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.

Employee complained of palpitations and feeling warm for approximately 15 minutes, symptoms resolved on their own. employee is 14 weeks pregnant.

Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.

Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration

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.

Intially started as lip numbness, then tongue, lasting for about 10-15 minutes. It went away, then about 10 minutes later her Right arm became numb, then it returned to her lips on the Right side of her mouth, and then feeling wobbly, weakness on the Right leg. Elevated blood pressure, 182/112. Got medication prescribed and is lowerin blood pressure now, within an hour of taking medication, but numbness remains.

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.

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.

Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.

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.

Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.

Approximately 5 minutes after vaccine administration, patient began to feel flushed and she was tachycardia. Brought patient away from public area, gave cool pack, oxygen and called EMS. EMS monitored patient and issue resolved within 20 minutes.

I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.

Palpitations & HYPERtension Narrative: 143/94 98, 100% on RA, 98.2 degrees, rr 14 at 1457. 158/96, 97, 100% on RA, rr 16 at 1501. Denied headache, rash, SOB, uticaria. 138/87, 85, 100% on RA at 1530. Denied dizziness and palpitations. History of palpitations. History of anaphylaxis allergy to IV iodine.

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.

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.

Patient was given Covid Vaccine. She went to the waiting area to sit for the 15 min wait. She then came to the front desk to inform us that her heart rate was elevated and wanted to speak to a nurse. We then notified the nursing staff and took her to a room to be evaluated. After about 15-20 min nursing staff asked front desk to call 911.

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

Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.

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.

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.

1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.

11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL

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.

After sitting down in the observation area and I was just starting to register for vsafe my heart started to pound then I experienced a hot flushed feeling that went through my entire body and my heart started racing and felt not well. I told the nurses what happened and they said I looked pale. I laid down and started to feel better after a few minutes.

Started out with my shoulder blades being sore that night. I woke up the next morning and was sore all over, my head hurt, and my temperature was anywhere from 100.3-101. I checked it various times thru out the day. By the time I was ready for bed I felt a little better, but not up to normal standards. I slept thru the night and woke up fine. I wasn't sore anymore and my twmp was 98.2.

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

Roughly 3.5 hours after injection heart rate jumped to 161 out of the blue all of a sudden; I was able to lay down in the vehicle as we were traveling from home to location and after about 5-10 minutes of laying back my HR lowered to between 100-120; arrived at ED around 6:45 and while waiting 4 hours in waiting rom area to be seen HR remained around 110-115 for the 4 hours straight and finally after about 5-6 hours it retuned to normal rate.

Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, 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

Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.

Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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.

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.

This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablation in October, 2020 who presented to our Emergency Room on 1/12/21 due to the abrupt onset of left sided chest discomfort and diaphoresis. The patient awoke from sleep with this sensation. Chest pain was sharp, unchanged since onset, without ameliorating/exacerbating factor or activity. Participated in physical fitness training on day prior to presentation without unusual exertion or activity. Mild nausea on day of presentation. Obtained COVID-19 vaccine the day prior. No history of adverse reaction to vaccines in past. Normal labs/troponin and patient was sent home. Normal ECG. Following ablation in October, Following ablation in Oct, 2020, the patient reports no return of symptoms.

Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose

onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.

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.

Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.

Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89

Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium

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.

Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach cramps.

1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response

Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.

partial complex seizure; I lost muscle tone and collapsed; severe LUE weakness; severe pain; aura; I lost muscle tone and collapsed; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 40-year-old female not pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 30Dec2020 h 05:00 PM at single dose for COVID-19 immunisation, lot number: EH9899. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included epilepsy (well controlled with medications) and she was allergic to phenytoin (DILANTIN). Concomitant medications in two weeks prior to the vaccination included carbamazepine, lamotrigine (LAMICTAL) and fluoxetine. It was reported that on 31Dec2020 h 14:00 (also reported as approximately 22 hours after vaccine) patient experienced severe left upper extremity (LUE) weakness and severe pain. She then experienced an aura and had a partial complex seizure. Patient lost muscle tone and collapsed. The episode lasted approximately 1.5 minutes, no treatment was given. Patient was tested for Covid post vaccination, she underwent Covid-19 PCR Test (Nasal Swab) on 04Jan2021 and on 07Jan2021, both with negative results. She also underwent a Covid-19 PCR Test on unknown unknown date in Jan2021 with unknown results. Patient recovered on 31Dec2020 from the events.; Sender's Comments: There is not a reasonable possibility that the reported events were related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.

1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY 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.

Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours

employee reports LOC for approx. 10-15seconds witnessed by family member who states her eyes rolled back and she began to drool. she has a history of passing out when not feeling well or vaccine. Eval in ED, treated with benadryl IV and fluids. D/c home.

Within 6 minutes I had a metalic taste in my mouth, the roof of my mouth went numb, my tongue started to swell up, the inside of my mouth started to swell up. I lost sense of taste to even water. I was allowed to take my 50 mg of benedryl. My BP was 171/100. I was taken to the ED and that is where I received the vaccine as well.

patient began to experience chest pain (6 on 10 scale) 10 minutes after administration. no other associated symptoms. Vital signs normal. Evaluated in Emergency Dept. Discharged. Note that patient was very anxious prior to and after vaccination.

3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.

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.

Patient presented for evaluation of an episode of chest tightness and possible allergic reaction after receiving the Pfizer vaccination for COVID-19. Patient reports that she initially did well but while she was waiting the 15 minutes of observation after the vaccine she began to note intermittent chest tightness as well as feeling like her heart was racing. This may have represented an allergic reaction although she did not require any medication to treat it.

Severe pain in left arm (still in pain 1/20), unable to move arms above head (lasted 5 days for both arms), Chest pain and squeezing sensation in chest and both arms (lasted 6 days), altered heart rate (lasted 2 days), internal swelling (was told this is what was causing the "squeezing" sensation)

Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). 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.

2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; 2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; This is spontaneous report from a contactable Other Healthcare Professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: unknown, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included Symptomatic PVC's, Tachycardia, Bradycardia, CVA (Cerebrovascular accident) in 2018, Asthma, adhesive allergy, rhythm. Concomitant medication included flecainide, metoprolol for rhythm, spironolactone. The patient previously took hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and experienced drug allergy; received the first dose of BNT162B2 on 16Dec2020 03:00 PM in Left arm for COVID-19 immunisation, and experienced Hypertensive Emergency (BP 219/114) with no previous blood pressure issues, radiating chest pain, left arm pain, and jaw pain on 22Dec2020, admitted to the hospital. The patient received the 2nd vaccine dose administered on 08Jan2021, with a new increase of blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: new increase of blood pressure on an unspecified date; blood pressure 219/114 on 22Dec2020; Curative-SARS-Cov-2 Assay RT-PCR: negative on 01Jan2021. The outcome of the event was not recovered. Information on the Lot/Batch number has been requested.

Employee reported flushing, itching and burning sensation noted to her cheeks, nose, chin, and chest within hours of receiving 2nd dose of vaccine. She stated that she has continued experiencing it intermittently, has taken Benadryl at night time, and is planning on trying Zyrtec.

My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.

After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart rate (approximately 180). She sat back down for a few minutes and her heart rate slowly decreased. However, when she collected her belongings and began to walk , she noticed that her heart rate increased again and she felt dizzy. She stopped by a clinic within the hospital to have her heart rate checked on a pulse oximeter. It was reading about 130, but varied from 109 up to 140's/150's. She then called her doctor who encouraged her to contact the clinic. She does not feel unwell while at rest but did have dizziness when walking. After visiting with Dr she was escorted to the Emergency Department for evaluation.

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.

Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emegency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, light headedness, headache, and myalgias. In the emergency department vitals stable and within normal ranges including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted or reported. Patient adminsitered fluids with symptom improvement. Discharged to home stable.

Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emergency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, hight headedness, headhache, and myalgias. In the emergency department vitals stable and within normal ranges, including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted. Patient administered intravenous fluids with symptom improvement. Discharged home stable.

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.

Rashes to upper body anterior and posterior; Generalized body pain; chest pain; 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 VACCINE, lot# EK5730), intramuscularly in left arm on 01Jan2021 06:15 at single dose for COVID-19 immunization. Medical history was none. Known allergies: No. Other medical history: No. The patient was not pregnant. Concomitant medication in two weeks included colecalciferol (VITAMIN D). If other vaccine in four weeks: No. The patient experienced rashes to upper body anterior and posterior, generalized body pain, chest pain, all on 12Jan2021 17:00 with outcome of not recovered. No treatment received for the events. If covid prior vaccination: No. If covid tested post vaccination: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.

BP 180/110, HR 140. Baseline is BP 110/70, HR55. Slowly returned to baseline but with dizziness and lightheaded symptoms for the remainder of the day.

Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.

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.

fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL1287, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 04:15 PM at a single dose on the left arm for COVID-19 immunization. The patient was not pregnant. She received the vaccine at a workplace clinic. She had not received any other vaccines in four weeks. Medical history included arthritis. The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL), multivitamin, and airborne immune supplement; these are the other medications she took in two weeks. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL1284, expiry date: not reported), via an unspecified route of administration, on 23Dec2020 04:45 PM at a single dose on the left arm for COVID-19 immunization. On 13Jan2021 03:00 AM, within 12 hours of 2nd vaccine dose, the patient experienced fever 101, moderate headache, tachycardia at rest. The patient was not diagnosed with COVID prior to vaccination and had not tested for COVID post vaccination. The patient received no treatment for the reported adverse events. Outcome of the events was recovering.

body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.

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.

After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.

heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.

Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).

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

Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.

weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.

Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.

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.

Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.

patient felt lightheaded within 30 minutes after vaccine, then about 6 hours later she passed out and had to go to the hospital; she was treated with IV fluids, meclizine, and ativan

Approximately 15 minutes after vaccine patient began feeling flushed, but denied any rash or respiratory issues. Patient chose to leave facility and went to a store where she purchased Benadryl and took 25mg orally. Patient returned to site where vaccine was given (which is also her place of employment). Nurse evaluated patient and rash noted on chest. Blood pressure elevated to 220/115 and heart rate 120. Physician evaluated patient. EKG performed and patient found to have sinus tachycardia. Benadryl 25mg and Kenalog 40mg administered intramuscularly. Blood pressure came down to 150/104 which patient reported was close to her recent baseline as she recently had a medication adjustment. After approximately 15 minutes patient no longer felt flushed. Patient was instructed to take and additional dose of Benadryl 50mg orally that evening and a Prednisone dose pack was prescribed.

PT presented to ED complaining of fever (TMAX 102), frontal headache, chills, high heart rate (MAX 153), injection site pain PT took Tylenol at home, presented to ED r/t high heart rate

chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; 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, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.

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

Lightheaded; intermittent palpitations; felt like passing out; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported COVID-19 VACCINE; lot number: EL3246; expiration date: unknown), intramuscular right arm on 10Jan2021 at a single dose for covid-19 immunization. Medical history allergies to seafood, milk and peanuts. The patient was not diagnosed with covid prior to vaccination. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient previously took tetracycline but had allergies. The patient experienced lightheaded, felt like passing out and had intermittent palpitations on 10Jan2021. No treatment was received for the adverse event. The patient did not covid tested post vaccination. The outcome of the events was recovered on Jan2021.

Fainted, legs and arms went numb and my hands froze, felt almost like a stroke. Was ok after about 30 minutes,,was just very tired rest of day

The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG changes in the setting of a couple days of chills, sweats and malaise after receiving the covid vaccine. Initially there was concern for acute MI and he was taken for a coronary angiogram. The angiogram was clean and showed no obstructive disease. He had a cardiac MRI which showed findings consistent with myocarditis. He was treated with supportive care and eventually was discharged. He was worked up for other causes of myocarditis with none to be found.

Pfizer-BioNTech was administered at 4:19 pm, she was advised she would need to wait 30 for any adverse reaction. At 4:25pm patient started to fee palpations, braking out with redness on her chest and her left arm where the vaccine was administrated. Epinephrine 0.3 mg auto injector was given in her right thigh by the doctor. We then called 911 to transport her to the emergency room.

Client stated she felt her "heart racing". Client continued to be coherent. 1:33 pm B/P 144/98 pulse=103 Pulse Oximeter 98% 1:37 pm B/P 142/78 pulse=107 Pulse Oximeter 94% 1:42 pm B/P 110/88 pulse=087 Pulse Oximeter 94% 1:45 pm B/P 118/94 pulse=109 Pulse Oximeter 94% 1:47 pm B/P 120/90 pulse=107 Pulse Oximeter 94% Client stated she had a history of heart palpitations; also stated she had had a similar event after she received her flu shot. Client stated she felt fine. Was going to return to work. Encouraged to contact medical provider if symptoms returned.

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.

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.

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.

45 minutes after administration pt became nauseated, tachycardic, numbness and tingling hands and feet, progressing to the knees. Injection site warm, BP 132/96. On exam, oropharynx mild erythema - no edema and no stridor. Lungs CTA. Cor - S1 S2 slightly rapid. Abd soft, non-tender, positive BS. No rashes. Gave Benadryl 50 mg and prednisone 20 mg. BP 110/72. HR 72. O2 Sat 98%. Temp 98.3F.

Pfizer-BioNTech COVID-19 Vaccine Patient got first dose of vaccine on 2/3/2021. After getting dose, she felt anxious, increased heart rate and had a metallic taste in back of her throat. Patient was sent to ER for evaluation at 10:27am. Patient felt better and discharged at 12:11pm

Strong palpitations for about 12 hours. Palpitations improved slightly be sitting/leaning forward. I am a physician and this made me concerned for pericarditis. However, I am also on fluconazole which can contribute to cardiac arrhythmias. The palpitations had resolved in the morning and so I did not seek diagnosis and treatment.

10:32 : FELT FATIGUED, SWEATY, QUEASY, 'HOT"- POST VACCINATION VS: T: 98.2, P: 72; BP: LEFT ARM: 150/98; RT. ARM: 152/100. has hypertension, has not been taking her BP meds for over 1 month.

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.

Patient experienced tachycardia, chills, and itch within 15 minutes of observation. No treatment was given. Patient was observed and later discharged

Shortly after receiving the vaccine, I felt a very slight tingle in my lips- so slight that I thought I was imagining it and so I didn't say anything. As I was driving home, I started to feel it more and also felt it in my tongue. When I got home, the only antihistimine I had was claritin, so I took that. Then, I got nervous, felt tightness in my chest and went to the ER. They gave me benadryl and that helped. I stayed in the ER for an hour to be monitored and they said everything was fine.

my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.

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

uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.

Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's mother). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Patient age at vaccination was 40 years. The patient's medical history and patient's concomitant medications were not reported. The reporter stated the patient had COVID-19 vaccine 3 weeks ago and she will have the 2nd dose of vaccine 'tomorrow'. The reporter was kind of nervous about her getting the 2nd dose as the patient is experiencing a sweat breakouts and almost going to pass out, she sees the room as color yellow and red. The outcome of the events was unknown. Information on the lot/batch number has been requested.

After 5 days, I have had pain in my right arm to my chest and the same pain from my right arm to my back. This pain does subside when I take Advil but then will return later that day. I have now had this pain for almost 3 weeks.

Heart rate sped up very much immediately after the injection. I felt ancy & it lasted for a day. I also felt confused, disoriented, out of it.

I got the vaccine and about 15 minutes later I felt a little dizzy. My pressure was checked and it was very high. I believe 175/120. I ended up having to go to the ER. Doctor believed it was a reaction to shot.

I began having heart palpitations on 2/8/2021 which I recieved an ekg for which indicated I have a sinus arrhythmia - I have also had parasthesia in my R hand starting 2/13/2021.

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

01-13-2021 C/o syncope and collapse Body aches- Transported per EMS. to ER. Sometime around 10:00 am. Arrival ER . 10:39

Fainted twice! Causing massive head trauma & wounds. It happened 35 hours after the vaccination & I was given no warning that this could happen.

Days 1-2 after injection: tightness and ache in chest, collar bones, and ribs. Day 3: rash in left armpit Day 4: rash grew, swollen lymph node in left armpit noticeable Day 5: swelling and rash receding, still notable

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

Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hours The next menstrual cycle was very heavy period, soaking heavy flow tampons every hour, large clots, and lasted 6 days from a typical mild flow 3 day period

1st dose Vaccine 1/9/21; 2nd dose vaccine 2/14/21; developed hives/rash 2/15/21, resolved with Benadryl; developed chest pain, SOA, HA, jaw/teeth pain , and nausea 2/17/21; seen at Clinic 2/17/21 and sent to ED same day for eval; was d/c'd home from ED 2/17/21.

I received the vaccine on 01/06/2021 and had some arm pain. On 01/07/2021, I had flank pain, a mild headache. Then on Friday night I had chest pain right underneath the right breast that would at times radiate into the neck. My pain continued all day Saturday and into Sunday morning, I went saw a Pulmonogist. After testing, it was determined it was not cardiac and that it was muscular. On 01/11/2021, I saw my Chiropractor that made an adjustment in my back. I also was a massage therapist. After seeing both, the symptoms eventually subsided.

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

tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

tachycardia with postural changes with heart rate between 100 & 140 (pots) also hypertension with postural changes

24 hours post vaccine, developed bilateral eye swelling, itchy ness full body and right orbital pain along with the feeling of my heart racing. Swelling lasted 9 hrs, self medicated with Zyrtec (Benadryl makes my heart race) . Tylenol 1000mg every 4 hrs for headache pain. Headache is still present daily. Switched to 800 Motrin every 6 hrs. Headache and lower extremity muscle pain, as well as nerve twitches and cramping still occurring 8 days post vaccine.

Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95). Benadryl PO given.

Patient felt lightheaded and had already left observation area 10 minutes earlier than her 15 minute recommended timeframe. She sat herself down due to feeling of syncope and stayed with EMS to lay down for 20-25 minutes.

A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move.  This lasted about an hour (15 hrs post-vaccine).

complained of feeling weird and heart racing. HR 120s BP 168/78 at 1510. by 1600 HR down to 92, BP 142/76. Patient reported feeling better. Denied shortness of breath, chest pain and denied other symptoms. Advise to see primary care physician.

Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, which was attended by EMS. Patient regained consciousness within 30 seconds of episode. Patient has had previous episodes of syncope, but not with vaccinations. All vitals were normal when checked by EMS. Her BG was 121 mg/dl. Patient recommended to go to the hospital to get checked out but patient refused. Waited for husband to come pick her up - 5:45pm.

Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea

I noticed about 2:15 (15 minutes after injection)my elbow (funny bone) was very sensitive. Then the pain went up my arm, over my left shoulder blade, up the left side of my neck, and up into the left side of my chest. It has lasted and seemed to be more intense more than 24 hours after. 1:00pm the next day, I got extremely light headed and dizzy, sat down and it went away after a couple of minutes. Called my Primary Dr. and was told to report it. I will be seeing a Dr tomorrow the 25th. The pain, I thought was maybe a hit nerve from the injection, its kind of like an electronical zap

Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with RN All extremities contracted with grunting Airway maintained After activity was alert pale diaphoretic

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

During the observation period after the vaccine, at the 5-6 minutes time frame, my heart was pounding like palpitations. My arm was warm up to my chest. EMS was called. They took my vitals signs. All of my vitals were normal accept my pulse was elevated 113 and then it finally came back down to 108.

patient experience swollen neck, itching, and elevated heart rate. she was administered 1/2 iv dose of benadryl by local emt. Symptoms resolved.

About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.

felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.

Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throughout my body My chest, arms and legs felt heavy. It wasn?t hard to breathe exactly, but it just felt like it was hard to actually do it. If that makes sense Then, the scary one. My brain and my mouth were saying two different things. I became really pale (per medic) and I had a hard time figuring out how to say no. My mind just wouldn?t work correctly. And when I tried to speak, it was very confusing and I was told I wasn?t making sense by the medic. Then as quickly as it started, it stopped. Periodically through out the day today, I have gotten more confused than normal about simple things. Earlier I tried to say chicken. I said potato. I was thinking chicken but my stupid mouth said something different. The medic compared my symptoms to a stroke. Which was terrifying

patient experienced swelling of the arm and fainted. patient was provided 2 cold packs from local emt. 1 cold pack for arm. 1 cold pack for head/neck. patient was also monitored for cardiac abnormalities. no heart abnormalities were found. patient was able to return to vehicle.

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.

Dizzy Friday when given shot, Chills and fever Friday night, upset stomach, headache, low grade fever on Saturday, upset stomach, headache, lowgrade fever on Sunday, Swollen lymph nodes, rash on chest/shoulders/upper back and chills Monday, Rash spread to torso, arms, legs and neck, eyes burned and left ear hurt, chills, fever was 104, resting hear rate was 120 bpm

Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.

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.

Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pressure was running high with reports of 164/92, 169/102, 144/98 and then 135/89. Taken 10 minutes apart each time. Healthcare staff provided patient water and monitored during event. Began to feel normal again as bp went down. HR stayed between 69-79 during entire time.

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.

After getting the shot, I walked over to the observation area a few yards away. I sat down and my vision went blurry and the room lights were too bright. I spoke with a dr about taking ibuprofen for my ankle, as I was told to only take Tylenol. The dr said that I was fine to take it. I didn?t want to ask about my vision because I was embarrassed and didn?t want to be stressing or panicking and that be the cause of my vision issues. But it didn?t subside so I checked with a nurse before leaving, about 15 mins after the vaccination and asked if I was ok and she said yes, that she only had 1 other person tell her about blurred vision. I walked to my car and the sun was so bright I had to shield my eyes. I got in the car and took my mask off. I looked in the mirror and my cheeks and chin were flushed but my skin was pale. My husband sat with me for 10 mins and then went in for his shot. At this point it had been a little over 30 mins since getting vaccinated. I FaceTimed my mom so I wouldn?t be alone. As we were talking she said my face was getting puffy and I was getting darker circles under my eyes. I got off of the phone with my mom and called my husband on FaceTime. I asked him to talk to the dr for me and let her see my face. She said my face was swollen and red and asked if I could breathe or felt like my throat was closing over or tongue was swollen. I told her no. Once again I was told I was ok and to take Benadryl. An hr or so after the 1st dose vaccination I was able to get Benadryl and Tylenol. In a 12hr period I took 2 doses of Benadryl and 2 doses of Tylenol. My face got better in 12-24hr but I still have blurred vision and light sensitivity.

supraventricular tachycardia lasting approximately 40 minutes with heart rate ranging from 230-250 b/m

during observation a few minutes after receiving immunization, patient developed dizziness, low blood pressure and heart rate (vasovagal response), improved within 5 minutes with leg elevation and drinking water

8 minutes after the administration of the vaccine (while in the observation area) I started to feel really off (dizzy, anxious, ringing in right ear). I ended up becoming unconscious with seizure like activity. They rushed me to the ER and kept me for 6 hours with lots of testing. XRay, blood test, CT of head, EKG, Urine test...all came back normal. Doctor said it was likely a reaction to the vaccine. I am 40 years old with no history of seizures or allergic reactions to vaccines. The week following I experienced confusion, migraines, dizziness, slow cognitive processing, eye strain, word finding difficulties, and exhaustion. I had to take a week off of work to recover. This is the second week and I am still experiencing headaches and occasional dizziness/eye strain.

Within 5 min I had hives and facial swelling. I was given Benadryl and 20 min later I had body shaking/tremors

Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.

chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.

High Blood Pressure (170/78) I do not have hypertension. Irregular vaginal bleeding. Starting bleeding mid cycle for a day. This has never happened to me. I have a normal menstrual cycle.

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.

Patient became nauseated, light headed, pre syncopal and with diffuse paresthesia. Given epinephrine IM, sent to ED for eval

Near syncope (multiple events); vomiting (multiple events); chills; headache Onset approx. 12 hours following vaccine. Rapid onset with little to no warning, lasting approx. 2-3 hours.

Lightheaded following COVID -19 vaccine. Injection at 12:15 pm Vital Signs: B/P: 142/82 HR: 71 Resp.: 16 O2Sat: 95% Skin Signs: Warm and dry Circulation: Cap refill <2sec Resp.: Breath Sounds Clear Bilaterally Treatment: Pt assisted to cot. Requested to remain in sitting position. C/O dizziness and vertigo with head movements. Denies nausea , No flushing, skin p/w/d. Repeat Assessment: 12:45 pm Vitals: B/P: 132/82 HR: 74 Resp.: 16 O2Sat: 98% Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sounds bilaterally Treatment: Remains in seated position- Offered fluids- refused. Repeat Assessment: 13:02 pm Vital Signs: B/P: 122/88 HR: 73 Resp.: 16 Skin signs: Warn and dry Circulation: Cap refill <2sec Resp.: Breath Sounds clear bilaterally Treatment: Lightheaded, states "easier to focus eyes." No syncope, No increased light or vertigo with movement of head. 13:20 pm Pt released via wheelchair to vehicle to home with a friend. ALOx3, skin p/w/d. No further c/o dizziness . F/U Call: 2/4/2021 Fine after returning home. Woke up in the middle of night fell in BR x2 (no head injury) sweating, fevers, syncope, weakness, vertigo "spinning" disoriented felt delirious with 2nd fall in BR. Extremely nauseated.

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.

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.

flushed, rapid heart rate. No throat swelling, shortness of breath, vomiting. NO signs of anaphylaxis

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..

Progress Notes Expand AllCollapse All Patient: DOB: 4/11/1980 Date: 3/16/2021 MRN: Subjective Patient is a 40 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience generalized weakness, "need for a quick snack". She denied rash, shortness of breath, difficulty swallowing or syncope 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 red flag findings ALLERGY REVIEW OF SYSTEMS Previous Reactions: none Objective Vitals Vitals: 03/16/21 0944 BP: (!) 158/103 Pulse: (!) 102 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing or diaphoretic. Comments: Anxious on arrival to bay, "I think I just need a snack to feel better." HENT: Head: Normocephalic. Mouth/Throat: Mouth: Mucous membranes are moist. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: General: Normal range of motion. Skin: General: Skin is warm and dry. Neurological: Mental Status: She is alert. Motor: No weakness. Psychiatric: Comments: Anxious affect Clinically, post injection anxiety related event. Elevated BP on arrival, improved with rest and granola bar. Salient anxious affect, post injection histamine response, requiring warm blanket, prolonged rest Ambulated with assist, additional snacks provided and pt discharged after 45" stay Assessment/Plan Treatment included: 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)

experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in deltoid left on 22Jan2021 as 0.3 mL, single for covid-19 immunisation. Medical history included sensitive to drugs from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took celecoxib (CELEXA) and experienced ventricular extrasystoles, dicycloverine (BENTYL) and experienced ventricular extrasystoles and heart rate went up to 180 and blood pressure dropped. She has had this [premature ventricular contractions (PVCs)] occur a few times before, a history of it. Sometimes it occurs with medicines. Stated she is sensitive to drugs. Added, this occurred with Celexa, every 5-10 beats she would throw PVCs and it occurred until she was weaned off and stopped Celexa. The PVCs also occurred with Bentyl. When she took it her heart rate went up to 180 and her blood pressure dropped. She had to be taken by ambulance and was given fluids and she believes diphenhydramine (BENADRYL) and some other things, but she is not sure. The patient got her first COVID vaccine and experienced a fast heartbeat, felt sweaty and dizzy. She was wondering if what she experienced after the first shot a normal side effect and if it would be worse with the second dose. After the first COVID vaccine shot (after the ten-minute wait), her heart threw a few PVCs, her heart rate went up to the 160s, she was sweaty, and dizzy. She had to pull the car over. Stated she is worried about getting the second dose. Wondering if this reaction could be worse. Initially stated these events all resolved that same day, but then she followed up and clarified sometimes she still feels her heart throwing PVCs again. The patient stated she turned her car towards the Emergency Room (ER), but she ended up talking herself out of going. The patient underwent lab tests and procedures which included heart rate went up to the 160s on 22Jan2021 (fast heartbeat). The outcome of the event Premature ventricular contractions was not recovered while of the rest was recovered on an unspecified date.

Patient was advised to receive the vaccine regardless of an itchy throat with the first Pfizer Covid vaccine with some feeling like throat and tongue were swelling but EMTs on the scene administered IV benadryl with the first dose. With doctor recommendation to receive the second dose about 20 minutes after she received the second dose she started feeling her tongue have a fuzzy swelling sensation and began coughing frequently around 11 a.m.. Patient took 50 mg of Benadryl of her own immediately before the vaccine in order to counteract the same reaction from the first one. Due to increasing symptoms she received Epinephrine 0.3 mg/0.3 ml one shot at 11:09 a.m. and a second shot at 11:17 a.m. Patient began to show signs of improvement from the Epipen but not enough with one shot so she proceeded with the second one. She was able to leave the vaccine clinic to see her general practitioner that afternoon. She expressed that she felt jittery after the shots and we determined that the Benadryl liquid she had with her and took had Phenylephrine in it as well which combined with the Epinephrine was causing the shakiness. She felt stabilized but weak. Her blood pressure was 140/100 at 11:50 a.m. and 137/88 at 11:55 a.m. Her allergist and general practitioner were contacted and notified of the incident and they instructed her further to use Benadryl tonight and to contact them tomorrow about any further concerns. She reported this evening at 5:27 p.m. that she was okay and did not have any further issues or the feelings of the allergic reaction.

Increased heart palpitations; almost passed out; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies. The patient's concomitant medications were not reported. The patient had not been diagnosed with Covid prior to vaccination. She was not pregnant. On 21Jan2021, the patient experienced increased heart palpitations and almost passed out immediately after second shot. No treatment was received for the events. Events resulted to doctor or other healthcare professional office/clinic visit. Outcome of events was not recovered. The patient was not tested for Covid post vaccination. Information on the batch/ lot number has been requested.

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.

severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat; headache; pain in the injection site; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 26Feb2021 09:30 at a single dose for COVID-19 immunisation. Medical history included allergies: dairy. Concomitant medications included ergocalciferol, retinol palmitate (VITAMINS A & D), apple cider vinegar (APPLE CIDER VINEGAR), cranberry, and allium sativum (GARLIC (DEODORIZED). Patient is not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 14:30, on the first day, patient experienced moderate headache and pain in the injection site. On 28Feb2021, the second day, patient experienced severe headache, severe body aches, slight fever, chills, severe diarrhea, dizziness almost fainted, fast heart beat. Patient is recovering from the events. No treatment was received. Information on about lot/batch number has been requested.

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.

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.

Immediate but for 24 hrs only: bad taste in mouth elevated blood pressure/heart rate dizziness lasted two days: fever muscle/joint pain still continues: insomnia

I developed heart palpitations, visited an urgent care, my primary care physician, the ER, and a cardiologist and have subsequently developed tachycardia with changed in position/posture. I recently developed tinninutus on 3/13 that has not resided.

About 30 minutes after getting the vaccine I was driving home and suddenly felt like I was losing consciousness. It lasted for a few seconds and then the feeling went away. I called 911 because I didn't know what was happening and other than a bit of an elevated heartrate I was ok so I deferred the option to go to the hospital. At the time that the paramedics were checking on me, one of them noticed a red area on the inside of my right elbow. I hadn't noticed it until then, but it could have been there and I just missed it. After about 2 days the rash appeared on my left inner elbow. It didn't really itch but it was painful and felt very dry and irritated. I was told it looked like eczema so I began using eczema cream. It has seemed to help a little. I have never had eczema prior to this. I contacted my doctor and he said he had no way of really knowing if it was an allergic reaction.

40 yo F with palpitations about 10-15 mins after getting the vaccine. HR was 104, came down to 88, without intervention. BP was elevated 160s/100s. Pt otherwise asymptomatic. Advised to continue monitoring her blood pressure and follow-up with her doctor. Pt observed for 30 minutes then discharged home.

c/o lightheaded ness & heart palpitations for min. post injection. h/o increased BP; no meds taken this AM. Symptom quickly improved with mask removal & fresh air. Reported most likely R/T anxiety. On recheck - reported symptoms resolved. BP 130/86; HR 86; drove off lot independently.

anxiety Narrative: Veteran received injection in Left arm. Veteran notified monitoring staff of headache in forehead and dizziness stating "this is new since my injection." Veteran states they have anxiety due to PTSD and feels the new symptoms may be anxiety related but want additional monitoring just to be sure. Vet states "I have not left the house since last March." "I have PTSD, I feel this anxiety related but just want to make sure. Initial VS: 1343 BP: 148/92 HR: 68 RR: 18 PN: 01/10 SO2: 99% Veteran states "that is high blood pressure for me. Usually it is too low due to the medications I take for my anxity/PTSD." F/U VS:1400 BP:129/91 HR: 71 PN:01/10 SO2: 100% Pain 01/10-Headache middle of forehead-no change. Vet states "I think its anxiety." Declined Hot/Ice pack Agreed to a juice pouch. Declined EMS Veteran departed Vaccine Clinic. /es/ RN, BSN Signed :03/18/2021 14:53

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.

10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (only on left side of body)

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.

Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of severe allergic reactions to vaccinations. Administered 50mg of Benadryl PO. Patient condition worsened rapidly with hives and anxiety. 911 contacted for transport. 0.3mg Epi administered in right deltoid. Epi began working quickly. Care transferred to EMS and transferred to Hospital.

Bloody nose in my right nostril. I rarely get bloody noses and am unsure if it?s related to the vaccine. It took approximately 10 minutes of heavy bleeding to cease.

PATIENT MENTIONED SHE WAS NERVOUS, I MADE SURE SHE WAS BREATHING REGULARLY AND NOT HOLDING HER BREATH. AFTERWARDS HAD HER SIT IN WAITING ROOM FOR THE 15 MINUTES. AFTER A COUPLE OF MINUTES SHE APPROACHED COUNTER AND SAID SHE WAS NOT FEELING WELL, I HAD HER SIT BACK DOWN, HAD MY TECHNICIAN CALL 911, AND RETRIEVED THE EPI-PEN. AS I WAS APPROACHING HER SHE SLUMPED OVER. I TRIED TALKING TO HER, THERE WAS NO RESPONSE AND WAS TURNING PALE. I ADMINISTERED THE EPI-PEN AND WITHIN A FEW SECONDS SHE WAS RESPONDING. THERE WAS A NURSE IN THE STORE WHO BEGAN MONITORING THE PATIENTS HEART RATE AND BLOOD PRESSURE. THE PATIENT WAS TALKING TO US BUT STILL NOT FEELING WELL. A COUPLE MINUTES LATER THE EMS ARRIVED AND TOOK HER TO THE HOSPITAL

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

Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit

Pt began feeling lightheaded after receiving her vaccine. Medical staff was notified and witnessed a syncopal episode where pt was seen with flexed arms and bladder incontinence. Pt was AOx4 after regaining consciousness with SBP in the 80s, diaphoresis, and nausea. Pt did report history of syncopal events associated with needles and SBP around 90s. Pt was monitored and later released by medical staff and EMS after symptoms resolved. PT was instructed to follow up with PCM regarding possible concerns for seizures and hypotension.

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

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.

My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. About 15 mins after I got the vaccine, I had a racing heartrate and my palms were hot, but it went away. Around 3pm, I had a right frontal headache. I took a nap and it went away. About 5am Fri, I woke up to severe arm pain and it felt like I was being stabbed in the stomach. I took about 400mg of Ibuprofen, went to sleep and was fine when I woke up. About 5pm Friday, I began having vaginal bleeding. I called my doctor and was able to get in on Feb 11th. At my OB/GYN appointment, they tested my blood and urine, which confirmed my pregnancy. The NP examined me and told me that the bleeding was coming from my cervix, so they sent me for an ultrasound the following week. That's when I was given my calculated date of 10 weeks. A gestational sac was observed, but they weren't sure if a fetus was present. I had to see my doctor every week since I was still bleeding and that continued until March 18th, when I lost the pregnancy completely. I took my specimen to the doctor the following day. They told me that they were sending it out to be tested, but I'm not sure if the results are back. They did confirm that it was a fetus.

After 2nd Dose: 1st Day- 5pm onset: Markedly increased heart rate while sitting at rest. Fever, fatigue, intense muscle weakness & achiness, felt like weights in my veins. Sleep overnight was disrupted often. Intense strange dreams, perhaps lucid. 2nd Day- 9am: Fever & weakness subsided, muscles remained achy particularly with increased activity. Tiredness. 3pm: Fever returned. 5pm: Strong heart palpatations. Achy muscles. 8pm: Tiredness. Strange dreams, still lucid. 3rd Day- Still slight achiness. 3pm: Intense heart palpatations, pre-menstrual cramping (11 days early, my cycle is extremely regular). 5pm: Heart palpatations, muscles felt almost an electric pulsivity. 6pm: Tooth pain for about two hours. 8pm: Vaginal discharge (clear lubricant), lasted till 3am. 4am: Urine had extremely sour smell. *3rd day indicated to me that my hormones/hypothalamus may have been affected? Very strange, out-of-cycle behaviors. I have been sexually inactive for over 6 months.

After receiving the vaccination the patient presented about 10 to 15 minutes later with a spotted purple-red rash on the inner aspect of the forearms. This was the only symptom reported at this time. The patient was monitored for about 45 minutes. During this time the patient reported having a racing heart and some mild dizziness. As time passed no worsening of the rash was seen or reported. After sitting calmly for a period anxiety symptoms also subsided. After making sure the patient was able to walk and function normally she was instructed to get immediate medical attention if there was any worsening of symptoms or if there was no improvement.

She was given her 2nd dose for the Pfizer covid vaccine. As she was waiting her allotted time in the waiting room she became lightheaded and felt like she might pass out. She became nauseated and was sweaty. A nurse was present getting her 2nd dose and helped to care for her until the fire dept came and took over. She lay on the ground with her feet up until the FD arrived. Listening to her interview by the fire dept, it was discovered that she normally suffers from epilepsy and probably had a small seizure. She wasn't able to remember everything but she was coherent and able to answer most other questions. Her blood pressure was elevated and slowly came down as they monitored her. Her boyfriend and son were also present and the fire dept released her to their care after seeing her blood pressure come down closer to normal and seeing her able to stand and walk.

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.

Sudden onset of severe pain in the right scapula about 2 days after the vaccine. Pain progressed to the shoulder, chest, biceps, triceps, forearm, and parts of hand. Sensations of burning, cold, and tingling are also present since.

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 began feeling dizzy approximately 2 minutes after vaccination. Blood pressure 177/98, HR 145 bpm, O2 sat 99%. Patient observed.

Patient was shaking and had a high blood pressure. Vitals were normal upon arrival of paramedics, but was taken to the hospital for further observation.

Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.

Patient became lightheaded and had syncopal episode in chair, breathing irregular and snoring. 911 called, patient did come to in less than one minute, vital signs stable.

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.

Lightheadedness, palpitations, sweating, Anxious/jittery, headache, Tingling-face. Patient was Tachycardic after the vaccination. 21540: pulse 139, 15:45: Pulse116, 15:50 Pulse 106, 15:55 pulse 100 O2 sat: 98 Patient placed on recumbent position, water given and was sent home at 1606.

12:20pm Headache, cold sensation in mouth/throat, pressure in chest. Patient appeared drowsy and complained of having difficulty staying awake. Vitals: 12:25pm 122/60 81 18 O2 97%; 12:33pm 139/70 85 18 O2 96%; 12:44pm 142/98 82 18 O2 97%; 12:48pm 143/90 82 18 O2 96%; 12:45pm 50 mg diphenhydramine given IM. 12:33 PM EMS called; 12:45pm EMS arrived; 12:50pm EMS departed to Hospital; Pt. was alert and oriented upon departure.

At 10:30 I started feeling fatigued and over the next hour got the chills. I added layers and turned on a heater, started feeling worse and by 12:15 I had to give up working and spent 5 hours in bed. Low grade fever- 99.4 F. Also nauseous from 12:30 got about an hour. My heart rate was elevated from 10:30 am until 2:30am the next morning (my smart watch showed close to 100 for most of the time period.

Anxiety induced reaction to vaccine, felt heart rate / beat higher than normal, white in face, nausea, vomitting in bathroom, dizzy, requested 911, left with paramedics

She got her vaccine, and within the first 15 minutes felt like her tongue was fat. The reaction started at 1:15 and her headache was getting bad and turning into a migraine, and took her migraine medicine. She was getting a stretching and painful sensation in her skin over her head. She lost her ability to swallow, and everything around her face and neck were numb. She called the hotline and called her doctor, and was able to focus very hard and able to swallow but felt very narrow passageway. She then felt like she had a bubble in her throat, and then decided to call 9-1-1. The first responders came to her house and said that they could not see anything in her throat, they gave her Benadryl and within the hour everything seemed to dissipate and they stayed with her until she stabilized. Her BP was high and her heart rate was high as well, 98-100. Her temperature was 98.5. She felt really awful and nothing was going on with her throat or breathing after the Benadryl and felt foggy and tired and by the third day she was completely fine.

Generally occurring and resolving within 36 hours: Generalized neuropathic pain that turned gradually into generalized nociceptive pain / soreness; Pounding headache at the base of the brain; Tachycardia; Sensation of pounding heartbeats; Nausea; Sensitivity to light; Loss of appetite and thirst; Low-grade fever Still occurring at 48-53 hours: Nausea Light headache; Sensitivity to light; Some sensation of heart racing; Localized pain in different areas of the body

5 minutes after receiving COVID vaccine, the patient reportedly had a seizure like event. Patient was monitored and rapid response was called. The patient was transferred to the ED where VS monitoring, EKG (normal sinus), and labs were collected. blood glucose was elevated, patient received fluids. Patient's glucose appropriately decreased following crystalloid administration the patient was feeling improved and no labs were of concern. Patient was discharged from the ED.

I start seeing blood spots with passing tissues since then. no pain or any feeling. just slight bleeding. Called the doctors. they are monitoring

Pt reported feeling dizziness, nausea and feels like she is having a panic attack. Pt also is diaphoretic, appears pale and low blood pressure. BP 80/50 pulse 78, Resp. Rate 18, pulse ox 100%

I received the injection on Wednesday, by Saturday I was feeling very sick. I had a fever of around 102.5 on average and was feeling very weak. By Monday I was so weak I had to go to the doctor. In the dr. office I had a syncope event with tongue out, convulsions. Dr called 911 and was transported to the hospital via ambulance. The dr at the ER tested for Covid (negative) and stated this was a moderate adverse reaction to the vaccine. It took me a full 8 days to be able to not sleep all day and get some strength back.

Tingling toes started around 12:50-1:00 pm Heavy feeling in chest about 20 minutes after injection Heaviness in both arms within 30 mins after injection Pressure in chest next morning Burning, intense itching , hot inflammation around injection site next morning

dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)

10 minutes post vaccine administration, patient had a witnessed syncopal episode. Patient was lowered to the floor. No injuries occurred. Vital signs stable. After seconds, patient was alert and oriented x4. Continued to monitor for 45 minutes.

Nausea, vomiting, fever, chills for one day. Fatigue, flu-like symptoms for 2 days. Insulin-resistance and high blood sugar for 3 days.

Pt reported to post observation RN "I am feeling week, can you take my blood pressure?" Skin pwd. Pt denied pain, dizziness, nausea, SOB. Pt denied any reaction with her 1st dose of Pfizer. No significant medical hx. RN called for aid and walked Pt through breathing exercises and gave her juice to drink. EMS arrived and VSS. Pt reported "different feeling in my chest, but now its better". After VS by EMS, Pt reported feeling " well and I know to contact a medical professional is I need more help later, yes". Pt ambulated independently with steady gait and family to check out.

Patient stated she was having chest pain and that her chest was getting tighter and tighter. Pulse and blood pressure were normal. ambulance was called and they took pulse and blood pressure as well it was normal. they preformed more tests (unknown to me in the ambulance) she did not leave with paramedics

Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms: injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell Outcomes: since I didn?t feel well I rested on 4/7 and lost my consciousness at around 6pm on 4/7 and fell down to the front on floor. When I wake up, I found the I got injuries with my lip and teeth. My upper front teeth was broken.

Neck pain - moderate to severe Left arm pain - severe Headache - moderate Chest pain, left side - moderate

Acute onset large clot and profuse first time nose bleed (posterior potentially from sinuses which hurt), petechiae

patient has mitral insufficiency and vasovagal syncope. hit a vein and sight of blood and needle almost caused her to pass out. she was sitting on floor, very nauseous, blacking out, cold sweats, and palpitations.

Patient presents to ED one day after receiving Pfizer COVID-19 vaccine at outside facility with tachycardia. Seen earlier that day at an outside facility ED. Denies chest pain, shortness of breath, nausea, vomiting, abdominal pain. Breathing comfortably. Only other symptom is body aches. Has not needed any medications prior to arrival. Adminsitered acetaminophen and ibuprofen and discharged home medically stable. No escalation of care.

throat pain and chest tightness that began shortly after 2nd covid vaccine; sx started 5 minutes after vaccine administered. Given 50mg of IM Benadryl in office but O2 sat was still 89%. Clinic called EMS to transport pt to ER. Upon arrival to ER, patient discovered she was pregnant. She presented with sore throat and feeling of pressure and palpitations but denied any chest pain, lightheadedness, etc to ER physician. Pt was released home.

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.

Approximately 48 hours after receiving Pfizer Covid-19 mRNA vaccine, patient starting immediately throwing up with diarrhea and then developed chest pain and breaking out into hives, then her face started swelling on R side, phlegm in her throat, rashes on her feet; had full blown panic attack once she saw the face swelling; was too nervous to use her epinephrine pens. Took Xanax, Zyrtec and Benadryl.

About 1.5 hours after second dose of Pfizer COVID-19 vaccine, patient was driving and experienced what she believed was a seizure. She has a past medical history of seizures, but had not had one for over 15 years after being stable on Keppra. Patient did have a minor motor vehicle accident and went to ER. At ER, she returned to baseline and it was determined it was either a seizure or syncopal episode. She was instructed to follow-up with neurology.

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.

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.

Within minutes of receiving the injection I experienced waves of dizziness to the point of almost passing out, rapid heartbeat, full body hot flashes, sweating, hand tremors,, dry mouth Observed for 30 min and released with no intervention. Waves of vertigo continued throughout the day, but are decreasing in frequency but not intensity as days go on. Within an hour of injection psoriasis on left leg flared and was raised, red and extremely itchy through Sunday, 4.11.21. Severe headache through end of day on 4.9.21. Treated allergic symptoms with 10ml Benadryl every 5 hours for 2 days, Ibuprofen PRN for pain. All symptoms subsided except for headache and dizziness/vertigo but appears to be decreasing in frequency but not intensity.

I have been having high blood pressure issues after the vaccine. Been monitoring blood pressure and trying to control it without medication. Would like to know if anyone else is having the same issue as me.

presented with arm tightness and very mild swelling in the left arm. developed prominent left shoulder veins. Found to have:1. Acute appearing partially occlusive deep vein thrombus involving the left supraclavicular subclavian vein. 2. Acute focal superficial venous thrombus involving the left cephalic vein at the antecubital fossa.

3:41PM PT STATES SHE FEELS LIKE 'SHE MAY PASS OUT'. PLACED IN WHEEL CHAIR - SYNCOPE X30-60 SEC. MOVED TO COT; NOW RESPONSIVE. BP 150/90, HR 96, R 16, 02 SAT 99%. PT CALLED HUSBAND TO COME PICK HER UP. 3:46PM PT STATES 'THIS IS HER TYPICAL POTS EPISODE'. STATES SHE WAS WORKING ON HER KITCHEN AND PROBABLY JUST OVER DID IT. BP 128/80. STATES SHE FEELS BETTER NOW. 3:50PM A/O, PINK, W/D, RESP WITH EASE. BP 132/78, HR 77. 4PM SITTING UP - DRINKING WATER. STATES 'FEELS PRETTY GOOD'. 4:08PM TO EXIT PER WHEEL CHAIR; ASSISTED INTO AUTO TO BE TAKEN HOME PER HUSBAND. A/O, PINK, W/D, RESP WITH EASE. 4-14-21 9:30AM TC: PT STATES SHE 'FEELS SO MUCH BETTER NOW'.

After both doses of Pfizer Covid 19 vaccine patient reports significant elevated blood pressures that lasted 10-14 days.

Immediately after vaccine pt began feeling lightheaded, shakey legs, chest tightness and warmth. Denies tunnel vision, hearing changes and shortness of breath. Pt transported to obs at 1743 via wc. Around 1749 pt states she feels cold, lightheaded when sitting up and persistent chest tightness. Pt declines call to EMS and EMS transportation. She does agree to drive herself to urgent care for further evaluation. Pt states she feels safe to drive. Pt released by self at 1803. Vitals as follows: 1744 BP 134/90 HR 64 SPO2 100; 1749 BP 135/78 HR 65 SPO2 100; 1756 BP 155/87 HR 74 SPO2 100

15-20 minutes post injection symptoms included tingling and numbness in the limbs, flushed face, racing heartbeat, fogginess, confusion, extreme fatigue, panic/anxiety. Symptoms increased in severity over the course of 9-10 hours and dissipated following sleep. Migraine headache followed at 24 hours post injection.

Tunnel vision, near syncope, rapid heartbeat, rapid increase in blood pressure. Lasted at least 30 minutes while I waited at the clinic. Was given one Benadryl. Symptoms cleared but was still not symptom free when I drove home.

Patient started experience syncope symptom after the vaccine administration and during the waiting period (15 minutes). She started feeling light headedness on her chair and tipping over to the floor. Her father who arrived with her to the vaccination had come to the rescue, and together with the pharmacist on duty, helped situating her on the floor. Paramedic was also called to ensure the patient safety but left shortly after since the patient had recovered nicely.

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.

Burning in chest and throat. And weird taste along with it. As if after getting and iodine shot for a cat scan.. the same metallic taste.

102.4 F fever, fatigue, body aches, and accelerated heart rate . Only lasted 24 hrs. but it was rough.

About 3 hours after the vaccine I had an elevated heart rate, that came down after couple of minutes of fresh air. The next day, at about 10 pm, my heart beat was going up and down during rest. The next morning I went to the hospital and was diagnosed with heart palpitations.

March 24 - normal bloodwork April 5-7 heavy menses. First menses postpartum while exclusively breastfeeding. Delivery date 12/28/2020 April 10 noticed petechia and abnormal bruising but with high energy April 13 - second COVID shot. April 13 - nose bleed with continued petechia and abnormal bruising. No other symptoms

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

Approximately 11 days s/p 2nd vaccination, patient developed calf pain. After the pain persisted for two days she went to the local emergency room and was diagnosed with a DVT. No personal or family history of blood clots. No precipitating life events. No culprit medications. Age appropriate cancer screening up to date.

Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.

Repeated, extreme nosebleed with large clots. I was unable to stop it and had to go to the ER on 4/16. They had to cauterize the site of the bleed. I do have a history of mild nosebleeds but this was unusual. I do not take any blood thinning medications. The silver nitrate did stop the bleeding. The ER ductus was not concerned that this was vaccine related but I thought it was unusual enough to report.

About 15mins after the injection I experienced a fast heart rate. 139bpm. My heart rate went down to 115ish but lasted for 3 days. I monitored myself. I did not recieve medical attention. I don't not have a primary care doctor at this time. I would have contacted them. I have a pulse program on my phone for documentation.

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.

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."

Scratchy throat and sustained elevated resting heart rate between 80 and 100 (normal is low to mid 60s)

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.

Injection site pain/ soreness 4/21 11:00pm Headache 4/22 2:00pm Fever 4/22 9:00pm Increased heart rate 4/22 9:00 pm

Patient was initially seen on 4/16 in the ED and discharged after complaints of myalgias. She was tested for COVID and discharged home and instructed to take acetaminophen. On 4/20, she returned to the ED with continued complaints including abdominal pain, nausea, and diarrhea. She also complained of dizziness when she stands, and that her skin and eyes were jaundiced. The patient was hypotensive and was not responding to IV fluids. She was started on vasopressors. She was found to be in acute liver and kidney failure. She was emergently intubated and ended up being transferred to hospital. Due to the nature of her condition, the above therapies were continued and CRRT was started due to acidosis. A bicarb drip was started and was continuous. Arrangements were made to transfer the patient to hospital once stable enough. It was thought that she was in HLH. She was also empirically started on hydrocortisone, later changed to dexamethasone. She was started on antibiotics - cefepime, Flagyl, and vancomycin. She has now been transferred to hospital. Outcome unknown at this time. 4/22

Nausea, vomting, palpitations starting 10 minutes after vaccine administration. Generalized Tonic Seizure 2 days after vaccine. CT head negative in ED, discharged 8 days after vaccine, presented to clinic with continued daily seizure like activity, inability to stand due to leg shaking. Exam notable for Lower extremity myoclonus. Then, admitted to hospital on 4/8. MRI brain unremarkable. EEG with potential epileptiform activity. Patient discharged on 4/10 on keppra for seizure prophylaxis, Home health physical therapy and neurology follow up.

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

Headache, confusion, muscle and joint pain, inflammation, fatigue, etc etc. Including LUPUS FLARE- aggravated Systemic Lupus- which still continues 2 months later.. Also, developed DVT?s in both arms- previously dx.ed with APS- Antiphospholipid Syndrome and was already on anticoagulant therapy. Possible clot in/near artificial heart valve- further testing being done next week. After 2nd dose Also increase in Lupus Flare, as well as severe Fibromyalgia Flare- aggravated FMS. Extreme muscular pain/neurological pain, confusion, fatigue, etc etc.

Nose bleed, mainly from the left nostril but also some coming from the right side. I had been taking a nap in the afternoon. I was asleep for approximately an hour on my left side, and woke up with blood dripping out of my nose. I sat up and leaned my head forward while squeezing my nostrils together. It took over an hour, and the blood was still coming any time I would lift my head. My husband drove me to the nearest hospital. By the time I arrived, the bleeding had stopped on its own. By then it had been approximately 90 minutes that my nose was bleeding. I went into the Emergency Room and the physician assistant cleaned my nose, but she said she didn't think the nose bleed could be from the vaccine. She didn't say why it couldn't be from the vaccine. She suspected that my nose bleed could be from allergies and/or a mixture of sudden changes in temperature we have been having lately. I reminded her I haven't had a nosebleed since I was a child. However, she said that if it keeps happening then to see an Ear, Nose and Throat doctor.

I have Had A MIGRAINE Along with HIGH BLOOD PRESSURE... It started 2 weeks after my 2nd Pfizer Shot... I was admitted into the hospital because after A Cat Scan, MRI, And A Spinal Tap looking for Menengitis They Couldn't Find ANYTHING WRONG... I was in the Hospital for 8 days... They where unsure WHAT WAS WRONG SO THEY TREATED ME WITH MANY DIFFERENT MEDICATIONS INCLUDING HEPRINE FOR BLOOD CLOTS... AS OF TODAY 4/23/2021.. I CONTINUE TO EXPERIENCE THESE UNBEARABLE HEADACHES... HAVEN'T SLEPT IN A MONTH.. AND I CONTINUE TO HAVE SUPER HIGH BLOOD PRESSURE... IF THIS CONTINUES I AM NOT SURE HOW I WOULD LIVE... THE PAIN IS HORRIBLE... SO SO BAD

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.

Within 15 minutes after receiving the first vaccine shot I was I was lightheaded and had a metallic taste in my mouth. The metallic taste went away but I felt light headed until I fell asleep. At 2:00am woke up with severe muscle aches all over my body. The next morning I woke up sweating, muscle aches, lightheaded, fatigue, and nauseated. I also had a headache but it was a different type of headache than I?ve ever had before, it felt like my eyes were going to pop so I decided to check my heart rate and blood pressure and both were high. My blood pressure was 132/89, it is typically low (around 104/55). My heart rate was 109 and it?s typically in the 60?s or 70?s. I stayed with these symptoms until 04/17/2021. On 04/18/2021 I woke up for the first time since receiving the Covid-19 vaccine not sweating, hurting, and with a normal heart rate and blood pressure. As of today 04/25/2021 I am still dealing with fatigue.

lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.

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

Friday morning at 4:30am I woke up to go workout and as I was brushing my teeth I passed/blacked out. I came to and I began sweating profusely.

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 had a CT head without contrast that demonstrated hypodensity within left MCA territory. CT head/neck no findings to elucidate etiology of stroke. There is loss of flow in the V3 segment of the left vertebral artery with no reconstitution of flow distally. MRI brain without contrast with left MCA subacute ischemic stroke. Echocardiogram with no cardioembolic source. 7 weeks pregnant

First dose given 03/17/2021: momentary adverse reaction: racing heartbeat. Second dose given: 04/08/2021: no immediate adverse reaction other than soreness at injection site & general feeling of unwellness. Days after, tingling in the fingers…until the 17th, rib and back pain began. Pain radiated and worsened over the next two days. Was seen by PCM 04/20/2021, sent for XRAY, CAT scan, and ER, immediate diagnosis of Pulmonary Embolism in the right lung, as well as lung infarct in lower portion.

Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; 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 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered. Information about lot/batch number has been requested.

Radiating very red painful rash. Began at the hips, went down legs, then arms, torso and face. Hands and feet. Left large bruises. Rash diminished to small spots with prednisone/benadryl. Have photos.

Patient reported feeling itchy and "on fire" inside shortly after getting her vaccine. She said it took 5 doses of Benadryl to stop the reaction. Then her chest got tight later that day. She did not go to a doctor or seek emergency help. She said her autoimmune condition was already flared when she received the vaccine, and getting the vaccine made it flare up even worse. She denied hives, but she did say she developed a rash on her back. She came in today for her 2nd dose, but I advised her to try to talk to her doctor(s) about the reaction and see if they would be able to give her the 2nd dose since they would be more equipped to handle a potential anaphylactic reaction. She said she has not seen any of her doctors since the pandemic started, but that she would try to reach out to them.

patient reports feeling unwell after vaccine and then development of chest pain. chest pain persisted until office visit on 4/28/2021. also with headache that improved with ibuprofen. chest pain worse with breathing. patient was subsequently advised to go to ER on 4/28/2021 given persistent and worsening chest pain after COVID vaccine.

pt c/o chest pain following vaccination of 2nd dose Pfizer vaccine. 5min following complaints pts symptoms subsided. Vital signs were stable. BB 110/68

Vaccine 2/27. Chills, fatigue, headache, and dizziness - 4/28. Yesterday morning (second day after vaccine 4/29) I felt fine, slight headache. In the afternoon, the headache intensified, very specifically a sinus headache, isolated to my left side (left brow, toothache with left side molars, and an ear ache also on the left side). This morning (third day - 4/30), the sinus pain cleared but I had some sinus congestion upon first waking. I lightly blew my nose and had some blood in the tissue. Nothing further, seems to have been the last of it, just a bit odd. I figured it was worth documenting.

Fainting - I fainted twice the morning after the vaccine. Also had headache, body ache, fever, chills and loss of appetite

Intermittent racing fluttering heart; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in the right arm on 13Mar2021 at 18:30 (at the age of 40-year-old) and the second dose was administered in the left arm on 02Apr2021 at 13:00 (at the age of 40-year-old); both dose were administered via an unspecified route at a pharmacy or drug store facility as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not COVID tested post vaccination. Medical history included known allergies to Penicillin. The patient was on unspecified concomitant medications. On 20Mar2021, the patient experienced intermittent racing fluttering heart. It started the week after the first shot and intensified the week after he second. No treatment was given for the event. The patient had not yet recovered from the event. Information on the lot/ batch number has been requested.

After an hour, I felt a lot of pressure in my chest. It got worse over the next day and a half so I went to the hospital where I stayed for 3 days. I went back to the hospital a few days later and am still seeing multiple doctors regarding this. My symptoms are: Pain in the middle of my chest and the left side which they have said is from myopericarditis, I have inflammation in my esophogus and in my nerves. I also have endemetriosis and have had a lot of pain with this as well since my shot.

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

Initially, my arm started throbbing in the afternoon of the first day. Then I developed chills and started in the evening about 12 hours after my shot. I went to bed. When I woke up in the morning, I felt nauseous. I got out of bed at about 8am to take 2 tylenol and shower hoping that I'd feel better. While in the shower, I suddenly felt like I couldn't breathe and needed air. The moments after that are bit hazy, but I can tell you somehow I found myself crashed into the window on the opposite wall of my bathroom. Then I somehow made it out of my bathroom and somehow fell head first onto my carpeted floor of my bedroom. I think I must have passed out for a minute. Someone in my house heard me fall and came to help me back into bed and then I fell asleep in bed for the next 5 hours. I woke feeling better, but not well. I didn't feel considerably better until the next day. My right arm still has not regained its strength completely.

I started having tachycardia (rate in 180s) at about 3am on 1/29/2021. This lasted for about 36 hours. It also felt like my heart rate would drop drastically. I have a pacemaker, so I downloaded my report and I could see that my pacing had doubled from my normal activity. I have had my pacemaker for 4 years and have always been at 1% use for my pacemaker. After the vaccine, my rate went up to 2% (I was requiring my pacemaker double from what I normally would). I downloaded my report again about a month later and it was still at 2% usage. I go for my 6 month pacemaker check in June and will see what the usage is at that time. My pacemaker is used when my heart goes into 3rd degree AV block. So according to my pacemaker report, I was going into 3rd degree heart block twice as much as I usually do, in addition to my heart rate racing in the 180-190s. My heart rate would be racing and then drastically drop so low my pacemaker would kick in.

Pulse rate in the 160s, BP elevated 160/100 (this was a few hours after feeling sick and starting to feel better. Vomited x2. Dizzy, blurred vision. I have had elevated pulse like this prior bit never lasting for hours going through cycles of this. Horrible headache next day and completely wiped out. 4 days later still feel exhausted. I still get dizzy/fuzzy if I bend over. Called cardiologist and they had me take heart med to lower my pulse. Made appt to be seen.

Rapid heart rate, dizziness within 10 mins after injection. Severe migraines day 2-4 after vaccine. Loss of appetite day after vaccine (4/26/2021 -current 5/4/2021)

more than usual vaginal bleeding/with very dark blood with clots.; menstrual cramps; sharp pelvic pain; more than usual vaginal bleeding; more than usual vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Facility type Vaccine: Other. Medical history included known allergies: Sulfa and Folate deficiency. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206) on 15Mar2021 10:30 AM in left arm for covid-19 immunisation and experienced vaginal bleeding/blood clots at mid-cycle on 15Mar2021 08:00 PM. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient experienced more than usual vaginal bleeding/with very dark blood with clots, menstrual cramps, sharp pelvic pain, all on Apr2021 with outcome of not recovered. Clinical course: After the first dose, the patient had vaginal bleeding/blood clots at mid-cycle. The same day after the 2nd dose, she started feeling menstrual cramps and sharp pelvic pain. After taking paracetamol (TYLENOL) and feeling a bit of relief, she stood up and started having more than usual vaginal bleeding at the level that it reached the floor as if it was a hemorrhage with very dark blood with clots. This lasted for 1 minute. This lasted for 5 days and 7 days later, she started bleeding again with dark blood clots for a period of 3 days. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for events more than usual vaginal bleeding/with very dark blood with clots.

patient's sugars spiked by 40-60 points and sustained at elevated levels despite not eating any triggering foods; pregnant :Yes; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 at 04:15 (at the age of 40 years) as single dose in the left arm for COVID-19 immunization. Medical history included gestational diabetes and asthma. Last menstrual period was on 11Jun2020. Concomitant medications included pyridoxine hydrochloride (B6); doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]); acetylsalicylic acid (BABY ASPIRIN); magnesium. The patient previously took methylprednisolone (MEDROL DOSEPAK) and had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient became pregnant while taking BNT162B2. The patient was 38 weeks pregnant at the onset of the event and was due to deliver on 01Apr2021. On 10Mar2021, the patient's sugars spiked by 40-60 points and sustained at elevated levels despite not eating any triggering foods. It was unknown if patient receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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.

vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6206, via an unspecified route of administration, administered in left arm on 15Mar2021 10:30 as single dose for Covid-19 immunisation. Medical history included folate deficiency and allergies to sulfa. There were no concomitant medications. After the first dose on 15Mar2021, the patient had vaginal bleeding/blood clots at mid-cycle. No treatment information was provided. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association reported events causal relationship with BNT162B2 cannot be excluded. Case to be re-assessed upon receipt of new information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Irregular menstrual cycle--18 days instead of usual 28 days, and bleeding occurred exactly 1 week from each of the two doses.

Experienced lip swelling, redness, and tingling; tingling, itchy, and slightly swollen tongue; itchy throat; and fast heart beat. Symptoms began approximately 15 minutes after I received the vaccine. I was 4.5 months pregnant at the time, due date September 5, 2021.

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.

acute heart pain; low blood pressure (80/50); fever; dizziness; nausea; strong headache; This is a spontaneous report from a contactable consumer (the patient). This 40-year-old (non-pregnant) female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had tested negative for COVID-19 with the Nasal Swab Real-time PCR tests on 17Oct2020 and again on 02Feb2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did have an allergy to eggs and having no other medical history. The patient stated that she is completely healthy. The patient's concomitant medications were not reported. The patient did not receive any medications within 2 weeks of vaccination. On 02Apr2021 at 10:00 AM, the patient experienced strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever. No treatment was received for the adverse events. The patient had a low blood pressure measured 80/50 mmHg on 02Apr2021. The clinical outcomes of the strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever were resolved in Apr2021. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Patient received 2 doses of Covid-19 vaccine. First dose on 3/20/21 and 2nd dose on 04/10/21 Adverse event: 04/16/21 (Stroke) and was subsequently admitted to our facility for inpatient rehabilitation after initial admission to an acute care facility.

felt dizzy; her blood pressure readings are higher than normal; breastfeeding her 9-month-old baby; breastfeeding her 9-month-old baby; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she didn't take prescribed medications and was also breastfeeding her 9-month-old baby. She explained she received the first dose of the Pfizer-BioNTech COVID-19 vaccine last Friday, 16Apr2021 and developed potential side effects this morning, 20Apr2021. She explained she felt dizzy and her blood pressure readings are higher than normal, around 140/90-95. She specified her blood pressure was fine yesterday (19Apr2021) and was on average around 110/70. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021502578 child case

Pt received the second dose of Pfizer BioNTech Covid 19 Vaccine (exp. 8/2021) at 1132. At 1202, patient reported swelling and tingling on right cheek. Patient denied itchiness, rashes, hives, and difficulty breathing/swallowing/talking. Patient reported similar reaction to penicillin, no current medications and a heart murmur since she was a child. EMT assessed patient vital: blood pressure 140/60 mmHg, heart rate 106 bpm, and SpO2 98%. Patient given water. Patient tolerated drinking water. Patient offered oral diphenhydramine. Lead Nurse administered 2 doses of 25 mg/10 ml oral diphenhydramine at 1209. At 1214, vitals reassessed: blood pressure (unable to obtain due to unreliable blood pressure cuff, heart rate 98 bpm, SpO2 97%, and patient reported decreased swelling. At 1228, vitals reassessed: blood pressure (unable to obtain due to unreliable blood pressure cuff, heart rate 94 bpm, SpO2 98%, and patient reported decreased swelling. At 1233, patient reassessed. Patient reported swelling and tingling on right cheek "went away". Lead nurse educated patient on signs/symptoms of when to seek emergency care, to see an allergist, follow up with primary care provider about reaction to vaccine, and how to sign up on v-safe. Patient left facility with husband at 1235. Patient left facility with unlabored respirations and steady gait.

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

Her blood pressure spiked, and was very high the night of the day she got her first COVID-19 Vaccine; she had a high heart rate of 148; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on 24Apr2021 at 15:10 (at the age of 40-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included pre-eclampsia on 13May2010 (first diagnosed with pre-eclampsia while in labor with her son on 13May2010), blood pressure high from 13May2010 and ongoing, irregular heartbeat from an unspecified date and unspecified if ongoing (she had an irregular heart beat all her life, for at least 20 years. She said her heart skips a beat), leaky heart valve from an unspecified date and unspecified if ongoing (diagnosed approximately 7 years ago) and heart rate high (her heart rate was typically higher than most peoples). The patient had no history of previous immunizations with the COVID-19 vaccine. Concomitant medications included atenolol (TENORMIN; tablet; strength: 25mg) taken for blood pressure from an unspecified date and ongoing at 25mg, unspecified frequency. Other products were also reported as "no". The patient did not receive additional vaccines on the same date or within 4 weeks of the COVID-19 vaccine. On 24Apr2021 at 18:30 the patient experienced her blood pressure spiked and was very high the night of the day she got her first COVID-19 vaccine and she had a high heart rate of 148. The patient called to inquire whether an increased blood pressure was a side effect of the first COVID-19 vaccine dose. She reported that her blood pressure spiked and was very high the night of the day she got her first COVID-19 vaccine (on Saturday, 24Apr2021). She said her (highest) blood pressure readings were 184/170 and 218/130. She said she had a high heart rate of 148, as well. On Saturday, 24Apr2021, between 6:30PM-7:00PM, her smart watch alerted her that her heart rate had increased to 114, so she decided to check her blood pressure. She said she checked her blood pressure at home first with a blood pressure machine that she already had. She said when she saw her high blood pressure readings, she was hopeful that the blood pressure machine was wrong. She said she went out and spent $80 on a brand-new blood pressure machine to recheck her blood pressure, and her blood pressure readings were still high. Her husband and daughter got their COVID-19 vaccines at the same time she did. She said her husband and daughter's blood pressure readings were fine with both blood pressure machines she had used. She had already taken a blood pressure pill that morning (clarified as Atenolol 25mg), so she drank a bunch of water, and hoped for the best. The urgent care was already closed, and she did not want to go to the hospital because of the COVID-19 virus. She said she took 1 Atenolol 25mg tablet in the morning (on 24Apr2021). Her blood pressure was still higher than normal, providing 134/86 as her latest blood pressure reading this morning (27Apr2021). She said her heart rate was 75 this morning. She said her heart rate was typically higher than most peoples. She also reported that she was first diagnosed with pre-eclampsia while in labor with her son on 13May2010. She said from that point on she was told she would have high blood pressure. She stated her high blood pressure was treated. She said her blood pressure normally ran within a few numbers above or below 120/80. The adverse events did not require a visit to the emergency room or to the physician office. The clinical outcomes of the events her blood pressure spiked and was very high the night of the day she got her first COVID-19 vaccine and she had a high heart rate of 148 were both recovering/resolving. No Follow-up attempts are needed. No further information is expected.

Customer c/o uncontrollable shaking after taking the second dose. At customer was leaving the park at check point one customer pulled over to report shaking to staff. EMS and nurse responded to call. BP 149/82, HR 74, O2 99 and glucose 96.

I had the usual symptoms the first day after, fever/chills etc. It?s now a week later and I have had heart palpitations for 4-5 days, blurred vision and an urgency to urinate. I have felt faintish as well. I am hoping this passes soon.

Fever of 101.5, chills, lethargy, and body aches on 5/6-5/7. Widespread petechiae on arms and legs beginning the morning of 5/10 and spread through the evening of 5/11. Slight tachycardia at rest. 110 bpm. No other symptoms. No treatment given.

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.

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.

10:25 AM. Patient was in Observation Area post vaccination 2nd dose of Pfizer. Suddenly, she complained to RN who was the Observation Nurse that she has the pressure in her Left arm radiating to her neck and chest. She looked pale and clammy too. Oxygen saturation was on 83%, HR 93, Temp 97.5. No blood pressure taken due to unavailability of the apparatus at the site. 911 was called and took the patient into their VAn.

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.

fainting; POTS; Dysautonomia; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient (non-pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the left arm on 20Mar2021 (Lot number: EP7534) as single dose for COVID-19 immunisation. Medical history included hypertension and depression, allergies to penicillin. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), labetalol. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the left arm on 02Mar2021 (Lot number: EN6205) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Occurred on 29Mar2021, patient experienced dysautonomia: fainting and POTS. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of events was not recovered.

When I got the first vaccination at about 3 and a half hours I felt pressure in my chest and also nausea, headache and fever. But what worried me the most was the pressure in my chest when I took a deep breath, I felt pressure It lasted a day and a half and it went away. I have doubts in putting on the second, because I can feel very bad.

- 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.

Hot, itching ears outside and inside starting at 4:00pm. Followed by itchy mouth, racing heart, and all over skin itching. I took an extra Claritin at about 4:15. Then around 5pm I had a sudden feeling of an allover body sensation like a surge of electricity or drop in blood pressure, and had ringing in my ears and slowing of thoughts and movement and awareness. Went to the ER. Still itchy and ears were red. About 2 hours later all itching was gone and ears were no longer red. Stayed at the ER until 7:40pm.

Placental abruption (with heavy bleeding) occurred two days short of week 36 in first pregnancy (which was achieved via IVF with PGS-tested embryo), resulting in stillbirth on 5/6/2021; baby was 4lb 8oz upon delivery. Due date was June 4, 2021.

On the 26 and 27, it was fatigue, malaise, and headache. On the 26th in the evening, I could feel skipped beats of my heart heart palpitations. The headache started on the 26th and it lasted through the 31st and it worsened in intensity. Noted on the 31st: Blood Pressure was elevated to 161 over 110 I've never had a history of hypertension before. I called my Dr and she started me on medication Metoprolol XL 25 mg on February 1st or 2nd. The medication would work for a little while (a few hours) and then it would spike back up and so I saw a Cardiologist. High blood pressure and palpitations and headache lasted three weeks and then it all stopped and so I'm blood pressure medication and I no longer have any of these symptoms. 12/17/2020 I did have heart palpitations on day 5 and that stopped approximately 7 days later.

Found out I was pregnant day after shot week later I was bleeding for 3 days kind of like a period then it stopped on the 25 I started having high fevers chills facial flushing went to walk in clinic on 27 said I have strep throat took antibiotics 5 days in still having fever chills flushing went to primary dr did blood work showed I had infection blood pressure started becoming high went to obgyn pregnancy hormone low was told not a good pregnancy on 5/14 went to have pregnancy terminated blood pressure very high on 5/17 back at primary dr with high fever chills facial flushing again blood pressure still high put on a water pill to control blood pressure went back to obgyn everything good from procedure hormone levels almost back to zero

I woke up about 12 hours after my shot with leg pain (2:30am on Saturday. It came and went over the course of a few days and then was gone for maybe a day or so. It returned on Tuesday and continued to worsen and spread some. I was seen and had an elevated d-dimer test. They did an ultrasound for blood clots. Currently, I'm on day 7 and have aching, cramping, tingling, burning and cool sensations in both legs and a bit in my arms.

Increase in blood pressure/ spiked; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus/baby. This is the maternal report. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 03May2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Penicillin and experienced Allergy. The patient previously received TDAP vaccine on 03Mar2021 and first dose of BNT162B2 on 02Apr2021 for COVID-19 immunisation and experienced Increase in blood pressure/preeclampsia (11:00 AM, lot number: Ep7833). The patient experienced increase in blood pressure in May2021. Blood pressure returned to normal levels 3 weeks post-partum and spiked again after 2nd shot on 03May2021. Treatment was received for the event which included BP medication. The patient was hospitalized for 7 days for the event. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021516156 same report, mother/fetus case.

Right after vaccine injection site was extremely itchy. After a few minutes of vaccine my whole body was itchy . Left arm was extremely sore warm to touch and bruised 45 minutes after vaccine I bleed as if I was getting my period (Bright red blood) spotted until the next day then it was done. I was due for my menstrual cycle on 05/22/2021 which never came I am regular on my cycle. Topical rash on neck developed after 24hrs , redness, itching and burning

Rapid heart rate for four to five days following second vaccine dose. My resting heart was rate significantly higher than normal, and any activity, including standing up made my heart race faster, as high as my typical running heart rate.

Headache reported following administration. However, on 5/8 patient reported she had shaking chills, dizzy, fatigue- passed out twice in husbands presence. No fever.

Blood oxygen level dropped rapidly to 86 about 30min after shot. Caused a feeling of hypoxia and slurred speech.

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

I was very tired a few hours after the shot so went to bed a little early. Shortly after, I experienced sharp heart pains (this sometimes happens with my mitral valve prolapse). The sharp pain went up the left side of my neck (not normal with my MVP). The insides of my thighs felt tingly, not painful but not painless either. It almost felt like they were on the verge of throbbing. I?ve never had this before so it?s hard to describe.

tachycardia; sinus arrhythmia; heart palpitations; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the right arm on 06Feb2021 16:00 (04:00 PM) (Batch/Lot Number: EL9267) at the age of 40-years-old as unknown, single dose for COVID-19 immunization at a workplace clinic. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no medical history and no known allergies. Concomitant medications included daily multi-vitamin and an iron supplement, both taken for unspecified indications, start and stop date were not reported (reported as other medications in two weeks). The patient had heart palpitations beginning 08Feb2021 at 08:00 AM, then had an ECG with a sinus arrhythmia present on 10Feb2021, and then went to emergency room (ER) on 19Feb2021 for severe tachycardia. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive treatment for the events. The patient was tested for COVID post vaccination which was a nasal swab (PCR) with a negative result on 10Feb2021. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

I became very light headed and passed completely out. I do not remember anything leading up to this or while it was happening. When I came too, I couldn't hear, had ringing in my ears, couldn't walk on my own, and my husband said I was very cold. Two days later and i still have dizzy spells and extreme fatigue.

Before the vaccine, I had complete normal monthly periods. 28 days clockwork. I have not had a period since the vaccine. My FSH level have gone from normal, to 46.2mIU/ml. My prolactin is also elevated to 46.670 ng/ml CRP is elevated as well. I have hot flashes and night sweats and racing heartbeats. My doctor is going to re-run labs but has also ordered an MRI pituitary study

After receiving vaccination, patient was reported to have fainted, with a potential seizure, and fallen over resulting in injury to head and laceration to forehead. Pharmacist was notified in which patient was immediately placed in laying position with elevation to her head and support to neck. Patient reported nausea, confusion, attempted to vomit without success. Patient was able to report name when prompted. 911 was called, fire service and ambulatory service arrived for further assessment. Patient was deemed safe without necessity of going to emergency room.

Starting on the 1st day of the 2nd dose vaccine-elevated heart rate, chills, fever, body aches, nausea, neuropathy (hands, feet, arm and lower legs feels like pins and needles) and loss of appetite. Participant took Tylenol and Zofran. Fever and body aches resolved after 48 hours. Tachycardia and chest pains continued for up to 6 weeks. Participant had a follow-up already scheduled on 1/25/2021. Cardiologist doubled the dose of propranolol. As of now, cardiovascular symptoms and neuropathy are not resolved. MRI and stress test have been ordered .

1. Severe chest pain (stabbing) 15 hrs later that woke me up in the middle of the night. Went to emergency room around 11am (day after vaccine). 2. No menstral cycle for 7 weeks after the first injection. Visited OB/GYN

Heart was beating away fast; Lost a lot of weight; Really bad heartburn; Can't hardly eat; This is a spontaneous report from a contactable consumer. A 5-decade-old female patient (in his 40's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose (1st dose, single dose), with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's was beating away fast; had lost a lot of weight; had a really bad heartburn; and could not hardly eat. The patient was hospitalized on an unspecified date due to the reported events. The outcome of the events was unknown. The patient stated she would not be taking the second dose of vaccination. Information on the lot/batch number has been requested.

Started experiencing irregular heartbeat 1-6-21. Went to PCP for EKG 1-8-21. EKG was normal but I continued to experience palpitations intermittently for months.

Heart pounding and fluttering; Migraine headache; neck pain; dizziness; head and neck hot to the touch (no fever); eye pain; exhaustion; vertigo; mild nausea; Left temple throbbing and pulsating/headache; Heart pounding; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:30 (Batch/Lot Number: ER8736), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced migraine headache everyday, neck pain, dizziness, head and neck hot to the touch (no fever), eye pain, exhaustion, some vertigo and mild nausea, left temple throbbing and pulsating, heart pounding an fluttering occasionally, all on 30Apr2021 at 1730. No treatments were give for the events. Facility where the most recent COVID-19 vaccine was administered: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10May2021. The patient had not recovered from the events. Information on the lot/batch number has been requested.

Metallic taste in mouth; Chills/hot spells; nausea; vomiting; body aches; hip and back pain; sharp pain in left upper chest; Chills/hot spells; This is a spontaneous report received from a non-contactable Other-HCP. A 40-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN9581 and Expiration date not reported) via an unspecified route of administration, in Arm right, on 13Feb2021 at 02:30 PM (at the age of 40 years) as 2nd dose, single for COVID-19 immunisation. The patient medical history included Known allergies was reported as pseudoephedrine, Cephalexin, eggs, melon and concomitant medications included Multivitamin, St Johns Wort (medications in two weeks). Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246 and Expiration date not reported) via an unspecified route of administration, in Right arm, on 23Jan2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. The patient didn't receive any other vaccine in four weeks. There was no covid prior vaccination. The patient was covid tested post vaccination. On 13Feb2021, at 02:45 PM, the patient had experienced Metallic taste in mouth and feeling hot initially, Chills/hot spells, nausea, vomiting, body aches, hip and back pain, sharp pain in left upper chest. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which includes Rapid Antigen Nasal Swab test post vaccination on 15Feb2021 with the result of negative, on 17Feb2021 with the result of negative, on 19Feb2021 with the result of negative, on 22Feb2021 with the result of negative, PCR Nasal Swab test on 24Feb2021 with the result of pending. There was no treatment received for AE. Outcome of the events was reported as Recovered with lasting effects. No follow up attempts are possible. No further information is expected.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Pt's blood pressure at time of incident was 137/99. Pt also looked paler than usual. Pt is recovering with no worsening symptoms 10 minutes later under further observation

Within 10 minutes of injection vasovagal syncope occurred in vehicle while parked in observation area. Due to being in seat was not able to prevent syncope and nurses had to treat for 15 minutes until symptoms subsided. Blood pressure was monitored and dropped to 50/20. Finger pulse oximeter would not register. Nurses provided ice packs, alcohol wipes for smelling, and water. Unable to lay flat and extend legs so episode lasted longer than expected.

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.

I developed severely blotchy skin on my inner right thigh on Friday evening (5/28/21). It would not clear up and was subcutaneous (not chafing). It was a little sore to the touch in places. I did a Google search and was alarmed when one of the first things to pop up was possible clotting. I had also been experiencing strange heart fluttering/palpitations and my chest felt tight, like I couldn't take a deep breath comfortably. My husband brought home some chewable low dose aspirin. I took approx. 600mg (per directions - it said take 4-8 tablets every 4 hours). I took 8 tablets. Within 15 minutes the blotchiness started to fade in my leg, and within on hour it was 90% better. It was 100% better by the next morning. I have since been taking one low dose aspirin per day as a precaution. Heart palpitations also stopped with the aspirin. I emailed my doctor at the time of the event but have not heard back, as it was a holiday weekend. I chose not to go to the ER since the symptoms subsided, but I still worry and plan to see my doctor about this event. The heart palpitations were NOT a tachycardia event. I am all too familiar, and this was entirely different with chest tightness also noted.

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

High blood pressure. I?ve never suffered from high blood pressure before. I even had a physical done in January 2021 and it was perfect. Since the vaccine it has suddenly changed.

On 5/31/21, patient's husband described that the patient fainted and experienced seizure-like activity. She reported nausea and dizziness before and after the episode. It took approximately 2 minutes for her to regain consciousness and she didn't have any recollection of what had happened. On 6/1/21, patient's daughter contacted nurse triage after she experienced forgetfulness and word-finding trouble, performed a FAST exam, and patient was admitted. Work-up pending.

After receiving the first vaccine 3 week prior to this one (3/29/21) I had a vasovagal response a few minutes after. After the second dose on 4/19/21, I did not have this same immediate response. The following day I had expected symptoms of headache, fatigue, soreness in arm. On the next day 4/21/21 i woke up feeling extremely fatigued, and felt heart palpitations. I also started to get a sharp pain in my chest near my heart area. I saw my cardiologist a few days later and wore a heart monitor for a week. They observed I was having premature atrial contractions. I was told the frequency was not an emergency issue. (But I should note I never had these before). Coupled with the pain in my chest I was worried about myocarditis. All symptoms began to decrease on may 14 and by may 17 were completely gone. My echocardiogram wasn?t until may 26 2021, over a week after my symptoms stopped, and was normal.

Painless bleeding from nose and rectum for 4 days after receiving the 2nd vaccine, stopped spontaneously

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.

doesn't have much of appetite; 148/70 on the blood pressure; allergic response; tongue was a little numb; hard to swallow; Throat was closing up; mouth feeling numb; couldn't really speak; Coughing; super shaky; feet was also feeling numb; face looked swollen; Chest tightness; chest pain; abnormal EKG; Her throat was a little sore; tired; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left Arm on 17May2021 12:30 (Batch/Lot Number: EW0167) as single dose (at the age of 40-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number EW0158) on 15Apr2021 at 12: 50PM (at the age of 40-year-old) in the left arm for covid-19 immunisation and on 15Apr2021 her arm was numb on the side where she received the injection for more than 24 hours, it went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days, but the patient was unsure if that is an adverse reaction. The patient experienced tongue was a little numb on 17May2021 with outcome of recovering , hard to swallow on 17May2021 with outcome of recovering , mouth feeling numb on 17May2021 with outcome of recovering , throat was closing up on 17May2021 with outcome of recovering , couldn't really speak on 17May2021 with outcome of recovering, coughing on 17May2021 with outcome of recovering, super shaky on 17May2021 with outcome of recovering, feet was also feeling numb on 17May2021 with outcome of recovering, face looked swollen on 17May2021 with outcome of recovering, chest tightness on 17May2021 with outcome of unknown, chest pain on 17May2021 with outcome of unknown, abnormal EKG on 17May2021 with outcome of unknown, her throat was a little sore on 17May2021 with outcome of unknown, tired on 17May2021 with outcome of unknown, doesn't have much of appetite on 20May2021 with outcome of unknown. Details as described as follows: Reports she went to sit in the waiting area, after 5 minutes she noticed her tongue was a little numb. She took her card out of her purse, and noticed it was a little hard to swallow, this was within about 8 to 10 minutes. She sat for another 5 minutes and then decided to ask about her tongue feeling numb and was taken to the nurses station. She told them about her tongue, and as she was talking her mouth was feeling more numb and it was getting harder to swallow. As the nurse was talking to her it was like she couldn't really speak. The nurse said this is way past Benadryl and called to another nurse for an Epipen. Caller states she started to cough as her throat felt like it was closing up. They jabbed her with the Epipen within 15 minutes of receiving the vaccine. She got some relief for a couple of minutes and then her body went back into the allergic response. They put her on the oxygen finger machine and then her throat started to close again. They gave another Epipen and then the ambulance arrived. She is unsure how long after she got the second Epipen that the ambulance arrived but it was no more than 5 minutes. They told her they had to call 911 right after giving the first Epipen. When the ambulance team came, she felt like she had novocaine in her mouth, her mouth was super numb and she was super shaky. They said the shaking was normal from an Epipen. Adds her feet were also feeling numb. She didn't know before that the shaking was from the Epipen. She was able to walk to the ambulance and her husband came and the med team was asking him if her face looked swollen and he said her face looked swollen. States her mouth felt like it was moving funny and she was exaggerating her speech trying to make her mouth move right. Adds she was still unaware that this could be an allergic reaction and was just trying to remain calm. At the site, she noticed her vitals on the machine and she saw 148/70 on the blood pressure. Adds it was about the same in the ambulance, it was 148/64. She was not able to collect any information about the Epipen other than they were yellow with a blue cap and they held it in her leg for three seconds. No lot or expiration date known for the Epipens. In the ambulance she was treated with Intravenous (IV) steroids and dose of Benadryl 50mg. As she was being transported to the hospital, she started to have chest pain. They did an EKG in the ambulance with no remarkable findings. Adds she has a follow up with her Primary Care Provider (PCP) today. When she arrived at the Emergency Room (ER) they monitored her for a couple of hours. She had another EKG at the ER and was told that it was normal so they released her. She has no product information for the steroids or the Benadryl that she received. No lot or expiration date known. When she got home everything was calming down. Her throat was a little sore and she was tired. The next morning her chest was still tight. She called the doctor who told her to just relax and come back to the ER if she has palpitations or difficulty breathing. Mentions she got the results of the EKG in ER now, and it said it was abnormal as compared to a previous EKG she had, and something about the T axis. Adds now she doesn't have much of appetite and her tongue still feels a little off. Caller interrupts the call to say her doctor just called and she needs to go. Unable to complete the report at this time. The outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.

About 36 to 48 hours after receiving dose number 2 for the covid pfizer vaccine, I began to have recurring severe nosebleeds. The bleeds were difficult to stop (lasting 15 or more minutes) and with clots. These lasted daily for 3 to 4 days and then ceased completely. I met virtually with Dr., my hematologist, and he encouraged repeat PTT/PT bloodwork and visit to ENT. Met with Dr., ENT. There were no structural issues in the nose and bloodwork came back normal, so both concluded that vaccine may be cause of bleeds.

Slightly lightheaded; Slight ringing in my ears; Resting heart rate began to increase; Facial/neck flushing; Became hot; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration on the left arm on 17Mar2021 at 14:15 (at the age of 40-year-old) for COVID-19 immunisation. Concomitant medications (within 2 weeks of vaccination) included vitamin E, hydrolyzed collagen, vitamin C, biotin. She has no known allergies to any medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, she had not tested positive for COVID-19. On 17Mar2021 (within 2-3 minutes after the vaccination), she became slightly lightheaded with a slight ringing in her ears; Her resting heart rate began to increase from 70 beats per minute up to 131 beats per minute with facial/neck flushing and she also became hot. The symptoms resolved within the next 2-3 minutes. It was also confirmed that she was 5 hours out from receiving the vaccine without further issue. No therapeutic measures were taken to treat these events. The clinical outcome for the events became hot, facial/neck flushing, resting heart rate began to increase, slightly lightheaded, slight ringing in her ears was recovered on the same day (17Mar2021). No follow-up attempts are needed. No further information is expected.

Pt had a vasovagal episode with pt passing out few seconds. Pt received juice and crackers and felt better as well Pt vitals stable was watched 30 minutes

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.

Approximately 15 minutes after injection, pt c/o "gas/burning" in chest which happens frequently (has history of GERD). At 17 min after (~11:03am), p/co dizziness. BP was 100/60, after ~1 minute rechecked at 126/72. Dizziness resolved after water and granola bar given.

Patient reported to urgent care with left-sided chest pain with left arm weakness. Patient evaluated by Dr. called 911 and sent to Hospital, via ambulance. Follow-up appointment scheduled.

Symptoms are ongoing 8+ weeks post vaccine. I have had two doctors visits and numerous blood tests. All normal. I was perfectly healthy prior to this other than a vitamin D deficiency that is now within the normal range. No known prior COVID exposure/infection. Have been maintaining a small, strict family bubble since March 2020 - working from home, home schooling my son, no travel or even going into stores. I had the normal/expected next day reaction to the 2nd shot - extreme fatigue, body aches, headache. I rested for the full day on Saturday and felt better /normal by Sunday morning. However, by late Sunday afternoon, new symptoms came on. They started out on the left side of my body and then grew from there in the days that followed. First it was pain behind my left knee that radiated down to my ankle and later upward through my left thigh, hip, entire arm, and shoulder. From there, it progressed to all over pain in my joints on both side of my body and almost daily headaches - typically around the base of my skull. I am also experiencing prolonged periods (days and sometime weeks at a time) of constant muscle tension/soreness in both arms and legs and intermittent tightness in my chest. However, the pain has remained most intense/pronounced/persistent on my left side and a couple of different times in the last 8 weeks I've had bruising on my left foot and ankle. As a result of all of this, I am fatigued most days and it is all inhibiting my ability to function normally. I don't know whether it is related to the vaccine or not, but I know it isn't normal. My quality of life and ability to function as I typically have has decreased dramatically in the last 8 weeks and I am very worried and I don't know what to do. If someone can please contact me and advise whether they have received any similar reports and provided direction on some type of specialist or test that might be able to help, I would be forever grateful as I am scared and my primary care physician has basically just said I need to wait it out.

Patient complained of tingling of the mouth and throat "like when I have peanut allergy". Patient reported that she took a Zyrtec and denied difficulty swallowing or breathing. Vital signs stable. Complained of nausea and that her chest felt heavy. EMS called and was taken to the hospital.

The evening following the 2nd dose of covid 19 vaccine my arm was sore and I was tired. That night it progressed into a fever of 104, severe body aches in almost all my joints, headaches, bradycardia and body chills. The fever was minimal reduced by switching Tylenol and Ibuprofen every few hours to about 102. Fever, chill and body aches started to subside in about 24 hours. Today I have sore throat, pressure/fluids in ears, slight chest pains and bradycardia, light headache and swollen lymph nodes in throat , inject site is still sore but most bothering is dizziness that is setting in.

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.

AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY PAINFUL. SAW MY PA ON 03/25/21. VALTREX PRESCRIBED. BLISTERS WERE MUCH BETTER WITHIN 48HOURS. 03/27/21 UNEXPECTEDLY HAD MY PERIOD. I HAD JUST FINISHED UP MY PERIOD WHEN I HAD THE VACCINE ON 03/18/21. THIS PERIOD WAS UNLIKE ANY OTHER. THE BLEEDING WAS INCREDIBLY HEAVY, FULL OF CLOTS AND LASTED 9 DAYS. MY USUAL CYCLE IS 5. AFTER SECOND DOSE: ANOTHER UNEXPECTED PERIOD. THIS TIME NOT AS HEAVY, NOT AS MANY CLOTS AND DID NOT LAST AS LONG. SORE UNDERNEATH ARM AND LYMPH NODE UNDER ARM SWELLED.

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.

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)

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.

heart palpitations; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162be (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Mar2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse. Patient had allergies to medications, food or other products but it was not specified in the source report. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Allegra, Flonase, Melatonin, Yaz and Benedryl all for unknown indications from unknown dates and unknown if ongoing. Vaccine was administered in a Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 16Mar2021, at 13.30 hrs the patient experienced heart palpitations. The patient did not receive any treatment for the event heart palpitations. The clinical outcome heart palpitations was resolved on an unknown date. Information about lot number cannot be obtained. No further information is expected.

Dizziness, blurriness, weakness to the point of blacking out and falling. I woke up in the bathtub with a huge lump on my head bleeding.

blood disorder; hypercoaguability; Pulmonary embolism; pulmonary infarct; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Lot number: ER8729) in left arm on 08Apr2021 15:30 at age of 40-years-old at single dose for COVID-19 immunization. Medical history included Known allergies: Sulfa and Morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. Not pregnant at time of vaccination. Concomitant medications included patient received within 2 weeks of vaccination included: cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), over the counter multivitamin. Patient previously received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Lot/batch no.: EP7534) in left arm on 17Mar2021 13:30 at age of 40 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Diagnosed with pulmonary embolism and infarct as well as blood disorder-hypercoaguability on 20Apr2021. Event start date was on 17Apr2021 14:30. 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), Disability or permanent damage. Serious report. Since the vaccination, the patient had been tested for COVID-19. COVID test post vaccination: Nasal Swab on 20Apr2021: Negative. Patient received treatment for events included rivaroxaban (XARELTO). Outcome of event was not recovered. Information about lot/batch number has been obtained.

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.

Sharp pain in left leg toe for 30 minutes then a bumpy feeling. Next day morning showed up a bruise kind of spot (blood clot). No numbness, itchiness or pain in that area.

Patient developed palpitations and dizziness two days after 2nd Pfizer COVID-19 dose (4/5/21) and then had sustained ventricular tachycardia requiring cardioversion 4 days later. Cardiac MRI was normal (no evidence of myocarditis). Underwent successful ablation of right ventricular outflow tract ventricular tachycardia on 4/12/21. Has been event free since. No history of palpitations or premature beats prior to vaccine. No family history of arrhythmias.

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.

Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: The Patient fainted after receiving the covid vaccine. EMS came and attended to the patient. She left the store with her husband.

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.

swollen glands in her throat; dizzy/lightheaded; heart palpitations; inflammation on both sides of the back of her tongue; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ENG203) intramuscularly on 25Feb2021 (at the age of 40-year-old) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that the first day and a couple of days after (not clarified further) she had swollen glands in her throat, inflammation on both sides of the back of her tongue and lightheaded. These symptoms lasted a couple of days. The following week she was dizzy and had heart palpitations. She informed that "heart stops sometimes" (as reported) and she was experiencing that on and off. The caller was apprehensive about the second dose and wanted to know if her symptoms were an allergic reaction. The patient did her normal routine blood work with her doctor, unsure whether it was before or after the shot: it was normal. Tongue and throat were improving, reported to be resolved (not clarified further). Outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.

I started to get a weird quick sensation that started in my chest and moved down my body(kind of like when you go over a hill really fast but intensified)/felt like something inhabiting my body; really freaked me out; wasn't sure if I was going to pass out or not; my arm felt tingly, like when you hit your funny bone; This is a spontaneous report from a contactable consumer(patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the right arm on 14May2021 04:45 PM (at the age of 40-years-old) as first dose, single dose for COVID-19 immunization at a Pharmacy/ drug store. The patient's medical history was not reported. Concomitant medications included progesterone and estradiol; both taken for an unspecified indication, start and stop date were not reported. Patient was also reported to be on hormone replacement therapy. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 14May2021, right away after the shot, the patient experienced or felt tingly arm, like when you hit your funny bone (reported to have waited for 15 mins and felt fine) and on the way home about 25-30 mins after the shot, at 05:30PM, the patient experienced a weird quick sensation that started in her chest and moved down her body (reported as kind of like when you go over a hill really fast but intensified) and felt like something inhabiting her body (which was reported to have lasted probably less then a minute), that really freaked her out and wasn't sure if she was going to pass out or not. Luckily she was close to home. No treatment was given for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I felt sick with a headache and low grade fever and body ache from 24 hours post injection till 4 days post injection. On the evening of the fifth day, I felt somewhat better until I experienced extreme upper left side abdominal pain and left side chest pain. The pain persisted for approximately 2 hours and was not immediately relieved by otc pain reliever. It was accompanied by a fever and chills. I did not seek medical assistance.

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

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 was approximated 10 weeks pregnant and received her second dose of the Pfizer vaccine on 6/16. Four hours later, she began cramping and spotting. This worsened over 3 days. She began hemorrhaging hours prior to her ER visit . She was hypotensive and required an urgent suction curettage

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.

bleeds were difficult to stop (lasting 15 or more minutes) and with clots; severe nosebleeds; This is spontaneous report from received via health authorities from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 27Apr2021 05:15 pm (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation. Patient is not pregnant. Medical history included hashimotos, von willenbrands type 1. And patient avoided gluten and dairy for autoimmune disease. Concomitant medication(s) included levothyroxine sodium (SYNTHYROID) and methylfolate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Brand synthroid 200 mcg, multivitamin, l-methylfol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8734) administered in right arm on 06Apr2021 06:00 pm for covid-19 immunisation. About 36 to 48 hours after receiving dose number 2 for the covid pfizer vaccine, patient began to have recurring severe nosebleeds on 29Apr2021 16:00. The bleeds were difficult to stop (lasting 15 or more minutes) and with clots. These lasted daily for 3 to 4 days and then ceased completely. Patient met virtually with hematologist, and he encouraged repeat PTT/PT bloodwork and visit to ENT. Met with doctor, ENT. There were no structural issues in the nose and bloodwork came back normal, so both concluded that vaccine may be cause of bleeds. The adverse events result in doctor or other healthcare professional office/clinic visit. Patient underwent hematology bloodwork, ENT exam. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The event outcome for events was recovered on unspecified date.

Aside from 2nd dose giving 102 fever, diarrhea, vomiting etc. for 2.5 days post 2nd vaccine- and continual diarrhea now a month later: My menstruation was 10 DAYS LATE after the second dose. Took a pregnancy test on day 7 of missed period and it was negative just to be clear . Period came and was heavier than normal along with more intense cramps. Now, more than a month later my second post vaccine period came 7 DAYS EARLY and for the days leading up to this early period I?ve had breast pain (which isn?t a normal PMS symptom for me) along with intense cramping and heavier blood flow.

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.

I think I experienced Myocarditis. I had weird heart flutters that started a few days after first shot and got worse after second but cleared up about a month after second dose. I?ve never had anything like that before and I?m in very good physical shape.

The next day after the 2nd dose of the vaccine, I started getting flu like symptoms, headaches, chills, nausea, body aches, slight cough. These symptoms lasted for 5 days. I took cold medicine and Tylenol. I started to feel better, but I started to notice my heart racing. I went to the doctor and they confirm that your rate heart was a little high 90-95. My BP was OK and I was to keep an eye on it. I also noticed increase quantity of cysts around my thyroid from 3 prior to the vaccine to 7 after the vaccine. I went to get a sonogram to confirm the cysts. I have a appt with a surgeon this weekend to see if I need to have to get a biopsy. I go to the gym daily and I notice my heart rate racing and could visibly see my pulse beating on my neck and I also had chest pains. I went to the ER. They took my vitals, ECG, blood work and chest X-ray. Everything came back normal except my blood pressure and heart rate was elevated. I was diagnosed with possible anxiety and adverse events of COVID vaccine. I was discharge with no medications or instructions and to wait it out and let the vaccine the run its course.

feminine blood spotting starting about 4 days pos 2nd injection. Early menstruation cycle start leading to continuous spotting between cycles. Periods are irregularly heavy and consist of tissue and clotting materials. Cramping leading to bed rest requiring medication and heat.

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.

Lump like ball in the arm for almost two weeks; For the first 4 or 5 days, after receiving the first dose Pfizer Covid Vaccine, had chest pains; her heart literally had chest pains for 4 or 5 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm right on 08Apr2021 13:30 as 1st dose, single for COVID-19 immunization. Medical history included Chronic pain from 2004 and ongoing, high blood pressure from 2010 and ongoing, asthma from 2004 and ongoing. The concomitant medications were not reported. The patient did not receive prior vaccination within four weeks and other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events reported prior vaccinations. The patient has not received the second dose Pfizer Covid Vaccine yet because the she was scared.On 08Apr2021, at night the patient experienced chest pain. It was reported that for the first 4 or 5 days, after receiving the first dose Pfizer Covid Vaccine, had chest pains. The patient had high blood pressure because of chronic pain issues. The patient stated that her heart literally had chest pains for 4 or 5 days. The patient was reading about inflammation of the heart. The patient knows that inflammation of the heart happens in young people, the patient was wondering if this happened to her. The patient stated that few hours after first dose there was a lump like ball started forming and it went away but took almost two weeks to go away. When the patient pressed on it, the lump like ball felt like a bruise more like. She stated that she also had chest pains which began at the night when she received the first dose Pfizer Covid Vaccine on 08Apr2021, and this went away about 5 days later. The outcome for the events lump like ball started forming was reported as recovered on an unspecified date in 2021 while for had chest pains and her heart literally had chest pains for 4 or 5 days was reported as recovered on 13Apr2021. Information on the lot/ batch number has been requested.

30 minutes after receiving vaccine my arms abdominal and legs began itching and had red patches like hives. I ignored this and continued working. Then insides of my ears began itching. I told the pharmacy techs that were qt my place of work administering the vaccine. They gave me 50mg of benadryl, at that time my eyes had begun to itch and started coughing. Pulse rate was 160. No shortness of breath and no tongue swelling. They offered an epipen but as a nurse myself I declined and wanted to wait to see if benadryl would be effective. I was monitored for an hour. By the end of the hour I was not coughing, my eyes and inner ears had stopped itching and my pulse was back below 100. I still had hives and moderate itching to my body which resolved about 2 hours after taking benadryl.

Low grade fever; Arm soreness with some numbness around the injection site; Arm soreness with some numbness around the injection site; Nausea; Elevated heart rate; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Feb2021 (at the age of 40-year-old), as unknown, single, in left arm, for COVID-19 immunization at Workplace Clinic. The patient's medical history included glaucoma, bipolar disorder, corticosteroids allergy, and COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, patient experienced arm soreness with some numbness around the injection site, nausea, and elevated heart rate. Patient received Ibuprofen as a treatment medication. The patient had COVID prior vaccination and was not tested COVID post vaccination. The patient underwent lab test and procedure which included heart rate: elevated, on an unspecified date in Feb2021. The clinical outcome of all the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Sudden Cardiac Arrest, needed to be defibrillated twice. Life support for 2 days. No previous health issues. Hospital stay for 7 days. ICD implanted.

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

12 hrs post injection: facial flushing, prickly feeling all over body/skin, nausea, body aches, racing pulse 24 hrs post injection: persistent facial flushing/rash, facial blotches & bumps, upper back and neck aches, head ache, fatigue, right thumb joint pain 48 hrs post injection: right thumb/pinky joints painful & stiff 3 days post injection: both thumbs and most fingers painful & stiff (consistent for 1 month, sporadic to present) 1 week post injection: Noticed occasional low-grade fevers (99-100 degrees), continues to present 3 week post injection: Developed head pain in/around temples, sides of forehead, and scalp. These are sudden bursts of pain/ache and occasionally persistent throbbing. Veins on side of forehead are swollen and bulging. Stiff and painful neck and SI/lower back that would cause me to wake during sleep. Nausea, fatigue, and head pains continued. Occasional sore throat. Temples and scalp tender to touch and hurt when chewing or talking. Other veins throughout body appear more visible. 8 weeks post injection (present): Symptoms continue to include Rosacea flare up and everything listed at 3 weeks post injection to include sporadic pain in thumb and finger joints.

The day following the shot I had a very sore arm (which was to be expected) this went away in a day or two and felt completely fine after. On day 9/10 following the vaccine, I woke up with severe pain in the same arm at the injection point and pain with mobility of the same shoulder. Later the same day I unexpectedly began my menstrual cycle. It was 7 days early. It's never early, ever. My cycle is down to the day and regular, always. No usual menstrual cycle indicators/symptoms prior to it beginning either. The day after my cycle started, I noticed my heartbeat was pounding very loudly at night in bed, this lasted for 3 days with moments of minor chest tightness in the center of the chest, which was concerning, I almost opted to go to ER. this sensation subsided on the 4th day and has not returned.

A few minutes after receiving the vaccine I felt like I was fainting. My hearth was speeded up and I got pale. Five hours after I still feel dizzy and have fever. Really tired. And have a really strong metal taste in my mouth from the moment I took the vaccine. Food doesnt have any taste.

she was hospitalized for 4 days and treated for ITP.; nose bleed; Caller states she gave birth to her son 28DEC2020, and she had been exclusively breastfeeding; Caller states she gave birth to her son 28DEC2020, and she had been exclusively breastfeeding; they did a blood count and sent her to the ER because her platelets were 5 or 7, they were low; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left arm on 13Apr2021 10:30 (At the age 40-years-old) as single dose for covid-19 immunisation. Medical history included covid-19 from Mar2020 to an unknown date. Family Medical History Relevant to AE(s): None, all have had the Moderna vaccine and no adverse reactions besides fever and pain in the arm but nothing like this. The patient's concomitant medications were not reported. On 10Apr2021 the patient experienced she was hospitalized for 4 days and treated for itp, nosebleed from 13 Apr 2021 to 16 Apr 2021, on 05Apr2021 states she gave birth to her son 28dec2020, and she had been exclusively breastfeeding, on 05Apr2021 they did a blood count and sent her to the er because her platelets were 5 or 7, they were low. The patient was hospitalized for nosebleed from 13Apr2021 to 16Apr2021. Caller states on 13APR2021, she had her second Pfizer Shot. Caller states that night she had a nose bleed so she went to the Urgent Care and they did a blood count and sent her to the ER because her platelets were 5 or 7, they were low. Caller states she was hospitalized for 4 days and treated for ITP. Caller states then she did one treatment for ITP and then she did a second treatment for ITP. Caller states she was hospitalized a couple of weeks later and given treatment. Caller states she is taking a 3rd treatment currently. Caller states her Platelets keep crashing down. Caller states she has blood work drawn every few days and she is being monitored closely to make sure her platelets don't drop too low. Caller states one treatment was given for over a month. Caller states she had 2 dexamethasone treatments, 2 IVIG treatments and now she is on Prednisone and doing a slow taper. Caller states if this doesn't work, they are going to explore other longer-term options. Caller states she has no history of autoimmune disorders or ITP. Caller states when she says ITP, it stands for Immune Thrombocytopenia, or it is also called something else, Idiopathic Thrombocytopenia. Caller states she went to the Urgent Care first for the nosebleed and petechiae and she didn't think anything was probably going on, but they did bloodwork and her platelets were really low so they sent her to the ER and she was admitted to the hospital from 13Apr2021-16Apr2021 for 4 Days. Caller states she was admitted to the hospital a second time 23Apr-26Apr2021 for 4 days. The patient underwent lab tests and procedures which included antibody test: positive, platelet count: 5-7 low on 13Apr2021. Other Conditions tested Positive Antibody IVG Spike Protein and Nucleocapsid; states result from antibody test indicate that she has probably had Covid sometime in the past, only time would have been March 2020 when the pandemic started, she had symptoms that weren't reported as symptoms yet and she was traveling in India at the time. States she doesn't know what strain it may have been. States she tested for antibodies because she was interested to see how the steroid was affecting her response to vaccine. Patient was healthy before vaccination with no allergies. Outcome for the event immune thrombocytopenia, maternal exposure during breast feeding, off label use was unknown, event nosebleed was recovered, event blood count abnormal not recovered. Information on Lot/Batch has been requested.

(Athletic 40 yr old female endurance athlete, 115lb, no prescription meds or hormonal birth control). Have confirmed HLA-B27 antigen disorder (autoimmune eye issues, not in flare, not on meds). Also have chronic history of low-ish iron/borderline anemia. MILD case of blood spots / petechiae rash on both lower legs & forearms 48 hours after both pfizer vaccines, deep muscle aches, one severe nosebleed (nosebleeds are chronic, but had been under control for some months). Feeling of blood pressure surges in large muscles, esp lower legs. Petechiae resolved in one day and did not worsen. Nosebleed clotted normally in 5min. Consulted with family dr over telehealth & followed up with routine yearly cardio exam. No concerning pulse, headache or chest pain, did not feel need for urgent care. Normal athletic function recovered in 3 weeks, yearly physical vitals were normal 1.5 month later.

Tingling Lips and face; Sweating; Fast Heart Rate; Tongue Swelling; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 20Mar2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), zolpidem (AMBIEN), montelukast (SINGULAIR), lisdexamfetamine (VYVANSE) and cetirizine (ZYRTEC), all for unknown indications from unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received hepatitis B vaccine (MANUFACTURER UNKNOWN) on 26Feb2021 as immunisation, 4 weeks prior to the COVID vaccine. On 20Mar2021, the patient experienced tingling lips and face, sweating, fast heart rate, tongue swelling and headache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events tingling lips and face, sweating, fast heart rate, tongue swelling and headache. The clinical outcomes of the events tingling lips and face, sweating, fast heart rate, tongue swelling and headache were not recovered at the time of the report. Information about lot/batch number cannot be obtained. No further information is expected.

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

My heart stopped; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2, second single dose via an unspecified route of administration, administered in arm right on 06Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation at age of 40-year-old. Medical history was none. The patient had first dose of bnt162b2 on 06Mar2021 at right arm at age of 40-year-old. Concomitant medication in two weeks included omeprazole (PRILOSEC). No other vaccine took in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient heart stopped on 10Apr2021and she died at home, her husband brought her back to life, then she died in the ambulance they brought her back to life. Then in the Hospital trauma room they sent her to CT scan she died again for 5 minutes they saved her again. The patient was admitted for 6 days and received treatment for the event. The event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was recovered with lasting effects. Information regarding the Lot/Batch number has been requested.

Rapid Heart Beat; chest pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration in right arm on 04Jun2021 at 16:00 at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Relevant medical history was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. On 07Jun2021 at 02:00 AM, patient experienced rapid heart beat and chest pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Outcome of the events was not recovered. No treatment received for the events. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

Within a few minutes of the first shot, I felt my heart racing. I then felt lightheaded and had chest pain with some PVCs on the monitor.I was sent to the ER. No medication given. I was monitor for roughly 2 hrs and sent home. I did not receive the second shot. I, then presented to the ER on 5/31/21 with chest pain and tachycardia. I was diagnosed with pericarditis. The assumed pericarditis diagnosis was unknown but pressured to be viral pericarditis.

On June 10th I began to have chest pain. It was very bad so I went to the ER. 10 minutes after arriving I coded and had to have CPR and shock my heart back. I was airlifted to Hospital where they placed a stent in my LAD due to 100% blockage. No other blockage was found in any other artery. I spent two more days in the hospital and have have been recovering at home.

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.

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

I started on May 25th with bad chest pain, a week prior I had a bad cough, I went to my doctor, and they did an ECG/was normal at the time and they sent me home. They stated if it got worse, to go to the ER. It did get worse went to the ER later that night, and they concluded that I have inflammation around my heart. I was I given Meloxicam for inflammation around the heart.

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.

Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No period February lymph nodes under the armpit 3 days Persistent headaches No period March Persistent headaches No period One day of blood clots Er visit for upper gi severe pain ct clear April Headaches worsening No period May Headaches worsening No period Tremors in right hand ER VISIT migraine meds given no change June Headaches worsening No Period Stuttering and speech difficulty 6 10 15 16 dizziness and vomiting 6 10 difficult with walking Pain behind eyes moving side to side and up and down 6/19 carbonated sodas are flat can?t feel Carbonation in my mouth July Worsening head pain Consistent stutter Intermittent problems with walking July 5th hard time gripping items and equilibrium off. Treatments. EEG shows diffuse brain dysfunction, VERS shows optic nerve information. Intercranial pressure increased. No changes still testing

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.

On 1/12/21 (5-6 days after receiving the 2nd COVID vaccine) I began to feel new onset heart palpitations/arrhythmia. After 3 days of symptoms throughout the day, I saw my PCP on 1/14/21, who diagnosed them as PVCs. Labs for CMP and thyroid were taken and normal. We agreed to watch symptoms and wait; they came and went but happened at least three times a week for the next several weeks. Had regular physical on 4/9/21 and symptoms still present. PVCs became daily occurrence by mid-May so PCP ordered Zio Patch to be placed to monitor heart rhythm. Zio patch was placed on 6/24/21 and worn for 9 days until 7/2/21. Zio device/monitor is currently undergoing reading and interpretation of results. PVCs occurring multiple times daily

Heart palpation; back and shoulder pain; back and shoulder pain; High blood pressure; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 25Mar2021 at 13:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to sofa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient had experienced heart palpitation, shoulder and back pain and high blood pressure. Adverse 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 reported events. The clinical outcome of the events heart palpitation, high blood pressure, back and shoulder pain was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

The night of first dose I had a fast heart beat all night I couldn?t sleep The second day a terrible headache and nausea Now I have bad cramps and am spotting as if I am going to start my period which I already finished my cycle last week I never had break thru bleeding or spotting like this a few days after my period finished. I am having symptoms again

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)

Monthly cycle has been heavy bleeding, defibrilating cramps, and unpredictable. Spotting moments after the vaccine. Chest pain, and pins and needle sensation in legs.

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.

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

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.

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.

1- Heart palpitations that started slowly the day after the first shot, then increased significantly after second dose. Heart palpitations are extremely frequent. Twice an hour is the least frequent. 2- Shoulder pain within a day of the first dose, the left shoulder joint and muscles were very sore and unable to use fully, still sore but have retained use.

I started with a fever and a headache about 3 hours after receiving the vaccine. I took Tylenol and felt better. About 10 am that evening I had chills, I jumped in the shower to warm up my body which helped and I went to bed. Wednesday about mid day I became quite nauseated, dizziness and just did not feel well. I took benedryl that evening and went to bed. Thursday around mid- day again I continued to have nausea and dizziness, then I also started having chest tightness, I used my albuterol inhaler which is new to me for allergy induced asthma, which helped. Overnight Thursday into Friday I woke up in the night and had sweat through my clothes. I had the same symptoms carry on into Friday. Saturday I was beginning to feel better until mid afternoon I had a different chest discomfort and nausea and I reported to the emergency room they ruled out a cardiac event, gave me 2 baby aspirin and zofran and sent me home. Sunday I woke up with a terrible migraine I treated with alternating tylenol and ibuprofen for about 24 hours. Monday- Tuesday- Wednesday I just felt worn out, fatigued over all not well. Thursday I finally started feeling better and contiue dto feel better.

DVT left saphenous vein and left common femoral vein. Redness and tenderness inside of left thigh x 2 days. Got an ultrasound 1/29/21 that confirmed DVT. Treatment: eliquis x 3 months and for as long as I'm on tamoxifen. If discontinuing tamoxifen, daily aspirin recommended.

Dizziness, headache, body aches, increased heart rate with activity , fatigue, brain fog. Ordered meclizine and propanolol and rest and to follow up with primary care. Completed follow up with primary care next day due to symptoms worsening. To follow up with primary care if symptoms not resolved by 4 days. Blood work completed and normal. Medications help manage symptoms. Symptoms not worsened today, but have not resolved. Have also had ringing in ears. Will follow up with primary care on Monday for further instructions.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling hands and face. Patient felt dizziness for approximately 30 minutes. She was laying flat on floor with feet elevated. EMT was called and she was transported to ER where she remained for 1 hour until symptoms resolved. Followed up with her about 6 hours later and she is feeling better but tired. she is going to contact her primary care physician

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/27/21,pfizer,Lot#ER8733 2nd dose: 04/16/21,Pfizer,Lot# EW0162 Diagnosed covid positive:07/07/21 Exposure:Home exposure Symptoms:Fever,cough,loss of smell,abd pain. sore throat,runny nose,headache,chest pressure.

Body Aches, Fever, Chills, Headache, numbness/tingling in the legs and arms, Warm tingling and tightness of the chest, legs were tingling and had a lump in left leg, High blood pressure.

Severe ongoing chest pain for weeks, still have chest pain to date not as severe pain all the time, Pericarditis. Thought I had a heart attakcFirst hospital visit 6/13/21 had chest x ray, ultra sounds, blood work, ct scan. Have had probably 10 EKG ?s all abnormal since then during many dr visits. Still have chest pain

Extreme fatigue, severe sinus pressure, headache, ears hurt, loss of memory. Tried Ivermectin and it worked for 2 weeks, then I got sick again. Tried mucinex and resveratrol and it worked for 2 weeks, then I got sick again. Now I'm on singulair and it helps, but I get sick off and on.

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.

A few minutes after receiving the vaccine, patient's husband was calling for help. The patient appeared to be passed out but woke up. An ambulance was called and she reported to the hospital.

Patient returned for her second Pfizer Covid vaccine on 7/20/21 and stated that she had been treated for a blood clot in her lung(s) on 7/12/21. She received her first Pfizer Covid vaccine on 6/29/21. Treatment for clot is ongoing

Elevated heart rate; Light headiness; Throat felt scratchy; Throat felt weird; This is a spontaneous report from a contactable consumer via regulatory authority. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), on 01Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced elevated heart rate immediately after vaccination, which resolved 30 mins post vaccination and also the patient had a bit of light headiness and throat felt weird/ scratchy a few hours later which resolved in about 10 minutes. 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 elevated heart rate, light headiness, throat felt weird and throat felt scratchy was recovered on 01Apr2021. No follow-up attempts are needed; information about lot number cannot be obtained.

Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Pt felt a burning sensation right away and stated that their heart was racing. I checked BP several times and the range was between 130-158 / 70-90. Pt went to urgent care & MD monitored until BP & HR was normal. They are unsure if this was vaccine related or nerves. Pt was instructed to rest at home today & is feeling better but noted that she felt itchy when she first woke up this AM but it has since passed.

Contracted covid between doses of the vaccine, and had AFIB several months later in May (4 months after). Hospitalized, given IV cardizan, prescribed PRN cardizan, have not had to use it since, have not had another episode.

Patient calling for Chronic COVID-19 Vaccine, Arm Pain, and Skin Problem (burning senstion- upper extremeties ) Symptoms started x1 month. Symptoms include: Received covid-19 vaccine. Patient has had a burning sensation since in arm since vaccine. States sensation has been spreading to the rest of her body. Patient Has not attempted treatment at home.. Pertinent negatives include: Afebrile. HISTORY OF PRESENT ILLNESS Patient is a 41 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the clinic/location: on the date of: May 14th and approximate time of 2:30 Vaccine was administered to patient's: Right Deltoid Vaccine manufacture was: Pfizer No Previous Reactions to other immunizations Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: Headache, Localized injection site pain and Myalgias Patient is a 41-year-old female presenting with multiple different symptoms post COVID-19 vaccine. Patient reports that has any burning sensation in her vaccine arm. She reports that it almost feels like it is on fire or sunburn. Patient reports that at times the sensation travels to different parts of her body. She also reports that she had neck pain, Back pain, and upper chest discomfort. That time she reports that she has some numbness and tingling bilateral to her upper extremities. She denies any weakness. She denies any level of consciousness changes. She denies any trauma. She does not a family history of stroke or neurological problems. She also reports that she has had a change in her menstrual cycle. She reports that she is had 2 menstrual periods in the month of May and also in June. She also reports mild headache. She also reports that her eyes seem a little dry and feels as though her vision may be getting worse. 1. Adverse effect of vaccine, initial encounter At this time due to multiple different neurological symptoms and unable to do a good thorough neuro exam I would like her to be seen in person for further evaluation. Patient was educated on worsening symptoms and reasons to go to the emergency room right away such as any signs of the stroke which we discussed speech changes, numbness or tingling down one arm. Patient was agreeable to plan of care and is going to reach out to her primary care doctor. Called PCP office to let them know my recommendation for appointment as soon as available This visit was completed via health visit and 11-20 mins was spent as part of care with patient.

Night of injection I nearly fainted-very odd experience. It was awful. Next day was 101 fever, but as expected from vaccine reactions. Two days later extreme itching all over that lasted about a week. My scalp still itches daily seven weeks later. At about two days also my second toes on both feet (closest to my pinky toes) starting hurting. Next day my second finger on my left hand (closest to my pinky finger) starting hurting. Those still bother me but not as intense. In those next few weeks, I had heart flutters and general fatigue. The heart flutters weren't bothersome. At around July 2nd/4 weeks post second vaccine, I got intense stabbing pains in my chest area. So bad that if I didn't currently have bad health insurance, I would have gone to emergency room. I had the stabs of pain the next evening too. Fatigue worsened since those initial stabbing pains and has not been my usual normal since. Messaged doctor. He said he had a couple other patients wtih same issue and theirs went away. Heart has felt heavy since. It did seem to get better for about a week and then came raring back and had more stabbing pain episodes for a few days. ONe of which was when i was just simply taking my dog on a walk (not laying down which usually provokes it) It is worst when I am laying on my left side or laying back. Sleep was miserable for a week as I had to prop myself up on three pillows to even get remotely comfortable. I haven't been able to do anything that seem to get my heartrate over 100. I notice the extra heaviness in chest hurts when I go on a lenthier walk. During all of this I had several times where I typically would have gone directly to Emergency Room. I didn't go because of my bad health insurance currently from losing my job in last year. So please don't lower the severity of it because I didn't go to the emergency room. I have chronic condition, but my heart has never been effected/never had heart issues.

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.

tiredness; soreness; nausea; Extremely painful, sharp pain in center/right side of chest; Extremely painful, sharp pain in center/right side of chest and upper back (between shoulder blades).; 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 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 10:00 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, left kidney and appendix removed in 1982 due to cancer. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and cetirizine hydrochloride (ZYRTEC) from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 08Mar2021 at 12:00 (at the age of 40-year-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 4 weeks prior to the vaccine. On 02Apr2021, the patient experienced extremely painful, sharp pain in center/right side of chest and upper back (between shoulder blades) that came and went in waves for about three hours, 14-17 hours after the vaccine. On 02Apr2021 at 17:45, the patient also experienced more normal reaction of tiredness, soreness and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events extremely painful, sharp pain in center/right side of chest and upper back (between shoulder blades) was resolved on 02Apr2021 while that of the events tiredness, soreness and nausea were resolving at the time of the report. No follow-up attempts are needed. No further information is expected.

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.

2-3 days after 1st dose given on 5/22/21: heart palpitations and chest pain/pressure 12 hours after 2nd dose given on 6/12/21: numbness/cooling feeling in lower extremities (lower legs/feet), hot/tingly hands, feet/toes, weakness and muscle stiffness in both legs, hot/cool feeling in upper legs, continued heart palpitations and chest pressure

I have a weird tightening on the right side of my face. My right eye lid is droopy all the time and the right corner of my lip always pulls up, its kind of the opposite of bells palsy and the mornings are much more prominent. I have had occasional chest pain and R arm tingling when this first started. My vision is fine but my eye is very irritated and watery.

102 fever (1-2 days), purple nails (1day), freezing feeling (3 days), chills (3days), heart palpitations (3 days), aches (3 days), skin soreness (3 days), fatigue (1week).

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.

2 min after getting the vaccine I started to feel dizzy, my heart rate was high, nausea , vomiting and my throat felt hot /cold.... it was something that I never experienced before.

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.

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.

Daily bloody noses; 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: EW0171) via an unspecified route of administration in the arm left on 21Apr2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). 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 22Apr2021 the patient experienced daily bloody noses. The clinical outcome of the event daily bloody noses was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.

Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five days post COVID Pfizer vaccine. Symptoms strikes at random times. No prior health issues.

Heart palpitations and tachycardia. BPM 102. Lasted for at least 30 minutes. Drank 8 ounces of water, practiced deep breathing and went back to bed lying on left side. Eventually was able to fall asleep so unsure of total duration.

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

On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.

20 Minuets after injection hot air, red , moved across face, neck. 1 hour after injection. high BP chest heavy face and nose itchy @ 3:15 pm Benadryl 25 mg IM + difficulty swallowing.

15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid. Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.

Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.

tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.

NauseaVomiting,HYPERtension & HYPERglycemia Narrative: Employee received vaccine. Seven minutes later, she began experiencing nausea and vomiting. She vomited, and a STAT team was called and we transported her to ER for evaluation. In ER, she had BP of 157/106, and blood glucose of 288. Other vitals were O2 saturation of 100%. She is diabetic and states her fingerstick glucose right before lunch at 12N was 120. After about 30 minutes observation in ER she was released, nausea subsided and she did not require antiemetic medication.

Patient received COVID-19 vaccine. After receiving vaccine patient c/o nausea and feeling "something in throat". Vital signs obtained at 1853 175/96, HR 68, temp 98.3 and o2 sat 99%. Repeat VS at 1903 167/103, HR 78, O2 sat 100%. Having pulse ox desaturations while speaking. Patient transported to ED in stable condition. Patient monitored in ED with resolution of symptoms and was discharged.

Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), via an unspecified route of administration on 23Dec2020 07:00 at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient previously took oxycontin and experienced allergies. Concomitant medications included women multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced random heart palpitations, tachycardia, mild chest tightness and occasional fatigue five days after receiving the vaccine on 28Dec2020 12:00. No known underlying health issues before the vaccine. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events resulted in Emergency room/department or urgent care.

Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and BP elevated. She was given water and juice. Provider walked in and spoke with her regarding an adrenaline release causing some of her symptoms. Over the 5 minutes, patient became less shaky, BP and HR dropping. She stated she felt much better. She discharged with instructions to follow up with her PCP if needed. Provider felt she could discharge home. Several days later, patient reported continued "woozy" feeling, chills, and elevated HR. She was seen in the ED at that time, with no remarkable findings.

About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling like ? under anesthesia since then.

Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.

chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.

2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.

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.

Recipient came in c/o feeling "flushed". Denies asthma, allergies. lightheadedness. Color pink, no hives ,uticaria, SOB. @0916 VS=88-116/60-22 lungs ausc. clear. @ 0920 stated she felt increase in HR. HR = 102 RR=24 116/70 . HR 104. No c/o nausea. color continues to remain pink, lungs clear. continued observation. at 0940 HR decreased to 71, which she states is normal for her. RR-16 115/80. States she feels "better". Given instructions to call 9-1-1 if s/s of anaphylaxis or if symptoms return to notify PCP.

Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.

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

Palpitations Narrative: Employee received vaccine at 8am on 12-29. 45 minutes later experienced flushed feeling, heart palpitations, chest pain. See in urgent care at work, EKG showed ectopy. She was sent to the nearby emergency room, where she was monitored and given iv fluids, oxygen, and tylenol. She is feeling better today one day later, and will have follow-up with cardiology. Vaccine administration may have set off underlying predisposition for PVC's, ectopy. Was aware of PVC's previously but well-controlled on diltiazem. Has now been switched to metoprolol.

I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.

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.

Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain

CHEST TIGHTNESS SWIMMING FEELING IN HEAD PT W/ HX OF ASTHMA Narrative: VS TAKEN 144/107 1515; 147/91 HR 69 1325 140/89 75 100% RA RETURNED TO BASELINE AT 1325

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.

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.

Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.

Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm

Patient reported to observation area for monitoring post-Injection.   No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.   She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.   Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives. Oral: no tongue or lip swelling   Patient placed in supine position on stretcher, received water hard candy.   Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.   After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.

Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .

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.

The vaccination was given at 1802. At approximately 1804 the patient stated she did not feel quite right and something may be wrong. She stated she was feeling all warm. She was complaining of mild heat or burning traveling from the vaccination arm, across her chest to the other arm and down her torso. Did not complain of any breathing difficulties or other symptoms. Her heart rate and respirations were normal. Upper extremities were examined for redness or hives - none found. The heat flash lasted about 2 minutes then she stated she felt normal. She was observed for another 20 minutes. She was examined again before leaving and no signs or symptoms were noted at that time. She felt normal before leaving the clinic.

Numbness in the site of the injection which is the left side, my arm, only on the left side; Bloody nose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 04Jan2021 on the left arm at a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. On an unspecified date, the patient had numbness at the site of the injection which was the left side (arm), and only on the left side; and had bloody nose. The patient had received treatment for the reported adverse event. The outcome of the events, 'numbness at the site of the injection' and 'bloody nose', was unknown.

Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.

Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.

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.

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.

10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.

within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.

Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensation that her heart was racing . Slightly elevated BP returned to baseline by 1436.

I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.

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.

Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.

Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.

Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)

I started developing walloping palpitations around 3 hours after vaccine was given. They have continued now for 18 hours post vaccination and I have never had these before in my life. I have numerous per hour but can be symptom free from time to time. No significant cardiac history before.

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

Immediately experienced racing heart and severe dry mouth. My KARDIA 6-lead EKG stated "Possible AFib" and heart rate was 145-155. Blood pressure became elevated much higher than baseline (Normal is 90/60). Paramedics came to evaluate and performed numerous 12-lead EKG's and noted multiple Premature Ventricular Contractions and transported me to the hospital where I was observed and consulted on from ED Physician. Later was evaluated by electrophysiology cardiologist with echocardiogram and EKG. Multiple physicians have advised not to get second vaccine.

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.

Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tightness in chest. 25 mg benadryl given with a little improvement. Symptoms return and worsen- 25 mg benadryl given and rapid response called. Taken to ED and admitted. Given 125 mg of solu-medrol IV and albuterol inhaler. Symptoms eased and discharged to go home. 01-15-2021- 4:30am woke with burning in throat mild difficulty swallowing. Took 50 mg benadryl and inhaler. Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage. Continued clearing of throat. Took 25 mg of benadryl and inhaler.

AM after vaccine patient reported achiness, chills and palpitations starting 3-4 hours after vaccine injection

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

10 minutes after vaccine administered was lightheaded, heart rate increased. This lasted no more than 2 minutes and resolved on its own with no further recurrence. A few hours later developed rash to upper body (chest & back areas). Treated rash with antihistamines (Benadryl, Pepcid), Zyrtec. Rash resolved after 7 days, then flared after allergy medications stopped. Rash completely resolved at 16 days post vaccine.

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.

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).

5 min after dose admin c/o of cheeks feeling funny, L eye puffy. HR 138, BP 140/80, pulse ox 98%. A/o & talking w/friend. Over the course of 30 min cheeks feeling improved but felt that cheeks remained a bit numb. L eye puffiness gone. Left amb after 45 min HR 96, BP 112/70, pulse ox 99%.

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.

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.

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.

Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the side effects.

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 got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.

states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the vaccine clinic, and then escorted to the ED -states the ED observed until sx dec - was told she had a catacholemine response, states is feeling fatigued

itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.

Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out

Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.

For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.

About one hour post injections I started developing chest pain and pressure. It worsened throughout the day and because I was worried about a cardiac event, I went to the emergency room.

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.

body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm

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.

My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.

Starting from 12 hours after receiving the second dose of Covid vaccine, I?m experiencing palpitations, fatigue, muscle pain and dizziness. I took Tylenol and felt better

I had one episode of syncope in the morning on 1/22/2021 after waking up in the morning, two days after the 2nd shot but within 48 hrs. Other than that, I just had a moderate left arm pain (starting on 1/21/2021). Also generalized low energy level (starting on 1/21/2021) and very mild muscle soreness especially with both legs (starting on 1/22/2021) .

seeing gray spots room started spinning felt nauseous collapsed on the table; loss of vision; loss of hearing; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; seeing gray spots room started spinning felt nauseous collapsed on the table; loss of the onion ability to stand up or walk; loss of the onion ability to stand up or walk; This is a spontaneous report from a contactable other health professional (patient), a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm on 14Jan2021 08:30 AM at single dose for covid-19 immunization in a public health facility. Medical history was none. Allergies to medications, food, or other products was No. Patient was not pregnant at the time of vaccination. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient received within 2 weeks of vaccination included amphetamine salts 15 mg. Patient woke up in the middle of the night got out of bed walk down a set of stairs started seeing gray spots room started spinning felt nauseous collapsed on the table. Had to call her husband to carry her back up the stairs. she had loss of vision loss of hearing and the onion ability to stand up or walk. He laid her back in bed to pick up his phone and call emergency services within five minutes everything had gone back to normal. adverse event start date was 15Jan2021 03:00 AM. the adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The final outcome of the events was unknown (if patient recovered: Unknown). It was reported as non-serious. Seriousness criteria Results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all no.; 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.

weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.

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

All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.

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

40 min after vaccine, noticed that her throat red, hives, flushed, elevated heart rate to 120s-130s. Took Tylenol and Benadryl which improved. Mild lip tingling. Symptoms now resolved. She believes the heart rate was due to "anxiety" After the first dose, only felt flushed.

rapid heart rate and racing thoughts; rapid heart rate and racing thoughts; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Lot number: EL3246), via an unspecified route of administration on 14Jan2021 08:00 at single dose in the left arm for COVID-19 immunization. Medical history included peptic ulcers and acid reflux. Concomitant medication included sucralfate (CARAFATE) and esomeprazole sodium (NEXIUM). On 14Jan2021 09:00, the patient experienced rapid heart rate and racing thoughts. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of rapid heart rate and racing thoughts includes Benadryl. The outcome of the events was unknown.

This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.

1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states she is hypertensive with a normal BP of 130/80's , Juice and cookies given with additional observation time. 1000: BP 120/62 with patient still c/o dizziness, will continue to monitor. 1015: BP 130/82, patient states dizziness has improved slightly and that she has a ride and not driving, nurse encouraged patient to go to the nearest ER if symptoms persist. RN 1/28/2021 01:58:49 PM > contacted patient to f/u, message left

Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased

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

red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.

Patient had a covid vaccine at 9:25am. Please note the patient has no history of anaphylaxis, panic attacks, or heart issues. She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am. Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.

1/25 @ 3:30 Laid down and had a sudden racing heart rate. Maxed in the 150s, staying around 135 for a prolonged period of time. No activity during this time. Lasted 40-45 minutes. Not sure if related to vaccine, but no other changes in routine/diet/medications.

Woke up 7:15 am with Headache, chills, fever of101.4, body aches, joint pains, fatigue and on/off chest pain. Body aches and fever/chills resolved by 1pm and chest pains/joint pains and fatigue and on/off chest pains continued longer Treatment bed rest/Ibuprofen 600 mg x 2 doses

Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.

I felt like I was about to pass out within 10 minutes. I stood up and continued to feel like I was about to pass out. I felt more comfortable staying at work where I could get immediate help. I had an extreme case of brain fog. That lasted about 3 hours. I started to have the feeling that you get when your limb is asleep. On day 4, I started to exhibit the symptoms again. I felt like I do when I have thyroid issues, so I went to see my endocrinologist, but he didn't do anything. I did have labs done. I started having blood pressure increases as well. I haven't been able to work out like usual since the vaccine and my sleep has been very poor. I wake up in the middle of the night and am unable to go back to sleep. I am now on heart medication, which is what I was taking previously for thyroid flare ups. I go back to see my endocrinologist in March.

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.

Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, headache, tremors in neck overall difficulty with balance. Have had similar symptoms with antibiotic use.

Headaches; Rigors; Extreme fatigue; left arm pain radiating up to neck and skull; left arm pain radiating up to neck and skull; chest and back pain /stabbing pain in my left chest; chest and back pain; Nausea; heart palpitations; feeling of impending doom; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Jan2021 07:30 (at the age of 41-years) to as a single dose for Covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included that the patient received the first dose of BNT162B2 on 28Dec2020 at 07:15 (at the age of 41-years) in the left arm for Covid-19 immunization. There were no concomitant medications. On 18Jan2021 22:30, 15 hours after second injection the patient experienced symptoms which would best be described as a cardiac event. The patient elaborated that she woke from sleep with left arm pain radiating up to neck and skull, chest and back pain, nausea and stabbing pain in my left chest. This was associated with heart palpitations and a feeling of impending doom. The episode lasted 15 minutes and happened 4 times throughout the night. On 19Jan2021 at 07:30, 24 hours after injections the patient experienced headaches and rigors began with extreme fatigue. Unable to function type of fatigue. Fatigue persisted for 48 hours post injection. The patient was now 72 hours post injection and continued with headache and nausea. The patient did not receive any treatment for the events. The patient had not been tested post vaccination. The clinical outcome of event extreme fatigue, chest and back pain, heart palpitations feeling of impending doom, left arm pain radiating up to neck and skull and rigors was recovering. The outcome of events headaches and nausea was not recovered. No follow-up attempts are possible; information about lot number cannot be obtained.

Patient reported to the ED about an hour after receiving the first dose of COVID-19 vaccine (Pfizer brand). She complained of left sided facial numbness with no facial droop or slurred speech present at the time. Her vitals were taken, she was monitored and seen by a PA. She was given an education handout on allergic reactions to medications and scheduled to follow up with her primary care physician regarding her elevated blood pressure (182/100). Patient did not report prior history of hypertension. She was discharged and able to ambulate our of the ED and drive home. Coure of care approximately 1 hour.

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.

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

Heaviness in chest; Racing heartbeat; Fatigue; This is a spontaneous report from a contactable other hcp (patient). The 41-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Jan2021 10:15 in Left arm at single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks, no other medications in two weeks, increased protein. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The patient's concomitant medications were not reported. The patient experienced Heaviness in chest, racing heartbeat, fatigue on 22Jan2021. No treatment received. The outcome of the events was not recovered. No follow-up attempts are possible, information on batch number cannot be obtained.

Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 20Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home/Senior Living Facility. Patient age at vaccination was 41 Years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia, Hashimoto's Thyroditis, allergy to Penicillin. Concomitant medications included ibuprofen (IBUPROF), loratadine (CLARITIN), sambucus nigra extract (SAMBUCOL), fluticasone propionate (FLONASE), and multivitamin. On 21Jan2021 the patient experienced fatigue, dizziness, weakness, increased heart rate, all reported as non serious. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.

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.

Fainted; blacked out; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular on 27Jan2021 10:15 at a single dose on right arm for COVID-19 immunization. Medical history included low iron. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included ferrous sulfate, vitamin c [ascorbic acid] (VITAMIN C), chondroitin sulfate, glucosamine sulfate (GLUCOSAMINE CHONDROITIN SULFATE). The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (brand: Pfizer, lot number: EK9231, administration time: 04:30 PM, route: intramuscular, vaccine location: right arm, dose number: 1). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 23:45, the patient fainted and blacked out. No treatment was given for the adverse events. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visits. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient was recovering from the events.; Sender's Comments: Based on the compatible time association, the events fainted and blacked out are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pt received vaccine at 3:14pm. She started having a reaction at 3:27pm and flagged the nurse down. She stated she was having a tachy cardia episode and hot flashes. We gave her some water and she took off her beanie and the provider on site was asked to come over. Provider came in and started asked her reaction question. Pt denied any itching, SOB, chest pain/tightness and throat swelling/closing. Pt did indicate her heart rate jumped on her fit bit, doctor asked for a set of vitals 180/100, 130 pulse and 97%. At this point we took patient back into exam room. The patient was given Epi and Benadryl 3:34p 911 called Vitals checked: 3:37 168/88, 132, 98% Pt was monitored until ambulance showed up. Pt was transferred to MCR

1/29 headache 1/30 headache body aches fatigue 1/31 headache body aches fatigue and low grade fever 2/1 10 am chest pain heart palpitations headache and fatigue continued as well so I went to ER for cardiac work up all negative 2/2-2/5 symptoms the same with new onset of back pain...went to cardiologist he felt heart is fine but ordered echo and stress test for today 2/12 my symptoms improved not resolved since taking flexeril on 2/8. Today I still have the same headache chest pain back pain and palpitations. All of my tests have been normal so far this must be vaccine related and I?d like to speak with someone regarding this matter.

7 minutes after vaccine, I felt my heart pounding heavily and checked my iwatch. It indicated that my Heart rate went from 88 to 141 in the past 5 minutes while sitting. I then felt flushing throughout my body. I had the sensation of tingling on my face and lips and told the present employees that I felt weird. They retrieved the doc, who then took my pulse ox - registered at 96/97. Then they took my blood pressure and it was 180/100 (I typically have low blood pressure 98/60). I started to feel disequalibrium and nauseous and the doc to be back to a room. She administered a dose of IM EPI and IM benedryl and called EMS. My symptoms persisted and the doc told the EMS workers I had urticaria on my face during her case presentation. I was transported to the ED, where I was monitored. My symtoms had reduced following epi and benedryl but returned when I was in the ED. The doctor administered pepcid and solu-medrol and zofran. They also conducted and EKG- reportedly normal. These medications helped control my symptoms and my BP had returned to normal (120/70) following meds. discharged on a tapering dose of steriod and zofran prn.

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.

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.

Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.

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.

Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red. Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins. Diagnosis was idiopathic subclavian deep vein thrombosis (DVT). Started on enoxaparin and warfarin on Feb 15th. Referred to hematology and coumadin clinic to monitor INR.

extreme muscle pain for 24 hrs . started immediately as minimal and increase to extreme within 3 hrs. face felt numb for about 20 minutes after receiving shot that lasted 15-20minutes. there was a tingling sensation present during the numbness in the center of my forehead. possibly related: experienced light nosebleed day after shot. three days after shot experienced a heavy nosebleed with very large clotting.

deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours

Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.

Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.

Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, body aches, chills, and headache. I woke the following day with severe fatigue, headache and tachycardia. Five days out I had muscle twitching and lymphadenopathy. I had tachycardia with heart rate in 120-130s at rest and higher with exertion. I had sustained tachycardia for a solid two days and then intermittently for five days.

12 hours post dose 2 covid vaccine, patient had high heart rate to 160 and temp of 101 and diaphoresis

patient that fainted today. She reported on her screening questionnaire of passing out after receiving a injection. She was placed for 30 minute observation. The patient fainted several minutes after being seated. It was observed that she fell over from the chair and hit her head. Patient denied any symptoms other than her right toe being sore.. A + O x 4 medically stable. VS stable. EMS was dispatched due to patient hitting her head and c/o feeling dizzy still...however, patient declined services. She was with her husband and he agreed to drive her home.

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.

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.

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.

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.

Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.

sudden onset of rapid heart beat lasting up to 10 mins at a time with HR as high as 110 when laying/resting. Over the course of the last 5 weeks it has lessened in severity

After receiving the vaccine, patient experienced nausea with an episode of syncope. SBP 60 mmHg prior to syncope. Patient was given epinephrine 0.3 mg IM x1 dose. Patient was difficult to arouse and a second epinephrine 0.3 mg IM was administered! EMS was called on seen and patient was taken to the ER where patient received fluids and zofran and was discharged. Husband confirmed the patient has phobia for shot/needles.

About an hour after the Covid vaccine was given I experienced heart racing very rapidly, wave of nausea, feeling faint, knot in throat, this last about 5-10 minutes then passed, had knot in throat x 2 days.

Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.

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.

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

Racing heart Numbness and tingling from mouth to toes Weak Dizzy/lightheaded Foggy Happened about 8 times over 3 days

Racing heart, heat inside my body from my shoulders through my arms and my stomach. Last maybe a minute. I didn't tell the pharmacist.;/ it went away but my mom.daodni should report it

Other than the normal symptoms of chills, body aches, feeling run down....the day after I had the second dose, I experienced a fainting episode and collapsed on the floor.

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

Thursday evening I developed a burning sensation in the middle of my sternum/behind my sternum. It was localized and did not radiate. It was not made worse by standing, sitting, laying, moving, eating, drinking. I was not short of breathe nor did breathing hurt. The pain was mild - a 2 to maybe a 3. Enough to know it was there but it did not limit me in any way. It has continued through the present. Saturday (3-13-2021) I started to notice a very rapid heart rate, from just walking across my house. I went down the basement stairs and walked up and I felt my heart was racing and pounding (this is something I do multiple times a day with ease). I have an oxometer and my heart was very high. I tried resting (by sitting) and my heart rate didn?t drop below the high 80s. I walked through a room and up a flight of stairs and down (in my home) and my heart rate peaked at 154 (wearing oxometer). My BP was also high for me 148/94. I called my primary care physicians office, spoke with a nurse that recommended I go to the emergency room. Tests were normal and I was released. The burning sensation remains. Since returning home heart rate gets high very easily and I can feel it pounding when I walk, though fortunately it hasn?t gone over the mid 130s. My blood pressure when checked at home was still high for me but quite a bit lower than when I first checked it at home. To be honest, I?m far from a pro at taking my BP so I?m not sure of the accuracy of either measurement.

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 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.

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.

I got my vaccination at 4pm, waited the 15 minutes at the united center waiting area and felt fine. I went home to pickup my daughter and at 6pm was back on the road driving and started to feel tired. I stopped at the light at foster and had just called my parents to tell them i had gotten the shot. I mentioned I was starting to feel tired and as I said it started to feel more tired. My mom responded maybe you should pull over and that was the last thing i remember as I fainted/blacked out immediately after. When I awoke my daughter (in the back seat along with my dog) explained that I had accelerated and hit the back of another car and then drove around that car, ending with both cars facing the direction of travel with my car in front of the car i had rear-ended. I was completely disoriented and had not recollection of hitting the gas or break much less driving. I was told two times that the driver in the other car was fine and was told when asked a third time that he did have some pain possibly and went in the ambulance to get checked out. I felt disoriented and jittery last night, took 2 Tylenol before bed and have felt fine today beyond feeling confused and horrible about what happen. My husband picked me up form the site and took me to my parents a few blocks north of the accident.

- ten minutes after shot my top front teeth felt numb and I started to feel waves of hyper-awareness and disequilibrium that were accompanied with mild nausea. The numbness in teeth went away after approximately 5 min. The waves of disequilibrium continued for 24hrs, and now feel more like a pressure headache. During these ?waves? I also had increased heart rate. - an hour after the shot, my left arm felt numb down to the fingers. Then the right arm and upper back. This subsided after an hour.

sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

3/20/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate, reported feeling flush, and was visibly shaking. Assessment : Time of assessment- 1845. Alert and oriented. Actions taken: Vitals sign taken at 1845 BP 139/84, P 74, T-98.2,R 16, O2- `100%, JUICE OFFERED AND ACCEPTED, RECHECK AT 1858, BP-156/75, P-116, DRINKING JUICE, AT 1918 BP- 131/82, P- 105, VS AT 1933 BP-113/59, P- 98, AT 1951- BP- 114/80, P-95, PATIENT FEELING BETTER AND LEFT WITH FAMILY. Medications administered: No medication administered. Disposition: PATIENT GIVEN INFORMATION OF ALLERGIC REACTION, AND ADVISED TO FOLLOW UP WITH PCP. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/19/2021 6:36 PM 0.3 mL 12/11/2020 Intramuscular

Petechiae (red dots that didn't blanche) all over arms, legs, chest. Racing heart rate, flush face, red eyes, red web like moving up and down the arms and legs, injection site rash.

Diarrhea, racing heartbeat, heart palpitations, headache, nausea all started at 1.5 hours post injection.

Pt received first dose of the Pfizer covid19 vaccine at 1014. Immediately after pt stated feeling anxious, dizzy and like her heart was pounding. Pt was monitored, provided water and was released at 1140 after symptoms went away.

Within a couple minutes of receiving shot, felt pain at injection site that traveled up arm into neck. Heart rate went up to 122bpm. Left side of face felt puffy and numb. Left side of mouth and tongue were tingling. Reported this to vaccine giver, he had me wait about half an hour before suggesting Benadryl. Half an hour after 25mg Benadryl, symptoms were almost completely resolved. The next day (3/14) I felt tired. The day after (3/15) I felt hot and my skin was flushed. I was not running a fever. I generally felt unwell that day. I felt better by the time I woke up on 3/16. I also had a bad/metallic taste in my mouth through 3/21, which has resolved. My nurse practitioner suggested that I take Benadryl before I receive my second vaccine dose on 4/3/21.

About 2 hours after receiving the vaccine, I started to have kinda like tunnel vision, my ears felt cloggd. Tachycardia, palpitations, nausea/vomitting, extreme Fatigue, weakness, headache, dizziness, and loss of memory. I had this type of episode 2-3 times over 5 days, lasting about 20-30 minutes, last one being at work, all of a sudden, same type of episode. Went to ER after Coworkers stated I was " in coherent " or in and out, my BP upon arrival to er was in the 160's/90's. They ran multiple lab tests, CT head, CXR and ECG. By the time I was dicharged my BP was normal I believe it was 116/81. Some side effects like nausea lasted a week, I was given an antinuasea prescription

Developed ITP (Idiopathic Thrombocytopenia Pura); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date not reported), via an unspecified route of administration on an unspecified date (at age of 41 years old, no pregnant) at a single dose for COVID-19 immunization. The patient medical history was not reported. There was no COVID prior vaccination and no COVID tested post vaccination. The patient's concomitant medications were not reported. The patient developed ITP (Idiopathic Thrombocytopenia Pura) on 23Feb2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment received dexamethasone. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Tachycardia Patient states that she felt like her heart was racing s/p the vaccine administration. Patient is alert, oriented x3, NAD. Vitals: 136/85, HR 97, oxygen sat 97%. Lungs clear, Heart RRR. Blood glucose 140.

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.

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.

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.

Vaccine administered 3:10pm, reaction started within 5 minutes. Felt lightheaded and experienced hypertension (209/152), came down to 201/140, and again to 165/100. A pillow was placed under her and her legs/feet were elevated. While in our care, patient was provided and consumed 5 bottles of water and 2 packs of peanut butter crackers (pt is prediabetic and only thing she had consumed all day was a double espresso). She complained of oscillating between hot and cold... when she was cold she was provided a blanket. Patient refused our offer to call EMS. Patient consented to us reaching out to her physician, but they did not answer and patient refused our offer to leave a voicemail for her doctor. Patient left area and went to restroom to evacuate bowels and reported she felt significantly better. Patient stated she did not have a BP cuff at home and was provided both a BP cuff and acetaminophen and was advised to check her BP in a couple of hours. She walked out on her own and was advised to contact her doctor and that we would call her later that evening. When contacted that evening, she reported she was doing well.

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

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.

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.

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.

Swollen, painful right neck lymph node 8 hours after injection. Heart palpitations/arrhythmia 3 days after injection. Ongoing as of 3/26/221

Heart beats really rapidly for about a minute a couple times a day. Also, feel small heart palpitations that I've never experienced throughout the day.

Patient c/o nausea, light headed and dizzy, chest tightness, pain and pressure about 20 min following injection. No rash or shorness of breath. NO swelling or redness to injection site. Transported patient to hospital in wheelchair for evaluation.

Patient reports she developed fever and chills overnight Friday into Saturday after 2nd dose of Covid vaccine on Friday. On Saturday morning states she became dizzy and fell in her bathroom against the tub, reports she thinks she lost consciousness, as she woke on the bathroom floor to her husband yelling her name. Denies that she was seen in the ER for the fall and loss of consciousness, states "I had a fever and did not feel like going anywhere". States she has no idea how long she may have been out.

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

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

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.

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.

My skin has been itchy in various places since the first dose. My stomachs (upper and lower), My chest especially in-between my boobs and under them and my chest has broken out into red bumps when I itch it. I have a sensation of lactation in my breath even though I haven't been pregnant since 2017. My breaststroke feel cystic and swollen but my period isn't due. Lots of extra sensation in my chest. I feel more irritable. The itching has been every since my first Pfizer shot. I am sweating abnormally in my chest area. Daily. Since first dose. Arm had more tenderness with the first dose than the second.

Body aches and ringing in my ears started about 5 hours after the shot. I went to bed at 10pm thinking I was feeling ?fine?. I woke up at 1am, covered in sweat, nauseous and the room was spinning. I stood up because I thought I was going to throw up and lost consciousness. After a few minutes my husband called 911 because I was non responsive and vomiting. I gained consciousness as the paramedics were arriving, but had slurred speech and couldn?t see clearly. As they took me to the hospital I was awake and speaking but extremely weak. They did an ecg. At the hospital they did a blood test and ecg. They gave me an IV of fluids which helped. They had a hard time getting my blood pressure for the first few minutes, trying multiple cuffs. Ultimately, they said the echo looked ok, so they discharged me since I was no longer having an emergency episode and advised that I follow up with my primary and cardiologist

started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after; fainted/blacked out right after; she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 41-year-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Mar2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization . There were no patient's medical history and concomitant medications. The patient waited the 15 minutes at the site and felt fine. She got on the road at 6pm and started feeling tired. She was on the phone with her parents and mentioned she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after. When she woke up, she was still behind the wheel the drivers steering wheel airbag and airbag at her legs had deployed. She has no memory of what happened but her daughter (age 9) was in the back seat of the car with the dog. The patient's daughter said that she accelerated into the intersection passed through ("I blacked out as the light was changing to green") she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended. The driver in the other car was taken in an ambulance with she believes the other driver had some discomfort in the neck/back but she was not 100% sure. It was reported that the outcome of events was recovering. It was unknown if the patient receive treatment for the events. The events were considered as serious due to hospitalization. Information on the lot/batch number has been requested.

Heart racing and pounding 30 minutes after injection. Intermittent heart pain, heart pressure, left arm pain, palpitations, heart fluttering continuing for 10+ days following vaccination. EKG revealed short PR interval of 110.

12 minutes after getting the shot my heart started to tighten, I got a burning sensation down my shoulders, chest, neck and head. I felt like I was on fire. It went away and then came back. Went away and came back. I got light headed and passed out. I work up throwing up. I was taken to the ER. I was told I had a reaction to the vaccine. I?m still having symptoms and have a burning sensation off an on.

1 day after the vaccine, I noticed itching around my wrists, under my breasts, back, back of my neck, in between my legs, and back of my legs. It went away a night, but came back the next day. The itching eventually turned to hives. I've had hives before but not like this. Also I noticed on Day 2 that my chest felt really heavy and felt like severe heartburn, I took Tums, and that went away, so unsure if that'st related. The itching and hives went on until Day 4 after the vaccine, then I took an OTC Zyrtec Day 4, and Day 5 they went away completely. Now I'm on Day 8 and I noticed itching on my hair/head, neck, and wrists. I took another Zyrtec Day 8, today, and they haven't returned.

45 minutes after injection of Pfizer (dose 1) patient felt dizzy. Was brought back to nurse that administered vaccine. Red splotchy chest, red ears, still dizzy and nauseous. Was admitted to ER where patient had 200/120BP and 140 pulse. Patient diagnosed with anaphylactic response to covid19 vaccine.. Epinephrine administered. Pepsid AC, Prednisone, and IV fluids. Vitals normalized and patient discharted ~2 hours later and prescribed pepsid, prednisone, and anti-nausea medication.

Racing heart (160 BPM), sores in mouth, confusion, high fever (104F +), vomiting, and most concerning: I couldn't not figure out how to use my hands. I could move them, but not where I wanted to. For example, I couldn't 'find' my face or get my right hand to make contact with my left hand.

Vaccine was administered in drive thru. I pulled out after and into one of the waiting spots. About 10 minutes after I was suddenly drenched in sweat and started to see black. My left side of body started to feel a burning sensation. I had been told to honk and put on flashers if anything went wrong. I did and waited more than 30 minutes. No one ever came to check me. After about 10 more minutes I started to feel better but was still pale and my face looked slightly puffy. I never saw anyone so I eventually drove home, drank a ton of water, ate some saltines and then slept a little. Had chills off and on that day and remained tired the next day. Felt fine by day 3

Pt had syncopal episode and seizure following first dose of covid vaccine, resulting in calling 911, transferred to the ED

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

Chest tightness, dizziness, hives/itching entire body. Chest tightness ended about 12 hours later. Dizziness and hives/itching still persistent after 24 hours

Fatigue, migraine got worse, dizziness, irritability, lightheaded, blood pressure and heart rate went up

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

Rash on arm (opposite arm of injection) 30 mins after shot that spread to 80% of my body over the next 30 mins or so. Dizziness, headache, nasal congestion, rapid heartbeat. Next morning 10 big bruises all over my body like I had been battered. Rash covering the rest of my body except the skin on my face except for a sliver of rash infront of my ears. Low grade fever and just feeling very unwell.

Passed out 6 hours after shot, not normal(3rd shift worker), fever set in 10 hours after shot, headache set in 18 hours after shot, fever subsided 18 hours after shot, currently experiencing constant sweating(rarely sweat even in heat), woke up with two hives on left arm that have gone away since I noticed them itching, right arm soreness, actual pain in right armpit.

Early Menstrual Cycle with Heavy bleeding: Period started on the 20th of March, 10 days early. Bleeding was very heavy. Period lasted ten days as compared to the normal 5 days. Bleeding was heavy the first 3 days then reduced and then increased again on day 5 and seemed like it was two periods. Noticed spotting again on the 5th of April. Spotting continued until the 7th and extremly heavy bleeding started on the 8th of April. Other symptoms: Tiredness and paleness

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

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.

Pfizer-BioNTech COVID-19 Vaccine EUA first dose administered approximately 2:52pm. Reaction started approximately 2:57pm after seated in observation area; sense of feeling "not right" then heart started racing, chest felt tight, vision got strange and I couldn't really move. Once this episode passed I got up and told a volunteer I thought I was having a reaction. Moved to secondary observation area, hooked up to machine that tracked heart rate and blood pressure. Next episode occurred at approximately 3:10pm; heart rate shot up to 160 (unsure of BP), same feelings of immobility accompanied with urge to pee/poop. These episodes continued for 4-5 rounds until approximately 4pm and lasted multiple minutes each time.

Patient received her first dose of the Pfizer/BioNTech today at 0850. She reports intense dizziness and syncope soon after (5 minutes after) at the location where she received it. She was bought to the ER by EMS and received some continuous NS via IV by medics which she reports helped her feel normal again.

Severe chills, fever up to 102.5, headache, high resting heart rate of up to130 throughout duration of symptoms, nausea and vomiting

Patient came to Vaccine POD to receive first dose of Pfizer vaccine (LOT #ER8731, Expires 07/2021) on 4/10/2021. Patient has a medical history of hypertension and has allergies to ibuprofen and penicillin. Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1459 by RN. The patient was given an observation time of 30 minutes with RN, who was performing the EMT observer role on site. At 1530, the patient reported experiencing "tingling" in her lips and tongue. Lead RN was called to assist with the patient. The patient presented with redness localized on face. The patient was assisted to anti-gravity chair at 1531. At 1532, the patient's vitals were taken by RN: BP 160/90, HR 83 BPM, RR 21/min. RN administered 50mg/1mL Benadryl IM in the patient's right arm at 1537. The patient denied difficulty breathing. The patient's vitals were reassessed every 5 minutes for 30 minutes. The patient remained A&Ox4 throughout 30 minute observation period. The patient's vitals at 1538 were: BP 200/118, HR 88 BPM, RR 22/min. The patient states she forgot to take her blood pressure medication in the morning. She states her baseline blood pressure is around 160 systolic. At 1543, the patient's vitals were: BP 160/102, HR 90 BPM, RR 22/min. Visibly, the patient was less flushed. Patient was able to look at herself through her cell phone camera and pallor returned to normal limits, per patient. At 1548, the patient's vitals were: BP 155/108, HR 83 BPM, RR 20/min. At 1553, the patient's vitals were: BP 160/102, HR 79 BPM, RR 18/min. The patient states the tingling in her lips and tongue has resolved. The patient sat up with her feet dangling below her, her vitals were as follows: BP 167/110, HR 79 BPM, RR 17/min. The patient reported "feeling better" and requested to drive herself home. RN provided patient with education about side effects of Benadryl, including fatigue. Patient states she is unable to find a ride and must drive herself home. Patient states she is "feeling fine" and lives "3 minutes away". The patient was given education related to when to seek medical care, including shortness of breath, chest tightness, and sensation of throat tightness. The patient demonstrates understanding of teaching and states she will call her doctor if her symptoms worsen. The patient's gait was steady and patient denied any dizziness or lightheadedness. At 1601, the patient requested to drive herself home. She was escorted to her car by RN. Upon departure, patient was ambulatory, A&Ox4, with no reports of trouble breathing, dizziness, or lightheadedness. Patient drove herself home AMA at 1604.

pain and tenderness over the thyroid; left axillary adenopathy/lymphadenopathy; significant thyroiditis; neck pain; fatigue; palpitations; This is a spontaneous report from a contactable physician and a pharmacist. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular, administered in arm left on 10Jan2021 13:00 as a single dose (at the age of 41-years-old) for covid-19 immunization. The vaccine was administered at the hospital. The patient had no known allergies and no other medical history (reported as none). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), administered in arm left on 20Dec2020 1:00 PM (at the age of 41-years-old) for covid-19 immunization. On 14Jan2021, the patient developed left axillary adenopathy which then subsided and developed left cervical lymphadenopathy and significant thyroiditis. The patient also experienced neck pain, fatigue and palpitations on 14Jan2021. On 15Jan2021, she had severe pain and tenderness over the thyroid. The reported events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received prednisone, propranolol, Tylenol, antibiotics as treatment for the events. The patient underwent lab tests and procedures included SARS-CoV-2 test both via PCR and Nasal Swab: negative on Jan2021, 17Jan2021 and 24Jan2021. The outcome of lymphadenopathy, thyroiditis, pain and tenderness over the thyroid was recovering and unknown for the rest of the events.

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.

Following symptoms were experienced about 7 minutes aster receiving the vaccine: Feeling of warmth in abdomen followed by increased heart rate and palpitations. HR 148/min (normal resting heart rate 50-60/min). Blood measure 150/100 (baseline around 115/80). Also feeling of dry mouth. Observation prolonged - BP dropped to 130/90 after about 30 minutes, HR dropped to 80. Episdoes of increased HR kept re-occurring for about 2 hours after the shot. No respitatory distress or cutaneous symptoms. After about 90 minutes after the vaccine, feeling tingling in lips and scratchy throat. Administered Benadryl 25mg per mouth, lip tingling and scratchy throat resolved within 30 minutes thereafter. All of the above symptoms resolved about 4 hours after the vaccine, HR at 60. Following symptoms developed within 12 hours of the vaccine: Chills, fever (100F), myalgia, artralgia, fatigue, nausea. Treated with ibuprofen and acetaminophen, resolved about 48 hours after the vaccine. Note: No known history of Covid.

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.

Tightness in left side of chest, pain in left side of chest when breathing deeply, tiredness, headache

Patient was intially responsive.. After waiting approximately 5 minutes patient informed staff at pharmacy that she felt like she was going to have a seizure. Patient moved to floor from chair. Was conscious for about 5 more minutes. Lost consciousness during seizure (approximately 2-3 minutes). Emergency medical personnel was called at that time. Patient regained consciousness and went with EMS to hospital for further testing.

Delivered preterm infant (stillbirth) at 24 weeks on March 9, 2021. Infant had IUGR noted at 19 weeks. Placenta showed 2 blood clots restricting blood flow at delivery. Mother with no known clotting disorders. 2 prior healthy infants.

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

10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 mins after adminstration tongue, face and throat swelled up. Hand of injection arm went purple, cold and numb. Toes went purple and cold. Had to get taken in ambulance to er hospital due to blood pressure and lack of oxygen. When arrived at hospital broken out in hive,blood pressure went up to 175/104 and severe pain in kidneys, stomach, lower abdominal, legs, arms. Day 2 high blood pressure, fever, hives, stomach, kidney and lower abdominal pain. Painful to urinate and poop.

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.

20 min after receiving vaccine, paresthesia felt in left arm. Spread to left half of face and left leg 3 days later. Two weeks after that, paresthesia spread to whole body. 3 days post-vaccine, chest pain, abdominal pain, nausea, and weakness began. 9 days post vaccine, abdominal bleeding began. Chest pain resolved in 1 day. Abdominal bleeding resolved in 2 days. Nausea lasted two weeks. Weakness and paresthesia continue 3 weeks post vaccine.

Superficial blood clots in both upper legs; each leg had one in the front and one in the back. They were very painful and tender with bruising around the area. The clots could be seen and felt.

Patient received first dose of Pfizer vaccine and waited her required 15 min observation time. About 5 min after her injection she felt dizzy and lightheaded. RN assessed pt and gave her water, had her put her head back and legs up. After a few minutes she was feeling better until she started complaining of nausea and abdominal cramps. Her pulse was thready but pt was awake and alert, responding to questions. Patient elected to go to the ER via ambulance.

Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started with Severe pain felt like a charlie horse in my left calf and foot that would not go away for more than 24 hours. My Blood pressure spiked and i got a migraine from the pain , My left leg and food felt like stone.. The next day I called the nurse from my insurance company and she advised I go in to the hospital. Went to ER got a Ultrasound, blood tests and the ultrasound came back positive for a DVT clot. Treatment is Xarelto and follow up with my primary. Lab Results came back normal.

he evening of 3-4-21 when I got home from work, I ate dinner, then started shivering badly with temp of 100.5. The shivering quickly changed to more of a convulsing and temp got up to 104.7F. When I woke the next morning, temp was back down to 101-102F and most of shakes were subsiding. But I noticed that I had a deep, cutaneous pain reaction from head to toe when I awoke on 3-5-21. I could not brush my hair because my scalp was too tender. I couldn't let anything touch me and put pressure against any part of my body. Then at 3:30 that afternoon, I went to bathroom and had a bowel movement. It was so excruciating that I truly though my colon might have come partially out. I was in too much pain to flush, so I crawled across the house to my bed and laid on my side for an hour, crying. When I was finally able to go back to the bathroom to flush, I was expecting a large BM. It was not. It was about 2" x 1" and soft. There was no blood. It just felt like it tore me up. ****Then at 7:30 PM on 3-5-21 was when things got very serious. I was sitting down watching TV after a light meal. Suddenly, I started noticing discomfort deep in my upper back, between my shoulder blades. Within 5 minutes, it was at its worst....I was have rated it 11/10 pain. The pain was just very deep, behind the spine, about palm sized radius and unrelenting. My first thought was "maybe this is musculoskeletal since I've been in bed a lot because of the pain today." So I looked in my medicine cabinet for what I had and took 5 mg of Oxycodone and 10 mg of Cyclobenzaprine. An hour later, these meds hadn't touched it. I was beginning to really worry about an MI, or aortic dissection or pulmonary embolism (though I had no SOB). Lying flat on my back on a hard surface seemed to provide the only relief (though minimal relief, 9/10 pain). I called another provider who was on call and told her. She said that I could try taking 800 mg of Ibuprofen, but if I wasn't relieved in 1 hour, I needed to call 911 or have someone take me to the ER. I was asleep in an hour. I took it easy the next two days but started feeling back to normal during the days. I continued to sweat throughout the nights and skin pain continued so much that I had to cut some of my hair out. That following Tuesday, the deep upper back pain returned.

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.

symptoms of dizziness, slight "disorientation", shaky, nausea; notes very sensitive to meds. 1340 BP 158/100, pulse 99, p ox 99%. Able to drink water; no issues swallowing, able to breathe without issue. Still nausea, hot, shaky. Continued monitoring. Denies headache or vision changes. 1350 BP 136/100, pulse 99; complaints of heart racing, hot, comes and goes. No issues breathing. Wanting to go to bathroom; feels stable; accompanied by staff. 1400 BP 140/90, pulse 106. 1410 BP 138/90, pulse 95, p ox 99%. Feeling more herself; still some shakiness. Refused ED evaluation; feels comfortable going home. Brother accompanying; will drive.Aware if symptoms worsen/issues breathing, to seek medical attention; agreed.

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).

Patient reported headache, tingling in her hands and feet, chest pressure, and lightheadedness 25 minutes after receiving her first dose of the Pfizer vaccine. Blood pressure and pulse were was slightly elevated (140/90, 80), and patient was encouraged to lie down. Juice and a snack were provided, and 10 min later reported feeling better. Blood pressure had lowered as well (125/90). Allergy history includes seasonal allergies and Tylenol. No history of anaphylaxis.

About 15 mins after pt received her Vaccine she reported that she was feeling a tightness in her chest. Vitals were taken and they were BP 130/90 witch pt stated was high for her and spO2 was normal. She was evaluated for another 30 minutes. Pt stated that tightness was very minimal now and she wanted to leave. Her mother would be driving her. Pt advised to go immediately to the ED if her symptoms returned or became worse.

DIZZINESS AND LOW BLOOD PRESSURE. PARAMEDIC WAS CALLED AND THEY CHECKED VITALS AND SHE FELT BETTER AND WALKED BY HERSELF TO CAR AND LEFT. FOLLOW UP WAS DONE WITH PATIENT BY PHARMACIST AND PATIENT CONFIRMED SHE WAS FEELING OK.

At 1555, RRT was called on a 41 y/o F with c/o lightheadedness, dizziness, and ?feeling cold?. Vaccinated at 1543 on the R arm. She states that some of her symptoms she is experiencing may also be because she has a condition called Chiari malformation. She stated feeling hot and then feeling extremely cold is her baseline and feels dizziness with temperature changes. Head-to-toe assessment completed. Client was cool and clammy. Baseline skin color is pale. BP: 108/62, RR: 21, 0/0 pain. Hx of anemia, asthma, emphysema, and scoliosis. Allergies to NSAIDS, bee stings, PCN, and cipro. Took Megace in the AM. Client stated she wanted to lay down on the floor. Nurses laid a drape on the floor and nurses assisted client to lay on the floor. Client stated she felt better doing that. Throughout monitoring period, client?s condition improved. Client did not want ambulance assistance. At the end of monitoring period, client stated she felt better and opted to go home with her husband. Client left vaccination clinic @ 1620 in stable condition, ambulatory, accompanied by her husband. Husband drove client home.

presents with a potential reaction to the COVID19 vaccine. Patient-reported a small hive on her left hand scattered erythema on the upper chest. She had no airway symptoms and mild tachycardia. She was given oral Zyrtec and monitored closely. Patient with scant urticaria which resolved after oral Zyrtec and monitoring. Tachycardia resolved as well. The patient returned home at baseline.

My heart went into A-fib and was racing for almost a week. Beating really really hard. I was traveling at the time and didn't have my llo recorder remote available to track symptoms but the same day I returned home, my doctor called me to tell me my heart was in A-fib (03/17/2021).

About 5 minutes after Pfizer dose #2, patient complained of inability to move left UE, then had trouble responding to questions, follow commands, seemed almost aphasic. BP was high, up to 240/140, but HR, O2 sat were normal. After a few minutes, she was able to talk and move left UE, stated that everything had gone black or dark for a bit. She was monitored, sent via ambulance to ED.

I felt fine until I got up in the middle of the night to use the restroom. It was when I tried to get up from the toilet that I lost consciousness and fell forward. My husband discovered me laying there some time later. Before passing out I felt hot, and my ears were ringing.

Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given

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.

I woke up to a bit of a neck strain which I thought was from my computer use but the strain got progressively worse through the day to the point where my whole left shoulder, chest and neck were in severe pain. I could not move or lift my arm up in certain directions without severe pain and there was also severe muscle pain in my chest. It only got better by the following Monday/Tuesday. I could not do much around the house during this time period or physical exercise.

Evening vaccination was given she experienced chills, body aches, temp-102 and heart rate greater than 150 bpm. Symptoms pretty much resolved next day.

Approximately 10 minutes after immunization she began experiencing waves of light-headedness and a racing heart. No rash, no swelling, no wheezing, no difficulty breathing. She stated that her skin was feeling flushed, intermittently. Dr on site and evaluated her. Initial heart rate was 90/minute, cap refill <2 sec. No wheezing, no retractions. About 10 minutes later she experienced a second wave of light-headedness. Ambulance was called and about 5 minutes later she experienced an episode of vomiting. She was then transported to the local ER.

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.

Patient is a 41 yr/o female with a history of anxiety, hypothyroidism, and seasonal allergies, who presents to the emergency department for evaluation of chest pain. She states that she received her Covid vaccination (Pfizer) yesterday. Roughly 2 hours ago, she developed a tingling sensation along her left upper extremity. She soon then developed midsternal chest pain, that she described as a pressure sensation. Symptoms are improved with taking deep breaths. She then felt lightheaded. She ate a couple of lemon heads, and then her symptoms improved. She has a history of anxiety, and is not sure if her symptoms could be related. She had spoken with a friend on her way home from work, who encouraged her to come to the emergency department to be evaluated. She denies associate shortness of breath, nausea, vomiting, fever, chills, dizziness, back pain, or any other complaints at this time

- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS

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.

Patient presented for 2nd dose of Pfizer covid vaccine. While waiting after vaccination, patient felt unusual and walked to front counter for assistance. Patient then lost consciousness and fell backward onto the floor, hitting the back of her head. RN arrived to patient, who regained consciousness within ~15 seconds. Shortly after transferring patient to wheelchair patient lost consciousness a second time. Patient was transferred to clinic exam bed where she regained consciousness again within ~15 seconds. She was provided apple juice at this time and EMS was contacted. Vitals via automatic cuff measured with BP range: 100/65 to 120/76, HR 58-74, SpO2 98-100%. EMS arrived to evaluate patient and transported to hospital.

5 days after receiving my first vaccine, my heart went into Atrial Fibulation. That has never happened before. I was put into the hospital to get it back into normal rythm. I was 9 1/2 weeks pregnant when the incident occured. I do have some minor heart issues already known such as Mitral Valve Prolapse and a small PFO. However other than a flutter here and there the last 25 years of my life, I havent had any issues. It makes me wonder if the vaccine set it off.

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.

hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.

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

Received a call from Lead RN at facility, patient received Pfizer vaccine @ 1200, patient became diaphoretic, passed out hitting the floor. Per RN patient lost consciousness for a few seconds, awoke and answered all questions appropriately. No lacerations or open areas noted. Vital signs and blood glucose within normal limits. EMS called and arrived at 1215, evaluated by EMS, per patient she does not want to be transported to the hospital. Patient left site via private vehicle in stable condition.

palpitations; fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) at the age of 41-years, via an unspecified route of administration in left arm on 09Mar2021 15:15 at single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medications were not reported. The patient experienced palpitations and fatigue on 19Mar2021. The events result in emergency room/department or urgent care. Treatment was received for the adverse events. The patient underwent lab tests and procedures, which included X-Ray, Cat scan and Blood work, all with unknown results on unspecified date. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered/not resolved. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021371063 same patient/SD, different AE/dose

After her second dose palpitations came back; After her second dose palpitations came back; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 15:15 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation. Medical history included was not reported. No pregnant at the time of vaccination. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 immunization (Dose number: 1, administration_time=03:15 PM, Batch/lot number; EN6204, Anatomical location: Arm Left). Prior to vaccination, the patient was not diagnosed with COVID-19. The consumer reported few days after she received first she started having palpitations and fatigue on 19Mar2021 03:45 PM. Event resulted in: [Emergency room/department or urgent care]. Went to the ER did cat scan, X-Ray and blood but nothing was found, and treatment received. After her second dose palpitations came back in 2021. The event was reported as non-serious. No covid tested post vaccination. The event outcome was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021370209 same patient/SD, different AE/dose

Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EW0162) via unspecified route of administration on arm left at a single dose on 08Apr2021 17:00 for COVID-19 immunization. The patient medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 17:15 patient experienced nausea, fainting, dizziness and fatigue. The outcome of the events was recovered on an unspecified 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient woke up with jaw pain and left arm pain. When this didn't subside, she went to the ER and was found to have an NSTEMI. cath showed no abnomalitys echo showed inferior/infeobasal hypkinesis differential: takotsubo cariomyopathy, viral myocarditis, vaccine reaction Patient wore a heart monitor for a week which showed no abnormalities. Since this time, she has had occasional chest pains, squeezing sensations and pressure. A return visit to the ER because of continued chest pains showed a normal EKG and negative troponin. She is scheduled for a cardiac MRI tomorrow on 4/27/21. She is currently taking 10mg Amlodipine, 25mg metoprolol, a statin and a baby aspirin. The amlodipine seems to have done the most with respect to helping with her symptoms. She does not smoke. 1 glass of wine per week. She is not overweight. She has low cholesterol and low BP prior to this. Only other medical condition prior to this was occasional migraines (2 per year).

24 hours after shot had hallucinations, then 3 days later started having sore throat, lost voice, and scratchy chest feeling. no fever, no cough, no sob.

Flu-like symptoms (fever, aches, fatigue, chills, sweats, lymph nodes in throat sore), plus arm pain at site of vaccine. Second day began having acute chest and abdominal pain which primary care doctor wanted to see me for. Did EKG which was normal. Pain (including chest and abdominal pain) lasted several days, along with fatigue. 11 days later I still have intermittent pain down my arm all the way to hand on arm that got the shot.

Within the first 10 mins, I had chest tightness but I did not need my inhaler. After 5 hours, I started to develop numbness, weakness, heaviness and tingling in my arms and legs. I also felt dizzy when standing up. I had poor coordination when walking and in order keep my balance, I had to walk very slow. Bending down or getting up too quickly would cause me to lose my balance or feel very dizzy. Objects "feel" heavy and it takes much effort to lift anything over 10 lbs. This has continued since 4/16 with gradual improvement. As of today, I still have numbness and tingling in my arms. Fine motor tasks are very difficult and take lots of effort. Items over 10 lbs still require much effort to lift. I still get dizzy when moving fast or bending down or standing up from a sitting position fast. Walking is still an issue as I need to walk slowly to keep my balance. Walking up or down stairs or inclined surface is somewhat difficult for me to keep my balance.

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.

mental fog, severe fatigue, chest pain, elevated d-dimer, neg chest CT fatigue gradually improving though not to baseline as of 4/28/2021

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.

Pt. started having fever that evening, headache, and lower back pain (significant). Yesterday drove to ER due to continued severe lower back pain and pubic pain. On the way to the ER, she started bleeding a lot. At the hospital, she had a sono and was told she had an abortion. They performed a D&C. She was 10wks. This is 2nd pregnancy, which was uncomplicated pregnancy.

Feeling of blacking out; Nauseous/nausea; Light headed; Vision clouded over; Ears started ringing loudly; Pale; Vasovagal response; 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, Lot number and expiration date were not reported), on the left arm on 14Apr2021 (15:15) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included hypothyroidism, allergies and sulfa allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID). On 13Apr2021 (15:15), the patient had a feeling of blacking out; nauseous/nausea; light headed; vision was clouded over; ears had started ringing loudly; was pale; and had vasovagal response. The events had resulted in doctor or other healthcare professional office/clinical visit and emergency room/department or urgent care. The patient had received an anti-nausea medication, fluids and antacids as treatment for the reported events. The patient's bloodwork was fine and vitals were good, both on 13Apr2021. The outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.

Shortly after patient received second dose, she had flushing with redness and hives across chest and neck. She also had tachycardia. HR noted to be up to 118 in clinic, O2 sats remained stable, BP 124/90 Redness and hives noted to recede while monitoring. Did not require medications while on site. Patient denies EMS transport to hospital as she has personal epi-pen.

migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; blood pressure has been so high/My blood pressure reached 200/198; I lost 30 pounds; I had a stroke; pulse high; in pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included pain, anxiety, two back surgeries previously, and smoke all the time. Concomitant medications included clonazepam (KLONOPIN); and pain medications for her back and anxiety medications (unspecified). She got her first dose of the Pfizer COVID vaccine 36 days ago (11Mar2021) and within 5 minutes, she had the worst migraine of her life. She has had two back surgeries previously and after the COVID vaccine, she felt like she had had her third back surgery that night (11Mar2021). That night, she was also throwing up, had diarrhea and was having horrible stomach cramps. Since then (Mar2021), her blood pressure had been so high that they were afraid that she was going to have a stroke at any minute. For her migraine, she had been to the hospital 4 times for it and they had given her three doses each time of the migraine cocktail and that hadn't touched her migraine. She went back to the doctor and her blood pressure and her pulse were both still high (2021) and with the migraine she was ready to jump off of the dock because it hurts so bad. She was on 4 medicines to try and combat what this vaccine had done to her. She can no longer function. She needed to know an antidote or something to get this out of her system. She stated that she "is going to die from this". She didn't know what to do. They said she was going to have a stroke. She can't work and no one knows what to do because there were no studies on this because it is so new. She wanted it out of her body. Her life literally has turned into her just lying in bed and moaning in pain. She was in the emergency room (due to migraine), there were 3 people in there who had complained from the Pfizer vaccine (unspecified). She was calling because she got her first shot of COVID vaccine and she had a stroke (unspecified date in 2021) and she was going to die. She needed an antidote to get it out of her system because she been to the hospital 5 times now. She had migraine that is so bad that they gave her 4 doses of Topamax, it didn't touch it, she threw up everything she eats, she lost 30 pounds (2021) & her blood pressure reached 200/198 and she smoked all the time, they said she had stroke. She had bad migraine and nothing helped at all. She had doctor appointment, and nobody can give her answer. Regarding second dose, that was 21 days after, but she was not going to get it (second shot) and they said she was 80 % vaccinated. At hospital, when she was in emergency room (for migraine), where they do lab tests (2021), they were fine. She was not getting better, getting worse (not clarified for all events). Date of hospitalization: the day after she got the vaccine and next was two days ago, 3 different times (further details unknown). She further stated that she was driving to doctor. She lost her life because she can't work, this drug had ruined her life (as reported). The outcome of the event migraine was not recovered. The outcome of other events was unknown. Information about lot and batch number was requested.

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.

Severe dizziness , numbness in right arm tightening in chest was diagnosed with vertigo prescribed meclizine 25 mg

The first shot my entire left arm was extremely sore for about 24 hours. Second shot I received my arm was sore for about three hours and then the following day I I began to get a headache. At the moment it is two days after my injection and I still have a headache. My left side of my chest hurts also.

Left chest pain radiating to left arm, into armpit, and up into left ear. Burning aching pain that intensifies with activity, caffeine, and deep breathing. Vomiting on 4/26 with nausea and loose bowels continuing on 4/27. Continuous sweats, lightheadedness, and periodic left sided headache. Was since by medical team on 4/30/21 and evaluated for ear or sinus infection which were ruled out. Lungs sounded clear and no abnormal vitals or bowel sounds.

bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements. The patient previously took amoxicillin and experienced allergies. The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. Information on the lot/batch number has been requested.

I was having an abortion; cramps; bleeding (light red); 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), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor's office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered. Information about the Lot/batch number has been requested.

didn't feel good; sick; blood pressure went high; smells smoke; pulse change; migraine; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date, and 5 minutes after she "didn't feel good". The patient was sick, blood pressure went high, smells smoke, pulse change and migraine up until 36 days later. She was on migraine medicine, and that she lost her job because of this. The patient already went to the hospital four times, and her doctor five times. The patient sought guidance on how to remove the vaccine from her system. The patient considered the events as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Patient c/o heat beating fast. On initial assessment she was noted to be tachycardia at 111. Benadryl was given. Pulse went down to 103- sent home. Advised to go to ER if she feels worse

At 9:44 PM patient reported severe nausea and feeling "hot". Her temperature was normal, but her forehead was warm. Her pulse was normal. Her oxygen levels were normal. She looked pale. We asked for medical assistance from Amazon. Four blood pressure readings were taken and all were slightly elevated. Her lips were not swollen, but she reported her lips were tingling and her tongue felt thick.

Patient had loss consciousness (fainted) immediately after vaccine given while still in chair. BP 84/58. Was taken to observation area via wheelchair to be monitored. She laid flat for 10 minutes then sat up. She left without assistance. BP 118/72 No known adverse reactions noted.

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.

41 yo female chronic smoker with PMHx of Migraine currently in no treatment came in to de ER with severe bilateral muscular leg pain. Patient was found with severe CPK elevation ( baseline 47,400) elevated AST (baseline 515) elevated ALT (baseline 141) . Patient denies use of statin or medications, viral hepatitis titer negative and no known other cause of CPK elevation. Naranjo adverse drug reaction probability scale reported as 5 which may be consider as a probable vaccine reaction.

severe allergic reaction; Experienced elevated heart rate while driving; Dizziness; Weakness; This is a spontaneous report from a contactable consumer. This 41-years-old female consumer reported (patient) that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0169) at single dose on 16Apr2021 2:30 P.M for COVID-19 immunisation. Relevant history and concomitant drug was unknown. The patient did not have additional vaccines administered on Same day. The patient had not have prior vaccinations within 4 weeks. The patient had experienced elevated heart rate/ fast heart beat while driving, within an hour of getting the vaccine. However she mentioned that when she went home, she just relaxed and it eventually went away. But 12 hours after, she experienced the same elevated heart rate side effect and she just sat down and it went away. This happened again after 24 hours. She also mentioned that she had experienced dizziness coupled with weakness. She did not have any side effects or issues until her heart rate started increasing after she left the vaccination site. She read the papers and saw that technically a fast heart beat was considered a severe allergic reaction. She did not notice it was listed at first, because all of the severe allergic reactions blended in together for her. She was wondering when she can expect her heart racing to go away. It had been coming and going. She had experienced it three times now. She did not realize that it was technically a severe allergic reaction. She thought that it was just a side effect, and that it was normal to happen. After receiving the covid vaccine, she waited at facility for 30 minutes afterwards. She was advised to wait because she was allergic to strange things. She did not have any reaction while she waited. Her heart started beating fast on her drive home, within an hour of receiving the covid vaccine. She received the covid vaccine at 2:30PM. Her heart rate rapidly increased again on Saturday morning, probably about 12 hours after receiving the covid vaccine. The third time it happened was within 24 hours after that. She was not overexerting herself. She was working in her yard. She works out 5-6 days a week, but she has never experienced her heart beating fast like this before. The second time it happened was on 17Apr2021, about 8:00AM, and it caused her to stop what she was doing, and sit down. She was unsure whether it was improving or persisting, but she definitely knew it had not worsened. She was second guessing herself about choosing to get the covid vaccine. She never had covid. Her worked offered the vaccine to her. She thought it would be a seamless transaction. She was a healthy individual. In the past, she has been closely exposed to people that had covid, and she never caught covid. She was concerned that her fast heart rate may be long term. If because of the covid vaccine, she has a heart thing now, she will be devastated. Outcome of the event was unknown. The patient did not require a visit to emergency room or physician office. She thought it might be relevant that she donated blood earlier in the day. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

PALE, DIAPHORETIC, LIMB BUT RESPONSIVE, NEAR SYNCOPE, CODE GREEN CALLED, BP 85/55 HR 70, IVF STARTED, TRANSPORTED TO HOSPITAL.

within 30 mins I experienced palpitations, within an hour, I vomited. then felt dizzy and nauseous through out the day. at night I was having chills for 3 days. day 2-4, I had sever body aches, fatigue and generalized weakness, dizziness, nausea, feeling hot all over my body and face but no fever based on thermometer and unable to do adls. day 5, no more body aches but still weak, dizzy, lightheaded with nausea. day 6 till present at day 8, no more weakness but still experiencing dizziness , lightheadedness and nausea intermittently, like a motion sickness. unable to perform prolonged walk without feeling dizzy and unsteady indoors and outdoors.

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.

On March 6, 2021 when I received my first injection of the Pfizer Covid vaccine, I immediately began to feel sick about 5 minutes afterwards. I had instant dizziness, flush feeling, tired, weak and a little nauseated. When I got home I immediately laid down because I felt like I was going to pass out. I slept the rest of the day. Those exact symptoms lasted from March 6, 2021- March 13th, 2021. They began to dissipate the evening of the 13th. I thought all the symptoms were gone but I began urinating blood on March 18, 2021 and I haven't stopped as of yet. I have had constant kidney paid, leg soreness and cramping, dizziness, low blood pressure, chronic pain in my hands and feet, constant fatigue, intermittent headaches, loss of weight, loss of appetite, pain with urination due to the blood. I had a hysterectomy in 2016 so this is not an issue of a heavy period, I no longer have a uterus.

Clotting and breakthrough bleeding for 4 weeks following 1st vaccination, then swelling of lymph nodes 48 hrs. following 2nd vaccination.

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

long vertical bruise on inner thigh along the saphenous vein; ultrasound confirmed that patient had superficial thrombosis; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 13:15 (lot number: EW0150) as SINGLE DOSE for COVID-19 immunization. Medical history included polycystic ovaries and penicillin allergy. Concomitant medications included metformin; loratadine, pseudoephedrine sulfate (CLARITIN-D); acetylsalicylic acid, caffeine, paracetamol (EXCEDRINIL); calcium carbonate, colecalciferol (VITAMIN D 2000); zinc. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 11Mar2021 at 08:30 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Apr2021, the patient developed a long vertical bruise on inner thigh along the saphenous vein. The event resulted in emergency room/department or urgent care as this can be a sign of clotting. Upon arrival at the ER, the doctor checked the patient's platelets and palpated the area and determined that an ultrasound is needed to rule out deep vein thrombosis. The ultrasound confirmed that patient had superficial thrombosis. Therapeutic measures were taken as a result of the events which included treatment with Baby aspirin for two weeks. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Sharp lower lung pain. Felt like when I had Covid last year (also when had pneumonia). It occurred 5x over the course of 8 hours. Other symptoms were expected: aches, chills, sweats, headache, nausea-all lasted 24hrs.

Patient complained of dizziness after vaccine and put her head forward. A Rapid Response was called and patient taken to observation area via wheelchair. During transport patient has a near syncopal episode. Moved to gurney. Nurse Practitioner evaluated. 1528 BP 108/69, P 69, 02 98%. Patient responsive and denies any other symptoms. She states she has a prior history of syncopal episodes with a tongue piercing. She responded well to reclining on gurney. Given water and crackers. 1533 BP114/79 P 72, 02 100%. 1558 patient discharged home with husband. BP 106/73 P 66 02 98%. on discharge. Patient advised to lie down when receiving second vaccine

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.

Menstrual cramps and bleeding that started a day after the vaccine and have lasted over a week. This started 2 weeks after my last period.

Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased with minor swelling and Ultrasound showed DVT.; swelling; Ultrasound showed DVT; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: er8733, at age of 41 years old) as single dose for COVID-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included: Levonorgestrel; Pravastatin. The patient previously received Penicillin, dairy products. Left calf pain started around 12Apr2021; went to Total Access Urgent Care on 28Apr2021 as pain had increased with minor swelling and Ultrasound showed DVT (Deep vein thrombosis) in Apr2021. The adverse event result in Emergency room/department or urgent care. The patient received treatment for the adverse event: On Eliquis blood thinner for 3 months. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the event deep vein thrombosis cannot be excluded, due to 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.

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.

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

Transient moderate headaches and nose bleeds 3-7 days post-injection, including sneezing out blood clot Menstruation lasted longer than normal Mild fatigue 1-5 days post-injection

The day following the vaccine, I had the typical flu like symptoms but didn't think much of them. Not quite a week later, I was feeling very unwell. I am a nurse, as is my spouse. I told him I felt like my BP was off. He checked it and I was basically in hypertensive crisis - 196/98. My BP stayed elevated this way for several days, but finally came down the following week. During this time, and continuing for about 2 weeks, I noticed my heart would often race, I felt lightheaded at times, sometimes I felt like I couldn't regulate my body - almost as though I was in constant fight or flight (very random adrenaline rushes). It felt like my autonomic nervous system was completely out of whack. I still don't feel 100% all the time, but am better.

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.

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

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.

41 yo female with PMHx morbid obesity (s/p gastric bypass) and HTN, p/w LH, after COVID vaccine. No h/o LH, palp, arrthythmia. Has h/o HTN, on losartan and metoprolol. Took meds today, no recent dose changes, though has had doses decreased in past year after gastric bypass. Has not had BP checked recently due to doctor visits being mostly virtual now. Has had h/o dumping syndrome, but none recently. Felt better after sitting down, HR initially high 40s, BP 108/80, shortly after HR up to 55 with resolution of sxs. After 20 min, orthostatics checked, which were negative. Pt ambulated without symptoms. Pt released after 30 min observation period.