

Resting heart rate in the 140s, normally in the 80s with heavy pressure on chest started 1 day after shot and lasted for 2 days followed by asthma symptoms.

About 5 minutes after patient came back out into the waiting room she waved the technician over saying she was not feeling well. RPh went out to her and she reported feeling light headed and having trouble breathing. Her breathing did not sound labored and she had no swelling anywhere. We asked her if she wanted us to call an ambulance and she declined. She reported that she had not ate or drank anything all day so we gave her some OJ and a granola bar. She sat in the waiting room under RPh and technician supervision for about another 20 minutes until she eventually felt ok enough to leave and drive.

Shortly after the vaccine was administered, pt endorsed feeling as if a "lump" was in her throat. Felt some tightness with swallowing. No SOB, wheezing, nausea/vomiting, urticaria. Normal vitals and exam, post oropharynx clear, no angioedema and no wheezing on exam. Pt given oral Benadryl, a nd observed in car for 30 minutes prior to discharge

Client was in the monitoring room after receiving first dose. Reported to the nurse felt like throat was swelling and having difficulty breathing and swallowing. Nurse reported client was visibly having a hard time with breathing. Client reported felt weak and legs felt "like noodles." Epi Pen given Left thigh. 911 called . Client accepted transport for further evaluation.

Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.

Pfizer-BioNTech Covid 19 Vaccine EUA Tight throat about an hour after vaccine injection. Tight throat lasted 14 days. Took ibuprofen . Itchy all over after 24 hours. Lasted 14 days

Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship 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.

Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

RN notified vaccine administrating RN from facility after pt. c/o itchy lips, weakness and feeling "fait" in post-vaccine waiting room. At 2:05 with pt. experienced difficulty breathing. RN gave epinephrine 0.5ml pt. on R deltoid. Then, 911 was called. Pt. was examined by paramedics refusing to go to ER. RNs encouraged pt. to see PCP. Pt.'s husband was called by pt. for ride home.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium

Patient is a 41 Y female who presented today for COVID Vaccine c/o of scratchy throat, throat tightness hoarseness, able to speak in full sentences, able to drink water without difficulty remains on RA no hives/rash noted, monitored closely. States throat tightness is resolving, remains on RA. 1133-patient states symptoms continue to resolve, and is ready to for discharge. BP 153/99 Pulse 81 Temp 97.4 °F (36.3 °C) (Temporal) SpO2 99%

3-24-21 7:06PM PT STATES 'CHEST TIGHT/PRESSURE, SOB, NAUSEA & LIGHT HEADED'. A/O, W/D, RESP REG WITH EASE. NO DIFFICULTY SWALLOWING. NO ACUTE/OBVIOUS DISTRESS. 7:15 AMBU TO BATHROOM. 7:26PM STATES SHE 'FEELS BETTER AND OK TO GO HOME'. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. RESP REG WITH EASE. NO DISTRESS NOTED. 3-25-21 8:15 TC: PT STATES SHE IS 'ALL BETTER TODAY'.

Severe allergic reaction to 1st does of the Pfizer vaccine. After 15 minutes "throat clearing" started and between 25-30 minutes my throat got "thick" and my body began tingling all over. My breathing became labored and difficult, my lips were numb. I was immediately administered an EPI pen, and was transported by ambulance to the ER . I was also treated with albuterol, solumedrol, and benedryl. I remained in the ER for the entire day, and was discharged in the evening. I was prescribed Claritin, and prednisone, and given an epi pen. I followed up with my doctor on the following Monday, still experiencing chest pressure and numbness/tingling in my throat/face. The Claritin was continued, and the prednisone was extended. I followed up with another doctor on Wednesday as symptoms were not resolved. Claritin has been increased and am trying to phase out the prednisone. I continue to suffer from tingling in my lips, and chest pressure. Doctors have no idea how long symptoms would last.

I experienced left sided chest pain 2 days after the vaccination lasting 2 days. Then 4 days after the vaccine, some back/Lung pain causing difficulty and painful breathing lasting for at least 3 days. I went to the Emergency department 6 days after the vaccination. I am reporting this information on the 8th day of vaccination.

24 hours later, I developed issues with my throat. I have spasms that feel like my throat is tightening up. This has been going on for 3 weeks. I have trouble swallowing and i constandly feel like something is stuck in my throat.

Headache, Myalgia, CoughWheeze, Syncope, chest pain Narrative: 3/12 0830 second dose of COVID-19 Pfizer vaccine. 3/12 1230 onset of headache which is persistent as of 3/19. 3/13 onset of cough, body aches, and chest pain all of which resolved within 2 days. 3/14 onset of diarrhea which lasted through 3/17. 3/25 - Employee reports headache is better, but still has slight headache in the morning. Her diarrhea resolved as of 3/20.

This could certainly represent allergic reaction which she has had the vaccines in the past. She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours. At no point did she worsen or express a desire to have an additional epinephrine dose. She was never hypotensive. She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76

2 days after 2nd dose all day moderate headache and nausea, 3 days after 2nd dose woke up at 4am with tingling in lungs and shortness of breath.

41 yr/o female covid vaccinee this AM First dose of pfizer Medication and food allergy, but no vaccinee Throat tight, hot, scratchy Tingling sensation No swelling sensation No rash, itching No dyspnea, wheezing Got benadryl 50mg IM Mild improvement

Red rash formed on left neck within 14 hours. Rash worsened day-by-day to where it infected all body parts, especially the face and neck. Intense itching and redness. Shortness of breath on day 7 and 8. On day four, prescribed two Zyrtec a day and Triamcinolon. On day seven, prescribed Prednisone. On day nine, prescribed Hydroxyl, Epineprine 0.3 MG/INJ AMNE, and Aug Betamet 0.05% Oin Foung

Initial dizziness, light-headedness, brief shortness of breath, elevated heart rate 2 days of flu symptoms: mild fever, chills, nausea, diarrhea, headache 10 days (so far) of heart palpitations, elevated heart rate, and spikes in blood pressure

While walking to the observation area after I got the vaccine, I became lightheaded and short of breath. I needed assistance to a chair. Things began to spin, voices sounded far away, I felt like it was hard to breathe and my throat began to close up. I felt really hot - my clothes were soaked with sweat and my husband (and the paramedics) said I was bright red. I genuinely believed I would pass out. When I sat for a minute with my head back I felt more stable. Then I felt like I had pins and needles all over my body, worst in my feet. The symptoms felt like they came in waves - once I sat down I felt less dizzy, but still struggled with my breathing. When one thing got better, another would intensify. After a couple of minutes my breathing felt much better and I got a metal taste in my mouth and my feet really hurt with pins/needles. The whole thing lasted about 8 minutes, when although I felt tired and my clothes were wet, my body felt safe and almost back to normal. I was surrounded by nurses and paramedics who monitored my vital signs and had medicine nearby, but never administered anything. My body recovered on its own and after 15 minutes I felt great and I gathered my things and drove home. The EMT who said goodbye encouraged me to call my doctor if I felt I was getting worse.

Pt received first dose Pfizer vaccine at 1528, at 1550, pt was in observation area and reported feeling "strange" like her throat was tight. Pt has PMH of anaphylactic reaction to multiple medications and foods. Nurse encouraged pt to begin pursed lipped breathing. At 1552 pt became SOB and felt her throat "closing". Administered 0.3mg Epinephrine IM to L quadriceps muscle, applied O2 via mask running at 12L and called 911 for ER transport. BP 138/72, HR 100, O2 sat 99% temp 98.2. Paramedics arrived at 1558, pt was stabilized and transferred to higher level of care.

At 1555 participant walked back into Vaccine Site covid monitoring area and c/o SOB & tongue edema; was post 1st Pfizer Covid vaccine at about 1525. At time participant escorted to monitoring cot and laid down. She explained experiencing chest tightness and feeling of tongue swelling upon exiting building post vaccine; she attempted to sit in car until s/s ended but no improvement. 1555 B/P 151/ 85, P 79, O2 Sat 99% with noted tongue edema / SOB. 1558 Called 911 and on site clinical assist alerted. 1559 Benadryl 50 mg IV given via left deltoid by RN. 1600 BP 140/82, P 71, R 18, O2 sat 99%. Noted allergy hx; yeast, mold, grape seed oil. 1603 Participant voiced feels decrease in tongue swelling and more relaxed feeling; no noted skin redness - BP 122/89, P 70, O2 sat 99%. At time EMS arrived on scene and began assessment. 1610 EMS assessment completed and participant declines transport to hospital; voiced will monitor self at home & call 911 if s/s return. 1614 BP 140/83, P 73, R 18, O2 sat 99% with visible noted decrease in tongue edema. 1615 Participant remains semi reclined on cot and making attempt to contact husband for transport home. 1619 took few sips of H2O with no difficulty swallowing. 1626 BP 115/91, P 62, O2 sat 99%. 1629 Attempted to stand participant and noted c/o dizziness, HA and feeling that tongue edema was returning; returned to cot in lying position. Assessed; clear lungs, noted increase in edema, no SOB - O2 sat 99%. 1630 EMS called to site; BP 148/96, P 62, O2 sat 99%. 1637 EMS arrived on scene and resumed care. 1641 Participant leaves site via stretcher with EMS for transport to hospital. Participant's husband arrived on scene and given participant's purse and car keys per her approval.

TIREDNESS, MUSCLE PAIN, CHILLS, SWEATS, JOINT PAIN, FAST HEARTBEAT, DIFFICULTY BREATHING, WEAKNESS AND DIZZINESS

Status post vaccine- hyperventilation, shaking. patient c/o trouble breathing had some patchy redness to neck which resulted in epinephrine being administered IM per Dr. Epinephrine administered at 1831. BP 138/82 HR 78. PT was transferred to the local ER for further evaluation and was released at the ER.

Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.

After 15 minutes c/o left sided headache, left neck pain, tingling in feet and felt like her "throat was closing". Medicated with 60 mg Allegra as per vaccine protocol. O2 sat in 100%. Transported to ER in wheelchair in no acute distress.

Pfizer-BioNTech COVID-19 Vaccine EUA 41-year-old female with history of anaphylaxis to fish and cashews, asthma, aortic stenosis, eosinophilic esophagitis, and chronic idiopathic urticaria presenting to emergency department for chest tightness, dyspnea, nausea, vomiting, and throat discomfort following 1st dose COVID-19 vaccination (Pfizer). Vital signs remained normal and stable during this ED visit. On presentation, patient was in moderate distress. Physical exam was notable for retching and tachypnea upon arrival. Patient's presentation consistent with anaphylaxis likely due to COVID-19 immunization (Pfizer). Epinephrine, famotidine, benadryl, solumedrol, zofran, and fluids administered with complete resolution of symptoms. Patient observed for 4 hours without worsening of symptoms. Patient discharged home.

Patient received 1st dose ofCovid vaccine & was anxious about receiving it. I gave the vaccine at 10:40 & She started to have tingling in her hands about 15 mins after. I took her blood pressure at 11:00am because she was getting dizzy/lightheaded. It was 135/85 & her pulse was 85 so I believe she was getting more anxious. At 11:05 she stated that she was having trouble breathing, so I confirmed with her several times that she was having trouble breathing & gave EpiPen in left leg 0.3mg then called 911. She felt like she was breathing easier but was going to pass out so had her lay on her back with feet elevated until paramedics arrived.

Patient developed rash, itching and throat swelling shortly after administration of 2nd Pfizer COVID vaccine dose. Treated with IV Benadryl 50mg, symptoms resolved within 15 min.

angioedema; Developed lip swelling; difficulty breathing; mouth numbness/tingling; mouth numbness/tingling; dizziness; This is a spontaneous report from a contactable other health care professional. A 41-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-years-old, intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the vaccine clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone, Pepcid, and Allegra, after about 2 hours of observation in ED with swelling decrease and no shortness of breath. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown the patient has been tested for COVID-19. Event outcome of lip swelling (angioedema) was recovering, of shortness of breath was recovered, of the remaining was unknown.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that the events are related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Within 5 min of receiving the shot there was a minor itch such as a tag rubbing my neck. I am not an itchy person so I noticed it right away, but ignored it. Then with in the 10 minutes I felt an elevated breathing as if one were hyperventilating. I told myself that I was probably anxious any that too went away within 3+ minutes. The itch continued to increase after leaving the site, and by 6 pm it had become like an ?morphine drip? type itch . An itch that you get after a procedure in a hospital and they give you opioids. An annoyance but harmless. This has continued for 3 days. After the first day, I asked a pharmacist what would be recommended for the itch. She suggested benedryl. It worked for a short period of time 1 1/2 hours. Calamine lotion was also tried with a cool shower. After the 3 day I went to the urgent care where no testing was done, but I was prescribed hydroxyline

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Weakness-Severe, Additional Details: Vaccine and Epi-pen administered by RN - 618-830-0993

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild

Approximately 45 minutes after shot administration, patient began to feel light headed, dizzy, and onset of flushed face and ears, nausea. She was still onsite and presented to facility's ED. She presented to the ED at 11:22, there she started to experience a thick throat that was phlegmy, a blotchy rash down back and across chest. Also noted from ED MD other symptoms she was experiencing tingling in her fingers and hands, she began to hyperventilate and a tight feeling in her throat. Her medical course of treatment was labs were drawn at 11:28. Epinephrine administer subq at 11:30, iv fluids (sodium chloride) started 11:40, DuoNeb at 11:45, diphenhydramine HCl and methylprednisolone administered at 11:51, and famotidine at 11:56. Outcome: all treatment gave positive results, symptoms much improved, and patient was monitored for any further development and was discharged at 13:25.

tightness in chest, tightness in throat, hoarseness burining sensation in throat 50 IM Benadryl given in right arm

High blood pressure, trouble breathing, swallowing, sharp abdominal pains. Fever Crushed 2 Benedetto and swallowed within 0 minutes of taking shot. Took Tylenol and Pepcid AC. Took third Benadryl later in evening.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Anxiety-Medium, Systemic: Hyperventilation-Mild, Additional Details: Patient was extremly anxious about getting the vaccine prior to the administration

Patient was in her 15 minute wait after vaccination, and complained of swelling, itching, tingling, difficulty in breathing, coughing and gagging while in our observation tent. Client was brought inside by wheelchair to our emergency area for further evaluation. Client was answering questions, pulse ox read 100%, pulse 106. Client had increased complains of tightness in throat, was coughing. 4:11 pm- 0.3 Epi pen given in right thigh. Lot # OFM534, exp: 9/20222. Call made to 911. Client then lost consciousness, eyeballs were fluttering underneath lids. Sternal rub- did rouse client, but then she became unconscious again. Daughter then reported a history of allergy to MRI dye, Pulse 110, 2 L O2 started. Client remained unresponsive, but was breathing normally. 415- call to Dr to assess whether Benadryl should be given or not- since client was unconscious. 415 shaking/chills began, and daughter reported history of non-epileptic seizures, but none since 2019. 416pm EMS arrived- IV started and seizure #2 witnessed by EMS. Seizure meds given per EMS- client transported to hospital.

Patient states after the vaccine, she developed wheezing, shortness of breath, headache, cough, and hot flashes. She states her chest feels tight, but denies any irritation or swelling in her throat.

Started after going to bed night of vaccine. Severe body pain, sharp shooting pain in bones, severe headache, difficulty breathing, fever, sore throat on left side of throat only, fatigue, severe pain in left shoulder where injection was that felt like pain in my rotator cuff, unable to lift arm to take shirt off.

Developed abdominal pain 4/7. Diagnosed with acute appendicitis 4/9 and underwent laparoscopic appendectomy 4/9. Also incidentally noted to have complex cystic pancreatic tail mass up to 8.3 cm with 7mm and 4mm RLL subsolid lung nodules. Patient has been discharged after appendectomy, and further workup of the pancreatic mass is planned. The appendicitis AE is resolved, but the pancreatic mass and lung nodules (likely not related to vaccine) are ongoing at this time.

Within 20 minutes, my body felt like a sandbag with dizziness and my equilibrium was off balance followed by a sense of falling forward. Paramedic took my blood pressure and oxygen. He offered to get me ride to hospital. I declined. I decided to call my doctor, then I started to feel allergic reactions with tingling nose lips and tongue and also back of throat was itchy and scratchy. I felt out of control. Doctor asked me to come to office and get seen. Within an hour, my symptoms worsened. I had a hard time walking and the doctor assessed me. Looked at my throat and listened to my lungs. I was wheezing. I had to take high doses of Benadryl and a steroid. I was told if any symptoms worsen, I have to go to hospital. I had all symptoms for 48 hours before I felt a turnaround and things lessened. I was not able to do much at all and could not go to work. I have continued symptoms with asthma and some allergy reactions that are lingering.

Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Embolisms in both lungs; transferred via ambulance as medical emergency to another hospital for treatment Released from hospital on 4/11/21 and currently under treatment

Pt, approximately 25 minute safter vaccination, developed urticaria, shortness of breath, and complaint of tightness in her throat. Pt assessment showed patent airway with rhonchi for which she was given .3mg Epinephrine IM and 50 mg Diphenhydramine for urticaria. Pt recieved no further medication and was transported via emergency services.

Pfizer-BioNTech COVID-19 Vaccine EUA. Shortly after injection, during the initial 15 minute waiting period until 5 or 6 hours later, there was a weird taste in my mouth and a tightness in the back of my throat, as though the glands were swollen and constricted my throat making it uncomfortable to swallow. There was no pain. Between a rating of 1 to 10, the discomfort level was about 5. I also felt weakness in my whole body and walking felt strange and lasted for the entire day. The injection site has mild soreness even 24 hours later.

My lymph nodes in neck became very painful at 7 am and got worse through the day. I had to leave work bc pain was so severe. I had bad wheezing and a terrible cough. I now three days later still have swollen lymph nodes, low temp, and hot sweats.

I received my 2nd Pfizer\BioNTech vaccination on 2/12/21 at approximately 4:00 p.m. Around 10:00 p.m. to 10:30 p.m. on 2/13/21 I began to experience severe chest pains and heart palpitations. When I attempted to lie down that night I also had difficulty breathing. **It should be noted that I had not previously experienced any chest pains/Shortness of breath prior to receiving my second dose of the aforementioned vaccine.

Dizziness, numbness in face, tongue, and throat feeling tight. 4:00 PM Vital Signs: BP 116/78 HR 40 O2Sat 97% Skin Signs: Diaphoretic, Other - Cool fingers Circulation: Cap Refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Approx 10 min after vaccine, tongue and lips began to feel slightly numb. Briefly a little dizzy, but that soon passed. Taken to triage at 4:05 PM when numbness increased. 4:15 PM Vital Signs: BP 124/76 HR 66 O2Sat 98% Skin Signs: Cool and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally 4:30 PM Vital Signs: HR 69 O2Sat 96% Skin Signs: Cool and dry 4:40 PM Vital Signs: BP 130/78 HR 67 O2Sat 99% Notes: Decision made to call husband to transport to hospital. Face and tongue feeling worse. 5:00 PM Vital Signs: BP 132/80 HR 62 O2Sat 99% Sent to ER with husband 5:10 PM 04/14/2021: 11:45 AM: Follow up phone call to patient. Doing very well today. Stated she was observed in ER for 1 hour last night. Symptoms gradually subsided over 4 hours. No treatment needed.

Per Client received Pfizer COVID 19 vaccine second dose on 3/28/2021, at 1:00pm in left arm. Client C/O symptoms starting on 3/28/2021 around 9:00pm, fever and chills. ON 3/30/2021 started having difficulty with breathing, chest pain, racing pulse an increased blood pressure through 3/31/2021, so the Client went into the ER on 3/31/2021. In ER Client had a CT of chest performed and is currently wearing a internal heart monitor for other medical concerns present prior to vaccine. Per Client some of symptoms have subsided and Client will plan to follow up with PCP. PHN suggested that Client continue to monitor symptoms, follow up with PCP and go back to ER if needed and call 911 for medical emergency.

Patient with complaints of tightness of throat, but could breathe very well, she stated. Vitals initially were B/P 170/100, HR 61,, R 20. O2 saturation 99%. Offered rest period. Offered EMS transport for further evaluation at the Emergency Room and Patient declined. After rest, patient drank water and tolerated this well. Second set of vitals after rest and water were: B/P 124/89, HR 60, R 20, O2 saturation 99%. Patient stated she felt better, and was transported to her vehicle per wheelchair for release.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe

Throat was "thick"; Difficulty breathing; Entire body tingling; Facial numbness; Throat clearing occurred; Severe Allergic Reaction to Vaccine; Chest pressure; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, in the left arm on 20Mar2021, 10:15AM (batch/lot number: ER2613) at 41 years old at a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Public Health Clinic. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient had previous allergy to Rituxin. The patient did not receive any other medications within two weeks of vaccination. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 20Mar2021 10:15, the patient experienced severe allergic reaction to vaccine (allergy to vaccine). It was reported that after 15 minutes (at 10:30), throat clearing occurred (throat clearing). After 25 minutes (at 10:40), throat was "thick"; patient experienced difficulty breathing (dyspnoea), entire body tingling (paraesthesia), and facial numbness (hypoaesthesia). EPI was administered at the site, patient was transported by ambulance to ER where steroids and other medicines were administered. The patient remained there until evening. Patient still have to take medications and her doctors have no idea when symptoms including chest pressure (chest discomfort), breathing difficulty, facial numbness and tingling will subside. Patient was on hold with Pfizer's vaccine line for 1 hour 45 minutes and was then cut off. Patient demanded some answers. Therapeutic measures were taken as a result of the events which included continuing multiple medications. The events resulted in ER visit/ urgent care and Doctor or other healthcare professional office/clinic visit. Patient was recovering from the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in both lungs). Context: After the first vaccine (about a week before my second vaccine), I self diagnosed myself with a calf injury due to extreme pain in my calf that felt like a continuous cramp. The extreme pain lasted until my second shot (about a week). When going for my second shot, I reported a rash with hives on my lower abdomen that had appeared within five hours of my first shot, so they requested I stay a little longer for observation. That night I began having some breathing difficulties, but assumed they were to be expected. The breathing difficulties continued to get worse until my nurse practitioner told me to go directly to the nearest ER (2/16/21), where I was officially diagnosed with multiple bilateral pulmonary embolisms. I was admitted to healthcare facility for 24-48 hours, until an EKG revealed heart abnormalities that caused them to use a physician's transport to move me to another unit. I was discharged from the hospital on 2/2/21 after I stabilized from heparin shots, avoiding more invasive procedures. I have been in ongoing recovery since then, receiving ongoing care from a hematologist and pulmonologist. A little extra context for you - I arrived to the hospital with diabetic ketoacidosis and have an endocrinologist since hospitalization that has diagnosed me with Type 1 Diabetes (previously misdiagnosed as type 2 - I'm now on insulin which is controlling my blood glucose well).

0835 161/110 125 98% RA RR 20 Vaccine 0830 administration by NP who screened patient. Allergy history, explained monitoring for adverse event to patient. Reaction 0835 feeling flush, throat tightness. First responder called and arrived quickly. NP examined LS clear No cyanosis No signs angioadema 25 mg Benadryl liquid given at 0843 0845 to ED via wheelchair with first responder and security guard

Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; She felt panicky, because it felt like her throat was "closing"; very odd, uncomfortable feeling; This is a spontaneous report from a non-contactable consumer reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 in left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced mouth & throat felt numb & tingly. She felt panicky, because it felt like her throat was "closing". It was a very odd, uncomfortable feeling that lasted roughly 1.5-2 hours. It scared her. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered on unspecified date. No follow-up attempts are needed. No further information is expected.

delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.

Developed wheezing, shortness of breath, hives starting a little over 30 minutes after vaccination and progressing to severe enough illness pt took her epipen and quickly get better, also took benadryl before vaccine. Within an hour after using her epinephrine, she felt back to normal.

Minor strider (itchy throat, feeling like I needed to clear my throat) that resolved with use of albuterol inhaler however since vaccination, my asthma has remained acute with around the clock use of my rescue inhaler in addition to daily maintenance inhalers.

Heart was racing/ pounding heart; chest pain; chest pressure; shortness of breath; heart palpitations and fluttering; Two EKGs have shown shortened PR interval of 110; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left, at the age of 41-year-old, on 26Mar2021 11:45 as SINGLE DOSE for covid-19 immunisation. Medical history included Pituitary adenoma, seasonal and penicillin allergy. The patient is not pregnant at the time of vaccination. The patient was not diagnosed nor tested for COVID prior vaccination. Concomitant medication included fluticasone propionate (FLONASE). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported), via an unspecified route of administration, administered in Arm Left on Mar2021 as SINGLE DOSE for covid-19 immunisation; and Amoxycillin and Clindamycin and experience allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 12:15pm, her heart was racing about 30 minutes following vaccination. The patient felt pounding heart throughout the night as well as chest pain and pressure. Over the next several days in 2021, the patient felt heart palpitations and fluttering, intermittent chest pain, and shortness of breath. Two EKGs in 2021 have shown shortened PR interval of 110. No other testing has been done. The patient is currently wearing a Ziopatch. The patient did not receive treatments and required physician office visit in response to the events. Outcome was recovering at the time of the report. Information on the lot/batch number has been requested.

11pm the same day I started getting sever aches and chills. This progressed and a fever also developed. I rotated tylenol and ibuprofen all day and ran a 102 fever with that. I was so cold my body shivered uncontrollably at times. The next day a developed a small dry cough and felt winded after walking. My heart rate as elevated all day. My normal resting rate is 60 and yesterday it was 75. After about 36 hours of this my fever broke and I have felt better each hour since. I have not felt this sick due to chills and aches in many years. I found it strange that my the cough stopped within a day. Other strange symptoms included pain the same Location of the shot but in the opposite arm and I got the shot on day three of my monthly cycle, it basically stopped that day which is unusual It normally lasts 5 days.

41 y/o F w/ PMHx panic d/o presenting with difficulty talking, reporting ?feeling a lump in my throat,? chest tightness/shortness of breath, hazy vision, and tingling in bilateral arms/hands 10 minutes after her first dose of Pfizer (given at 12:03 PM - symptom onset at 12:13 PM). Reports symptoms started suddenly with chest tightness and hazy vision which then resolved after approximately one minute. Reports symptoms then localized to her throat and she felt like she had to gag. After 2-3 minutes of having difficulty talking, she reports she feels like she can fully talk again. Reports her throat swelling sensation has resolved and only residual symptoms are a ?caffeine rush feeling? and tingling in her hands. She did not have water or breakfast today and endorsed feeling nervous prior to her vaccine today. Only medical hx includes panic d/o (occasional - last panic attack 1.5 yrs ago). Not on daily or prn medications and never has been; no h/o seeing psychiatry or therapy. Reports her current symptoms feel different than other panic attacks. No other chronic conditions or daily meds. Denies h/o serious allergic reaction to any medications (oral, intravenous, injections). Reports feeling dizzy with Excedrin PO 10 yrs ago. Never been given Epinephrine. H/o hay fever with weather changes - does not take medications. Pt denies swelling of the face, itching of the skin, rash, CP, dizziness, extremity weakness, HA, n/v, or abdominal pain.

20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate to full anaphylaxis but remained a steady wheezing feeling for a number of hours after. It dissipated be evening but returned 4 days later along with tingling in my lips that comes and goes. It continues on and off 2 weeks post vaccine. I do not have any other illnesses or reasons to think this other than a side effect from the vaccine. I do not have a history of asthma either.

The patient received the Pfizer COVID vaccine and did not have any apparent reaction initially. Sixteen days after vaccination, the patient developed pain in her neck and shortness of breath. ER evaluation revealed a DVT in her right brachiocephalic vein and acute pulmonary embolism.

Patient developed hives on their chest and bilateral arms and difficulty breathing with concerns for anaphylaxis. On examination in the ED, the patient was noted to have a urticarial rash, mild oropharyngeal swelling and erythema, inspiratory stridor. Patient was initiated on anaphylaxis therapy after RRT on arrival to resuscitation room, starting with 0.3 mg of IM epinephrine. Also provided 50 mg of Benadryl, 20 mg famotidine, 125 mg of Solu-Medrol. Lactated Ringer's infusion began, received 1L LR. Patient was discharged home after resolution of symptoms.

Ninety minutes after injection, face and lips tingled and went a little numb, lost some feeling. Throat went tight and tongue tingled and lost some taste. Throughout the three weeks since it started it comes and goes in severity but has not stopped. One dose of Benadryl was taken and the symptoms did not go away.

Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma attack, the nurse I seen took me to a curtain room and gave me 6 pumps of albuterol my bp was dropping at first and I was extremely weak and I took 2 more puffs and my BP went up now and the nurse wanted me to go to the ER and I got up and almost fell I was so dizzy I was given Benadryl at the hospital and received chest X-rays and was watched over and I was continuing to take Benadryl and albuterol around the clock, I was itchy all over and I?ve had to take my albuterol more often then usual now even though feeling better my heat rate is all over the place and and my period is extremely off as well clotting, tissue passing as the vaccine is now itchy again and swollen and hurting after 2 days as of your symptoms were gone

At 7:10 am on 4/14/21, I first started shaking uncontrollable because I was so cold w/ chills. Then about 7:30 am I started breathing hard. My eye sight went black for a few minutes, I almost passed out. Both hands went numb for a few minutes. Then I got a fever, highest was 102.7. Had fever off and on all day and body aches then by 2 pm the fever was better. Then at 7:30 pm, I started shaking again and my fever spiked to 104.5. I got it down to 103 and it was like for about 3 hours then it broke. Then for about a week, I was very exhausted and had no energy and couldn't like normal, no appetite. It took me a week to get to feeling better.

I felt a sudden jolt of severe chest pain 2 days after receiving my second vaccine dose. It happened three times, the third time was so intense that I nearly fell on my knees. The pain lasted for about 45 minutes and it hurt to breathe the entire time. I also experienced shortness of breath and fatigue. I felt another jolt in my chest this morning, which was mild and only occurred once so far.

Within 10 minutes of receiving her vaccine she developed dry mouth, nausea, lightheadedness, shakiness, and then a tightness in her throat associated with "gagging."

asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

DVT of femoral vein of left lower extremity, shortness of breath during exertion, cough, diaphoresis, malaise/fatigue, chest pain, flu-like symptoms, POX 96%, woke up at 3am 4/14/21 short of breath and wheezing with POX 94%, headache, dizziness only when short of breath, left leg pain. Pt treated with Eliquis.

Patient called call center on 4/28/21. States she got 1st dose Pfizer vaccine on 4/22/21 at Church. Pt states she got fever, muscle and body aches, headache, fatigue, nausea, abdominal pain and wheezing starting 4/23/21. Pt states fever is gone after 2 days. Pt states she has asthma but have not used inhaler for years and recently used inhaler for her wheezing but only helped for 2-3 hours and the wheezing would come back. Advised pt to go to ED immediately for evaluation and pt states she will have someone to take her.

feeling of blood moving in arms/legs with cold sensation.; Face numbness.; SOB; Events of low blood sugar (not diabetic); Dizziness; Clammy feet; Very scary; Thyroid was in rage during this event; This is a spontaneous report from a contactable health professional (patient). A 41-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 41-years-old), administered in Arm Left on 08Mar2021 10:00 (Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included Hashimoto's. The patient had no known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced Face numbness, Dizziness, Events of low blood sugar (not diabetic), SOB, Clammy feet. Most importantly, feeling of blood moving in arms/legs with cold sensation. The patient was hospitalized for the events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The onset of events was 09Mar2021 07:00. The patient also reported that it was "Very scary" and "Thyroid was in rage during this event" on an unspecified date. Went to ER twice weeks apart. Lasted for 3 weeks. The patient underwent lab tests and procedures which included blood glucose: low on 09Mar2021. No treatment received for the adverse events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation). The events (face numbness, dizziness, events of low blood sugar (not diabetic), SOB, clammy feet, feeling of blood moving in arms/legs with cold sensation) required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events "Very scary" and "Thyroid was in rage during this event" was unknown while for the rest of the events was recovered with sequelae (Recovered with lasting effects). Not diagnosed with COVID prior vaccination, not COVID tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Dizziness, nausea, weakness in arms and legs, sluggish, tight throat and chest, itching within 2 hours of shot. Treated at ER with Epi shot, benadryl and other meds. Most symptoms continued day two with fever in cheeks and neck and high blood pressure. Some dizziness, nausea, weakness on day three and four. Treat with benadryl at home.

About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass out, told the nurse I was going to throw up. I was given zofran and Dr monitored Vs. I continued to experience waves of dizzyness, nausea, abdominal pain. Shaking followed (I felt so cold), along with frequent need to urinate and urgency to have a BM (loose) for several hours. I was given fluids and monitored. They gave Ativan 0.5mg 2.5 hrs later? I was discharged home at 8:45p.m. by Dr and told not to get the 2nd Vaccine. Symptoms continued and worsened on day 3 with Shortness of breath, chest pain and tingling in my arms that spread to my legs, back and neck. The first week I could barley walk and was seen in the ER 2 times for chest pain, shortness of breath, dizzyness, tingling, heart racing, diarrhea, nausea, muscle weakness, insomnia due to shortness of breath (gasping) with heart racing, & unable to control my body temperature. Given Prednisone 40mg which exasperated symptoms. 1/13/21 In ER and given Benadryl 3 bags of fluids, potassium and sodium. Postural tachycardia was noticed. Referral to Neurologist.High D-dimer at ER on 1/16/21 CT scan performed to rule out blood clot in lungs. Reffered to Cardiologist. Metoprolol and Colchicine was started in Jan by Cardiologist Dr . Weekly visits with Dr for the first couple months. More meds started to decrease inflammation. Furthur referrals to Immunologist, infectious disease, and Rheumotology. At 3 months worsening of tingling in my neck and headaches/burning that felt like shocks and shooting down neck and ears. Neurologist performed 3 view MRI to rule out transverse Myelitis. In ER early April for new onset of Petechiae, CBC labs normal. Immunologist states he felt i experienced an allergic reaction followed by secondary anaphalaxis. He is testing me for Mast cell activation syndrome (not diagnosed yet). Now almost 4 months later still unable to work. Waiting results to rule out POTS. Currently battle daily fatigue, chest pressure/pain, lung SOB, heavyness/pressure, with any exertion. I am limited with daily walking/normal activities. Symptoms that come and go are tingling, nausea, diarrhea, flushing of frequent urination, neck pain, regulating temperature.

Patient received her 1st COVID Pfizer vaccine at 1658 pm. She developed hives around the vaccine site L deltoid and forearm approximately 5 min post injection. She was given po Benadryl 25 mg po x 1. No report of SOB initially. VS at 1710: 169/104 HR 86 Pulse ox : 96 %. Sipping water without difficulty. 1715: VS: 153/104 HR: 87 Pulse ox 96% room air. States feeling like she is short of breath. Benadryl 25 mg IM x 1 at 1715. 1720: States no improvement, c/o difficulty breathing and feels like her throat is closing up and difficulty swallowing water. Epi Autojet 0.3 mg IM given L thigh x 1. 911 called for transport for eval of acute allergic reaction with no prior history. NO HX of any acute reactions to anything in the past, she does not carry an epi pen. Only HX of environmental allergies to dust and mold. She does not take any regular meds. She felt jittery after the epi but began to improve greatly. 1730: VS: 178/94 HR: 102 RR: 20, states breathing is greatly improved, itching less and hives much less. EMS here, report to EMS. 1745 Patient released in care of EMS to go to Hospital. Feeling much better. VS: 162/68 HR 93 Pulse ox 97%. Does not feel SOB any more, she is breathing easier, able to drink water. Hives gone.

felling of SOB with normal sat; dizziness; nausea; abd pian; elevated HR; headaches; body aches; sore throat; This is a spontaneous report from a contactable consumer. This 41-year-old female (Non pregnant) consumer (patient) reported that she received second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, solution for injection, LOT: EL3302 Expiry date: unknown), via an Intramuscular route of administration in right arm on 27Jan2021 at 13:00, at a single dose for covid 19 immunization. Patient historical vaccine included she received first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, solution for injection, LOT: EL0140, Expiry date: unknown), via an Intramuscular route of administration in right arm on 06Jan2021 at 12:00, at a single dose for covid 19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not tested for COVID-19 since the post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included Clonazepam, fiber, but vitamin D3 and medical history included that 'Botox' done on 20Jan21 for hemifacial spasms on right side of my face. Patient had no allergies. On 28Jan2021 05:00 after received the second dose the patient was feeling dizziness, nausea, abdominal pain, elevated HR, felling of SOB with normal sat, headaches and body aches, on 3rd day better but now with a sore throat, headaches and every some often heart rate going fast. Patient didn't take treatment for the events. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

On day three after my Covid vaccine, after experiencing mostly mild side effects for the first two days, I experienced a severe episode of tachycardia while walking uphill. This is a walk I do three times a week and have never felt this way before. I couldn't catch my breath, and my heart rate remained abnormally elevated for another fifteen minutes. I walked down the hill and spoke to my doctor, who said it was likely a vaccine side effect and I should rest for the day. I continued to experience episodes of tachycardia, with heart rate in the 130s, throughout the rest of the day. I was short of breath just walking to the bathroom. My doctor had me come in and performed an EKG, which was normal. I continued having these symptoms the rest of the day, until eventually my heart rate stabilized after 9pm. The next day I felt very tired, but no longer experienced the tachycardia. I had a follow up at my clinic and another normal EKG. Then yesterday evening, which was day 5 after the vaccine (technically day 6 maybe), I was walking my dog on a flat surface, taking my time, and I became short of breath, with pressure and tightness in my chest. I was unable to get a deep breath for another 30 minutes. Today, day 6/7 after my vaccine, I am fatigued, and continue to feel pressure and tightness in my chest throughout the day. I have asthma, and this feels different, though I have been using my inhaler to try to open up the tightness I'm experiencing. I also continue to have stomach pain and diarrhea since day one after receiving the vaccine. I also had that with the first vaccine three weeks ago--stomach pain and diarrhea.

wild swelling of tongue and throat. given benadryl, symptoms subsided. Cleared by telehealth to go home.

Received 1st dose of COVID vaccine while pregnant on 3/19/21. Subsequently had an uncomplicated vaginal delivery on 3/30/21. Received 2nd dose of COVID vaccine while postpartum on 4/2/21. After receipt of 2nd dose, started to feel unwell, ultimately spiking a fever and clinically worsening on 4/7/21. Presented to the hospital on 4/9/21 with fevers and pelvic pain. Was found to have MSSA bacteremia secondary to left septic pelvic thrombophlebitis. Required broad spectrum antibiotics with a plan for 4 week IV cefazolin as outpatient, as well as therapeutic anticoagulation with lovenox with a plan for a 3mo outpatient course.

within 15 minutes my throat started to get tight. After 15 more minutes it was harder to swallow. The nurses looked at me and noticed hives on my chest, back, neck and up my face. They drove me to the ER where they did an intramuscular shot of benedryl since they could not get an IV into my veins. They tried 8 times between both arms and even had another nurse attempt. Neither were successful. They discharged me 3 hours or so later with prescribing me benedryl 25mg twice a day for three days.

urticaria; allergic process urticaria; swelling of the face; cough; shortness of breath; high blood pressure; dizziness; This is a spontaneous report from a contactable Other HCP, the patient. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 at 10:00 (Lot Number: Ew0150) as a single dose (at the age of 41-years-old) for COVID-19 immunisation. Medical history included allergy to animal from an unknown date and unknown if ongoing and COVID prior to the vaccination on an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication included anti contraception (unspecified product). On 12Apr2021 at 01:00 the patient experienced allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness. The events all required visit to emergency department. The clinical course is as follows: on 12Apr2021 the patient started with a allergic process urticaria on the body and swelling of the face and this condition was getting worse with cough shortness of breath and high blood pressure and dizziness when on 14Apr2021, the patient couldn't stand it and went to the hospital. The patient was medicated with antiallergics and corticosteroids, but the patient still didn't feel well, her pressure keeps going up she still feel dizzy. Therapeutic measures taken as a result of urticaria, swelling, cough, shortness of breath, high blood pressure, and dizziness included unspecified antiallergics and corticosteroids. The patient was tested for COVID post vaccination on 14Apr2021 with molecular test (Swab sample) with negative result. The clinical outcome of the events allergic process urticaria on the body and swelling of the face, cough, shortness of breath, high blood pressure and dizziness 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 reported events of urticaria, allergic reaction, swelling, cough, shortness of breath, high blood pressure and dizziness. There is limited information provided in this report. 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.,Linked Report(s) : PFIZER INC-2021477200 mother/baby

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: Administered benadryl with bottle of water, noticed improvement within 5-10 minutes. No additional symptoms. Monitored for additional 20 minutes with no worsening of symptoms.

sinus congestion, post nasal drip headache fatigued and winded at times, congested and sinus pressure

chills, cough, shortness of breath and headaches May continue to take over-the-counter medication for symptoms such as Tylenol/ibuprofen for fevers and body aches,

large local reaction. Erythema warmth located 2-3 inch diameter surrounding where shot was given left deltoid. Started several hours after the vaccination and has continued now almost 2 months. Still pruritic. She has some dyspnea and tachycardia associated. Some response to topical steroids. This was after the first injection, she tolerated second injection no problem.

Throat tightness, itchy throat after 2nd dose. Patient reported that with 1st COVID-19 vaccine developed itchy throat and mild tightness and received Benadryl. Patient denied shortness of breath and wheezing. Patient reports that she took her own Benadryl 25mg at 11:15 am, about 45 minutes after 2nd dose. Patient also reported that "this time is much better than 1st time" and may be related to anxiety. Stable. Released from vaccination site.

Patienty complained of symptoms of nausea, trouble breathing, tightness in chest, feeling of syncope, itching, tingling of tongue and lips, possible swelling of tongue. ambulance was called and patient went to hospital.

1 shot - By the evening of that day, came home feeling exhausted, headache, took tylenol and slept for 11 hrs. Next day felt less tired and weak but felt normal again by the following day, 2nd shot - Next day had strong headaches, took 600mg tylenol around the clock for 3-4 days. Symptoms include headaches, motion sickness, exhaustion, difficulty breathing which lasted for 7 days. After 1st shot, I haven't had my period which is now almost 3 months. Since my 1st shot, I've been having hot flashes and vaginal dryness. I was thinking these symptons were due to stress but it doesn't explain vaginal dryness. So my dr ordered menopause blood test. My FSH level is at 54mIU/mL. I just started all these symptons after my 1st vaccine shot and my FSH level is very high already.

Within about 1/2 hr, I had mild breathing trouble, metallic taste and itchy tongue and throat. About 24 hours later I (May 12) had a rash covering my chest and stomach with more itchy throat/ tongue (I would say moderate). I went to urgent care and was given a steroid shot and prescription. I continued to have a rash and breathing has gotten worse. I returned to urgent care today (May 15), I was given a breathing treatment and prescribed an inhaler as well as another steroid shot. I am still having symptoms, both rash and labored breathing.

Around 1315 Patient complains of throat tightness and difficulty swallowing. RN observation nurse reports to NP of patient's reaction. After assessing patient, NP administers Epi-Pen for continued throat tightness and difficulty swallowing. Patient symptoms subsided post administration of Epi-Pen. EMS were called but patient refused to be transported. Husband by her side. Educated patient of the importance for continued monitoring of symptoms and to call 911 ASAP. Patient verbalized understanding. Final V/S readings 117/78, P79, 18R, O2 96%,

8 DAYS AFTER RECEIVING VACCINE (APRIL 16TH @ 2:00 PM) - WAS AT ARCADE WITH CHILD WHEN I FELT LIKE I WAS HAVING A HEART ATTACK. THE CHEST PAIN TRAVELED UP TO MY NECK AND JAW, STOPPING JUST BELOW MY EARS. ARMS FELT HEAVY AND ALMOST USELESS (NOT NUMB). PAIN WAS AT A 10 - SENT ME TO THE GROUND, WHERE I STAYED FOR ABOUT 5 MINUTES UNTIL I WAS ABLE TO GET UP. DROVE HOME, CONTINUED TO HAVE CHEST PAIN, AROUND PAIN LEVEL 5. AT 5:00 PM IT HAPPENED AGAIN - THOUGHT I WAS HAVING A HEART ATTACK. INTENSE PAIN LASTED 15 MINUTES. WENT TO E.R. - GOT CHEST XRAYS, CT SCAN, BLOOD WORK. NO EVIDENCE OF HEART ATTACK OR BLOOD CLOTS FOUND. CHEST PAIN HAS STAYED AT ABOUT A 5 EVER SINCE THE ORIGINAL EVENT ON THE 16TH. APRIL 25TH A RASH

Pulmonary Emboli, Shortness of breath started on 4/30/2021, just after arthroscopy of RLE on 4/28/2021.

Blood clot in neck; Shortness of breath (dyspnea); Pressure on her chest; Edema to her feet; Weight gain of 2 pounds overnight; Rash on chest; Rash on chest, possibly due to tape (dermatitis contact); Heart palpitations; Oxygen saturations dropped to 85% on room air; Diarrhea; This is a solicited report based on information received by Pfizer. A contactable consumer reported that a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 03Mar2020 to an unspecified date at 0.041 ug/kg, then at 0.045 ug/kg with therapy dates unspecified, and then at 0.049 ug/kg with therapy dates unspecified, for primary pulmonary arterial hypertension; and macitentan (OPSUMIT) on 11Jan2021, orally from 11Jan2021 at 10 mg, 1x/day for primary pulmonary hypertension. Medical history included ongoing primary pulmonary arterial hypertension. Concomitant medication included sildenafil citrate. On 15Jan2021, the patient had a blood clot in neck. The patient was hospitalized from 15Jan2021 to 16Jan2021 due to the blood clot in neck. It was reported that on 15Jan2021, which is 10 months 13 days after initiating IV Remodulin, the patient was hospitalized due to blood clot in her neck. The patient went to the emergency room on 15Jan2021 and she was planned to be admitted to change her catheter, later she was hospitalized on the same day and her Remodulin central line was changed as per the prior plans of getting the catheter changed. The patient was discharged on 16Jan2021. The patient then had a rash to her chest (dermatitis contact previously reported) that started on 20Jan2021. The patient believed it was from the original dressing that was placed after her catheter was replaced. The rash to left chest around her Remodulin catheter line (dermatitis contact previously reported) was also reportedly itchy at night. On an unknown date in 2021, the patient's oxygen saturations dropped to 85% on room air (oxygen saturation decreased). The patient continued to have rash on her chest (dermatitis contact previously reported). On 29Jan2021, 10 months 27 days after initiating IV Remodulin, the patient was in the emergency room due to increased shortness of breath, pressure on her chest, edema in her feet and a weight gain of 2 pounds overnight. All the tests were negative but during walking test, the patient's oxygen saturation dropped to 85% on room air. The patient was advised to wear mask continuously. 2 weeks after receiving the first COVID-19 vaccine, the patient had heart palpitations, shortness of breath, and chest pressure 2 weeks after receiving the first COVID-19 vaccine (dyspnoea and chest discomfort previously reported). The patient went to the ER (emergency room), had worked up and was seen by a pulmonologist, nothing was found, and the patient was released home. The prescribing physician's practice ordered her to wear oxygen (O2) continuously. The patient said that she only wears it when she leaves the house and at night and was fine. She felt this episode was related to the COVID-19 vaccine and was not receiving the second dose. The patient stated that her physician had took her off the Opsumit due to shortness of breath (dyspnoea previously reported). The events 'blood clot in neck', 'shortness of breath (dyspnea)', 'pressure on her chest', 'edema to her feet', 'weight gain of two pounds overnight' and 'heart palpitations', resulted in emergency room visit. The event, 'diarrhea', was controlled with diphenoxylate and atropine (LOMOTIL). The patient had a walking distance test on an unspecified date in 2021 (results were not provided) and weight was 209 lbs on an unspecified date in 2021. The events, shortness of breath (dyspnea)', 'pressure on her chest' and 'heart palpitations', was reported as serious (medically significant). The events rash on chest, and rash on chest possibly due to tape (dermatitis contact) had not resolved while the outcome of the rest of the events was unknown. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Mar2021): This is a follow-up solicited report based on the information received by Pfizer. Additional information included medical history, suspect drug data, reaction details and clinical course details. Information on the batch/lot number has been requested. Follow-up (04May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the available information the events are most likely related to an intercurrent or underlying condition which is not related to the subject drug. There is a reasonable possibility that the drug contributed to occurrence of the event rash. The follow-up information received does not alter the previous company clinical evaluation. 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.

5/12, 5/13 and 5/14 - Arm Pain, specially when trying to lift anything. 5/15, 5/16, 5/17 - noticed shortness of breath, very sleepy, throat clearing, heavy post nasal drip. Weird taste in mouth. 5/18 - Neck Pain 5/19 - Felt a small moving ball on top of the left side of my collarbone, closer to my throat, it is painful and tender to the touch. My neck feels in pain, actually more like a burning sensation

Within 10 minutes after getting injection - Hives/rash, swelling, increased heart rate and blood pressure; Treated by ems on site with benadryl injection Took 1 benadryl tablet at home - 6pm same evening; Day 1 after - hot flashes/off and on fever with some redness of upper arms neck chest and face - approximately 10 times only lasting a few minutes each time; Day 2 after - muscle aches - all over weakness, odd pressure in back of head in the am lasted for about 20 minutes then moved to side of head and subsided after about 20 minutes Tightness in chest across whole front - felt like lungs were tight - never had trouble breathing or swallowing, but dr heard wheezing on occasion - prescribed albuterol. Redness and warmth/hot flashes a few times again. Went to clinic- explained all symptoms, had evaluation - all vitals/numbers good. Ride it out, side effects have been odd and are lasting longer than 24-48hrs. If not feeling any better by Monday call/get checked again; Day 4 after - slight tightness pressure in upper chest/lungs took 1 puff albuterol, returned after dose wore off. Feeling chills starting in the early afternoon then 1 hot flash. Feeling muscle aches more noticeable in upper legs after am dose of advil wore off; Friday - tiredness, muscle aches, pressure in lungs; Saturday - tiredness, muscle aches, pressure in lungs. Experienced menstrual cramps and spotting. I am on Depo Provera and have not had a cycle or cramps in a number of years. Sunday - pressure in lungs, aches, muscle aches, all morning to mid afternoon. Felt better mid afternoon to evening. At night, 2 hot flashes, pulse up a little; Next few days, continued muscle aches, tiredness, and occasional lung pressure. Overall symptoms lasted approximately 10 days. A month later I still have occasional pressure in my lungs.

Extreme fatigue, headache, slightly felt strangled on and off, body aches, lymph nodes hurt, body felt heavy, foggy brain(felt slightly drugged on and off ), injection site felt stabbed. Started 4 hours after shot on Thursday evening and lasted until Saturday morning. Also Smelled chlorine in my nose in the beginning.

Started with rash on left hand, then on left forearm developed a spotted pin prick red rash. About 5 minutes later, my throat started to swell up. I took liquid children's Benadryl which helped the rash go away and the throat swelling to go down. About an hour total trying to figure out what to do.

Pt had first vaccine and four hours later felt her throat was "closing" off. She did not need any treatment and it resolved. Right after that, a fever of 101 started and lasted 5-7 weeks. The first day she also had a sensation of painful skin all over that lasted one day. SHe had arthralgias and myalgias that lasted a week. A week after vaccine her right grip became weak and she felt n/t at times in her limbs and difficulty knowing where her feet were at times and coordination was off. This resolved almost completely before second immunization. When having second immunization, within a couple of hours later her symptoms of joint pain, muscle pain, lack of coordination and weakness and weakened grips worsened. THis has continued.

High fever - normally 97.6^F, fever 103.3^F; severe headache; lethargic to the point of severe exhaustion - no energy to walk more than 5 steps; central, focal chest pain/pressure at base of the heart/lower sternum that lasted approximately 20hrs, associated mild wheezing/SOB for the last 10 hrs or so of that window. No appetite for 3 days following vaccination. Chest pain/pressure and shortness of breath resolved after ~20 hrs. Headache resolved within 5 days. Fever resolved within 3 days. Fatigue and lethargic resolved within approximately 1 week.

Patient described reaction to first dose as follows: almost immediately after her first Pfizer COVID injection, she states that she felt nauseous and short of breath, then vomited. Per pt, EMS said her blood pressure was ?through the roof? (no exact vitals given). She was observed for 30 minutes, stated she felt much better and went home voluntarily. At no time was epi administered per patient. Today, patient gave her vaccination history from 4/14/2021, stated that she felt fine today and that she wanted to proceed with her second Pfizer dose. It was determined that there was no contraindication and the vaccine was given at 3pm. Within 3 minutes, patient stated that she was having difficulty breathing and was nauseous. EMS arrived immediately, pt coughed up some sputum, vitals as follows: 144/97 105 98% initial temp 101.7, but pt was in the back of a car with engine off and the warehouse was a little warm. EMS repeated vitals 140/88 100 98%. Pt was able to ambulated out of the car to a chair, eyes closed, but at no time did she appear SOB or in any distress, RR remained 16-18 bpm. Final by 128/88.HR 99 SaO2 99%., blood glucose 140, repeated temperature out of the car 99.1. EMS stated that she appeared to be stable, but pt insisted that she did not feel good, was nauseous and SOB, and that she wanted to be transported to a hospital. Pt taken to Arizona General by ambulance, with stable VS and in NAD, AOx3.

After the vaccination, around 9 PM 01/24/2021 I had arm pain that lasted about 12 hours. About 4 days after the vaccine on 01/28/2021 there was a prolonged period of time where my chest felt heavy and it was hard to breath, I felt like I was overweight. It wasn't as bad enough for me to use my inhaler. I had shortness of breath as well. The chest pain lasted about a month and a half. The shortness of breath lasted about a month and a half as well. The air felt very thick. Fatigue was about 2 PM the same day of vaccine on 01/24/2021 where it felt like my body shut down and I had to take a nap.

05/21/2021 Routine Covid-19 screening. later developed fever (subjective), cough, sore throat, shortness of breath, Chills, headache, muscle aches, lost taste and smell, diarrhea and later developed chest congestion.

My first vaccine you had all covid except short of breathe, I was very fatigued, I woke up the nest day after my second shot could not breathe and went to the ER right away.

Night sweats; little shortness of breath; white dots on back of throat; Throat pain; bunch of bumps on the back of her tongue/throat; little cough; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number EL3248) via an unspecified route of administration in left arm on 12Jan2021 as unknown, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was also reported that on 12Jan2021 patient took the Pfizer COVID vaccine and 3 days later i.e., on 15Jan2021, she had night sweats and a little shortness of breath, like upstairs, or if she runs too fast, or talks too much, that was pretty much for two weeks now, then the last 2 days she had white dots, white dots in the back of her throat, and she went to urgent care and it was negative for strep, she was prone to strep. They said it was not strep, she was having throat pain, and now that morning, she had a bunch of bumps on the back of her tongue, and she was given Clindamycin, she wondered if the throat pain was related to the vaccine, she got tested for strep, and they said it was negative so now maybe it was related to the vaccine. Night sweats outcome: if she puts on a fleece blanket, which she loves to as she was always cold, but now she cannot unless she was waking up with a drenching sweat, and she did not sweat. She did not call about the sweats, since she thought she was 41, and it maybe that, but then with more thought it could be the vaccine. She did light jogs up and down stairs, she walked all over the hospital, and never got out of breath, and now she had to stop and breathe in deep. She had a little cough every now and then, and when she went to urgent care, because of the cough and her throat hurting, they did a COVID test, and it was negative. She told them she got vaccinated, they said they would still do the test, it was a rapid COVID, in the office strep and they put strep in the lab for 3 days. For white dots: her throat was hurting a while, and she looked with a flashlight and saw white dots, now states this was more than 3 days ago, the test took 3 days, so this was 4 or 5 days since she saw white dots. Last night, she did not see before the bumps in the back of her throat, she thought she had food in the back of her throat, she felt something there, and she looked at it with a flashlight and now she has bumps in the back of her throat, she tried to remove what was in the back of her throat. She did not see the white dots anymore, before the test came in, when they saw white dots. Treatment included clindamycin which was at home and she has not started. On an unspecified date in Jan2021, the patient underwent lab tests and procedures which included rapid COVID test and strep test with results of negative. The outcome of the events was unknown. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.

Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches approximately from injection; throat swelling; nausea; diarrhea; itching; headaches; chills; dizziness; weakness; congestion; exhaustion; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 12B3) via intramuscular route of administration in left arm on 14Jan2021 at 12:00 PM as single dose for COVID-19 immunization. The patient medical history included hypothyroidism, hypertension, allergies year round and allergies ciprofloxacin, penicillin, peaches, bananas, strawberry, cockroaches, trees, grass, dander, dust, mold, cats and dogs. The patient did not receive any other vaccine within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included, levothyroxine, amlodipine, setraline, losartan and women multivitamin. On 14Jan2021 at 12:15 PM, the patient experienced stinging whelps and hives on injection site with swelling, bump arose 3 inches approximately from injection, throat swelling, nausea, diarrhea, itching, headaches, chills, dizziness, congestion, weakness and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl. The case was considered as non-serious by the reporter. Since the vaccination, the patient had been tested for COVID-19 including nasal swab test on 15Jan2021 with result: negative and throat swab test on 29Jan2021 with result: negative. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Heavy period Trouble with vision Eyelids swollen Erratic Heart rate Blood pressure Shaking Throat swelling Tingling in feet/hands No appetite Weight loss Pressure on chest Cough Ulcers in mouth Neuropathy These symptoms have been going on and have not let up. Currently on Lyrica .

throat felt like she had been talking all day and swollen; felt that they were giving a shot; couldn't get a full breath; right side of her face drooped a little; tongue was swelling; face, lips, eyelids and around them were swollen; intermittent chest pain; heart it felt achy at times; had a head rush; felt very hot suddenly; her ear started ringing and buzzing; she could not hear well; she felt immediately as if someone was trying to put her to sleep; She felt heaviness in her body, and in her chest and said it felt as if someone was lying on top of her.; her nose and mouth started to become gray and blue in color; numbness in her left arm; face, lips, eyelids and around them were swollen; face, lips, eyelids and around them were swollen; couldn't get a full breath because of the heaviness on her chest; fingers stay cold a lot; This is a spontaneous report received from a contactable consumer. This 41-year old female consumer (patient) received BNT162B2 dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: ER8730) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included allergic to shellfish and almonds from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced a head rush after the first dose of the Pfizer-BioNTech Covid-19 Vaccine and felt that they were giving a shot . Everything was normal but when she came home, within an hour and 20 minutes, she suddenly felt very hot, her ear started ringing and buzzing, and she could not hear well. She said she felt as if someone was trying to put her to sleep. When the caller went to wash her face, she noticed her face, lips, eyelids and around them were swollen. The right side of her face drooped a little, it looked different on the jaw than the other side. The caller's tongue was swelling and her throat felt like she had been talking all day and swollen. She felt heaviness in her body like a weighted blanket and in her chest and said it felt as if someone was lying on top of her, it was like she couldn't get a full breath because of the heaviness on her chest. She also noticed that her nose and mouth started to become gray and blue in color but she could still swallow. She also had residual symptoms such as numbness in her left arm , it,feels like its asleep and intermittent chest pain like her heart it felt achy at times. This has gone away but it would come and go and feel like it was lightning, like thunder in her chest. Her fingers stay cold to the touch a lot from where they bend down to the tips more on her left than anything. She did not take herself to the emergency room or the doctor for the events. The caller didn't seek medical care because she had some medications at home that were for allergies from her allergist and it helped with the swelling. The patient reported the medicine was a powder tablet that is dissolvable, unknown name, she thinks she may have used it once, it has numbers on it. The swelling went down to where she felt like she was fine after taking them. The swelling in her face and her eye lids were puffy for a few days. The patient had blood work done the day of the vaccine, prior to receiving the vaccine and an electrocardiogram (EKG). Therapeutic measures were taken as a result of throat felt like she had been talking all day and swollen, tongue was swelling, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen, face, lips, eyelids and around them were swollen. The outcome of right side of her face drooped a little was unknown, recovered from head rush, felt very hot suddenly, ears started ringing buzzing, couldn't hear well, trying to put her to sleep, face was pounding, face, lips, eyelids and around them were swollen, tongue was swelling, felt like something was heavy on her body, heaviness on her chest, blue and gray around her nose and mouth, chest was hurting, trying to put her to sleep, and felt that they were giving a shot on 06May2021, recovered on 09May2021 from face, lips, eyelids and around them were swollen, recovered on 10May2021 from chest was hurting and recovering from fingers stay cold a lot and numbness in her left arm. No follow-up attempts are needed. No further information is expected.

Immediately after injection felt suddenly a hot sensation throughout body, heart started pounding rapidly and uncontrollably, especially on left side of chest, entire left arm started tingling and becoming numb down to my fingertips. I felt like impending doom and windpipe felt like it was starting to close up. I dialed 911 and took two puffs of my inhaler to open up my lungs.

Shortness of breath, severe headaches, dizziness, fatigue, fever after second dose, went to urgent care 5/30 - doctor called over to ER due to coming in with presented symptoms of blood clot in left calf, ER performed ?standard? testing - and was dismissive to any symptoms I reported and my concern that this was related to vaccination. I felt I was dismissed on my overall health at time of ER visit, and was never seen by an actual doctor.

Hives started 30 minutes later, lasted 2 weeks. Took prednisone and benadryl to control them. She also had subjective SOB and dysphagia.

Chills, night sweats, fever of 103.5, brown urine, body aches, shortness of breath, rapid heart rate, eye twitching

Vision blurriness 15 minutes later, subjective throat tightness 3 hours later, gone by next day. no symptoms with second dose.

My lungs and my heart became full of pain and very swollen and lasted 2 days and nights. It felt worse when I sat up, coughed, raised my voice and walked up and down stairs. My heart felt like a filled up tight balloon and it hurt a lot. I looked it u and I think they describe this as mycarditus.

About a month and 20 days after my second vaccine I had trouble breathing. I work in the hospital, so I thought maybe it was bronchitis, the mask made it harder to breathe. I had the weekend off and decided by Monday I would go to the doctor if not better. I woke up on Sunday, still achy, not wanting to move, couldn't really eat, I was just mostly drinking water. I woke up Monday and came back to bed, moved the blanket and then could barely breathe. My skin got very clamy, feeling scared and unsure if it was a heart attack. I called 911 and was taken to hospital to a shock trauma. I am only back to work 4 hour days, and working with a pulmonologist.

Starting on the day of the vaccine 2nd dose, I had a fever that evening. I had a lot of pain on my left arm and high heart rate. I took Tylenol for the symptoms. I woke up the next morning and felt ok. After 2 days, I noticed a red rash on my chest. It was not itchy or painful. I went to Urgent Care and the doctor recommended ice pack and the rash went away. After 10 days, I had diarrhea and nausea. I went to Urgent Care again, I was given Zofran medication for nausea and they ran some tests which all came back normal. The nausea and diarrhea went away after 2-3 days. Currently, I still have a little bit of difficulty breathing and shortness of breath.

Sharp chest pain 4 days later started- similar to heart burn but not sure. Kept happening on and off for about a week. Had extreme anxiety and high blood pressure following week. Prescribed anti anxiety meds. Had regular cbc at dr appt a week after when got anxiety meds and high Bp reading. Extremely low vitamin d levels. Get winded, heart rate up for not too much activity at week three. May have had covid end of last February before they had testing out

possible breast cancer; strong systemic reaction; throat swelling; tachycardia; rash; Repeated right breast ultrasound May 2021 due to pain and area felt larger and more tender.; Repeated right breast ultrasound May 2021 due to pain and area felt larger and more tender.; This is a spontaneous report from a contactable other HCP (Nurse, patient). A 41-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EJ1685, expiration date unknown) via an unspecified route of administration in the arm left on an unspecified date (reported as 18Dec2020 11:00 AM and pending clarification) at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included depression, anxiety, COVID-19. Patient had drug allergies to morphine and doxycycline. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EJ1685, expiration date unknown) via an unspecified route of administration in arm right on 18Dec2020 at 11:00 AM (as reported) at age of 41-year-old at 0.3 ml, single dose for COVID-19 immunization and had strong systemic reaction. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had usual regimen (unspecified) within 2 weeks of vaccination. It was reported that patient had strong systemic reaction with both doses. 2nd injection was sent straight from the employee health to Emergency Room due to throat swelling, tachycardia and rash. The most concerning was the area under her right Axilla found about 5 months ago. It's was originally a small bean size area. Patient had seen her primary care physician and she could felt it so got a mammogram and breast ultrasound and the radiologist did see and confirm area but felt it was related to her recent COVID 19 vaccine. There was no family history breast issues. Patient had repeated right breast ultrasound in May2021 due to pain and area felt larger and more tender. Patient had an additional area of concern moving her to BARDS 3 concerning for possible breast cancer. Patient would repeat ultrasound in 1 month so Jun2021. Patient had never had any issues and had no family history. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient had emergency room visit and multiple PCP as treatment for the events. Seriousness criteria of the events was reported as disability or permanent damage. Outcome of the events was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.; Sender's Comments: Based from temporal occurrence of events and vaccination schedule, the causal association of reported events in relation to suspected drug BNT162B2 cannot be totally 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

My whole thighs is hurting; I couldn't move my arm for 2 days, it was stiff I couldn't move my hand; Joint discomfort and inflammation; Joint discomfort and inflammation; Even inhaling, exhaling is not comfortable; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; Whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0179), via an unspecified route of administration on 03Jun2021 (at the age of 41-year-old) at single dose for COVID-19 immunization. The patient medical history included blood pressure high, asthma, diabetes and vertigo. The patient concomitant medications included amlodipine besilate (AMLODIPIN (BESILAT) DEXCEL) taken for blood pressure high, metformin taken for diabetes, atenolol, olmesartan taken for blood pressure, cinnarizine taken for vertigo and diazepam (VALIUM). Patient did not receive any other vaccine prior to Covid vaccine. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162), via an unspecified route of administration, administered at arm right on 13May2021 (at the age of 41-year-old) as single dose for COVID-19 immunization. The patient experienced my whole thighs is hurting, I couldn't move my arm for 2 days, it was stiff I couldn't move my hand, joint discomfort and inflammation on an unspecified date. On 04Jun2021, the patient had whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely, even inhaling, exhaling is not comfortable. Patient stated, I think I am having some kind of reaction with the shot (COVID-19 vaccine) because my whole entire body from my knee up to my neck is swollen. My whole right side where I got the shot from my neck to my ankle is swollen, my back, my arm, my neck, my thighs everything is swollen and it hurts extremely. Even inhaling, exhaling is not comfortable. Patient further stated, the next day the middle of the day almost every day my right arm started swelling up and next day my neck started swelling up. My whole thighs was hurting and was swollen. When I take vaccine I dont take any other medication, so I am not sure what is actually causing any problems. I havent taken anything else other than Tylenol. So, first time I didnt take anything I just took Tylenol but my arm swell up the same day. I couldn't move my arm for 2 days, it was stiff I couldn't move my hand. I put some heating pad and ice pad like stuff on it and about on the third day it started to get better but then 2 days after that I woke up swollen and I couldnt move. This was freaking me out. Under my arm and all the way down I don't think it should swell up like that and it is on whole body. The patient underwent lab tests and procedures which included TSH was unknown on 22Apr2021. The patient received Tylenol as a treatment medication for relief joint discomfort and inflammation. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Difficulty breathing; joint pain; headache; chills; nausea; diarrhea; body ache; hives; my throat started to close down it was very hard to breathe; I could barely talk; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0161) on 08Apr2021 at 13:00 (at the age of 41 years), as first single dose, in left arm, for COVID-19 immunization. Medical history included penicillin allergy, latex allergy and peach, papaya allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levocetirizine dihydrochloride (XYZAL) pro air inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09May2021 at 14:00 the patient experience difficulty breathing, joint pain, headache, chills, nausea, diarrhea, body ache, hives, her throat started to close down, it was very hard to breathe and she could barely talk. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included allergy medication, another inhaler and epinephrine (EPIPEN). The events were resolving. Since the vaccination, the patient had not been tested for COVID-19.

I had my 2nd vaccine on 4/5 @ 4:30pm. I felt slightly tired afterwards and noticed that I couldn't stop yawning. After getting home, I ate dinner and went to bed at around 9pm. At around 2:30am, I woke up feeling an intense heaviness on my chest as if something was sitting on top of me and crushing my upper chest. I stood up and had to immediately crouch over due to the intensity of the pain and heaviness. My husband had to hold me up and suggested going to the hospital. I was terrified and just wanted to wait and catch my breath. It was hard to believe what was happening and I did not want to go to the hospital. After about 5 mins, the intensity of the pain subsided and I was able to breathe normally. I was able to go back to sleep with minor discomfort and woke up at around 6am without any symptoms. About 2 weeks later, I started to have chest pain, which I had never experienced before. I tried to attribute it to all sorts of things, but it didn't go away so on 5/1, I went to City MD to have an EKG and chest X Ray. Both came out normal and they told me to follow up with a cardiologist for due diligence. I followed up with a cardiologist and they also ran an EKG and X Ray with normal results. Depsite normal results, I thought it was important to report this because I am a healthy and fit 42 year old with no prior heart history and found it uncanny that I had my first "heart event" within 12 hours of my 2nd vaccine.

9 hours after receiving my first dose I had severe chest pains. tremors, insomnia, migraine headaches. The symptoms lessened after the first 3 days but still come back randomly and are now becoming constant again- constant chest pains, dizziness, shortness of breath and fatigue. Pain is radiating down my left arm and legs as well. I have notified my cardiologist and will be requesting further evaluation of side effects.

On 4/14/2021, I received my first vaccine at about 8:40 AM. Within about 5 minutes, I had a rash on my neck and chest. My blood pressure and heart rate were checked. They gave me an injection to counteract the allergic reaction in the left arm. I had a fever for 2-3 days, headaches, and dizziness. Both of my shoulders hurt, so I was confined to my bed. I was advised to take Tylenol, drink plenty of fluids, and stay in bed. After 3 days, I felt a little bit better, though I still had some dizziness, headache, and pain, but they were less severe. I received my second vaccination on 5/5/2021. I had red, itchy, painful eyes that came and intermittently for about a week. Sometimes I couldn't breathe well. I developed a rapid heart rate, and I called my doctor; he advised me to go to the hospital. I went to the ER on 5/28/2021. They gave me an IV and three medicines to counteract the allergic reaction. The red, itchy, painful eyes on 6/8, and I went to the ER again. They checked my heart rate and examined my eyes. The doctor prescribed eye cream to treat the itchiness. I went to the PCP, and he prescribed me 25 mg of Banotaen. I have recovered from most of my symptoms, but I still sometimes feel a little dizzy and lethargic.

Within a few minutes of the shot I had difficulty breathing, swallowing, my throat felt like it was closing up, and I had chest pain. I was incredibly shaky and had to be monitored by the paramedics and receive oxygen for almost 1.5 hours. In the following days I experienced extreme fatigue, muscle soreness, fever, loss of energy, severe headache. It took me about a month to fully recover and feel well again.

Tachycardia heart rate 135 bpm at rest; shortness of breath oxygen saturation 90%; Chest tightness; burning; This is a spontaneous report from a contactable other hcp/nurse (patient). A 41-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EK9231 and expiry date: unknown), dose 1 via intramuscular, administered in Arm Right on 13Jan2021 14:30 as SINGLE DOSE for covid-19 immunisation. Medical history included female pattern hair loss. The patient previously took clindamycin and experienced drug hypersensitivity, compazine [prochlorperazine edisylate] and experienced drug hypersensitivity. Prior to vaccination, the patient was diagnosed with COVID-19. Patient not tested covid post vaccination. No other vaccines were received within 4 weeks prior to the COVID vaccine. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), montelukast sodium (SINGULAIR), vitamin d3 (VITAMIN D3), folic acid (VITAMIN B12 & FOLIC ACID) and finasteride (FINASTERIDE). The patient experienced tachycardia heart rate 135 bpm at rest, shortness of breath oxygen saturation 90%, Chest tightness and burning on 13Jan2021 23:45. The patient underwent lab tests and procedures which included heart rate: 135 bpm at rest on an unknown date, oxygen saturation: 90 % on an unknown date. No treatment received for the events. Outcome of all the events was recovered with lasting effects. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Symptoms: Nasal congestion, Fullness in ears, Intermittent shortness of breath, Vertigo. Most symptoms persisted for 1.5 weeks. Vertigo present a couple of days. Treatment: Amoxicillin 7-day treatment

After vaccine on 4/18/2021, major chest pain, shortness of breath, fatigue and sweats began. 4/22/2021- went to Urgent Care doctor advised to go in ambulance to hospital, 4/22/2021 I was admitted in hospital for pericardial effusion and had surgery on 4/26/2021 for pericardial Effusion Tamponade.I was in the hospital for 8 days. No pre-existing conditions prior. Treatment was to surgically remove fluid from sac & drain, oral Colchicine for 3 months to prevent immediate inflammation. Continue to follow up with Cardiologist to check for effusion.

A hot large rash around my injection site; Large rash around my injectionsite and pain in that area; swollen at injection site; Shortness of breath; tingly mouth; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 1715 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma. The patient had soy and sulfa allergy. Concomitant medications included singulair (MANUFACTURER UNKNOWN), zyrtec (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) for unknown indications received on unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the right arm on 23Feb2021 at 1900, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 1800, the patient experienced typical allergic reaction which was vaccination swelling, shortness of breath and tingly mouth. On 19Mar2021, the patient noticed a hot large rash and pain around her injection site. Therapeutic measure taken as a result of the events vaccination swelling, shortness of breath and tingly mouth included benadryl (MANUFACTURER UNKNOWN) and it relieved most symptoms. The clinical outcome of the events vaccination site swelling, shortness of breath, tingling mouth, hot large rash and pain around her injection site were resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Urine infection; anxiety attack; panic/anxiety attack; Her body started tingling and was numb; her body started tingling and was numb; The end of her hand cramped up; I don't know how to breathe/short of breath; whole body started shaking; Racing heart beat; Feels like throwing up; had a fever; She reports she began to feel tired/she was weary and tired; didn't feel well at all; body felt warm; Hands hurt; Felt chilled; stomach was tight; She might have respiratory alkalosis; She woke up hungry and weak; She woke up hungry and weak; Sleepy; This is a Spontaneous report from a contactable consumer (patient husband) reported for a patient (reporter's wife). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, in left arm on 08Jun2021 at 13:00 (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing high cholesterol. She did not take a medicine for that. It was genetic and runs in her family. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller was a consumer calling on behalf of his wife. Patient was present for this call. She was having a serious side effect from the Pfizer Covid-19 Vaccine. Wife reported that she received the first dose of the Pfizer Covid-19 vaccine on 08Jun2021 Tuesday at 13:00. Wife reported was getting home around 15:00 and went to shower. At around 14:30 she started to feel tired and her body felt warm. She was really really tired and can't stand up. It started when she came home after the vaccine. She got hungry and started shaking and it was hard to breathe again. She reported, she began to feel tired, did not feel well at all, took a nap and also felt chilled. She stated she didn't check her temperature. She reported she thought she would feel better the next day, but she felt worse. She stated she checked her temperature and had a fever, so she took some Tylenol. She reported she still felt tired. She reported that last Friday (11Jun2021 at 10:30) in the morning when she woke up, she felt like she did not know how to breathe and my stomach was tight. On Friday 4 days later (on 11Jun2021) she developed shortness of breath, It was about the same. She used brown bags to inhale and exhale and they didn't work. Husband reported, his wife started to feel short of breath, her body started tingling and was numb It started last Friday 11Jun2021 morning at around 10:30, the end of her hand cramped up. Her two hands cramped. It happened 3 or 4 times which was why they called the ambulance. He stated that was serious and we had to call an ambulance. He reported that the medic came and checked her temperature and oxygen and said she had no problem, and it was an anxiety attack. Husband reported he did not know why she had this as she had never had before now. She has had no anxiety problems or mental problems in her life. The doctor said to breathe slowly and relax. The hand cramps happen 4 or 5 times a day, and she had to try relaxing a little bit. It will calm her body shaking but she still had shortness of breath. Husband reported that after the medic left, she was still feeling uncomfortable about an hour later and they went to urgent care where the doctor reported she might had respiratory alkalosis. Caller reported that the doctor didn't do any blood tests but gave her hydroxyzine 50 mg for allergies and maybe she had a panic/anxiety attack that put her to sleep. She went to sleep and felt better, but as soon as she woke up she would shake and the shortness of breath would came back. She woke up hungry and weak, and when she had some food she will feel a little better but was not breathing well. Husband stated that was okay for 2 days. He reported that on Saturday (12Jun2021), they went to family doctor for check-up. That doctor also thinks she had an anxiety attack and gave her anxiety medication alprazolam 2.25 mg and gave her something for heartbeat and also propranolol for a racing heartbeat. The hydroxyzine, alprazolam, and propranolol are in amber colored pharmacy bottles. Alprazolam expiration date was Feb2022, Propranolol expiration date was Sep2022. She saw the doctor today. She was taking that medicine for her heart. Husband stated a medicine to slow down heartbeat. Husband reported she had a severe attack Monday (14Jun2021) again and went to the ER. He reported the hospital gave her lab tests to check on body and physically everything looked okay to them. He reported they did x-ray of lungs and organs and nothing seems wrong. He stated seems weird. Husband reported they went to family doctor again today (16Jun2021) and took more medication. The doctor advised wife to go to a psychiatrist. Husband reported they went there, and psychiatrist did assessment and thinks she did not have psych problems as psych problems wont give her fever and she reportedly had 11 days of fever until now. He stated, it did not go away, no one can help her, they had anxiety pill on their hands but nothing was helping her breathing, they did not understand what causes this. Wife reported her whole body started shaking every morning when she woke up and sometimes in the afternoon she started shaking again and took anxiety medication. Husband asked why the doctor did not give her breathing medication? We had inhaler but it did not help. Earlier they went to saw psychiatrist and the psychiatrist asked them to call pfizer to guide them what to do. Husband states we went to 3 different physical doctors and went to psychiatrist and it's not psych problem, psych problem won't give fever. They went to different departments and they had no idea what to do. They want to find out more about it. They seek help from different doctors but they did not have solution. Wife reported her temperatures around 100.6F, 100.5F, 100.1F, and 99 something. Wife stated a lot of time it was 99 something. She had the fever again the next day on 09Jun2021. Last night her temperature was 100.4 or 100.5, and this morning it was 99 something. She had not taken Tylenol yet. She didn't feel good at all. She felt cold and then was hot the next day. She felt really tired and checked her temperature. Her fever had continued for 11 days now. She took Tylenol before bed and it brought it back to normal 98 or 97. She went to the hospital on Monday (on 16Jun2021) and they said she probably had a urine infection. Today the family doctor gave her some antibiotics. Her stomach felt tight when she started getting shortness of breath. It was tight like she didn't know how to breathe. She felt like throwing up sometimes. It started Friday. When she came back after the shot she was weary and tired, chilly, sleepy, and her hands hurt. Then she couldn't breathe. She stated they didn't go anywhere this whole year not even grocery store, they shop online. They only went in the backyard that's it. Her first time was to get vaccine. Caller's question was if these symptoms have been reported before and what should they do? He read the description on the product and none of that what she experienced. She went to her family doctor and to the ER. She went to so many different doctors and also a psychiatrist with no solution. His wife was experiencing shortness of breath and her whole body was shaking. He asked if Pfizer has heard anything about these side effects before. Reporter seriousness for events reported as unspecified. The events resulted in emergency room and physician office visit. Patient was not hospitalised. Outcome of events I don't know how to breathe/short of breath, whole body shaking, her body started tingling and was numb, The end of her hand cramped up, She reports she began to feel tired/she was weary and tired, didn't feel well at all, had a fever, racing heart beat, feels like throwing up, hands hurt, body felt warm was not recovered and outcome of other events was unknown. Information on the lot/batch number has been requested.

Itchy body 24 hours after vaccine; Tight throat an hour after covid 19 vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6198) via an unspecified route of administration in the left arm on 09Mar2021 at 18:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis. It was also reported that the patient was allergic to penicillin, sulfa drugs (sulfonamide drugs), walnuts and bee stings. The patient did not receive any medicine within two weeks to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in 2021, the patient underwent lab test color COVID-19 test (nasal swab) and resulted negative. Since the vaccination, the patient had been tested positive for COVID-19. On 09Mar2021 at 19:30, patient experienced tight throat an hour after COVID-19 vaccine and it lasted 14 days. On 10Mar2021, the patient experienced itchy body after 24 hours of vaccine and it lasted 14 days. The patient did not receive any treatment for the adverse event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of wheezing was recovering at the time of this report. The clinical outcome of the events tight throat was recovered on 23Mar2021 and itchy body was recovered on 24Mar2021. No follow-up attempts possible. No further information expected.

About an hour after I got vaccinated, I started to go into anaphylactic shock. My throat started to close and I was having adrenaline rushes, heart rate instability, and dizziness. I felt very shaky and weak. I was able to reverse it with Benadryl and other antihistamines. I did not need my Epipen. My symptoms subsided after about 4-5 hours. I did not eat anything after getting the shot, and I was not exposed to any other allergen that could have caused an anaphylactic reaction. I have not started any new medications that could have caused this either. I believe my reaction was related to the vaccine.

pt described swelling of tongue and difficulty breathing administered 25mg liquid Benadryl and 0.3mg EpiPen emergency services was called, emt check out pt, advised likely anxiety related reaction

Pt c/o dizziness and chest pressure following administration of second dose of vaccine. Pt used her inhaler at 1402 and started to feel better but after using the restroom she reported feeling like her throat was closing and it was hard to swallow. Pt also began coughing, dry heaving and vomiting. Pt was given Epinephrine at 1452 after a second assessment by the provider and EMS was called. Pt was transferred to the hospital.

After 1st, shot, within days I developed painful sinus pressure in cheek above left jaw that persisted for a week, followed by constant pressure and mucus drainage; coughing; wheezing; sneezing. After 2nd shot, same as above has persisted. HOWEVER, I have not menstruated ! I had typical period pains, felt like I was going to start on schedule, but I have not to date. All typical menstral pains are now gone. Date of last cycle began normal on 6/5/21, lasted 4 days.

Trouble breathing; Acute migraine; Hives; Muscular pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263) via an unspecified route of administration, in Arm Right on 26Feb2021 13:15 (at the age of 41 years old), as single for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. The patient did not receive other vaccine within four weeks of COVID vaccine and she did not take other medications within two weeks of vaccination. The patient did not have COVID prior to vaccination. The patient concomitant medications were not reported. On 28Feb2021 15:00, the patient experienced trouble breathing, acute migraine, hives, and muscular pain. These adverse events resulted in emergency room/department or urgent care visit. The patient received treatment with benadryl and pain medicine. The patient did not test for COVID post vaccination. The outcome of all the events were resolved, on an unspecified date in 2021.

On April 10th, I developed unprovoked pain in my lower left calf. I went to my primary doctor April 12th, who sent me for a doppler scan to rule out DVT. It came back negative. I was told it was likely a calf muscle strain & to rest it. The pain was still active when I received my second vaccine dose on April 18th. On April 19th, I fainted at home, had several seizures, and difficulty breathing. I was sent by ambulance to the emergency room. There I suffered a massive pulmonary embolism, cardiac arrest, and numerous cascading issues affecting my liver, lungs, kidneys. I underwent a thrombectomy and several other procedures. I was told by doctors that less than 10% of people survive what I went through. con't

I was afraid to receive any of the none PDA approved vaccine shots because of side effects. After my 1st dose i felt pain later that day and i had diarrhea. My left arm was sore and my left lung hurt worse. I know the arm is supposed to hurt but not my lung. After two days my arm didn't hurt as much but it's day three and my lung still hurts so bad. With every move i make my lung slows me down. I haven't been able to do my daily task or sleep at night. I just want the pain to go away. My family and friends are scaring me by saying that i might have a blood clot developing in my lung. Today i have taken Tylenol to ease the pain and i made my own ice pack. If there's no change by morning i'm going to the ER. This pain makes me not want to get my second dose.

The morning following my injection I had very bad left armpit pain and I could actually feel a swollen lymph node. This pain was worse than the injection site pain. As the morning went on I developed a heaviness in my chest-which was worse when I took a deep breath-and palpitations. I also had all the typical symptoms like lightheadedness, body aches, fatigue, nausea, a low grade fever and headache. All the symptoms resolved after 1-2 days except for the chest heaviness and occasional palpitations. After 6 days of no relief of the chest symptoms I went to my local clinic. My heart rate was elevated but the Dr there told me I did not have a PE based on my symptoms. He said to go to the ER if I wanted to have a CT scan of my chest to rule out a PE for peace of mind. The next morning I saw my primary doctor since I didn't get any real answers of what my symptoms were. Again my heart rate was elevated. She did an EKG which did not show any palpitations but she diagnosed my symptoms as peri/myocarditis and I was prescribed 5-10 days of naproxen.

Allergic reaction - tightening in throat; lower arm/nerve pain; tingling 6 days later; This is a spontaneous report from a non-contactable consumer, the patient. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via an unspecified route of administration in left arm on March2021 as a single dose for COVID-19 immunisation (at the age of 41-years-old). Medical history included IBS from an unspecified date. The patient was allergic to shellfish. Patient took other medications in two weeks which included multivitamins(MANUFACTURER UNKNOWN), mentha x piperita oil (IBGARD), probiotic (FLORASTOR) from an unknown date for an unknown indication. 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 other vaccine within four weeks prior to vaccination. On an unspecified date in Mach2021 the patient experienced allergic reaction- tightening in throat, lower arm/nerve pain and tingling 6 days later. The patient did not receive any treatment for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of allergic reaction- tightening in throat, lower arm/nerve pain and tingling was not recovered. No follow up attempts are needed. No further information is expected.

I experienced chest and lung pain and had to be immediately rushed to the hospital. The ER doctor ordered tests to look at my lungs to find out why I was experiencing an adverse reaction the vaccine. I was admitted to the hospital and was there for 4 days. My lungs were bleeding and there was bacteria in them. I am getting ready to have another series of tests done on my lungs and my doctor suspects that the vaccine is what caused my lungs to flare up. My breathing is really bad and the pulmonologist stated that my lungs are continuing to bleed. I am on 4 nebulizers and other medications.

Horrible issues the last four months. 1. Early period /cycle is off 2. Gastrointestinal issues 3. Nerve pain 4. Muscle spasms and twitches 5. Thyroid went out of control 6. Went to ER with shortness of breath and chest pains

Heat and swelling at injection site 12 hours post vaccine continuing until at least 23 hours post vaccine when reported Pain and weakness in right hand 13 hours post vaccine continuing until at least 23 hours post vaccine when reported Heart racing and trouble breathing 16 hours post vaccine intermittent symptoms coming and going continuing until at least 23 hours post vaccine when reported Nausea 17 hours post vaccine intermittent symptoms coming and going continuing until at least 23 hours post vaccine when reported Swollen and painful lymph node in right armpit 21 hours post vaccine continuing until at least 23 hours post vaccine when reported Pain in right breast 21 hours post vaccine continuing until at least 23 hours post vaccine when reported

Patient was given a covid shot . She waited for 15 minutes and being ok ,, she was sent home. On July 16 , the mother came and told us that her daughter was having side effects from the shot and was gone to ER . She was having HEART PALPITATION, ABDOMINAL PAIN , GAS , and SHORTNESS of BREATH if she walked a short distance . She visited her PCP , who couldn't identify the cause . Blood tests were done at the doctors office.

This is an addendum to a previous report I filed (VAERS ID: 1446698, E-Report Number: 578250). My reaction continued and got much worse after I filed the other report. About an hour after I received the first shot of the Pfizer Covid vaccine, I started to have an allergic reaction. I felt very dizzy and weak, my throat started to close up, and my heart rate was all over the place. I took some Benadryl and some other antihistamines and that reversed the allergic reaction. I didn't need my EpiPen. About 6-7 hours after I got vaccinated, I started to experience a strange neurological event. It was like I was extremely drunk. I was slurring my speech, my vision went dark & blurry, I was very confused, couldn't make the right words, couldn't remember how old I was. My friend called 911 and sent paramedics to my house. They assessed me for a stroke or heart attack and said my heart rate & blood pressure were very unstable, but it didn't appear that I was having a stroke or heart attack at the time. I refused to go to the hospital as it was 4th of July, very late at night, and I was confused about how I was going to get home (I live very rurally and didn't have a partner who could have come with me). The next day I went to the hospital. They said something was going on with my heart and referred me for follow up care. They said I had an abnormal EKG. The ER doctor said I did appear to have an allergic reaction and advised me not to get the second shot. He could not explain the neurological event. He said it could have been a TIA or something similar, but there would be no way to evaluate that unless I had a brain scan at the time of the reaction. He advised me to follow up with my PCP and a cardiologist and any other specialists I may need. It has been nearly 3 weeks since I had the vaccine injury and I am still having heart problems. I am waiting on follow-up care with a cardiologist, but they are booked 2 months out so I don't know what's going on. I have palpitations several times a day, and shortness of breath. Sometimes it's very difficult to breathe. These episodes come on suddenly and will resolve, but will happen again throughout the day. Sometimes at night my heart will be pounding so hard it wakes me up. Sometimes if I'm lying in bed, I can see my heart pounding so hard it shakes my chest and abdomen. This is new and has not happened to me before. It's worse on exertion but happens when I'm sitting or lying down. I don't know what this condition is, but I did not have it before I got vaccinated. It doesn't appear to be myo- or pericarditis, as there is no severe chest pain or fever. I think it's something else, but so far nobody can tell me what it is.

about 30 minutes after the shot my throat began to feel strange and then I started coughing. I realized that my throat was swelling some. I coughed and was nervous for about an hour and then my throat start to let up. I felt very disoriented for several days and was unable to drive a vehicle...felt very dizzy. I felt tightness in my chest/lungs and it hurt to breath and finally after a week of this, I went and saw my PCP. I discussed what has happened and he said that he did not recommend that I get the second covid shot but if I did that I should wait the full 6 weeks. I was put on a steroid and a nebulizer.

heavy head with extreme fatigue like waking up from surgery. Lasted for 7 days. nausea came and went for 10 days. congestion in chest with little phlegm started day of shot, approx. 30 minutes post injection and will occur seldom since till now. left peck pain in what felt like my breast rather than in my chest cavity. has been occurring very seldom since 3rd day post shot until now.

Tightness in chest; Trouble breathing, sometimes if patient inhale air, feel like need to cough; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 31Mar2021 at 09:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within two weeks of vaccination. Patient did not report any known allergies to food, medications or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) on an unknown date 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 COVID vaccine. On 02Apr2021 at 19:00, the patient experienced tightness in the chest and trouble breathing. Sometimes if the patient inhaled air, the patient felt like need to cough. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event tightness in chest and trouble breathing were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Chest tightness; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 16:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included uterine fibroids. Concomitant medications included vitamin B complex (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and D (unspecified), all taken from unknown dates for unspecified indications. The patient previously took 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 08Apr2021 at 16:45 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 06:00, the patient experienced shortness of breath and chest tightness. The clinical outcome of the events shortness of breath and chest tightness were resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Anaphalactic Reaction treated by double dose of hydroxyzine on site at clinic. Throat swelling - hard to swallow all day - went away next day. 4/22 - Legs heavy, tired for two days. May 8: Spasms/Twitching - Left side of head behind ear, which continues to this day. May 10 - Hearing loss - ear muffled, full feeling; Entire left side head felt inflamed, swollen at base of skull. Dr. sent bloodwork which showed high inflammation marker. Said I needed temporal artery biopsy. Consulted with surgeon that day and scheduled for biopsy on 5/11, which came back negative for arteritis. During surgery recovery started 16 day prednisone taper after inflammation still high crp levels. this helped my ear in the long run. still have tinnitus. Since 5/10 I've been seeing Drs for all left side symptoms of: tinnitus, nerve pain, sharp stabbing pains in head, moving nerve pains in head, base of skull pain, left side head soreness - dull, achy, burning, sharp - ever changing in nature, insomnia, new allergic reactions to different foods, anxiety, new electrical shocking/zaps in left toes and in front teeth, PTSD from th severity and frequency of symptoms, eye floaters/damage, spasms/twitching. Been in physcial therapy for 6 weeks. New nerve pains in limbs. Lightheadedness and some speech changes. Similar to COVID long haulers - never had COVID.

10 MINUTES POST VACCINATION PATIENT BECAME DIAPHORETIC, RAPID BREATHING, TACHCARDIA, PROGRESSED TO NUMBNESS AND TINGLING IN DISTAL EXTREMITIES. EVALUATED IN THE HOSPITAL ED FOR OBSERVATION

pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.

Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site

Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for right deltoid after first dose. Hemodynamically stable and afebrile. Differential diagnosis includes but is not limited to allergic reaction, anxiety, panic attack, asthma attack, sequelae of hyperthyroidism. After resting comfortably in the room for approximately 15 minutes, she reported that her symptoms were starting to subside. She happily excepted diphenhydramine (dose not documented). She was observed for 2.5 hours and had no worsening of symptoms. Her vital signs were stable and she had appropriate SPO2 on room air throughout her stay in the emergency department. We discussed strict return precautions for evidence of allergic reaction, chest pain, worsening shortness of breath, altered mental status or fever. She will follow-up with her primary care doctor. Discharged in stable condition to the care of her husband.

Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.

Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)

Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.

Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg given PO, cough worsening. 1122 second dose of Benadryl given, called for MD. Brought pt to Private room via wheelchair. Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126. IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy. 1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given. Lungs clear. 1140 Coughing stopped, pt able to speak now. Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105 1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114

About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.

Immediately after the vaccination she experienced chest pain, tachycardia, and throat tightness. She was given benedryl and epinephrine and EMS was called.

About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.

Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.

After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.

Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.

Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.

While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm".   Pt stated that her heart felt like it was "pounding".   VS: 162/96, 99% RA, HR in the 70's.   Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home.   The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist.   Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications.  

patient began to have headache (pressure back of head), some shortness of breath with an elevated blood pressure. Patient stayed for monitoring for 30 mins and symptoms aleviated

TACHYCARDIA AND HYPERTENSION WITH ''TIGHTNESS OF THROAT", TREATED WITH IM BENADRYL, IMPROVED AND PATIENT RELEASED SAME DAY

2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.

Day 1 Started with throat itching followed by cough with in 20 mins post vaccine later in evening left lung pain with SOB Day 2 Shortness of breath , left lung pain, cough Day 3 - Day 4 PVCs Taking Zyrtec and Pepcid for 4 days , Evaluated by EMTs onsite , did allergy treatment and evaluated by PCP

Was unable to swallow, breathing was not affected. Throat muscles felt weaken. Was given a Benadryl, symptoms resolved soon after.

wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital

reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.

headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.

Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.

Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and needs to tilt head up. Advised patient to sit under observation. At 11am continues to have throat soreness and light shortness of breath. Continues to need to tilt head up. Light tingling around throat. Has never felt this before. No dermatologic symptoms. Moved her for observation at ED at 11:30am

from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and started driving home I began to notice that my face was slightly numb (Iike I'd had too much novicaine). This was maybe 20-25 minutes after the dose. When I was home I also noticed that the back of my throat felt a little swollen. This probably lasted for a couple hours.

Patient received Pfizer COVID-19 vaccine without any immediate complication on 1/14/21approx 1455, was then escorted to observation area for a 30 minute observation time. Pt had previously had a known reaction to contrast media. Approximately 5 -8 minutes into observation, pt had one audible cough. Nurse asked patient if this was a new onset cough. The patient stated she would try to "manage" cough. Pt escorted to bay for monitoring. Pt developed shortness of breath and wheezing rapidly. Rapid response team called and local 9-11 also called. Pt received albuterol nebulizer treatment, placed on O2 at 8L. O2 sat 99%, HR 115-120. Respiratory therapy assisted and Rapid Response Team monitored pt while waiting for EMS. Physician order to give Epinephrine 0.3 mg IM in right deltoid, given as directed at approx 1515. Second epinephrine 0.3 mg IM given approx 1530-1535. HR 144, O2 sat 99%. Patient transported to local ER, pt intubated approx 1927.

Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea

Less than 2 min after administration developed throat fullness and difficulty swallowing. This persisted. Never any wheeze, never any SOB

About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.

Approx. 30 hours after this vaccine had acute onset mild-moderate shortness of breath, coughing and drop ~20% in peak flow. This was treated with a single dose of albuterol 2.5mg/3mL nebulizer. Concurrent also mild tiredness, muscle aches and headache

At approximately 30 hours after the second dose, had acute onset of mild-moderate chest tightness, drop in peak flow (~20% decrease) and coughing. This was treated with a single dose of Albuterol 2.5mg/3mL nebulized with complete resolution. No further shortness of breath. (Concurrently, also had mild tiredness and muscle aches.)

10:35a: COVID vaccine #1 Sitting in monitoring room. 11:05a: checked for symptoms and reports shortness of breath and wheezing. Has history of asthma and has albuterol with her. 11:08a: O2 100% RA, HR 116 Took albuterol inhaler x2 puffs Ongoing shortness of breath. Reports sharp pain in her chest. Reports dizziness. 11:10am BP: 110/84, O2 99%, HR 113. No wheezes on exam Drank fluids and given snack. Reports difficulty swallowing. Sharp pain in chest is worsening. Shortness of breath worsening. Reports nausea. 11:18a: glucose 178. HR 112, O2 100%. Ongoing sharp pain in chest and worsening shortness of breath 11:20a: Given Benadryl 25mg and orange juice. 11:30a: Requests to go to ER ? 911 was called. Repeats albuterol inhaler 11:40a Reports shortness of breath worsening and closing sensation in her throat. Burning sensation in her mouth. Chest pains worsening and ongoing dizziness. Given epipen 0.3mg [due to shortness of breath, sensation of throat closing, nausea, dizziness, tachycardia] 11:43a: EMS arrive, assess and transport to ER

Patient was administered 2nd vaccine on 1-8-21 by a nursing student. During 15 observation period, arm began to feel cold at injection site area. At that point the patient realized the vaccine was given toward the back of upper left arm near the fatty tissue instead of toward the middle of the arm. Approximately 20 min after vaccine administration, patient became short of breath, dizzy, light headed, and throat felt a little swollen and almost passed out. A rapid response was called and the patient was seen by Occupational Health. The patient's BP and heart rate were elevated but normalized during observation in Occupational Health. At this time, the patient did not feel they needed to be seen in the emergency department. The patient was discharged home at this time. 12 hours after the shot, the patient began experiencing normal side effects from the vaccine. The nursing student was informed of administration at the incorrect site.

Every time I stood up, my heart rate went up into the 120's and I felt an intense pressure in my chest. I felt like I couldn't breathe. All day that day I has also experienced feeling hot but I never got a fever. The chest pressure last for a few hours every time I tried to get up. I had a couple of minor episodes over the next 2 days where my heart rate went into the 120's and I felt slightly short of breath but no pressure.

Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no other vitals available), gradually improving over about 30 minutes, followed by severe fatigue

5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone

Joint tightness/tightness of her joints and muscles; Muscle tightness/tightness of her joints and muscles; Tiredness/felt tired; fast heartbeat; Difficulty breathing; Dizzy; Nausea; Joint pain; Muscle pain; she was not feeling well; swelling and tightness in her left arm; swelling and tightness in her left arm; Injection site redness/redness of her left arm and injection site swelling; Injection site swelling; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in upper left arm, on 08Jan2021 09:25, at single dose, for COVID-19 immunization, in a public health department. There were no medical history and concomitant medications. The patient did not receive prior vaccinations within 4 weeks. The patient reported she received the COVID-19 Vaccine on Friday, clarified as 08Jan2021 at 9:25 in her left upper arm. She stated experiencing a little bit of side effects since receiving the COVID-19 Vaccine. Shortly after receiving the COVID-19 Vaccine, on 08Jan2021, she was not feeling well. She said she had swelling and tightness in her left arm that started approximately a half hour (30 mins) after receiving the COVID-19 Vaccine on 08Jan2021. She then experienced redness of her left arm and injection site swelling on 08Jan2021. On 10Jan2021 (at night), she felt tired, and had tightness of her joints and muscles. She also experienced a fast heartbeat, and difficulty breathing last night, 10Jan2021. She said her dizzy feeling, nausea, tiredness, and joint and muscle pain were persisting at the time of the report. She reported she thought she was feeling fine up until Sunday, 10Jan2021. She stated her new symptoms started in the late afternoon, and the symptoms have stayed into the morning of 11Jan2021. She reported having previously scheduled a doctor's appointment for 22Jan2021 and will speak with her doctor at that time if she continues to have symptoms. The patient declined treatment for the events. The outcome of the events are joint stiffness, muscle tightness, fatigue, dizziness, nausea, arthralgia and myalgia was not recovered; peripheral swelling, musculoskeletal stiffness, heart rate increased and dyspnea were recovering; vaccination site erythema and vaccination site swelling were recovered on an unspecified date; and malaise was unknown.

14 hours later I woke up seeing black spots and felt trembly. My BP was 187/92 and my pulse was 120. I went home from work and became itchy to my neck and arms . At about 20 hours later I became short of breathe and pulse standing would go up to 140. I rested and continued taking Motrin and Tylenol as suggested . I ate minimally despite nausea . I messaged my Dr the next AM. By that time my glucose was settling down to normal and my Bp and pulse . The headache got worse and I had a pain in my axilla on the same arm I received the vaccine. I developed ?lymphadema? in that area which is sore to touch or move my arm. I reached out to infectious disease Dr at the hospital I work at and he suggested to continue Tylenol and Motrin and wait a week as this is due to vaccine. It is now Day 3 following vaccine and I am yet unable to work. My arm and axilla area is sore and I can?t lift my arm without pain, I have headaches and nausea as well.

Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up with a rapid heart rate extreme headache and a fever of 102 I had shortness of breath and was taken to hospital. The ER performed a work up and my main complaint was my heart was hurting really bad I felt like my left carotid artery was swollen or occluded

Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.

Blurred vision, headache, disorientation, fatigue, chest pain, chest pressure, shortness of breath, severe muscle and joint pain, hypertension, tachycardia, severe skin sensitivity, abdominal epigastric pain and spasms, severe cough, dizziness, lightheadedness. Reaction symptoms were not all immediate and developed over next 3 days requiring evaluation and treatment in the ER. I required decadron injection to stop inflammatory response and was sent home on oral decadron. I am still experiencing symptoms but not as severe. I have to take my albuterol inhaler so I can breathe easier. My monocytes count was elevated.

Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.

About 8 minutes into shot, I got rapid heartbeats, sudden fatigue, chest pain, shortness of breath, and itching. I was taken to the hospital where I received Benadryl and compazine in an IV for nausea and headache and to fight reaction. Released at 5pm. Next three days felt like I was having panic attacks, very jittery, tired, body aches, nauseated, and a headache. Felt extremely bad. Today first day about to focus and fill out paperwork. I had COVID 10/27/2020. Fought it for 32 days and was given colchicine for paracarditist.

Systemic: tight throat was given 50 mg of benadryl and water and recovered with an hr; symptoms lasted 1 day

chills; heart rate shot up to the 120's; chest pressure; felt like I couldn't breathe every time I stood up; This is a spontaneous report from a contactable nurse (patient). A 42-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date: unknown), intramuscular on the right arm on 29Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included occasional premature ventricular contractions (PVCs) and high blood pressure. The patient had no known allergies, is not pregnant and had no COVID prior vaccination. Concomitant medications included vitamin C [Ascorbic Acid] (VITAMIN C [ASCORBIC ACID]), vitamin D3 (VITAMIN D3), bromelains (BROMELAIN), quercetin (QUERCETIN), zinc (ZINC), acetylcysteine (NAC [ACETYLCYSTEINE]) and Probiotic. The patient had no other vaccines in four weeks. On 06Jan2021 at 21:00, the patient experienced chills all day but no fever. Around 9pm, her heart rate shot up to the 120s and she had chest pressure and felt like she couldn't breathe every time she stood up. When she laid down, it was better. These lasted about 3 hours. She had some very mild shortness of breath twice after this on the 7th and 9th, but it was not nearly as bad as on the 6th. The patient did not take any medication when these happened. The patient tested for COVID post-vaccination (07Jan2021) through COVID-19 PCR (Nasal Swab) which resulted negative. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The events resolved on an unknown date in Jan2021.

Hot to cold, headache, fatigue, cough, chest pain, boughts of breathlessness this was day 2, day 3 headache, body ache, chest pain probably from coughing. Cough was deep and hard in the morning after waking through out the morning I would cough a couple more time by noon I'm not coughing but my chest is heavy.

12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose

Allergic reaction; This is a spontaneous report from a contactable consumer (patient's spouse). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 14Jan2021 15:00 at a single dose in a hospital for COVID-19 immunization. Medical history included allergy to sulfur and latex. There were no concomitant medications. The patient previously took dexamethasone (DECADRON) and experienced allergy. The patient had Covid vaccine at the hospital yesterday (14Jan2021) about 3pm and around 315-320, she had an allergic reaction. The patient was given epinephrine and stuff like that but ended up having to call an ambulance and took to another hospital. There, they had to put her in ICU and on a ventilator. The patient's spouse asked what might have been in the product that she would have been allergic to. The patient was transferred to hospital. She is a respiratory therapist. The patient was treated with epinephrine, albuterol and she was put on a bi-pap but she couldn't breathe and was told by the doctors that her body can't take it so they intubated her about 7:30 pm, she was put on a ventilator. The patient had an emergency visit. The patient had no prior vaccination (within 4 weeks). The outcome of the event was not recovered. Information about lot/batch number has been requested.

approximately 15 minutes after vaccine I felt a headache and dizziness. A few hours later I felt my heart racing, throat swelling, chills,weakness, tired, pain and swelling at injection site(right arm)

13 hours after vaccine I woke with a fever around 103 with chills, body aches, joint pain, headache, ear pain and upset stomach. All of Saturday these symptoms went on and I had a tightness in my throat, not pain. I was very delirious and speaking jibberish when awake. Sunday the fever lessened and I felt more alert, but a large swelling started in my armpit in the left arm. Monday the fever was gone but I still had major joint pain, off and on headache and overall sick feeling. Today I woke and have a very upset stomach and achy feeling all over. The lump in my arm pit has gotten smaller but is still painful and visible.

(This RN was not direct observer of initial incident. Initial events as reported by initial responding RNs). Pt had just received Pfizer vaccination and was seated in observation area. Was observed to be "not looking well" and approached by staff. Pt began to hyperventilate, exhibit repetitive jerking motions to upper body/"pseudo seizure-like activity", and reported feeling nauseated. Began to slide out of chair, x2 RNs assisted pt to floor. Pt then placed in wheelchair and taken to Triage tent A. Pt remained alert and oriented throughout duration of event. VS @0915- BP 128/77 HR 131 Sats 100% on RA. 0.3mg IM epinephrine given at 0919. VS @ 0920 HR 108 0938 O2 sats 87% on RA, applied 0.5L O2 via nonrebreather mask. Sats back up to 100% @ 0939. Pt remains alert, intermittently exhibits periods of jerking actions and hyperventilation between periods of calm. With staff assist, called husband who was en route. VS @ 0940- HR 101, Sats 100% on 0.5L via nonrebreather. 50mg IM Benadryl given at 0940. VS @ 0950 HR 109 sats 100% on RA. Husband, to bedside. Pt remains alert. 1007 EMS arrives for transport to Emergency Department

12-30-2020 Erythema, soreness and itching on right arm below the injection site. 12-31-2020 Nausea. Itching and erythema. Ears began to swell and became hot and red. Face and neck uncomfortable. Took Benadryl when went to bed at midnight. 1-1-2021 In evening began severe itching and erythema form head to breasts including arms which lasted three hours. Right eat internal soreness. 1-2-2020 Fifteen minutes after eating began sudden stomach crapms and then larger amounts of diarrhea and vomiting. Later had another episode of vomiting and diarrhea. Felt weak with labored breathing, chills, Fever 100.2, another bout of diarrhea and vomiting. Productive cought that started in the evening with clear mucous.

blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. 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.

15 minutes after received COVID 19 vaccine, developed shortness of breath, dry mouth and throat dysphagia, high blood pressure and anxiety.

shortness of breath; Several episodes of racing heart; chest pressure; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 04Jan2021 at 15:30 at single dose for COVID-19 immunization. The patient medical history included allergies: shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 04Jan2021 at 15:45, the patient experienced several episodes of racing heart, shortness of breath, chest pressure and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. Therapeutic measures were taken as a result of the events and included treatment with albuterol. The patient outcome of the event was recovering. The information on the batch number has been requested.

-ADR: Allergic reaction (SOB and throat tingling/swelling -Inpatient - 0.9% NaCl Bolus, famotidine (PEPCID) injection 20 mg ,diphenhydrAMINE (BENADRYL) injection 25 mg, methylPREDNISolone sod succ (SOLU-Medrol) injection 125 mg, diphenhydrAMINE (BENADRYL) injection ADS Med, famotidine (PEPCID) injection ADS Med -Treatment: discharged with Benadryl and Medrol Dose pack

chest tightness and nausea, hyperventilation, 1st dose pfizer vaccine @ 1610, benadryl 25 mg IM given

Lungs closing up, trouble breathing, pulse ox drop. Like an asthma attack but inhaler did not help. It lasted about 4 hours. Shooting nerve pain through my body for several days. Overall sluggish for two days, body aches, exhaustion.

I felt fine that day and waking up the next. Then as I moved around, I started to feel uneasy. I vomited forcefully several times. My neck and upper back became stiff and painful. Then came chills, shaking, and more nausea. My throat felt like there was a lump in it that was closing me off. I felt very weak and easily fatigued. I started to have visual issues, confusion, and was unable to focus. Neck pain continued to be severe. The next morning I woke feeling good, but within 2 hour again I went downhill. Symptoms are only about half as bad as the day before. Very very tired.

After receiving vaccine, pt started experiencing red face, itchyness, and shortness of breath. Pt was examined and took 50mg benedryl that she brought with her. Within 5 minutes of taking benedryl, she stated she was feeling better. Redness went down along with itchy feeling around her neck and chest.

I was in observation for about 45 min due to the symptoms I had with the first dose. About 10 min after vaccination, I felt itching on my face, and it progressed to my back and hands. I also started coughing, no rash. In the evening, at home I started feeling shortness of breath and started using my albuterol inhaler and symbicort. I had a feeling like someone was sitting on my back, squeezing my left side, my left lung. I also experienced chest pain. I had to use symbicort and albuterol for about 5 days and the symptoms persisted for at least 3 days, itching, cough, chest pains. The symptoms went away and they returned 3 days ago. Now I am once again starting to experience cough and shortness of breath.

Information provided by patient as follows. I do not have access to urgent care notes to provide that information. ALLERGIC REACTION TO VACCINE. SWELLING IN INNER AND OUTTER BOTTOM LIP. THROAT AND EARS ITCHY AND THROAT FELT TIGHT. DIFFUCULTY SWALLWING. WENT TO URGENT CARE AND RECEIVED STERIOD SHOT.

I developed hives, itching from head to toe and throat felt restricted. I went to 2 ER visits was given IV and steroids. The symptoms lasted for 6 weeks.

extreme brain fog 8 days post vaccine - had it a little after shot for day and a half came back very strong have had it all week intermittently. Shaky, racing heart, high BP all intermittent, gastrointestinal upset, headache, feeling run down, trouble breathing but lungs fine Disruptive to working, thinking daily life feel very weird on and off

Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives traveled down the left side of my body. I sought treatment at Urgent Care. They prescribed 4 mg pack of 5 day steroid. On Saturday morning, the hives returned worse and covered my entire body except my face. The injection arm was swollen and red. I also begin to have shortness of breath. I went to the ER and they gave me an IV of benedryl and prednisone. I was released with another 4 day course but with 20 mg of steroid .

About 10 minutes later become itchy upper body and mild asthma. Vitals taken by observation Medic were normal. No respiratory distress. After 30 minutes of observation, I left back to my work unit within the hospital and walking back I became dizzy, felt faint and weak. Developed a headache and felt mentally foggy. It lasted about 2-4 hours. No further medical attention seeked at that time. 3 days later at rest at home about 6/7pm, I experienced dizziness, headache, pain to base of neck R side, pain down my spine and lateral back. Numbness to R cheek bone. Twitching to L hand. Numbness, tingling and weakness to L arm. Tightness to chest and back. Emergency department diagnosed degenerative cervical disk disease. Negative on neuro exam.

The patient presented to the Emergency Department today secondary to symptoms which she states started about 1 hour ago prior to arrival after she received her Covid vaccine first injection at 11:40 AM, states that she went back to work as a teacher and started to feel a sensation as if she had some swelling of her throat and a mild sore throat as well, she states that she developed some nasal congestion as well as lightheadedness, she denied any dyspnea, no coughing or wheezing, no chest pain, vomiting or diarrhea, she called her doctor and was told to present here for evaluation, she did not take any medication for symptoms prior to arrival and states that her symptoms are very similar to her previous allergic reactions but has never required epinephrine. Treatment required: NS1L IV bolus, Famotidine 20mg IV, Solu-medrol 125mg IV, and Diphenhydramine 50 IV all x1. The patient will be given a prescription for a short course of steroids at home and has been advised to take benadryl and pepcid at home if needed.

Pt reporting SOb and palpitations. Her vital signs were normal. she felt better after drinking juice.

Neuropathy, Anxiety, Nausea, Vivid dreams, Head squeezing, Shortness of breath, Fatigue, Light Sensitivity. Going on a week now This was my first vaccine.

Pt received vaccine and reported red blotches on arms and started feeling faint. Pt reported dizziness and headache as well as difficulty breathing. Vitals: 1156 112/71, HR 62; 1208 116/72, HR 62. Pt observed for 30 minutes on stretcher. At 30 minutes, pt reported feeling ok to leave and was wheeled out of facility and ambulated to car.

08:03- Vaccine administered at Hospital in ED. Observation time increased to 30 minutes related to history of anaphylaxis. 08:18- Pt complains of difficulty swallowing and feeling as though throat swelling. Patient placed on monitor. O2 sat 98-100% on room air. Epi 0.3mg administered in left outer thigh at this time. 09:21- Patient continued to be monitored in ED but not registered as an ED patient. Patient denies needing to be seen by provider. Symptoms resolved. Patient states "I'm fine. I'm better than fine, I'm great." 09:25-Patient discharged from observation. Instructed to return to ED or call 911 if symptoms return. Patient voiced understanding.

Approximately 20-25 minutes after injection, dizziness, tingling in face, and throat tightness occurred, which resolved after about 15 minutes. No shortness of breath experienced and symptoms were not severe enough to seek medical treatment.

Patient reported arms and legs being itchy approx. 10 min post-injection. Administered 50mg Benadryl orally. Patient also complained of tightness in throat, which improved after Benadryl. Vitals did not indicate anaphylaxis, continued to monitor BP over course of symptom reporting. Also applied ice pack to left forearm and back of neck. EMTs arrived to check vitals and reported no signs of anaphylaxis, inquired if patient wanted to return home or wanted to get higher level of care, and she chose to go to the hospital. There, the providers found no emergent medical issues. Nurse called and checked on patient 4pm same day, the patient reported no issues and all concerns were resolved.

Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.

Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated she started to have anaphylactic reaction to the Pfizer -Biotech COVID vaccine around 7:00 PM that same day. Her eyes swelled up and her throat started to feel like it was closes so she went to the ED at Hospital. At the hospital, she received an Epipen and a shot of benadryl. The reaction was taken care of and she was able to return home later that night with no lingering effect of the reaction.

I am 5 days out from the 2nd dose. I had to make an urgent care visit because of shortness of breath, blurred vision, light headedness, brain fog, nausea, fatigue, feeling of fainting and tightness in throat. These symptoms have been present and overwhelming for over 3 days presented themselves after day 2 of vaccine. The original symptoms of headache, body aches and chills subsided by day 3.

In recovery pt stated "felt like numb head to feet I had cough and sore throat past couple days" (spoke broken English Asian decent) brought to recovery area in wheelchair to lie down supine Assess: - LOC, -SOB, - N/V, slight pale - Rash. - facial swelling, - tongue swelling. stated she was anxious to get vaccine Left Deltoid site benign, VS 130/72, HR 95 reg strong, resp 12 reg non labored. Medical called to evaluate. Encouraged hydration, Provided reassurance monitored 1 hr (per pt request) No further symptoms developed. Advised if anything occurs later in day call 911 if life threatening or go to urgent care. sign to V-safe . Ok'd to exit 9:45 am

On Mar, 25th , around 4.30 pm I got vaccinated. I went back home. I ate my summer and Took Tyelenol as I was tired and arm was little sore. I slept around 7.30 pm and got up at 7 am. I felt weakness and after I had my break fast , my body pains started. Every muscle ached and every joint ached. I had weakness and lethargy. I took tyelenol extra strength so the pain was subsiding . I had temperature 100.3 since Fri , Mar 25th. When the tyelenol was wearing off the pains used to become horrible. I was not able to move and I was on my bed bed most of the time. On 28th I even tried Ibuprofen as Tyelenol was not helping a lot with pains but Ibuprofen did not work at all. I sent messages to my dr who thought these side effects are expected. On Mon she replied if the side effects did not resolve I can go to Immediate Care. My arm was sore but that soreness was nothing compared to body aches I had. I called off from work on Fri and Sat. My employer wanted return to work clearance. I went to discuss with Immediate care doctor as I had same weakness and tiredness and little walking was making me breathe heavily. As it was almost the end of 4th day after I got my vaccine they tested me for Covid and my results were negative. I still have to be in quarantine for 7 days from yesterday. I was tested Covid positive in Mar 2020 around mar 24th. I had same horrible pains but had high temperature like 1049.8 and with tyelenol it was 102.5. I am scared to take the second dose that might trigger same reaction. I suffered a lot like people suffered after 2nd dose. First dose is sensitizing dose but I showed such reaction that means my body recognized the threat and began to fight in first dose then what is the need of second dose that is actually a booster dose. My main concern is I might feel the same way how I felt now. I am still weak and cannot perform my daily activities like cooking and I have 4 kids aged 7- 12 yrs age.

Encounter Date: 3/23/2021 Hide copied text Hover for details 245PM Pifzer first dose Vaccination given. 320 Complaining of not feeling well. States she stayed beyond her 15 minutes as did not feel well. BP 119/80 P86 R 18 Pulse ox 100%. When asked how she was feeling she stated she feels something in her throat. Complains of itching to her back. When examined, found many reddened areas with scratch marks over mid back near bra line. Consulted Dr. regarding giving Benadryl 25 mg po. She advised to administer. 325 Benadryl 25 mg given po. Denies difficulty swallowing but states not getting air as well. Lung sounds audible but diminished at bases. Unable to auscultate heart sounds per NP due to acoustics. 335 BP 125/85 P 132 R 22. Pulse ox 99%. States more difficulty getting air. Epinephrine 0.3 mg IM given complains of lip feeling tight. 337 Squad arrived and given report. BP 124/67 P138 R 22. Pulse ox 98%. Shivering from Epinephrine administration. Patient taken to Emergency Department, unable to see records from that facility.

has a hx of Rheumatoid Arthritis and takes gabapentin and Relafan. She states she is immunocompromised. She received her second dose of COVID-19 vaccine on 1/7/2021 without adverse events. on 3/23/21 she developed signs and symptoms of COVID-19 and tested positive for the virus on 3/26/21; she reported the following symptoms: headache, chills, nausea, diarrhea, congestion, SOB, myalgia, and malaise. She was treated with Bamlanivimab infusion on 3/29/21.

42 yo female with c/o itching to neck/throat, sensation of throat swelling/SOB, dizziness ~1:43 pm. She has prior h/o anaphylaxis to IV contrast and appeared to be very anxious. Pt was given Benadryl 25 mg PO, water, and rested in a recliner. BP 140/80, HR 88, o2 sat 100%. 911 was called as pt's symptoms were not improving and she had travelled to vaccination clinic alone by bus. She remained A&Ox3, was speaking in full sentences, and no swelling or erythema to throat visualized.

Pt received injection of Pfizer Covid 19 vaccine at 10:28 am, complaint of feeling lethargic and coughing noted at 10:45. complaints of sore throat and difficulty swallowing. coughing getting worse, b/p 154/95, HR 133, o2 sat 100. 0.3 mg of epi given in right thigh @10:46, symptoms improved slightly . bp@10:55 145/92, HR 122, o2 sat 100%. patient starts to have difficulty breathing again and cough returned. 0.3 of EPI given again @ 11:00 , still have complaints of difficulty breathing, 125 solumedrol given IM right upper quad Gluteal muscle. patient starts to improve, b/p 143/86, HR 118, o2 sat 100%. patient monitored for an additional hr because she stated that she did not want to be transferred to the hospital due to lack of insurance. monitored from 11: 15 til 12:20. Discharged home accompanied by daughter, B/P @ 1215 127/90, HR 108, o2 sat 100%. Symptoms all resolved no complaints at the time of discharge. she was able to go to the restroom without issues.

Approximately 10 minutes after the vaccination, the nursing staff noted the patient looked unwell. We provided water and APAP 650 mg per patient request. A few minutes later, she reported throat tightness and that she needed her albuterol inhaler but did not have this on her. We arranged to have a prescription sent and expedited to OP pharmacy for albuterol , which she received and administered with minimal improvement. The nurse continued to monitor her and she advised she felt itchy and diphenhydramine 25 mg was administered. Ultimately after over thirty minutes, there was no change in the patient's status. The patient refused the ED stating she had additional obligations at home. A long discussion of risks ensued, patient verbalized understanding and signed AMA form.

Beginning the afternoon of 3/31/21: headache, chills (came and went for 3 days), body aches that were constant (head/neck/shoulders), soreness in spot of injection, night sweats, fever (came and went), fatigue and loss of appetite. Several days after the onset also had shortness of breath that lasted three days. I finally feel 90% normal on 4/6/21 with just a very slight headache in the morning and slightest tightness in chest. I only took one ibuprofen pill every 9 hours if my symptoms were terrible.

At 9pm on 3/6 felt fatigued and went to bed. Awoke at 11 pm with nausea, severe muscle pains, inability to breathe. Crawled back to bed and had fatigue until night of 3/7. Had a temp off 100.7 in the morning of 3/7 that was gone within 2 hours. On 3/8, started waking up to neuralgia in both hands with hands burning and inability to grasp objects. Since 3/8 (continues to this day) this has continued almost nightly and now occurs during the day along with major muscle aches and pain and stiffness in neck all the way down to the back.

I broke out in Hives over my whole body and my throat was swelling a bit. Got dizzy and shaky. I was given 2 shots in Hips and a steroid.

Reported shortness of breath and difficulty swallowing. O2 given 10L via face mask. Pt declined to go to ED.

slight shortness of breath from 1500-1530; Nausea; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:15 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included Hashimotos, HBP and Known allergies to latex, nickel, some fragrances. Concomitant medication(s) included valsartan (VALSARTAN) taken for an unspecified indication, start and stop date were not reported; levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient received these medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Since 24Mar2021 13:15, the patient experienced Dizziness and Nausea and slight shortness of breath from 1500-1530. The events were assessed as non-serious. No treatment received for the adverse event. Outcome of the events was not recovered.

42 y/o female, hx of fainting ?when getting shots?. c/o SOB, stated ?I feel numb on my face from nose down to my mouth?. Also stated ?I feel like my throat is closing and having hard time swallowing?. Pt is hyperventilating, crying. Paramedics V/S taken HR 95, BP 149/88, O2 Sat 100%. Educated on calming and deep breathing techniques, given po fluids tolerating well. Pt now more calm and sent home without s/s acute distress.

I was find after the 15 minute waiting period. By the time I had pulled out of the complex in my car my cheeks were bright red and it continued down my neck. My right side of neck felt tight/stiff. By the time I got home I had a hive above the right clavicle. Right hand felt numb. Heart rate accelerated, face became puffy. Lips and gums felt numb, throat got red and swollen, hive on right gum and back of throat felt itchy. Never lost ability to breath or swallow. High anxiety, felt extremely uncomfortable in my body. Took Histaminum hydrochloricum via bioAllers Pollen Hayfever treatment several times between 6:30pm and 10pm. Took Skullcap via tea between 7pm and 8pm. Reaction started to calm down around 8:45pm, and I felt back in my body by 10pm. It took until about 2:30am until my heart beat regulated. I will see a PCP hopefully today (Sunday) if not tomorrow.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: bilateral lower leg edema-Mild, Additional Details: Hx of asthma, previously diagnosed with COVID > 2 weeks ago, pt complained of bilateral lower leg edema 12 minuts after vaccine was given, pt given benadryl, 3 minutes later complained of throat tightening and tongue swelling, pharmacist administered epinephrine and called 911, EMS evaluated but pt refused transport

Redness; swelling; large knot at injection site; swollen lymph nodes in armpit in injection; tingling down to fingertips of arm injected; shortness of breath and heart palpitations.

Approximately 3-5 minutes after receiving shot, I experienced rapid heartbeat, rapid deep breathing, light tingly and numbness on my lips and feet and mild stomach weakness. I was immediately attended by the fire rescue on site who took my heart pulse and blood pressure. After leaving the location I experienced two more episodes of the same symptoms within 1 hour of receiving the vaccine. After that I have been okay. I would like to know if after having experienced these symptoms should I still receive the second dose.

An hour after I received the vaccine, I became light-headed and started feeling tingling in my upper body. My lips were tingling and became numb. My throat also started to feel tight. I did receive Benadryl IVP 25mg within 5 minutes of reaction.

Patient stated few minutes post vaccine her throat was tightening. Patient was hydrated, stayed for longer observation and felt better

Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. Patient developed shortness of breath, chest pain, cough, headache, body aches, and low grade fevers shortly after vaccination. She was tested for COVID on ~4/2/21 and on 4/11/21, and both tests came back positive. Patient presented to the ER on 4/11/21 and was admitted for COVID treatment.

Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. The next day, she developed fever, was told that she had a sinus infection, and was treated with amoxicillin. Patient tested positive for COVID on 4/7/21 at her primary care doctor's office. On 4/8/21, patient presented to the ER with cough, shortness of breath, fever, chills, and weakness, but was sent home. Patient returned to the ER on 4/9/21 with worsening symptoms and was admitted to the hospital for COVID treatment.

I received my 1st vaccination on Friday, April 2nd. Minutes after receiving the vaccine, my throat started itching and feeling tight. I stayed for 30 minutes and the reaction never got any worse. Luckily, my airway was never blocked nor my breathing impaired. I went home, took 2 Benadryl, and about 2 hours later I went to bed and slept for 13 hours (approx). My throat was still a little tight that Saturday and my left arm was really sore, but by Sunday I felt completely normal.

41/ YEAR OLD FEMALE COMPLAINEDOF TROUBLED BREATHING 10 MINUTES AFTER RECEIVING VACCINE. ON SITE EMS RESPONDED, VITALS BELOW. AFTER BEING MONITORED SHE WASN'T FEELING BETTER AND WAS TRANSPORTED TO RECEIVING HOSPITAL VIA EMS.

Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.

Feels like throat is closing, dry throat (not mouth), feels like swollen throat, dizziness for 10 minutes, nausea

Vomiting for hours, sore throat, stabbing pain near heart when breathing, severe headache, body aches, fever, fatigue

10 days after 1st dose, started with severe itching burning tingling on left flank early morning. For a few days prior had headaches as well that would keep coming back. Was able to get into see primary next morning, confirmed shingles, prescribed valacyclovir 7 day course. As days progressed red rash appeared, also along that and up left back flank greenish yellow bruising as well. Meds help stop progression of blistering, blisters did not appear. It has been about seven days now. Today, Sunday 4/18/21, I went to ER for mid upper thoracic spine pain discomfort and into chest, weird heavy inflamed feeling in chest, little shortness of breath. This pain and feeling been going on for few days or more. ER Doc did not do xray of lungs. Jist prescribed 5 day course of prednisone. Said neuralgia shingles and fatigue malaise. No fever. Blood pressure was 146/69. Pulse 90 at time of ER visit. Normal BP for me is 70-80/60 approx. Said to take Ibuprofen on schedule to keep in system and help with inflammation. CBC done on Fri 4/17 , showed normal values, same with PTT PT. I am to followup with primary Dr on Tuesday. Still in a lot of discomfort, neuralgia I assume. Hoping meds start working to help. Not going into work tomorrow per doc recommendation.

April 12th started having severe itching, burning, tingling on left flank area. Days prior have had headaches that would not go away and always come back. By later on the 12th, skin started to be red. Was able to get into see Dr next morning on 13th. Dr. prescribed Valacyclovir 7 day course to take as shingles was diagnosed. Had red rash area but wasn't raised. Itching , burning, tingling still. Within a few more days, more red purple, no blisters formed. Bruising also near the red area and also on back up flank somewhat. Bruising was greenish yellow. Skin sore and sensitive to touch as well. Also spine, mid thoracic upper thoracic spine pain discomfort and also chest feeling weird and heavy, inflammed chest had felt weird too along with the pain in back, deep spine pain discomfort. Feeling of shortness of breath or something. Hard to explain. Pain and discomfort would not let up, constant in spine. Decided to go to ER today, Sunday April 18th. ER prescribed Prednisone for 5 days to take to help with inflammation and said to continue Ibuprofen regularly to help. No xray of chest or additional testing was done in ER. ER doc said neuralgia due to shingles prob causing spine pain discomfort and such. Said to take a day off work to rest and followup with my primary by tuesday. Headaches also during the week, feeling weak, run down, shaky at times. Worse in evening many days.

With the first Pfizer dose on 02/16/21, I experienced immediate pain at the injection site. This pain increased and became increasingly severe and extremely intense within 5 hours of the vaccine. At that time other symptoms began to develop, including a very severe headache (crown/back of head), swollen glands and stiff neck, rapid heartrate, shortness of breath. These symptoms lasted at an intense level for 2 days, and at a moderate level for a total of 14 days (last symptoms were observed on 02/23/2021). Please also note that I started my period that month on 02/17/2021. My second Pfizer dose was on 03/9/2021, 1:40pm. (COVID19 Pfizer~BioNTech, Lot EN6205, intramuscular, left arm). I experienced mild pain at the injection site within 5 hours of the vaccine. 24 hours after the second dose I began to develop moderate/severe symptoms including headache (crown/back of head), swollen glands and stiff neck, rapid heartrate, shortness of breath. These symptoms lasted at a moderate level for a total of 14 days (last symptoms were observed on 03/23/2021. Please note that I started my period that month on 03/17/2021. This month I started my period 2 days later than usual on 04/14/2021. In addition to my regular menstrual symptoms (including migraine temporal headache and mild cramps), I experienced additional symptoms starting on 04/15/2021. These included moderate/severe headache (crown/back of head), swollen glands and stiff neck, rapid heartrate, and shortness of breath. These symptoms are still present at a moderate level today, 04/22/2021.

2 MINUTES AFTER RECEIVING HER VACCINE, SHE FELT LIKE HER THROAT WAS CLOSING. ON SITE EMS RESPONDED. SHE HAD NO PROBLEMS TALKING OR BREATHING. AND NO COMPLAINTS WITH THE FIRST DOSE EITHER. VITALS ARE BELOW. 25MG DIPHENHYDRAMINE WAS GIVEN ORALLY. SHE FELT BETTER AND WAS RELEASED HOME

Shortness of breath and feeling of chest tightness and cinjestion. Coughing and feeling as though coughing is necessary to breathe fully.

Nausea and cold sweats, unable to catch my breath - panting like running a marathon. Then sudden onset total numbness in arms and legs and uncontrollable muscle contraction in my hands - I couldn?t move my hands and they clenched into tight fists on their own. Total time for event around 10 minutes.

Aggressive vomiting, diarrea, weakness, shortness of breath, chills, over sweating and feeling faint 15hrs after vaccination. 911 came. Low Blood pressure 89/57

Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.

Cold sweats, heart palpitations, racing heat, chest pain, shortness of breath, numbness and tingling in extremities, head ache, light headedness, joint and muscle pain, diarrhea, and pain at injection site.

Patient reported lightheadedness, minor throat swelling, "foggy" feeling. Reported some dizziness. Advised patient to lay down and monitored them. Offered snacks and drinks. Patient reported feeling better after an hour and left on own will with no symptoms.

10 days after my first shot I have been experiencing dizziness, headaches, increased blood pressure, muscle pain, fatigue, difficulty breathing

At end of 15 minute observation period, client walked outside then returned within approximately 1 minute. Upon return, she stated 'when i walked outside, my throat started to feel tight'. Oral airway assessed with flashlight and no edema noted - respiratory effort unlabored/ no audible wheezing - appears comfortable - skin color within normal limits. Apple juice provided - swallow intact. Additional 15 minute wait time completed. Client states the sensation is unchanged but she wanted to leave to pick up child. Continues with no distress. Discussed not driving and calling 911 if symptoms worsened. Client verbalized understanding. At 5pm, writer contacted client to assess condition - client states she feels 'great' - symptom resolved by 4pm and no further symptoms developed. Discussed monitoring self and contacting provider or 911 as needed. Client verbalized understanding.

My initial reaction within 5 minutes after vaccine injection I was sitting in waiting/observation room and had 2 major dizzy spells. Felt like I was going to faint and heart rate felt elevated. This subsided somewhat. Stayed in waiting room for 30 minutes. When I left facility heading home as someone else was driving me, I had another sudden side effect attack but much worse. The side of my mouth/chin area started to flutter and then that was followed immediately by shortness of breath, minor feeling of throat closure, very dizzy and extremely rapid heartbeat.

Palpitations; a weird feeling under her skin; Shortness of breath; the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs; Dizziness; At the time she was given her COVID-19 Vaccine shot, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back; dry eyes; she was coughing more; the increase in coughing had made her voice huskier sounding; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 08:45 Arm Left (Lot Number: EP6955, Expiration Date: 30Jun2021) single dose for covid-19 immunisation. Medical history included ongoing Crohn's disease from 1999, ongoing Hidradenitis suppurativa at the end of 2019, ongoing Small Fiber Peripheral Neuropathy diagnosed at the end of 2019. She said her doctor was not sure of the Small Fiber Peripheral Neuropathy's cause, or if the Small Fiber Peripheral Neuropathy was associated with any of her other medical conditions. She said she had symptoms for sometime, and was diagnosed with a lot of things at the end of 2019 because she was finally able to see a specialist. Concomitant medications included adalimumab (HUMIRA AC) from in Feb2020 at 40mg injection pen once a week for her Crohn's disease. Reported she has had no reactions to flu or pneumonia vaccines for immunisation in the past. She said she had her first COVID-19 Vaccine dose on Thursday, 18Mar2021. She said on Saturday morning (20Mar2021), she had shortness of breath, dizziness, and chest pressure. She said her shortness of breath, dizziness, and chest pressure has been lasting for 20-something days, and she doesn't know why. She said she had taken two (different) week long prescriptions of Prednisone. She said she had 2 EKGs, 2 chest x-rays, and blood work, which were all normal on 13Apr2021 and 2021. She said her doctors don't know why she was having the shortness of breath, dizziness, and chest pressure. She said she was using inhalers, medications, and everything, and still had her symptoms. She asked if what she was experiencing was a side effect of the COVID-19 Vaccine, or due to her 2 autoimmune diseases because her doctors were grasping at straws at this point. Reported she had so many medical conditions, and was taking so many different medications. Reported she has had shortness of breath and chest pressure every day, but the dizziness wasn't constant, and had lessened. She said she has never had the shortness of breath and chest pressure before. She said she has never had anything last that long either. She said she was wondering if her shortness of breath and chest pressure were caused by the COVID-19 Vaccine. Clarified the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, saying it was an odd feeling. Reported she was coughing more, and she believed the increase in coughing had made her voice huskier sounding in 2021. She said she had a cough associated with outdoor allergies, but the cough she had now didn't feel like her normal allergy cough. She said she had no mucus. She said she was not sneezing, or coughing out anything. She said the cough she had now was different. Reported at the time she was given her COVID-19 Vaccine shot 18Mar2021, she had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her fingertips. She said the warmth feeling also went to the left side of her back. She said she was kept longer after she got her COVID-19 Vaccine for monitoring. She said the warmth feeling in her left arm, left fingertips, and left back didn't last long, and went away. Reported she had gone to the Emergency Room on Tuesday, 13Apr2021, because she had palpitations, and a weird feeling under her skin. She said while at the Emergency Room, she had an EKG, chest x-ray, and blood work. She said the doctor was looking for a blood clot. She said all her testing came back negative for a blood clot. She said earlier that day (13Apr2021) was her 3rd visit to her doctor since her symptoms had started. Reported she had started Restasis on 19Mar2021, the day after her first COVID-19 Vaccine. She said she was prescribed Restasis for dry eyes, and didn't have the dose, NDC, Lot, and Expiration Date because she was not at home. AEs require a visit to Emergency Room and Physician Office. Treatment included Stated she had taken 2 different week long doses of Prednisone to treat her symptoms. She said she first took Prednisone 40mg, once a day, for 7 days. She said she was off the Prednisone 40mg for 2 days, and had instructions to call her doctor if she wasn't feeling better. She said she went back to her doctor, and was prescribed Prednisone 60mg for 3 days, then Prednisone 40mg for 3 days, and then Prednisone 20mg for 3 days. She said she did not have the 2 Prednisone prescription NDC, Lot, and Expiration Dates. She said she was also put on a 10-day Azithromycin 250mg tablet prescription. She said she took a Azithromycin 500mg (2-250mg tablets) dose the first day, and then Azithromycin 250mg, once a day, for the next 9 days. She said she did not have the Azithromycin 250mg tablet NDC, Lot, and Expiration Date. She said she was also prescribed an Albuterol (90mcg per actuation) inhaler, providing: NDC Number: 66993-019-68, Lot Number: A63H, Expiration Date: Jan2022. She said she didn't feel like the Albuterol inhaler was doing the rescue part, and that she could take the Albuterol inhaler every half hour. Reported she was prescribed an Albuterol inhaler (90mcg per actuation) for shortness of breath. Outcome of the event Shortness of breath, the chest pressure was in the middle of her chest. She said the chest pressure felt like something sitting on her lungs, coughing more, the increase in coughing had made her voice huskier sounding was not recovered. Outcome of the event Palpitations, a weird feeling under her skin was unknown. Outcome of the event Dizziness was recovering. Outcome of the event had a warmth that went down her left arm (the arm she received her COVID-19 Vaccine in) to her left fingertips & to her left back was recovered on 18Mar2021. No follow-up attempts are needed. No further information is expected.

Pt with allergy to Codiene and previous similar reaction c/o SOB and chest pain with rapid breathing immediately post Pfizer dose #1. Per EMS, vitals WNL, 50 mg diphenhydramine administered and patient transported. Pt advised to seek allergist consult prior to dose #2. A note was left in her chart not to give dose #2 without medical consent.

Patient received her first COVID-19 (Pfizer) dose at approximately 1100. Because she reported a history of allergies to medications and raspberries, she was asked to stay in clinic for 30 minutes following her vaccination. About 20 minutes after her vaccination, she told the RN her throat was feeling "spongy" and tight. She also reported a racing heart and feeling faint. Recommended she go down the hall to the ED and escorted her there. and got her checked into the ER. She did report worsening throat tightening upon arrival to the ED.

After taking normal medications prior to bed became acutely short of breath, mother states patients face turned blue then respiratory arrested followed by cardiac arrest. CPR was performed for approximately 10 minutes before pulse returned.

Patient complaint of difficulty breathing, shallow breathing, feeling weak, difficulty talking after the 2nd dose of Pfizer vaccine. Pharmacist lay patient with legs elevated. Called 911 immediately. 1 dose of 0.3 ml epinephrine given on right thigh(ndc 001151694-30 lot g201101x) monitored bp and hr every 2 minutes. Vitals remain stable and paramedics arrived to release patient.

Two hours after receiving the first doze, I started to get dizzy (the room started to spin). I contacted the pharmacy to ask if it was a common side effect, and the pharmacist told me to lie down on my side to see if the dizziness goes away in about 30 minutes. It didn't. I contacted the office of my primary care physician, and the nurse told me that it was not a common side effect, that I should go into the urgent care or ER. I did not take myself in, as I was feeling extremely dizzy. After 8 hours from getting the shot, I started to feel better and went to sleep. I felt better the next morning; however, I continued to have on and off dizziness/vertigo for the next 10 days, to the point that I chose not to drive my children around. In addition to dizziness/vertigo, during the first 10 days, I also experienced sensitivity to sounds and a feeling of a band around my head, squeezing. From day 11 to day 14, I experienced extreme fatigue. I was out of breath and my heart was racing from doing basic activities, such as cooking, cleaning the floor, and walking from one room to another.

Very bad pain and soreness in arm. As of today arms still a lil sore, both arm and legs very weak, lost of appetite for days, headache, drop in daily energy, menstrual cycle has been off and on since first vaccine on 4/8/2021

Dull chest pain which increased with deep breath or bending over. Blood tests revealed extremely elevated Tropinin-i and CRP levels. Required hospital stay, for 2 days

14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.

flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive on 16Apr2021 (blood test) , CXR with unknown result on 17Mar2021. Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events. There is limited information provided in this report. 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.

She began having shortness of breath after getting her second shot. He parents found her dead in her bed this afternoon. No other known comorbidities.

Sore throat; Gets winded while talking; headache; feeling like she has a cold; joint pain; This is a spontaneous report from a contactable consumer or other non hcp (Patent). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0150 ), dose 2 intramuscular, administered in Arm Right on 26Apr2021 10:30 as single dose for covid-19 immunisation. First dose was given 05Apr2021, 10:00 Pfizer COVID vaccine, Lot ER8733, Expiration was unknown. Injected intramuscularly in left arm. The patients concomitant medications were not reported. The patient did not had any prior vaccination before to this vaccine. On 26Apr2021 21:00 patient had joint pain and achiness , On 28Apr2021 19:00 the patient experienced headache, on 28Apr2021 12:00 she was feeling like she has a cold, On 29April2021 12:00, she has sore throat, on 29Apr2021 12:00 she reported she gets winded while talking. The events were worsened. The patient was recovering from joint pain. The patient had a queried that she had first and second doses of Pfizer COVID Vaccines but is having some symptoms and is not sure if she has gotten COVID or not, she was not sure whether should get tested or not. The outcome of the rest of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

My heart was racing.132bpm; I felt lightheaded; tightness in throat; tingling in my arms and hand; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 05Feb2021 15:00 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included known allergies to Pineapple, Bananas, onions, several environmental allergies; asthma. Patient didn't have COVID prior vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); cromoglicate sodium (ALLERGY) shot; clarithromycin (CLARITIN); mometasone furoate (FLONASE); fluticasone propionate (PROAIR); all taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. Around 8 minutes after vaccine (as reported) patient felt lightheaded, tightness in throat and tingling in her arms and hand. Her heart was racing.132bpm. She told the workers and was taken by ambulance to the hospital. Adverse events start from 05Feb2021 03:15 PM and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent car. Treatment received included Oxygen, benadryl shot. The outcome of the events was recovering. COVID was not tested post vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

I started to receive severe back pain. Developed a fever over 102.5 while taking ibuprofen. Severe sweats. The pain worsened til chest became tight. Breathing was labored. Shivers from fever. After 24hrs fever broken and paid became minimal

Severe back pain; difficulty inhaling deep breaths; lung inflammation; This is a spontaneous report from a contactable other health professional. A 42-year-old female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 08Feb2021 at 05:00 PM (at the age of 42-years-old) at single dose for COVID-19 immunization. The patient had received first dose of vaccine on 13Jan2021, at 03:00 PM, in the Left arm. The patient had history of allergies to Sulfur . Other medications included Vitiman D3. On 08Feb202 at 10:30 PM the patient had severe back pain with difficulty inhaling deep breaths She went to Emergency room/department or urgent care. Treatment received was Tylenol/Ibuprofen for lung inflammation. The outcome of the events was recovering. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

pt complained of not feeling well, redness in the vaccinated arm visible, pt then complained of swelling of throat, swelling of face and lips evident, epi 0.3mg administered per protocol

1 week following second dose of vaccine, left subclavicular lymohnode became swollen and tender. Chest x ray showed no findings. Two months later lymoh node edema persisted and I had a chest/abd/pelvic ultrasound which indicated a 4.5 cm mass in left lung, possible metastasis to the spine, liver, and now shows metastasis to the brain in recent brain MRI. CT scan findings confirmed by biopsy indicating adenocarcinoma.

At 30min after shot my heart started racing, redness on face and going down neck, then difficulty breathing with swelling of my throat.

Pain in the arm and migraines. When I was trying to walk up the steps I had shortness of breath. I tripped up the steps because I got lightheaded. I went to my doctor. I took Excedrin. I wanted to be sure the SOB was checked. Doctor checked my medication, and took my vitals. BP was high, then I had to wait 45 minutes for the doctor to take my BP again. The second time my BP was taken it was a bit lower.

Pain, fever, swelling, hard knot at injection site, chest pressure, shortness of breath, throat feel like it was swelling shut, cough, difficulty talking. The chest pressure began Sunday morning and readily got worse eventually resulting to a trip to the ER when Benadryl, rescue inhaler, and EPI pen didn?t work.

Nausea immediately for over 48 hours Diarrhea for over 48 hours Feeling that I'm not getting air even with deep breaths Feet burning on bottom

Pt started to have facial and neck swelling, pain and tightness in throat and difficulty with breathing x12 hours before coming into ED.

Mild fatigue and headache day after first shot only, and mildly sore arm for a week or so. After second shot -3 days very sleepy, increased chest pain, increasing activity intolerance, then less sleepy but severe activity intolerance, palpitations and tachycardia sitting up for extended periods, SOB with walking distances or stairs and sharp chest pains again, waking from sleep SOB, unable to tolerate lying flat on back with SOB. It was like much earlier in the long Covid again. About 1 month after the vaccine I took prednisone 20mg for 5 days, against medical advice and all symptoms improved, to just a little worse than before the vaccine. My mother had a similar reaction to the first dose and was hospitalized, and got no testing or treatment, just monitoring. She had Covid at the same time as me.

Numbness in left hand. Left arm heavy and sore.Fever. Chills. Cough. Heart palpable. Shortness of breath. Stomach cramps. Nausea. Diarrhea. Pain behind eyes. Burning itchy skin. Uterine bleeding.

Recurring smaller allergic reactions; Felt a little unwell; I made it 2 blocks when my pulse went up to 134bpm; i felt nauseous; Shaky; Weak; Head and nose pressure; Head and nose pressure; Throat felt tight; Congested; My symptoms became rapidly worse; Teeth chattering; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EW0172), via an unspecified route of administration, on 04May2021 at 09:30 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing, systemic lupus erythematosus from an unknown date and unknown if ongoing. The patient reports being allergic to dairy, wheat, eggs, sesame, ginger, garlic, onion, tomato and tree nuts from unspecified dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. The vaccine was administered in a hospital. The patient did not have COVID-19 prior to being vaccinated. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EW0150), via an unspecified route of administration on an unspecified date in Apr2021 at 09:30 as a single dose in the left arm for COVID-19 immunization. Concomitant medications included montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; etonogestrel (NEXPLANON) taken for an unspecified indication, start and stop date were not reported; valacyclovir (VALACYCLOVIR) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccine. The patient previously took sulfa drugs and experienced drug hypersensitivity, ADVAIR discus and experienced drug hypersensitivity and an unspecified flu vaccine and experienced drug hypersensitivity. The patient reported that, after receiving the 2nd dose of the vaccine, she sat for the required 15 min. Because of allergic responses to food and the flu vaccine in the past she had her Apple iwatch set up to moniter her heartrate; it was 65bpm at that time. She felt a little unwell but thought she was ok. So she left at the 15 min mark. She walked to her car and as she left her symptoms became rapidly worse. She made it 2 blocks when her pulse went up to 134bpm. She felt nauseous, shaky and weak, teeth chattering, head and nose pressure, throat felt tight and congested. She was not sure if she was going to throw up or pass out. She did not feel well. She went back to the vaccination site and her blood pressure was ok so they did not administer the Epi pen. Instead they gave her Benadryl and observed her for 1 1/2hrs. She experienced recurring smaller allergic reactions over the next couple days. She has taken her Prednisone pills to help.She has an upcoming appointment for allergy testing to some of the vaccine ingredients. The patient experienced recurring smaller allergic reactions beginning on 04May2021 09:45 with outcome of recovering, felt a little unwell on 04May2021 09:45 with outcome of recovering, pulse went up to 134bpm on 04May2021 09:45 with outcome of recovering, felt nauseous on 04May2021 09:45 with outcome of recovering, shaky on 04May2021 09:45 with outcome of recovering, weak on 04May2021 09:45 with outcome of recovering, head and nose pressure on 04May2021 09:45 with outcome of recovering, head and nose pressure on 04May2021 09:45 with outcome of recovering, throat felt tight on 04May2021 09:45 with outcome of recovering, congested on 04May2021 09:45 with outcome of recovering, symptoms became rapidly worse on 04May2021 09:45 with outcome of recovering, teeth chattering on 04May2021 09:45 with outcome of recovering. The patient underwent lab tests and procedures which included heart rate of 65 bpm on 04May2021 and heart rate of 134 bpm on 04May2021. Therapeutic measures were taken as a result of the events and included Benadryl and prednisone.

Charge nurse called to attend to patient after receiving her second Pfizer vaccine. Family members reported she was anxious since yesterday about receiving her second Pfizer vaccine today. It was reported by patient that she had symptoms of nausea, dizziness and anxiousness today. As per her family same thing occurred with her 1st Pfizer vaccine. She denied any significant Medical hx , other than decreased vision, which she does not take any medication for. Charge nurse and vaccinating nurse, moved her to a private tent to vaccinate her and to be monitored. Charge nurse and myself elevated her feet, and had her take sips of water. Wet cool cloth was applied to the back of her neck. She confirmed she felt better after the cloth. She was left in stable condition with vaccinating nurse. I was called back at 1330, because she felt with SOB and more anxious. She did not have any emesis at any point while she was at vaccination site, and no syncope occurred. She was more relaxed after breathing exercises. She was walked over in stable condition closer to EMT to be monitored closely. Vitals were taken. At this time, she was more relaxed and denied any nausea, headaches, SOB or any other symptoms. Family members continued to give her water and she was able to sustain without any emesis. Pt left with family members at 1400, in stable condition.

My blood pressure dropped, started getting heart palpitations, feeling short of breath at times, body (arms/legs) would go numb easy. Would see "stars" at times. Lasted for a good 10-14 days and still don't feel 100% back to normal, but most has subsided.

lower back pack that has not gone away - any lower back pain that I have had in the past only lasted 2 days. This has lasted two weeks without signs of abating. Shortness of breath during light exertion - walking, climbing stairs, light exercise. These are similar to when I was recovering from Covid-19.

Patient received COVID vaccine at 1550 and immediately started feeling throat tightness/anxiety/sob. Brought over here by clinic staff. A/Ox4/airway patent/sat 100%. Given IM epi. Given Benadryl, Solu-Medrol, will add on Pepcid continue to monitor on cardiac monitor. Discharge tachycardia noted, secondary to epinephrine. No repeat epinephrine required during ED course. Patient is on daily steroid, we will not add steroid on top of this. Prescribed EpiPen if symptoms were to significantly worsen.

difficulty breathing; severe sore throat; headache; At Injection felt woozie; This is a spontaneous report from a contactable consumer (patient reported herself). A 42-years-old female patient (non-pregnant) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 at 1: 10 PM (at the age of 42 years 10 months, non-pregnant) as 0.3ML single dose for covid-19 immunisation. Medical history included polycystic ovaries, diabetes mellitus (ongoing), gastrooesophageal reflux disease, hypertension (HBP) and allergy to Red plums. Concomitant medications included Dienogest, estradiol valerate (NATAZIA), Metformin , Glimepiride,Insulin glargine (TOUJEO) for diabetes mellitus, Spironolactone , Lisinopril , Atorvastatin ,Omeprazole ,Amlodipine and vitamin D NOS for all the indication and medication dates were not reported except the indication for Insulin glargine (TOUJEO). The patient previously experienced allergy to Cipro [ciprofloxacin], Keflex [cefalexin] and Betadine [povidone-iodine]. There were no other illnesses reported at the time of vaccination and up to one month prior to the vaccination. On 27Jan2021, at 2:20 PM after the vaccination, the patient experienced At Injection felt woozie, thought just needed to eat 1 hr after injection, difficulty breathing, severe sore throat, headache. The patient visited Emergency room/department or urgent care due to the events. The patient was not resolved from the adverse events. Follow-up attempts are completed. No further information is expected.

Pt felt dizzy, took slow deep breaths, then fell asleep onto husband's shoulder in chair for 30 seconds. Pt awoke and said she was cold and shivering, pt admits to some "chest pain", pt's vital signs were: 126/80 mmHg, 91 bpm pulse, 99% O2 sat on room air. Pt stated she has had a panic attack 4 years ago, she stated this episode "felt similar to last time". Pt given candy by staff, warm water, and emotional support by staff and spouse. Pt reported some abdominal pain after the panic attack, but improvement in other symptoms following being given warm water. No medications were administered.

Heart racing, shortness of breath which leads to mild headache; noticed approximately Monday, May 24 Miscarriage symptoms began on Tuesday May 25th

Severe migraine headache; 10 minutes after taking vaccine experienced itching in right ear; Itching in throat; blood pressure was 156; throat was swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 42-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration on the right arm on 14Mar2021 at 15:30 pm (at the age of 42-years-old) as single dose for COVID-19 immunisation. Medical history included allergy, asthma and pre diabetes, the patient was allergic to baby aspirin, peanut and pecans. Concomitant medications included ZYRTEC, SYMBICORT and azelastine (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 14Mar2021 at 15:45 pm, 10 minutes after the vaccination, the patient experienced itching in right ear and throat which lasted for 40 minutes. On the same day, patient blood pressure was 156 (unit not specified) and five hours later the patient throat was swollen, which went after sometime. On 15Mar2021 at 3.30 am (12 hours after shot), the patient had severe migraine headache which lasted for 36 hours. No treatment was received for the reported events. The clinical outcome of the event blood pressure abnormal was unknown and for event throat swelling it was reported as recovered on 14Mar2021. The outcome of the event itching in right ear was recovered on 14Mar2021 at 16:25 and for event migraine, it was recovered on 16Mar2021 at 15:30. Information about lot number cannot be obtained. No further information expected.

Anaphylaxis sharp pain left side by chest swelling in nape of neck by thyroid extreme sinus pressure between eyes tongue swelled glands under ears swelled throat swelled. Epi pen given by HCP in pharmacy

my heart started racing; my chest and face turned red; coughing; difficulty breathing; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6205, Expiration date: Unknown), via an unspecified route of administration, in left arm on 17May2021 at 04:00 pm (at the age of 42-years old) as 1 ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history included gastroparesis, seasonal allergy, allergy to soy, pencillin and sulfa allergy. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within two weeks prior vaccination included prilosec, synthroid, allegra, hydroxizine, Pepcid. The patient was not diagnosed with COVID-19, prior the vaccination. Since the vaccination, patient had not been tested for COVID-19. It was reported that on 17May2021 (30 minutes after receiving the vaccine), her heart started racing, chest and face turned red and also she experienced coughing and difficulty breathing. The case was considered as serious (hospitalization). The patient was taken to the ER and received IV Epinephrine, Solumedrol, Benadryl and Pepcid as treatment for the events. Patient was an inpatient for 2.5 days in the emergency room. The outcome of the events palpitations, redness was unknown and outcome for other events was not resolved.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Cough, Erythema, Dyspnoea and palpitations. 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.

I was breathless and extremely exhausted for several weeks prior to the most extreme symptoms presented. I started feeling excruciating chest pain so much so that I thought I was having a heart attack, could not sleep at night because the pain grew increasingly worse, radiating pain down my arms, and it was extremely difficult to even complete sentences I was so winded. As these symptoms progressed I thought they were an injury from yard work and wrote it off as costochondritis and suffered. Eventually I was at work and could not even get a sentence out without extreme pain and breathlessness. I was taken to urgent care where they instructed me to go to the emergency room at hospital. There I was given a series of tests. I believe I had a echocardiogram where all my findings were normal. Then they did a blood test where they look for clotting as they were concerned about a blood clot. That was a slightly elevated number which then brought me to a CT scan with contrast. This is where they found that it was not a blood clot but pericarditis. They followed up with a ultrasound of my heart where they saw the sack around my heart inflamed with fluid. The first question I asked the doctor is could this be related to my vaccine which I just completed. The more I learned about pericarditis, the longer I realize how long I have been suffering with breathlessness. I dismissed it for such a long time because I had recently had another baby and was doing a lot of heavy lifting carrying her around as well as mask wearing as a teacher. Because of the mask I dismiss my breathlessness and ignored it for a long time.

Patient received 2nd dose of Pfizer vaccine on the 14th day after the first dose. 1st dose given on May 13th 2021 2nd dose given on May 27th 2021 reported having the following symptoms after the 2nd vaccine; soreness of arm, fatigue, slight shortness of breath per patient yesterday.

swelling of throat and tightness of airway . Took 100 mg of benadryl around 4pm swelling of throat improved immediately. Air was tight most of the night the next morning took inhaler and losen up my airway

Approximately 2 days after the vaccine, I started experiencing shortness of breath, fatigue, profound muscle weakness in my lower legs and lower arms, and tremors. The symptoms got worse over the next 3-4 days and then started to gradually lessen. I'm now 2+ weeks post vaccine and I still have arm weakness and some leg weakness.

I got a fever the next morning and shortness of breath. The fever went away after 36 hours but the breathing difficulties continued to get worse. I was admitted to the ICU through the ER at the Hospital on May 25th for a Myasthenia gravis crisis.

Patient called pharmacy at 2:30PM on 6/13/21 stating that she was concerned she may be having allergic reaction to Pfizer COVID vaccine administered on 6/11/21. Patient states this AM she has developed a rash at the injection site. She describes the rash as being approx. 1 inch in diameter, raised, red, and hot to the touch. States rash looks similar to a spider bite. Patient denies the presence of a fever as well as facial swelling. Upon further discussion, patient states that shortly after receiving vaccine she experienced some shortness of breath and the sensation that her "throat is closing". She reports the SOB and "throat closing" sensation is still present during pharmacy call today. Patient also states she had a "weird taste in mouth" immediately following vaccine administration. Instructed patient to seek medical attention ASAP as SOB/ "throat closing" symptoms indicate possible allergic reaction to vaccine. Patient expressed understanding and said she would seek medical care.

Asthma, fevers, high blood pressure, lymphnodes in armpits and nipples ruptured resulting in discharge at nipples

Received 1st injection on lunch break around noon. Went back to work and a few hours later I felt light pressure on left side beneath left breast. The pressure became worse and felt tight. It became hard to breathe. I kept trying to take breaths but could not get enough air. It was frightening so I went and told one of the doctors I work with what I was feeling. He told another doctor. They both told me I may be experiencing anxiety as I wouldn?t be able to feel reactions from the vaccination so soon. I can?t tell you exactly how long this tight/pressure hard-to-breathe feeling lasted but it was enough to make me lightheaded. It was enough to make me call the number on the Pfizer booklet they gave me but the number took me to a hotline and it was confusing and there wasn?t a clear option to talk to someone to tell them what I was experiencing. I also had to continue working. I was so happy when my chest started to gradually feel less pressure. Then breathing became easier. I was tired after I went home and experienced soreness at the site of injection after approXimately 5 pm. This was serious and now that I had a abnormal EKG and am scheduled for an echocardiogram, makes me wonder if what I felt was due to the vaccination.

Right after the vaccination, within 15 minutes, I was feeling dizzy. I went home I started having difficulty breathing, hyperventilation, dizziness, nausea, severe headaches and anxiety. I used my pulse ox and my pulse rate was very high around 125-130. I also got tinnitus. The next day, I developed a tick in my hands and facial ticks. My hands were also very shaky. A week after I got the shot, I went to the doctor and my BP was 145/90. My BP is normally low because I have history of POTS. I had neuropathy in my extremities (hands and feet) , headache, dizziness, extreme brain fog, could not concentrate, anxiety, extreme fatigue, sleeping all the time, tinnitus, light sensitivity and mild arthritits in my hands. This seem to be my exacerbation of my prior lyme's disease symptoms and/or my autoimmune system. I had some IV fluids at the doctors office and was referred to a neurologist. All my doctors agree that the vaccine have triggered my autoimmune system to go into overdrive. It has taken me 2 months to recover and feel better again. I still have fatigue, tinnitus, and light sensitivity.

Swelling in my chest on the left side with pain; Swelling in my chest on the left side with pain; at times I feel I can't breathe well; tingling in my left arm,; slight fever; headache; chills; This is a Spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on the left arm on 13Jun2021 at 01:45 PM (Lot number: EW0196) at the age of 42-year-old as single dose for COVID-19 immunization. Medication history was yes. Past drug event was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. known allergies was none. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23May2021 at 12:00 PM (Lot number: EW0187) at the age of 42-year-old as single dose for COVID-19 immunization. On 13Jun2021 at 02:30 PM, the patient experienced swelling in chest on the left side with pain, at times the patient feel can't breath well, tingling in left arm, slight fever, headache and chills. No treatment was received. The outcome of events was not recovered.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: ANXIETY-Medium, Additional Details: WE CALLED 911, paramedics came and her oxygen, heart rate, bpwas fine. pt was given option of going to hospital, but she did not want to go.

has been with a multitude of symptoms since receiving Pfizer COVID vaccines, first symptoms was intense epigastric pain which developed 1 wk after first vaccine. Was placed on PPI without significant Improvement. delayed second dose to give body chance to recover. Had upper GI series completed, negative for any acute finings. Still with intermittent exacerbations of abdominal pain despite daily use of PPI and intermittent use of H2blocker. Has continued to see several specialists and multiple visits to the ER secondary to symptoms after second vaccines. Symptoms after second vaccine seems to be more cardiovascular and pulmonary in nature. Reports symptoms seem to be changing over time. Has been with intermittent paresthesia's, heaviness to the extremities, chest pain, palpitations and shortness of breath. Initial work up with cardiology essentially normal. (Holter monitor study, ekg, and treadmill test) Seen allergist who did V/Q scan to Rule out PE, only perfusion portion completed secondary to pandemic D-dimer was noted to be elevated- was sent to ER again for STAT imaging which was negative for DVT and PE. They placed her on prednisone for a few days which seemed to help alleviate some of her symptoms for a short period of time. Saw COVID-longhaul specialist for further evaluation/management- PFTs abnormal, unclear cause. Recommended further labs- unknown which ones. Was started on another round of prednisone which only provided minimal relief. Returned to cardiology who feel she may have secondary inflammatory response post vaccine, going for cardiac MRI to rule out myocarditis/endocarditis. Leg heaviness and paresthesia's are returning again as is her epigastric pain/abdominal pain. These started about a week after second round of steroids.

This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration in the left arm on 19Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 27Feb2021 at 16:30 as a single dose for COVID-19 immunisation. On 19Mar2021 at 23:00, the patient had little soreness in the injection spot. She went to bed around 21:30, but she was awoken around 23:00 because she was feeling extremely cold, even after putting on layers, her electric heating blanket at the highest temperature, and She was under a down comforter. Then the scary part was her organs started to feel heavy and sore. Her lungs, liver, heart, kidneys were weighing down inside. It was difficult for her to get up and walk because she felt like she would damage an organ(s). On 20Mar2021, the patient had a fever for most of the day, and her kidneys were in so much pain. The patient tried stretching, and sleeping it off. Did not work. She drank turmeric tea and a tall glass of water with sodium chloride, himalayan pink salt, and baking soda. The pain started to subside by evening. On 21Mar2021, the patient felt much better, but had a migraine all day and felt very weak. Her kidneys were sore. The patient did not receive any treatment for events. The clinical outcome of the events Feeling extremely cold, Organs started to feel heavy and sore, Liver pain, Organs started to feel heavy and sore, Lungs pain, Organs started to feel heavy and sore, Heart pain, Difficult to get up and walk, Kidneys pain, Migraine all day, felt very weak, Soreness in the injection spot and Fever were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

congestion intermittently through the night; Headcahe; Earache; Nausea; Lymph node pain; General body pain; Pain from injection site; Joint pain /pain radiating to elbow; Chills; Fever; Cough; hard time breathing; This is a spontaneous report received from a contactable consumer, the patient . A 42-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in an unspecified arm on 22Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. On 22Mar2021, the patient experienced pain from injection site (vaccination site pain) which radiated to elbow, chills and fever, cough developed, hard time breathing (breathing difficulty), congestion intermittently through the night (nasal congestion) headache developed, ear ache developed, nausea, pain in lymph nodes (lymph node pain), body aches (general body pain) and join pain especially along the back (joint pain). No treatment was received for the adverse events. The clinical outcome of the events vaccination site pain, chills, fever, cough, breathing difficulty, headache, ear ache, nausea, nasal congestion lymph node pain, general body pain and joint pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Constant migraines ×4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; Swelling to injection site; Watery eyes; Congestion; Sob; This is a spontaneous report from a contactable other health care professional. A 42-years-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0175), via an unspecified route of administration, in left arm (at the age of 42-year-old) on 02Jun2021 16:00 at a dose number unknown, single as for covid-19 immunization. Medical history included Arthritis, Depression, Anxiety, PTSD, COVID-19. Concomitant medications included diclofenac taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was 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 02Jun2021 20:00 the patient experienced constant migraines for 4days, body aches, tiredness, cough, runny nose, loss of voice, blurry vision, swelling to injection site, watery eyes, congestion, sob. The patient did not receive any treatment. The outcome of events was recovered with sequelae on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.

Mild asthma triggered; Extremely itchy skin; This is a spontaneous report from a contactable consumer, the patient and contactable health care professional. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on right arm on 25Mar2021 at 04:45 (at the age of 42-year-old) as a single dose, for COVID-19 immunisation. Medical history included asthma, chronic fatigue disorder and anemia. The patient had allergy to naproxen sodium (ALEVE). Concomitant medications included lamotrigine (LAMICTAL), bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC), Montelukast sodium (SINGULAIR) and liraglutide (SAXENDA). The patient did not receive any other vaccine in four weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on left arm on 05Mar2021 at 04:45 (at the age of 41-year-old) as a single dose, for COVID-19 immunisation. On 25Mar2021 at 22:00, the patient had mild asthma triggered (just needed her inhaler) and extremely itchy skin. The patient had not received any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events mild asthma triggered and extremely itchy skin were unknown at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.

shortness of breathe; Raised BP; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was En6201 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 19Mar2021 at 17:00 (at the age of 42-year-old, non-pregnant) as dose 1, single for COVID-19 immunisation. Medical history reported as none and did not have allergies to medications, food, or other products. Concomitant medications included amlodipine besilate taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 17:15, the patient experienced shortness of breath and raised bp (blood pressure). The adverse events resulted in emergency room visit/department or urgent care. The patient received treatment Epi though IV (intravenous) for the reported adverse events. The outcome of the events was resolved on an unspecified date in Mar2021.

On the fifth it?s self I was tired felt sick to my stomach was weak on the seventh I woke up and couldn?t see lost my near site vision called my doctor and got my eyes examined and found out I lost my near sight I need glasses now lost my near side and some of my far vision on the 11th went to go see my dr. was having trouble breathing and had a sore throat I have respiratory issues throat issues losing my hair I have recently had an upper G.I. colonoscopy have been having lots and lots of health issues ever since my second Covid shot

dizziness; shortness of breath; her throat is tight; Sore Arm; Swollen; Warm/Hot; Painful; has a sore arm with swelling and warmth; has a sore arm with swelling and warmth; Sore Arm; Swollen; Warm/Hot; Painful; This is a spontaneous report from a contactable consumer reporting for herself. A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27May2021 10:00 (Batch/Lot number was not reported) as single dose (age at vaccination 42 years) for covid-19 immunization. Medical history included covid-19 from Jan2021 to Jan2021. The patient did not administer additional vaccines on same date of the Pfizer Suspect. Family Medical History Relevant to adverse events (AEs), AEs following prior vaccinations and Prior Vaccinations (within 4 weeks) was reported as none. There were no concomitant medications. It was reported that, got 1st dose and on 27May2021 at 19:00. she has dizziness and Shortness of Breath feels like she was kind of holding her breath; feels breathing pressure. It feels like when she has a food allergy. Her throat was tight. She has a sore arm with swelling and warmth. Also reported as Sore Arm; Swollen; Warm/Hot; Painful. Patient stated, she was concerned, and she knows she has to report it, but most people have common things like arm pain and fever. Caller asking if this is a normal reaction of if she should be concerned, she has had Covid before and this feels worse. Caller states she was also concerned because her kids were getting their shots next week and she doesn't want them to feel like this. Caller states when she feels breathing pressure, she starts freaking out. Treatment: None. Caller states she opened the windows and laid back to try and open the airway. Caller states she doesn't know if she should go to the hospital or not. Caller states she was searching for information, but it didn't seem to be a common side effect. Caller states is feels like she is kind of holding her breath. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The patient did not visit Emergency Room for AE. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; tingling/numbness of lips and tip of tongue; flushed face; slight constricting of throat; This is a spontaneous report from a contactable consumer. This 42-year-old female consumer reported. A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:15 (age at the time of vaccination was 42-year-old) as dose 1, single for COVID-19 immunization. Medical history included urticaria and dermatitis contact from an unknown date and unknown if ongoing, I get hives from dermal contact with certain plants/animals/chemicals from an unknown date and unknown if ongoing, allergy to chemicals and allergy to animals from an unknown date and unknown if ongoing. The patient's concomitant medications was not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other medication prior to COVID-19 Vaccine. The patient reported that after 15 minutes of injection, the patient experienced tingling/numbness of lips and tip of tongue, flushed face and slight constricting of throat on 30Mar2021 12:45. Drove to emergency but did not go in, effects began to subside 30 minutes later. No treatment was received for all the events. Outcome of all the events was reported as recovered on 30Mar2021. No follow-up attempts are possible. No further information is expected.

Was like something sitting on her chest holding her throat closed; Chest tightness; Arm swelling up; Arm pain/Sore arm; Lymph nodes very swollen; Arm pain at injection site: 5 to 6 hours after it was pretty intense; Sounded hoarse; Joint pain; was like something sitting on her chest holding her throat closed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0202, Expiry date was not reported) dose 2 via an unspecified route of administration on 28Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) and family medical history relevant to adverse events were none. The patient did not take concomitant medications (No other products). Patient previously had first dose of BNT162b2 (Batch/lot number: EW0185) at left arm around shoulder on 04Jun2021 (at age of 42-years old) for covid-19 immunisation and experienced fatigue which started 8 hours after the first dose and treatment - took acetaminophen, Body aches which was started - 8 hours on 04Jun2021 to 09Jun2021 and she just had a sore arm as well that was super mild at the injection site. No adverse evets following prior vaccinations. No prior vaccinations (within 4 weeks. No additional vaccines administered on same date of the pfizer suspect. On 28June2021 she was okay right after the second shot for the first 5 to 6 hours, she felt normal and only had arm pain. They did inject it in the same arm. Arm pain at injection site: 5 to 6 hours after it was pretty intense, she did well with the first one. Arm swelling up: It was not mild swelling it was the size of a large grapefruit. Treatment, they advised her to put ice on it and to take ibuprofen. She looked in the mirror and her lymph nodes very swollen and she sounded hoarse and had chest tightness. She experienced it was like something sitting on her chest holding her throat closed. Lymph nodes very swollen was started at bedtime 8 or 9 pm 28Jun2021 and treatment was she went to urgent care and they sent her to the hospital. Chest tightness was started at 10pm on 28Jun2021. She had pain and tightness. Treatment was she went to the urgent care and they sent her to the hospital. She was really concerned about the lymph node swelling, joint pain, and chest and asked them what treatment there was and what could she do to feel better. The urgent care suggested going to the Emergency Room. There was no relevant tests. The outcome of the events chest tightness and chest pain was recovering, arm swelling up and lymph nodes very swollen are not recovered and rest of all events was unknown.

The day after the vaccine I felt chest congestion and I was having trouble breathing. My chest felt very heavy. I went to the Urgent Care and they sent me to the ER. I was tested and discharged. I was given some medicine to allege the symptoms of Acid Reflux caused by the Ibuprofen I was taking. It has been ten days and I do not have the chest pressure, but I am still having trouble breathing. I have no history of breathing problems.

It started extreme shortness of breath for a long time even before, it started bad around 10 Jul 2021 and then the pain in my chest started with adding into it on that evening of 10 Jul and 11 there was a burning pain that extended out arms. Out of breath and it hurts by any activity and in the middle of the night on the 12 Jul, it caused me to go to the ER on the 13 Jul.

1. Hives 2. Facial swelling 3. Wheezing 4. Legs warm to the touch All occurring approximately 2 hours post injection and are still present 23 hours later.

Extreme body aches; Headache; Fever; Nose burning; Memory trouble; Confusion; Lethargic; Burning eyes; Shortness of breath; Sore arms; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 11:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic cellulitis, fibromyalgia, chronic sinusitis, chronic bronchitis, achromobacter infection, prior septic shock, brain surgeries, breast reconstruction, staphylococcal infection (staph infections), stroke and sulphonamide allergy (sulfa allergy). Concomitant medications included ceftriaxone sodium (ROCEPHIN) taken on 15Mar2021 in the right hip for an unspecified indication, ceftriaxone sodium (ROCEPHIN) taken on 16Mar2021 in the left hip for an unspecified indication and amoxicillin sodium; clavulanate potassium (AUGMENTIN) 500 milligrams taken from an unknown date for an unknown indication. The patient previously received PAXIL, EFFEXOR, TOPIMAX, CYMBALTA and morphine and experienced a drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced fatigue. On 02Apr2021, the patient experienced worsened fatigue and sore arms in the evening. On 03Apr2021 at 07:00, the patient experienced worsened fatigue, extreme body aches, a headache which was 7 on the pain scale that did not respond to medications, fever, nose burning, memory trouble, confusion, lethargic, burning eyes and shortness of breath. The patient reported that these events continued on the fourth day which was 04Apr2021. The patient reported that on 05Apr2021, the fifth day the patient still was fatigued and weak but there was some improvement. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/ department or urgent care. The patient did not receive any treatments for the events experienced except for headache for which she took unspecified medications. The clinical outcome of the events fatigue, sore arms, body ache, headache, fever, nose burning, memory trouble, confusion, lethargy, burning eyes and shortness of breath were resolved with sequelae on an unspecified date in Apr2021 at the time of this report. No follow-up attempts are needed. No further information is expected.

Heavy breathing; Binge eating sugary foods; This is a spontaneous report from a contactable consumer, the patient. A 42-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 arm left on an unknown date at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) and birth control (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. 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 21Mar2021 at 16:00 the patient experienced heavy breathing, binge eating sugary foods within 6 hours after both the first vaccination and second vaccination. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 30Mar2021, the patient underwent color (covid test type post vaccination was nasal swab) and the result was negative. The clinical outcome of the events heavy breathing and binge eating sugary foods was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Started having pain in lungs; Having palpitations; Shortness of breath; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration and an unspecified anatomical location on 10Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 31Mar2021 at 13:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient previously received BACTRIM for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced palpitations and shortness of breath. The patient reported that the palpitations and shortness of breath started since she was vaccinated. On 02May2021, the patient experienced pain in lungs. The patient reported that she had no symptoms or issues until after she received the COVID 19 vaccination. On an unspecified date in 2021, the patient underwent tests and blood works which were all found to be normal. The patient reported that she was scheduled for further tests. The events resulted in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events palpitations, shortness of breath and pain in lungs was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.

Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.

fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.

Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).

5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt throat swell. Not lymph nodes. Swelling sensation Inside throat. Had a mild headache. Was given 50mg of Benadryl. Taken to ER for observation. Swelling resolved couple hours later without any further reactions. Swelling never impeded my ability to breathe.

Dizzy, lightheaded, shortness of breath, tachycardic Vaccine given at approximately 1612 Benadryl given at 1614. 1615 Epi in L thigh. Pt transported to ED by wheelchair

Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzine without significant benefit (has brief relief is sx but recur before next hydroxyzine dos is due). Pt was seen twice in the ED for these sx. Pt was told sx were related to muscle strain. Pleuritic chest pain and cough. Ongoing cutaneous and respiratory adverse reaction.

ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest tightness. The patient is an employee and received her COVID-19 vaccine, first dose 20 minutes prior to ED arrival. She subsequently developed chest tightness and wheezing. She used he albuterol r inhaler and now feels improved. She says that she has been having increased asthma exacerbations lately because of the change in weather. She has had no prior allergic reaction to any vaccine. She denies any hives. Denies any throat tightness. Her symptoms at this point have resolved. Monitored in ED x 4 hrs. No treatment.

RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of vaccine administration. She was given oral Benadryl and one dose of epinephrine per epi pen. She was taken to the ER for further evaluation.

Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later after taking Benadryl and aleve.

Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swollen lips; Hard Ears; Warm Skin; Itching; Wheezing.

Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved

first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU

sob, headache, fatigue, joint /muscle pain, fever. Worst part is the right shoulder joint/muscle pain. This pain is very bad it has kept me up for 2 night and pain still present

I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anaphylactic shock, I broke out in hives, and my throat was closing

Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was examined in ER. CT of chest showed "questionable minimal small airway inflammation in upper lobes". Patient was discharged from ER home with Methocarbamol 750mg PO Q12 hours as needed.

Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report

5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction

During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm. Denied any other symptoms including SOB. Patient was taken to the ER for further observation where 50mg PO Benadryl was given.

Began with hives, itching. Quickly progressed to difficulty breathing. Brought to ER, IM Epi given in ER triage. Caregiver given racemic Epi and another dose of IM Epi in ED. Further care please refer to ED MD

Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.

Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking

I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.

Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachycardic and hypertensive. I was taken to the Emergency room . 48 hours after exam I had extreme periods of confusion and extreme forgetfulness.

Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.

Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.

approximately 12 hours after vaccine was administered, patient experienced the following symptoms: severe chills and muscle aches; fever of 102.6 that did not respond to Tylenol, headache, vomiting, fatigue, shortness of breath, and chest tightness. She states they lasted for approximately 18 hours, and have started improving in the past 24 hours. Still having symptoms of mild to moderate muscle aches and some shortness of breath. Using albuterol inhaler as needed. Patient is recovering at home currently.

Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after she received the vaccine, she began having severe chills and muscle aches with fever up to 102.6 that did not respond to Tylenol. Also had headache, vomiting, fatigue, shortness of breath, and chest tightness. After approximately 12-18 hours, her symptoms started improving, but still having mild to moderate muscle aches, fatigue, and shortness of breath. Using albuterol prn. Currently recovering at home.

Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & felt "slow swelling" in her throat. Also reporting "slow swallowing sensation" Patient brought out to back triage area, vitals stable, NO SOB, no wheezing, no lip or tongue swelling noted. 167/95, 63, 99% RA. Reporting feeling anxious. Only allergy or similar event patient reports is medication, ephedrine during delivery which was treated w/ O2 during her delivery Repeat vitals 134/90, 59, 99% Allergy MD on call notified of event, per MD continue to monitor for additional 30 minutes and call back w/ any further symptoms 136/93, 60 & 99% After 30 minutes, patients vitals stable, sensation has resolved & felt well enough to go home 127/92, 59 & 99%

After receiving the second dose of the COVID vaccine the patient went home but returned to the ED the following day complaining of shortness of breath that feels like prior asthma attacks. She presented to the ED at 0833 short of breath with a dry cough and hoarse voice. She was given albuterol then monitored and re-evaluated at 0921. At that time the patient stated that she felt a little better, and declined any further evaluation since she reported that she felt the same as she always does while having an asthma attack. She states that she would not have come to the ER if she had not been at work and been required to. She was discharged with prednisone at 0923.

Started with mild headache 1/7 night. Near 5am 1/8 had severe rib pain on right, 7am loose stools, midday body aches, chills, finger swelling and joint swelling ha, fvr low grade. I took ibuprophen. By evening add nausea, vomitting, near syncopal event (had to sit quickly b4 passing out), heart palpitations, light headed, chest pressure and just off feeling, fatigue. By 1/9 all same symptoms, 2 more near -syncopal events, rt knee pain, and asthma (I used inhaler x 3 times). Then 1/10 upon waking, I felt amazing and 100% better. During first 3days of symptoms, I slept alot.

Patient returned 2 hrs after vaccination c/o shortness of breath and "tingling fingers." Hyperventilating upon arrival. VS - 1326 - BP 129/78, HR 90, 100%. 1331 - 131/68 - HR 80, 100%. 1337 - 126/71, 83, 100%. Code yellow called. Patient to ED.

As soon as patient received vaccination, her left arm became heavy, then she became dizzy with chest pain on deep inspiration. Initially became short of breath, which resolved prior to EMS arrival. EMS transported patient to the emergency room with non-urgent acuity.

chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable

Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. 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.

Severe nausea/vomiting, SOB, throat swelling, dizziness, headache, chills. HRT recommended ED visit. She had IVF and Zofran. Symptoms improved.

10 minutes post vaccination developed metallic taste in mouth, then scratchy throat and throat began to close up and was given PO Benadryl - no relief. Required Epinephrine and transport to ER

Had a mild reaction 10-15 min after vaccine. My throat felt tight and uncomfortable as I left vaccination clinic. I took an Aler-Tec pill and felt better 20 minutes after. My arm was sore for 2 days after and couldn?t sleep on Right side, arm hurt. Injection site was purple and bruised one week later but no pain.

20-30 minutes after vaccine patient returned to observation center complaining of difficulty breathing and constriction in throat. Vitals stable, pulse ox 100%, pharynx clear without edema and no wheezing. However she was quite distressed, becoming diphoretic, and stating that breathing and throat constriction was worsening. She was treated with 0.3 mg epinephrine IM left thigh and 25mg Benadryl left deltoid. After treatment breathing improved, throat constriction resolved, and she felt a rapid heart rate and dizziness. These also gradually improved and she was discharge home with her husband, with prescriptions for famotidine, loratadine, to not take metformin today, and strict ED precautions for recurrence of breathing or throat constriction symptoms.

I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).

Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.

Within 2 mins of shot: Tachycardia, dizziness, some mild shortness of breath/chest tightening, reddening of face/chest (and strange almost metallic taste in mouth). The metallic taste subsided quickly (within 2 mins) tachycardia subsided quickly (within 5-10min), and I felt dizzy for approx 30mins (the skin on my chest still looks slightly red approx 2 hours later). The next day/morning I awoke with slightly puffy/swollen face and upper lip lightly swollen/tingly

15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and monitored. Continued to have itchy throat and some rash, felt like prior episodes of anaphylaxis, reported some sob though stable vital signs, sent to ED

Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92

Present to ER with SOB and coughing. Second COVID-19 vaccine was given at 10:30 am and she started feeling chills and cough about 2 hours later. Also, pt reported body aches and neck spasm. Patient given EpiPen as reports feels hard to breath, Solumedrol, Pepcid and Benadryl and reports sob resolved. Ptient watched for 2 hours, no return of symptoms, SOB resolved, and patient start eating and drinking and feeling well. discussed with patient use of Tylenol and Motrin for post vaccine aches and fever and follow up with employee health tomorrow. Patient discharge to home. Note: 1) patient doing well and get back to working the next morning (2/10/21) 2) Past medical history: Asthma and diabetes

Approximately 45 minutes after the vaccine began to have dizziness, increased anxiety, and wheezing. Progressed to difficulty breathing/shortness of air and unclear thinking. Related hypoxia occurred. Treated at home with antihistamines and albuterol. Epi-pen was not used, but should have been.

SEVERE ACHING IN MUSCLES AND JOINTS. FEVER UP TO 102 X 2 DAYS. POINT TENDERNESS TO ENTIRE BODY. COULD NOT WALK FOR 6 HOURS (MUSCLE WEAKNESS), CONFUSION, DIZZYNESS, HEADACHE, ABDOMINAL PAIN, CHEST PAIN, SHORTNESS OF BREATH.

Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat; sweating. She takes Allegra 180mg daily and took 12.5 mg Benadryl prior to injection. After symptoms began, she was treated with Pepcid 40 mg, Benadryl 25 mg, prednisone 40 mg. Symptoms of tachycardia and tightness in neck began almost immediately after injection. Other symptoms began 5-10 minutes later. Symptoms persisted in waxing/waning fashion for about 1.5 hours. Oxygen level remained at 100% on room air. Lungs were clear- no wheezing. She was observed for about three hours. Heart rate was in 80-90 range for the last 1.5 hours. She was released to home with husband. To continue prednisone 40 mg next three days, then taper off. Continue Pepcid 40 mg daily for 5 days. Benadryl 25 mg every 6 hours as needed for breakthrough symptoms. Continue her usual Allegra 180 mg daily. She has f/u on 2/15/21 or sooner if symptoms return and not controlled with above.

Within one minute of receiving the shot my throat felt like it was swelling and I had difficulty swallowing. Lasted about 30 minutes. Two days later my right leg felt dead and big, similar feeling to when I had a spinal for a cesarean section. The sensation was off and on for 2 days and then subsided.

Pt at vaccine clinic for 2nd dose covid vaccine with a history of anaphylactic reaction to immunotherapy. Pt presented with rash/itching on chest, tingling around ears and runny nose 20 minutes after vaccine administered.(0828) Doctor notified and Benadryl 25mg PO given VS at time 169/98, 60, 100%. 0847 pt c/o slight chest tightness, slight labored breathing, feeling of periorbital swelling,VS at time 173/91, 51, 99% Doctor again notified and an RN stat called, pt taken to the ER and report given to ER RN, pt appeared to be comfortable and feeling somewhat better

Patient was vaccinated at 11:06 AM with Pfizer vaccine then headed out to the observation area to sit for 30 minutes. At approx 11:45 AM, Patient s/w observer medical staff and c/o throat tightness. She was then moved to another area for further assessment while 911 was called. Nurse and Dr. stayed with patient until paramedics arrived at approx 11:48 AM. Patient was triaged by Paramedics then transported to Emergency Department at 11:55 AM. Patient was assessed and found not to be having an adverse event but possibly anxiety expisode. Patient was released to go home at 12:55 PM.

4 days with increased heartbeat and blood pressure under the normal values, with shortness of breath and dizziness. Felt tingling on left arm and face. Also bone pain and tiredness extreme.

Dose #2 pfizer; Pt reported onset of chest pain and SOB within 5 min of vaccine. Followed by nausea, vomiting, and feeling of swelling of lips, . Pt used her own albuterol, 2 puffs. RRT called. BP 166/99, HR 90, pulse ox 100, airway intact, lungs clear, cardio tachy but regular, skin warm and dry with no diaphoresis. Concern for anaphylaxis as pt symptoms continued and some increase in disorientation Epi Pen administered, O2 via NC. IV access attempted but unable to obtain. EMS called. Pt monitored with resolution of CP, SOB, nausea, lips swelling and disorientation. Pt continued to have feelings of swelling of tongue and transported to ED

EE reports getting her second Covid (Pfizer) vaccination at 11 AM on 02/16/2021. With having concerns of her throat feeling "hot" for about six hours after her first vaccination, EE pre-medicated with Allegra and Pepcid prior to the second vaccination. EE reports that within 20 minutes after the second vaccination her throat got hot and felt swollen, so she took Benadryl. Between 1900-1930 that same evening EE reports that her throat felt like it was tightening up, so she went to acute care. EE was given Solumedrol IM, Decadron orally, Benadryl 50 mg, and Pepcid. EE states that her HR was in the 140's, and she was flushed at this time.EE reports that she is now on a 10 days course of Prednisone, Zyrtec for 2 weeks, and Benadryl prn.

10 minutes after injection felt extreme dizziness to the point of feeling faint, tightness in throat, severe itchiness in throat, tongue, ears, mouth and all over my body, and felt nauseous. Had to be treated in Urgent Care for these symptoms, Benadryl was administered, and seemed to help the itchiness and tightness of throat

Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.

pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM

"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache

About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day

Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.

A 43 y.o. female received 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 lightheadedness and feeling weak. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. PMH: anxiety and bipolar. Takes Aripiprazole for this. No other medical history reported. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded), Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, joint pain and headaches. Previous Reactions: none. Vitals -- 02/19/21 0350 02/19/21 1610. BP: 131/77 125/77. Pulse: 89 75. Resp: (!) 22 16. SpO2: 100% 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 ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway/intact 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. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological -- General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time; Gait: Gait normal. Psychiatric -- Mood and Affect: Mood is anxious; Behavior: Behavior normal; 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). Pt aware of monitoring symptoms at home. Follow up as needed with pcp. Recommend that she eat a snack and hydrate prior to next vaccine #2 of Pfizer.

Patient became significantly SOB w/ increasing coughing and chest tightness. Patient also developed lightheadedness. She was transferred to a litter and had a pulse ox applied. She noted increased SOB after lying flat and was administered an Epi-pen and then placed in an upright seated position (supported). Symptoms did improve and she was also administered 4 puffs of her personal inhaler with additional improvement but not complete resolution. EMS was contacted and patient was evacuated to the ER for further evaluation and treatment. HR remained tachycardic and SPO2 98%.

This 43 yo ADSM received first Pfizer COVID vaccine Lot EL9264 on 1/29/2021 to left arm about 1440pm. Staff monitored her for 30 min due to past hx of "allergies" and 28 min post vaccine she c/o difficulty breathing in (described as sensation of heavy breathing/was taking deeper breaths than usual), a dry mouth/throat, and a very faint dull pain to her forehead. She denies any cp, mouth/throat swelling, angioedema, rash, myalgia, weakness, fever/chills, difficulty swallowing, no wheezing, cough or other systemic symptoms. Nurse came over and gave her epi pen at 1515 and sent to ER. In ER: VS 160/83, HR 103, Resp 28, O2 sats room air 100%, T98.9F. Lungs CTA in ER. Headache worsened, but no difficulty breathin

Patient complained of dizziness, coughing, and shortness of breath. She was alert, able to talk and was not wheezing. She was monitored for 30 minutes and symptoms subsided. Husband stated she has been coughing for a few days and was going to see her primary care doctor soon.

Around ten minutes post injection PT experienced tingling throughout body, slight constriction in throat, lungs clear throughout no wheezing, BP: 138/89, o2 saturation: 98%, HR: 89 PT then developed facial swelling , administered benedryl at 1815 PO, constriction continued as well as facial swelling post medication admin. PT declined Epi-Pen recommendation. At 1830 an addition PO administered, no change in PT condition. Decision to contact EMS at this point, Medic responded to the scene where patient was sent to hospital.

1/12 vaccination 6:30 I felt nauseous. Vertigo. Started to get chills and HA. Progressively got worse. 103 temp middle of night. Asthma was bothering me. Took my nebulizer, tylenol and motril. Called employee health; COVID test/negative, Symptoms lasted 2 days. PCP ONLINE; prescribed prednisone *Irritated my asthma for 2 weeks which was very unusual for me. Couldn't work because I couldn't breath with the 2 masks required. I would start to wheeze really bad just walking up flight of stairs.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium

Swollen, itchy, hot rash starting below eyes and continuing to spread down face. Swollen throat with mild discomfort.

Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin

Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.

Notes Expand AllCollapse All Patient: DOB: 6/11/1977 Date: 3/15/2021 MRN: Subjective Patient is a 43 y.o. female who was seen at 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 lightheadedness and "head rush", feeling dizzy and had a metallic taste in mouth (shortly resolved). Sensation of chest tightness as reported upon her arrival to bay. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , drooling, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. Medical hx includes asthma and allergies, pvcs and IgG deficiency ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness (lightheaded) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain and headaches R arm pain where injection site is. Ice pack given for site.: Previous Reactions: flu vaccine 20 years ago. She's done well with flu vaccines since then. Objective Vitals Vitals: 03/15/21 1244 03/15/21 1254 03/15/21 1310 BP: 128/85 122/65 Pulse: 86 86 86 SpO2: 100% 100% 100% Physical Exam 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 airway Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Comments: Hyperventilating upon arrival to bay. Pt improves with deep breathing. Pt did take her levalbuterol as well during her stay which did help her chest tightness. No wheezing heard pre/post administration. O2 sats 100% 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. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines, water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) R arm pain; injection R arm. Ice pack placed. Anxiety: hyperventilating, relieved with instructed deep breathing and removal of mask for short time. Lightheaded/dizzy: related to anxiety and systemic stress response. She reponded well to zyrtec, water and snack. Pt able to recover and stand w/o symptoms. She was ambulated out to the front w/o difficulty accompanied by this provider. She's to follow up with pcp/allergist. Pt voiced appreciation of care today.

After the first injection, I noticed mild mouth tingling, but nothing else, did not report as it was so mild and it was more notable in retrospect. A week after the first injection developed vertigo for the first time in my life. This lasted about a week had mostly resolved when I got the second dose. Immediately upon receiving the second dose I felt faint. I went to the observation area and when the feeling got stronger, reported it. My blood pressure was taken and although I always have normal blood pressure, it was extremely high - 195/100. My heart was racing. I was observed for longer because of this, and was asked to lie down. The faint feeling and high blood pressure lasted 30 min, at which time it started to improve and was sent home. I persisted in having bouts of feeling faint (but never fainting) in the days and weeks following, joined with shortness of breath which started the second day after the second injection. I also had the normal fever, aches and pains for 4 days. It is now a month after the second injection, and while the faintness and vertigo are mostly gone, I have persistent shortness of breath. Prior to the vaccine I had an albuterol inhaler that I would use 1-5 times a year for allergies. Almost never used it. I began having to use it multiple times daily after the second dose of the vaccine. I am not on a steroid inhaler. I have never had shortness of breath like this before. I was examined at the doctors office, not much can be seen that is wrong. An allergist believes that I did not have an allergy because my blood pressure was high instead of low as in anaphylaxis.

Patient received her first dose of the Pfizer vaccine today. About five minutes after injection, patient developed shortness of breath and a burning chest pain. She was talking in complete sentences without any issues. She had no other symptoms. Call placed to 911. Her lungs were clear through out, her heart rate and rhythm was regular. See vitals below. A 20g IV was placed to her L AC and Benadryl 25 mg IVP, Solumedrol 125 mg IVP and Famotidine 20 mg IVP was given by the RN. Her shortness of breath improved, the burning to her chest persisted. EMS arrived at 0914 and she was transferred to the nearest hospital for further evaluation and treatment. Patient declined contacting any family members by the staff, she requested to call her husband herself. 03/17/21 0923 BP: (!) 162/70 Pulse: 110 Resp: 22 SpO2: 98%

Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium

First shot - slightly tight feeling in my throat about an hour after shot, low grade fever second day Second shot - tight feeling in throat about an hour after shot for about 4 hours, and light headedness; fever later in day, fell asleep early slept 10 hours; second day ok in morning then fever getting higher all day but now better (6:30 pm so 33 hours after shot), extreme itchiness today day 2, like fleas - took Benadryl at noon and need more now; stomach ache and diarrhea.

Coughing, throat tightness. BP 155/124 (pulse 115), final BP 183/123 (pulse 96). Given EpiPen, sent to ED. At ED, received Benadryl 50 mg PO, Pepcid 40 mg PO, Decadron 8 mg PO. Resolved.

3/23/21 - pt called the call center to inquire about J&J vaccine availability and to cancel 2nd dose appointment. Pt reported that she had a reaction w/ pfizer vaccine. Received Pfizer vaccine on 3/2/21. From review of available outside records, pt called PCP (outside provider) on 3/5/21 reporting itchiness, lip swelling, tongue felt enlarged but no trouble swallowing or SOB 2 days post-vaccine. Pt was advised to continue benadryl and if s/sxs worsen to go to ED. Per pt, they later developed SOB and went to outside ED where she received epi-pen and prescribed prednisone course. Pt followed up with PCP on 3/11/21 and pt report improvement in symptoms. Pt was advised by PCP not to get 2nd dose of pfizer.

20 minutes after shot, tingling and numbness/swelling in throat and lips; did not feel any blockage in my airways and could breathe easily through my nose, but did feel constricted in my throat for about 40 minutes.

5 minutes after injection started to feel dizzy. Not room spinning dizzy. More like a fogginess. Had a hard time comprehending. Trying to use my brain made the dizziness worse. Was unable to drive. 90 minutes after injection started feeling winded while laying down. Took 25mg of Benadryl at 2hr mark after injection.

Patient is a 43 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER8732 on 3/25/2021. The patient experienced the following reaction(s) during the immediate of observation: 11:58am Patient vaccinated. 12:14pm Patient c/o difficulty breathing and shortness of breath at rest during observation period. Patient was treated/managed as follows: 12:15pm VS BP 142/72, HR 94, RR 20, O2 sat 96% on room air. Patient educated on breathing techniques. No swelling noted to mouth, tongue or throat. Patient reports symptoms slightly improving. 12:25pm VS BP 138/78, HR 85, RR 20, O2 sat 98% on room air. Patient reports feeling better and symptoms subsiding. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:33pm Patient escorted to car by site lead Parnesh and patients daughter.

Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.

Heart palpitations and labored breathing within 10 minutes of getting vaccine. Swollen tongue within 45 minutes

Swelling & itching: hands feet & throat Chills: with uncontrollable shaking Fever from 100-103 with Tylenol for 48 hours Extreme muscle pain- not ache, it hurt to lay still Bones would hurting, especially if pressure was applied to move or walk Shallow breathing Extreme thirst Sharp stabbing pain in head: bottom left toward back of neck Large Swollen spot under left arm under arm pit Increased heart rate- approx 130 bpm Went to emergency room in around 8:30 PM on Thursday March 25th. Was given via UV: fluids, Benedryl, medicine for pain & swelling. Discharged around 11:00 PM. Have Remained sick with normal side effects, feeling flu like, and a low temp around 100. Much more manageable. Today is Saturday & I still feel very unwell but no longer feel like I?m dying.

Fevers, Vomiting, Diarrhea, Migraines, Sinus, Wheezing, Wheezy Cough, Muscle and Joint Pain, Chills, Stomach and Chest Pains, Reflux and Heartburn, Flushing, Swelling/Edema, Dizzy, Lethargy, Brain-Fog// I?ve been trying to get diagnosed- have had some of these symptoms since September, but a couple/ few hours after the shot, I have been having all of those symptoms throughout the day and the ones I?ve had have been very-exacerbated; I?ve finally been able to hold down food.