Pfizer

Visible angioedema of the lips and ears. Complaints of throat swelling. MD on site called, consulted, EMS activated. Epi 0.3ml administered at right outer though. Swelling improved after 5-10 minutes. Stable VS. Transferred to hospital via ambulance.

Prior to vaccine administration pt told her mother she was nervous. Pt's mother stated that approximately one minute after vaccine administration pt began having difficulty breathing. Reaction nurse transported pt back to Med Obs 1 and med obs one gave graham crackers, water and assessed vitals 2x times. Both V/S presented normal. Pt was released at 1609 with last set of VS being time: 1606 hrs, P: 88, R: 18, BP: 114/70, SpO2: 99.

Patient received in RN triage area, post-COVID vaccination administration. Patient being observed for 15 minutes as recommended per CDC guidelines and facility policy on post-vaccination RN monitoring. Patient sitting in chair and reported feeling dizzy/lightheaded, blurred vision, ringing in the ears, patient noted pale, clammy, and diaphoretic, patient reporting feeling short of breath. Rapid response called. 14:05 Vitals: 75/34, HR: 54, 97% Patient placed on gurney, in the supine position. Patient and mother denies adverse reactions to vaccinations in past. Denies any medical history besides asthma. 14:10 Vitals: Bp: 105/53, Hr 83, 100% on 2L. Patient now denies any dizziness/lightheadeness, blurred vision, ringing in ears, and shortness of breath. 14;15 BP109/65, HR: 72, O2: 100%. COVID vaccination fact sheet and discharge information provided to patient on D/c from clinic, patient advised to review. Verbalized understanding. Appointment for 2nd COVID vaccination provided to patient. All questions and concerns addressed. Advised to follow up as needed. Patient departed with mother at 1435 symptom free.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Mild

Episode of syncope after receiving the covid vaccine. Secondary injury to back of head after falling out of chair. 3:05 PM Vital Signs: BP 118/62 HR 92 Resp 18 O2Sat 98 Skin Signs: Warm and dry Initial Treatment: Initial impression: altered mental status, shallow breathing, pupils Perla. Patient regained consciousness and was able to respond to questions. Patient was placed in a wheel chair and taken to triage area. Vitals taken. 3:20 PM Vitals: BP 116/82 HR 82 Resp 16 O2Sat 98 Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Denies nausea. AOx1 No longer feeling 'shaky'. Very sight swelling at the site of head injury. Ice pack in place. 3:35 PM Vitals: BP 116/66 HR 78 Resp 16 O2Sat 99 Skin Signs: Warm and dry Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Home with mother with CHI instructions.

Ringing in ears, blurry vision, difficulty breathing, tingling in left foot. Denies headache, chest pain/tightness. VSS. RR 16. O2sat 98%. HR 79. Symptoms improved with rest. Discharged with parent in stable condition.

Patient was administered first dose of Pfizer vaccine, and went to waiting area to wait with her father. About 2 minutes after receiving the shot she lost consciousness and pharmacy staff called 911 for EMTs. She regained consciousness approximately 1 minute later; stated she was a little short of breath. Pharmacist asked her to state her name (was coherent and aware) and asked her to take a breath normally; she was able to do so and could breathe normally with no difficulty. Her father laid her on the floor because she was still light-headed, but could breathe normally. EMT arrived very shortly after and began taking her pulse, checking her pulse-ox, and blood pressure. Pulse was on lower end, blood pressure was around 80/50, pulse ox normal. She was taken to ER per her father's request for further examination.

"Pt feels throat closing, reports mild shortness of breath. Patient is alert and able to communicate clealry- Speech is clear. No stridor. Lungs clear. Patient is not in apparent distress. Patient is accompanied by her father. 11:14 am patient reports slight improvement of throat swelling. Reports resolution of dyspnea. Discussed after care with patient and father-- follow up with PCP and ask for referral to allergist to clear patient for 2nd dose of Pfizer vaccine. 11:22 patient left via wheelchair with her father. Patient reports "less tightness of throat"" and resolution of dyspnea."

Ten minutes after shot she began complaining of tightness in throat and chest. Monitored for 45 min and then began throwing up at 7 pm. Vomited rest of evening and all the next day. Went to ER and given an injection of epinephrine. Sent home. Continued to vomit and went back into ER and admitted to hospital.

Noticed on apple watch HR was going up to 120s/HR still elevated. Goes up to 120 when standing. Went to take a shower and HR was 150; diarrhea; Developed rhinorrhea; Developed a pruritic rash on right side of back; chest heaviness; allergic reaction; SOB; chills; This is a spontaneous report from a contactable nurse. A 12-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported), intramuscular, administered in left arm on 15May2021 as first dose, single dose for covid-19 immunisation. Medical history included allergic rhinitis/conjunctivitis from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included medications the patient received within 2 weeks of vaccination as cetirizine 5mg, and clotrimazole 1% topical cream. The patient previously took amoxicillin and experienced allergies. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been tested for COVID-19 which included Covid 19-PCR (nasal swab) on 16May2021 as negative. On 15May2021, the patient received vaccine (Pfizer) and got chills a couple hours later. On 16May2021, patient developed a pruritic rash on right side of back and mom gave an allergy medicine (cetirizine), developed chest heaviness, and SOB (shortness of breath), no tongue/lip or throat swelling. Patient came to ED and received albuterol and decadron due to concern for an allergic reaction. On 17May2021, patient developed rhinorrhea; and chest and SOB improved, but continued to use albuterol. On 18May2021, patient had rhinorrhea and diarrhea; continued to use albuterol. On 19May2021, patient had diarrhea and noticed on apple watch HR (heart rate) was going up to 120s; last use of albuterol. On 20May2021, patient's diarrhea resolved, HR still elevated, went up to 120 when standing; and went to take a shower and HR was 150. The events were reported as serious medically significant, resulting in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures in response to the events included diphenhydramine, decadron, and albuterol. The patient recovered from the event diarrhea on 20May2021. The outcome of the other events reported was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported).

Complaining of chest tightness in the morning, then it progressed to pain, subjective fever, chest, rashes on arm and face, shivering. Feels throat is tightening.

6/8/21 -Presented with respiratory failure requiring intubation about 12 hours after 2nd dose of COVID-19 vaccine. Desaturated to the low 80's despite oxygen. Febrile to 38.8 after admission and had several breakthru seizures requiring loading doses of Keppra. 5/17/21-Had event of tachycardia into the 140s, and slight fever of 100.6, and 8 minute seizure after 1st dose.

Woke from sleep with chest pain and shortness of breath. The pain was worse lying down rather than sitting up. Monitored her (pulse ox finger monitor showed oxygen levels mostly above 96% and HR in the mid-80's) chose not to go to the ER. She did not return to sleep. Symptoms began to lessen around 10:30am, and were gone around 2:30pm.

Chest pain and pressure; fever of 101 degrees F; shallow rapid breathing; rapid heart rate (120); fatigue and tiredness; feeling of being hot and unable to catch breath.

1815: Pt received vaccine and Grandmother with patient waved down staff and quickly reported feeling unable to breathe to EMT on site VS: BP 128/76, HR 54, O2 97%, RR 16 Pt reports not eating for a few hours. Pt given PBJ crackers and soda. Pt reports feeling better and denies chest tightness. at approximately 1820. EMT took the pt back to a room where pt stated that she was having trouble breathing. Pt VS: BP 128/76, HR 48, SpO2 99%, RR 16. Pt stated that she was fine after her 1st dose but that today she had only eaten 2 granola bars. Pt stated that she felt like she just could not take a breath initially, but denied SOB currently at this time. No retractions or distress noted. Pt stayed under observation with EMT for ~ 20 minutes. BP 118/68, HR 74, SpO2 100%. Grandmother stated that the pt has no medical hx no asthma or any lung related hx. Pt was released under legal guardian's care (grandmother) at approximately 1839. Pt ambulated steadily, denied need for further medical care. No distress noted. Vitals stable.

Seen in office 6/16/21 - Complaints of Shortness of breath, cough, nasal congestion X5 days. Received COVID #2 on 6/11/21. Got fever + chills w/in 24 hours of vaccine. Treated w/ Duoneb + prednisone, QVAR + albuterol at home. Seen in ED 6/16/21 -abnormal EKG; Murmur; Labs ordered; Albuterol + Atrovent nebs, chest xray; Home w/ Albuterol, prednisone

Fever, aches, chills, headache, and asthma/hard time breathing from morning of 6-17-21 until the morning of 6-19-21. She was in the yellow zone of her asthma action plan for about 48 hours.

Anaphylaxis - throat swelling and difficulty breathing about 15 min after receiving dose. Grandmother interestingly had same reaction after her 2nd dose.

Patient is a 12 yr/o child with a history of mobility, pots, factor VII deficiency, scoliosis who presents with chest pain and headache after receiving the second Covid vaccine. Mom reports patient got the second Pfizer Covid vaccine yesterday. After the vaccine the patient had some nausea and dizziness which he occasionally has at baseline. This morning when the patient woke up he was having chest pain with deep breathing and complaining of burning in the chest. Mom reports the patient had a temperature to 100.7 at home. Mom endorses decreased activity level and mom noted the patient to have a heart rate to the 130s at home. Patient endorses chills and nausea without vomiting, no diarrhea. Patient also endorses a poor appetite today. the patient has difficulty describing the exact location of the chest pain, mom reports that the patient has always had difficulty with pinpointing the exact location of pain.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium

Patient stated, "It feels like I have bricks on my chest". Expiratory wheezing noted on auscultation. Patient uses an albuterol inhaler as needed due to being in the process for evaluation of asthma. Patient stated that she was not short of breath prior to the vaccine. Onset of shortness of breath and wheezing noted within 5 mins of receiving the vaccine. EMS called and patient transported to the ER for further evaluation.

Patient reports she developed severe headache, chest pain and shortness of breath 3 days after receiving the vaccination. Her symptoms lasted for 2 days. She did not need to seek medical care.

6/12 - patient developed fever and cervical lymphadenopathy. Worsened gradually with difficulty swallowing. 6/16 - presented to ED. Patient also reported rash in right lower extremity that is pruritic, 2 episodes of non-bloody non-bilious emesis daily since Saturday, intermittent chest pain and dyspnea, myalgias, diarrhea, generalized abdominal pain, and neck pain. Concern for infectious mononucleosis with lymphadenitis. Prescribed Augmentin and discharged home. 6/17 - returned to ED due to worsening rash (no longer pruritic) and diarrhea. Continued fever and neck pain. Hypotensive requiring 3L bolus and norepi. Large volume diarrhea. Mild AKI that resolved with fluid resuscitation. Treated broadly with antibiotics for toxic shock syndrome but rash was not consistent and cultures were negative, so eventually narrowed to ampicillin-sulbactam. Neck pain and swelling improved, but fever persisted through 6/19. Transferred to the floor on 6/20 and gradually improved without further intervention. Antibiotics were continued to target possible tonsillitis/lymphadenitis, but course did not seem to be truly responding to these antibiotics. CRP continued to increase despite antibiotics. Patient's presentation seemed most consistent with MIS-C; she also met criteria for incomplete KD with fever, rash, cervical lymphadenopathy and lab abnormalities, but this was felt less likely and she was not treated with IVIG or any other anti-inflammatories. Patient eventually improved and was discharged home 6/24.

Patient reported shortness of breath and tightness in chest that started around 4pm on June 26, 2021 during volleyball game that led to patient not being able to continue activity. On June 28, 2021 at 11am to 1pm, pt reported the same shortness of breath that led to patient not being able to continue strength and conditioning activity. Patient has been advised to contact primary care doctor for further guidance and evaluation.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium

Patient experienced chills, fatigue, headache on 6/10/21. On 6/11/21 she experienced shortness of breath, chest pain, and "feeling like she was going to die". Symptoms resolved by the following day. Suspect myocarditis.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium

asthma/hard time breathing; Fever; aches; chills; headache; asthma/hard time breathing; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A 12-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EP6955), dose 2 via an unspecified route of administration, administered in Arm Left on 16Jun2021 16:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone propionate (FLOVENT); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) as needed and Multivitamin. No relevant past drug history. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. On 17Jun2021 morning the patient had Fever, aches, chills, headache, and asthma/hard time breathing. The outcome for all events was recovered on 19Jun2021. Follow-up attempts are possible. Further information is expected.

headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine given; very tire 10 hours after; chills; shallow quick breathing; heart racing; very uncomfortable; dry throat; arm extremely sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in Left arm on 06Jun2021 at 09:00 AM (at the age of 12-year-old), as single dose for covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0180), via an unspecified route of administration on 25May2021, 09:00 AM administered in left arm as single dose for COVID-19 immunization. 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 the patient was not tested for COVID 19. On 15Jun2021 at 13:00, the patient experienced injection site sore arm four hours after vaccination/ arm extremely sore; she was very tire 10 hours after chills; had fever; experienced shallow quick breathing, heart racing, dry throat; and she was very uncomfortable. On the same day, she fell asleep about 11:30pm and threw up at 3:00 AM. On 16Jun2021 (on next day), she had headache and still on day 3. Therapeutic measures were taken with Tylenol, cool compress, hydration as a result of reported events. The outcome of event was resolving. Follow-up attempts are needed. Further information is expected.

Pericarditis. Patient was admitted on Monday night 6/28/21 with chest pain for 2 days- constant, pleuritic chest pain that was worse when supine, better when sitting up. EKG with T-wave abnormality. She was admitted for suspected pericarditis by EKG and history of chest pain. Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion. Started on colchicine and ibuprofen. She improved and discharged the next morning 6/29/21. Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever. Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.

Patient started complaining of not being able to take a full inhale on evening of July 4th. Temperature was normal 97.7. Scheduled televisit with family practice and subsequent bloodwork . Pulse oximetry came back normal at 99% and heart rate at 54 bpm. Normal bloodwork as well. Patient still has some labored difficulty taking full inhale but seems to be improving.

Per MD Note: She developed the shortness of breath on 06/25, which was four days after she received her first dose of the mRNA Pfizer vaccine. The child describes experiencing shortness of breath, but denies any cough, tightness of the chest, or fever. Since onset, her shortness of breath has been occurring random episodes, but more so at rest than with activity. She mentions that these episodes do not make her conscious of her breathing.

Patient developed shortness of breath and wheezing within 12 hours of receiving dose #2 Pfizer. These side effects were not noted with her initial vaccine. She required ER visit for this. Received Benadryl, Ibuprofen, Duoneb, CXR, EKG. She required continued albuterol over the next few days. She also required outpatient MD visit on 6/23/2021 and was placed on Flovent as well.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Medium

Approximately 3 minutes after injection, our daughter was sitting next to her mother, her head lolled over the back of her chair and she began to have a seizure. The event only lasted about 45 seconds before she came out of seizing. She had a bright orange ring around her mouth, trouble breathing and vision issues. the pharmacist called an ambulance. These symptoms were mostly cleared up before medical arrived, with only dizziness, disorientation and slight vision issues remaining.

Patient reported having difficulty breathing about 5-10 minutes after COVID-a9 vaccine administration. She took her mask off to allow for easier breathing and was given water and 25 mg benadryl. She sat for about 30 minutes and began to feel better. Patient's dad stated that she often gets worked up when getting a vaccine and is anxious about the possible side effects she may experience. Patient and father left. We called them about 1 hour later and spoke with father who said she is feeling better and thinks it was all self-induced.

Warm flushing on right side of face near the ear, then eventually on the left side of face. Nausea. Throat felt it was swollen.

Prior to vaccine with a few weeks of weight loss, fatigue, and mild cough. Two days after vaccination with headache, self resolved. Then around 7/17 she developed tactile fevers, increasing fatigue, and headache. On 7/20 PM she had acute onset of altered mental status- she was screaming and disoriented. She was taken to the Hospital emergency department on 7/21 AM. Work up initially concerning for ADEM, although subsequent imaging consistent with miliary TB with CNS disease (tuberculomas). Patient was exposed to grandmother with MDR pulmonary TB in 2018. Patient was prescribed treatment for LTBI (QuantGold pos but negative CXR) but unclear if she took it. Currently started on therapy for MDR TB and remains hospitalized.

Felt like throat was closing after 5-10 minutes after the shot. Difficulty swallowing. Water did not help. No other symptoms. Got medical attention at 30 minutes post-shot. Vitals all ok. Received Benadryl. No symptoms after 2 hours.

Patient began coughing uncontrollably several hours after administration. Required ED visit for asthma treatment, but did not respond predictably to therapy. Did eventually get better after many hours.

patient c/o difficulty to swallow 27 min after vaccine administration. Vital signs stable. no rash no SOB noted. throat assessed, Left side appears swollen. given Benadryl 25min PO x1. consulted Urgent care doctor, advised to send over patient to be seen for further eval.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild

3:55 vaccine administered 4:05 rash on arms- clusters of pinpoint dots. notified staff- diphenhydramine 50 mg given 4:05-4:30 rash spread to chest, neck. face flushed. throat "weird" swollen and lumpy. dizzy. No SOB. EMS called and responded- evaluated BP 130/70, O2 98. Released for private transport to Hospital ED. 4:35-5:00 private transport and seen at ED. 5:03 Epi given IM right thigh. required to observe x4 hours Symptoms resolved and discharged ~9pm

Parent mother reported to staff, patient experiencing throat tingling, itchiness and mild SOB while in the observation area around 0909. Per patient symptoms started approx 15-20 post vaccine administration. Patient was brought back to triage area. 0910: VS BP 110/80, HR 63, Temporal temp 98.3 F, 100% RA. Monitoring continued, MD and mother at bedside. Patient given benadryl 25mg per MD order and water. Patient reported symptoms improved after medication administration. 0920: Vitals BP 111/74 HR 57 Temporal temp 98F, 98% RA. Per patient SOB resolved. Throat itchiness and tingling improving. Leader discussed with mother regarding second dose. MD continued to monitor and patient discharged from triage at 0940 with mother per MD.

Patient received first dose of Pfizer at an unknown location and presented to the ED at with lip swelling and tingling. States the symptoms started 30 mins after the vaccine. Given treatment with steroids and discharged home. Patient returned to the ED on 5/15 complaining of nausea and throat tightening with a rash on her back and arms. Zofran, Benadryl, Pepcid and steroids administered. Pt was discharged home.

Stated she felt her throat closing up, SOB and anxiety. Was given 1 injection of epinephrine, declined calling an ambulance and was take to local ER by grandparent.

Patient began hyperventilating after receiving vaccine. Observed by provider on site. No intervention required. Parent stated that this has happened previously with other vaccines.

*Per patient's mom's report* After leaving pharmacy, Pt c/o throat swelling/difficulty swallowing. Within 45 min, angioedema + tongue swelling. Benadryl + prednisone given orally @ home. Dad rushed Pt to ER, IM Epi given, Pt admitted for observation over HS.

15 minutes after receiving the COVID-19 vaccine from Pfizer, the patient became short of breath and dizzy. The EMS was called and she was transported to the ER

Feeling of tightness in the throat and like a lump and acid reflux not getting better IM Benadryl felt better immediately OBS vs 99% HR 116 BP 115/73

Cough then throat pain and trouble breathing, started about 1.5 hour after vaccine given. Hx of asthma, but no symptoms prior to vaccine given

Patient received her first dose of the Covid vaccine without a problem. She was reading a magazine in a chair while waiting for me (her mother) to have the second dose in the same room. About 5 to 10 minutes has passed since patient had received her injection. I looked over at patient, her eyes had rolled back and she had slumped in her chair. I ran over to her - her face was very red and she did not appear to be breathing. Her eyes were open but were not focused. I sat her up as straight as I could while the technician who administered the vaccine ran for the pharmacist. This took a few minutes. By the time the pharmacist arrived patient was gaining consciousness but began throwing up (although mainly dry retching). Her face had gone pale. The pharmacist was very helpful - she gave patient some Coke to drink and took her blood pressure, which was low. After 30 minutes of observation we were allowed to leave. The event was very frightening. Patient was very pale for the rest of the day. She had a severe pain in her left arm (and leg) which gradually improved over the next three days. We are very worried about her taking the second dose of the vaccine.

after 20 minutes of the tennis lesson in the afternoon, she felt fast heart beat, light headiness and can't catch her breath. she paused the lesson, sit aside and took few sips of water and rested for about 5 minutes, then resumed the tennis lesson.

Fatigue, shortness of breath, trouble catching her breath, red face, lump in throat, dizziness, when exercising. Took rescue inhaler 5x , but did not see any improvement. Symptoms went away after an hour of rest.

Friday, 5/21 around 11:55 she received her first dose. 20 minutes later she complained that it felt like someone punched her in the face, and her left cheek was swelling. She looked woozy, with her eyes closing, and the nurses laid her down on the floor on a mat. Her tongue and throat began swelling, and she was having extreme difficulty breathing. She then could not feel anything from her neck down, like she was paralyzed. The nurse administered an Epipen and EMS showed up minutes later. In the ambulance, EMS administered another Epipen, gave her a steroid and Benadryl and rushed her to the hospital. Once at the ER, she was still having a hard time breathing, and could not feel anything from the waist down and could not move her legs. She also complained about her spine being in extreme pain around the mid to lower back. When her symptoms did not resolve, she was admitted to the hospital for observation and treatment. She had extreme pain in her joints - spine, hips, knees, ankles and toes, if someone tried to move them, she could not move on her own. She also had tingling and numbness that would travel up and down her body - weakness in her arms and legs. The medical staff continued with Bendryl - switched to Adderax, and Motrin and steroids (Prednisone?). She was discharged from the hospital Sunday, 5/23/21 in the afternoon. This morning (Monday 5/24/21) she is still experiencing back and leg pain, weakness and cannot walk with out assistance and it is extremely painful.

2 days after vaccine was give on 5/20/21 around 430 she complained of chest pain that was sharp and pressure and that it was hard to breath. She was taken to the ED for evaluation. At the time of exam she was feeling better in her chest and complained that the pain had moved to her upper abdomen. There were no findings on physical exam or heart monitor. Her heart rate was elevated mostly in the 90's and low 100's. No further complaints of chest pain, but continues to be achy 1 week post vaccine especially in her knees.

Chest pain shortly after the vaccination. Swallowing and throat. Long lasting and was sent to the emergency room. Labs and EKG were normal. Sore throat lasting up to five days after the vaccine. Tightness in throat and chest experienced

The day after my daughter received her vaccine, she began to feel congested and tired. This was on Sunday, May 23. We got up for school on Monday, May 24, but she was complaining about a really bad sore throat. The school nurse called and I picked her up from school because she was also getting more congested. She began to cough and sneeze constantly and took a long nap. When she woke, she was saying that she was getting short of breath and it felt like her heart was racing, even though she was just sitting. The next day her throat felt better, but the congestion was the same - still coughing and sneezing but her shortness of breath started getting more obvious. I emailed her pediatrician to ask about bringing her in, and they said to report this to the CDC and bring her if if she's not better in the next few days. Today is Wednesday, May 26 and she is still congested, short of breath and overall feels lousy. She is coughing up lots of mucus - greenish and thick. Yuck. I just gave her one pill of a mucus reducer to see if that would help. My biggest worry is about the shortness of breath because that is exactly what I experienced after my first dose of the vaccine. Mine was Moderna and I have seen dr's about it - and actually ended up in the hospital, but they do not believe it to be connected to the vaccine. I will contact them and let them know about my daughter's shortness of breath and perhaps they will think differently. Oh, she's had a slight fever of 99 F on occasions during this.

Approximately 10 minutes after vaccine she reported she felt hot and was ' having a hard time breathing'. Advised her to take off mask and she vomited on floor. Had her lie down on gurney. She denied SOB or breath or difficulty breathing BP 118/84 HR 73 02 sat 94% RR 16. After resting for 5 minutes she reported improved nausea, BP 118/84, HR 73, O2 sat 97%, RR 16. Offered small sips of water. Patient rested for 30 minutes with VS monitored every 5 minutes. Patient reported feeling better and denied dizziness, SOB, or with position change. parent instructed to follow up at ER or urgent care if symptoms returned or if concerns.

Pt got the COVID vaccine, felt sore right away and itchy all over -itchiness on right arm and left arm and then felt chest tightness and shortness of breath. Was monitored in ED and treated with benadryl, pepcid and then course of prednisone x 5 days. She seems better today but still having lower energy than normal. No vomiting or hives. She felt itchy on right arm, no rash.. Took some benadryl for this. She had COVID last November.

Patient awoke from a nap with chest tightness, difficulty breathing, and nausea, symptoms have continued interimittently, and are associated w/fatigue.

feelings of throat closing 10 minutes after vaccine; This is a spontaneous report from a contactable physician and consumer via Medical Information. A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly on 13May2021 (Batch/Lot Number: EW0179) as the 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was the public health department. The patient's medical history was not reported. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced feelings of throat closing 10 minutes after vaccine on 13May2021 at 11:45. The adverse event (AE) did result in a doctor or other healthcare professional office/clinic visit. It was further reported that the throat felt like it was closing 5-10 minutes after administration and they got medical advise 30 minutes after the shot. All vitals were normal and no other symptoms. Diphenhydramine (BENADRYL) was administered. Symptoms resolved within 2 hours. The patient recovered from the event on 13May2021.; Sender's Comments: Based on chronological connection to the vaccine and known the potential for severe allergic reactions after vaccination, a causal relationship between event "throat felt like it was closing 5-10 minutes after administration" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

She had troubles breathing. On the first day, she also had headaches and tummy pain. On the second day, she vomited in school. She also had a headache and troubles breathing. She had belly pain, as well. On Wednesday, around lunch break she called me to pick her up, she had troubles breathing and headache and feeling blah. Also on the first evening, Her arm was hurting and her left body side was hurting. (Wednesday this got a little bitter but she still had pain on her front left side -- especially her left leg.) I took her to primary care and he prescribed Prednisone. Prednisone started then. On Thursday, she still had troubles breathing and she stayed home from school. On Friday, it was okay for her to go to school.

Patient developed swelling in her throat and tongue within the 15 minute waiting time.. Nurses at the clinic administered an Epi-pen treatment and told us to go immediately to the emergency room. Patient was examined, monitored, and treated with three different drugs. We were at the ER for approximately two and a half hours. About four hours later she complained about similar symptoms and we returned to the ER. she was again examined, monitored, and treated again with one drug. The second visit was for approximately and hour and a half.

pt passed out turned while and grey stopped breathing received on dose of epi pen 0.3 mg came to and a sugar drink, emt called and came, blood pressure was good

On 05-22-2021, participant's mother states her daughter pain started at about 1:00AM. I took her to Urgent care because she was having chest pain, nausea and headaches. She also had 99.2F of fever but no congestion or cough. At the ER an EKG was done and it was a bit off, lab work was also performed, x-ray of the chest was also done and they gave her an Albuterol treatment. She was given IV fluids and steroids and a CT scan of the chest was also performed. After 9 hours, she was discharged home and could not find anything wrong. On 05-25-2021 I took her to her pediatrician who pushed on her chest and it hurt her when he did this, her pain level was between 5 and 8 out of 10 on VAS scale. EKG's were performed as well as lab work, x-ray of the chest at the pediatrician office. Her daughter also said her chest hurt her to exhale and inhale. The pediatrician said that her rib cage and breast bone where inflamed upon pressing on her daughter's chest and that she has s costochondritis. As of today my daughter still has nausea that comes and goes and also continues with the headaches and takes Ibuprofen as pain medication.

Full body seizure, loss of consciousness. Stopped breathing. Was transported to the hospital by ambulance. Outcome is pending follow up with neurologist.

She had her first shot vaccine yesterday June 2, 21 and today she has sintoms off.. nausea, disiness , can't eat , headache, and body illness, has well a lot of pain on the arm and body muscles, and difficulty on breathing..

approx 25 mins after vaccination, pt developed numbness to tongue, benadryl administered. Vitals: 11:05am BP 124/80, P 90, 11:13am BP 98/60, P 82. symptoms progressed to rash, dyspnea, chest pain and pedal edema. Epinepherine 0.3 mg given with Epi pen auto injector., rescue called. 11:36am 145/70, P 118. Pt transported to hospital vis rescue

Patient received her second Pfizer vaccine on Friday (6/4). She developed CP and SOB on Saturday (6/5) evening which resolved after sleeping. She then developed return of her chest pain and shortness of breath this morning (6/7) which prompted her to present to ED. She was found to have elevated troponins and was diagnosed with myocarditis. Treatment was supportive with NSAIDs/Tylenol for chest pain PRN and encouraged PO hydration. Troponins and EKGs trended every 8 hours to ensure troponins were down-trending and EKGs remained normal. No sign of CHF or pulmonary edema.

Anaphylactic reaction; left cheek started swelling; looking woozy; throat and tongue started swelling; throat and tongue started swelling; having a hard time breathing; from the neck down, she had a temporary paralysis and she could not move./she could not feel anything from the waist down.; whole body was shaking; numbness and tingling all over.; numbness and tingling all over.; extreme pain in her back; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; very weak; chest was tight.; cannot walk without assistance; itching all over and in her throat; itching all over and in her throat; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, 0.3 ML), at the age of 13-years-old , via an unspecified route of administration, administered in Arm Right on 21May2021 11:55 (Lot Number: EW0179; Expiration Date: Aug2021) as 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing asthma, Diagnosed as a toddler. Had RSV as a baby. ongoing seasonal allergy, To like grass and pollen. ongoing constipation, Diagnosed about a year ago. allergic to shellfish because she gets sick. She said that it happened when her daughter was 4-5 years old. Whenever she has contrast for a MRI she throws it up. The patient's concomitant medications were not reported. The patient previously took Azithromycin and Amoxicillin and were allergic. The patient experienced anaphylactic reaction on 21May2021 with outcome of recovering, left cheek started swelling on 21May2021 with outcome of unknown, looking woozy on 21May2021 with outcome of unknown, throat and tongue started swelling on 21May2021 with outcome of unknown, having a hard time breathing on 21May2021 with outcome of unknown, from the neck down, she had a temporary paralysis and she could not move./she could not feel anything from the waist down on 21May2021 with outcome of unknown, whole body was shaking on 21May2021 with outcome of unknown, numbness and tingling all over on 21May2021 with outcome of unknown, extreme pain in her back on 21May2021 with outcome of unknown , when they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain on 21May2021 with outcome of unknown, very weak on 21May2021 with outcome of unknown , chest was tight on 21May2021 with outcome of unknown , cannot walk without assistance on 21May2021 with outcome of unknown , itching all over and in her throat on 21May2021 with outcome of unknown. Patient was in hospital from 21May2021 to 23May2021. AE(s) require a visit to Emergency Room. No AE(s) following prior vaccinations. No Family Medical History Relevant to AE(s). No Relevant Tests. Clinical courses as follows: It was reported they wanted her to wait for 30 minutes after her daughter received the vaccine. She said that after about 20 minutes, her daughter said that it felt like someone punched her in the face and her left cheek started swelling. She said that her husband said that their daughter started looking woozy and her eyes were closing. The staff laid her down on a mat on the floor. Then her daughter's throat and tongue started swelling and she was having a hard time breathing. Then her daughter complained that from the neck down, she had a temporary paralysis and she could not move. Her daughter asked if she asked if she was going to die. The nurse gave her an EpiPen and called a ambulance. Her whole body was shaking, probably from the EpiPen, like almost convulsing. She said that they got her onto the ambulance and her daughter was having trouble breathing. They gave her another dose of an EpiPen in the ambulance. They also gave her daughter a steroid and some Benadryl through an IV. Her daughter was rushed to the ER, having a hard time breathing and complaining she could not feel anything from the waist down. Caller said that her daughter was also complaining of numbness and tingling all over. She also started to complain about extreme pain in her back. When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain. Her daughter had numbness from waist down. If they touched her foot she could not feel it. Her daughter was admitted to the hospital and got released yesterday 23May2021. She is still experiencing pain and numbness. The numbness is from the waist down and the tingling was up and down her arms. She said that her daughter was very weak and could not feed herself. They had to give her several albuterol breathing treatments in the hospital because her chest was tight. She was not wheezing, but they could tell it was constricted and treated her with Albuterol. She said that her daughter still cannot walk without assistance this morning. She was treated with Motrin, Benadryl and Atarax, and Prednisone in the hospital. The caller said that her daughter also complained about itching all over and in her throat. The caller said that her daughter did not have a rash though.

Note- This patient did not receive the vaccine at our facility so I do not have further details on the vaccine. 13 y/o female with hx of juvenille arthritis, migraines and anxiety, here for left sided CP, palpitations, fast HR, SOB since 6/8 receiving the 2nd Covid vaccine on 6/6/21. Pt states she is also having some nausea and fatigue. Pt has not taken any medications at home for pain. Pt currently taking methotrexate but no steriods. No family hx of blood clots or blood disorders. Differential Diagnosis: Electrolyte abnormality, dehydration, arrythmia, COVID vaccine reaction, myocarditis r/t COVID vaccine. EKG NSR. negative troponin.

She was observed for 30 minutes in the center of vaccination. At around 40 minutes, she started to smell a strange odor, later a strange laryngeal foreign body sensation, her voice changed tone to hoarse (dysphonia). Later she had difficulty breathing through her nose and in seconds general shortness of breath. Marked pallor of skin and lips. Strange sensation of the extremities. She does not remember what happened, she had for a few seconds cloudiness or a sensation of faintness. She spontaneously recovered from the shortness of breath around 5 minutes, time that we were able to get to the emergency room. We consulted the Clinic, emergency room. Where she was observed and monitored for two hours. She recovered well. The evening of 6/5/2021 she had fever up to 100.6, nausea, headache, mild myalgia.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Hyperventilation-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in fingers and toes

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient had a flare up of asthma. Once she used her inhaler symptoms subsided

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

She woke up the next morning (approximately 14 hours after injection) complaining that she was having difficulty breathing. I?m an RN so I checked her sats and pulse. Sats were ok at 99% but pulse was 150. Mild fever of 100.5. Gave her water and rechecked pulse but it was still 140-150. Called her doctor

Immediately after she exp fatigue and pain in left shoulder. Then when she woke up full body, heart palpitations and tightness in throat causing her having trouble breathing. Her Epipen shot to relieve her pain and she followed up at the hospital. The symptoms that are lingering which happened after 1st Dose sensation of throat(uncomfortable for her to swallow) and fatigue.

Pt had second dose of Pfizer COVID vaccine, initial sx of just arm pain/soreness at injection site. Three days later, went to ER due to shortness of breath, chest pain for evaluation. She had chest xray, labs, EKG that were all normal. Given albuterol and ibuprofen with improvement in the ER and sent home. She took a few doses of albuterol and ibuprofen the same night and by next day symptoms had all resolved. She previously did not have any reactive airway, allergy or respiratory history. She did not have any of these reactions with the first dose.

Complained of SOB, "crampy, sharp" non-radiating substernal chest pain (fluctuating in severity, the most severe becoming 8/10), fatigue, palpitations, HA, and sore throat which started on 6/14/21. Pt received her second Pfizer COVID19 immunization on 6/11/21. The first symptom to start was sore throat on 6/14/21, however Pt underwent negative strep and mono testing that same day. Pt's other sx began shortly thereafter, the most distressing symptom being the chest pain and SOB. ED Course: --febrile (39.3), tachycardic, and tachypneic which met SIRS criteria --received 20cc/kg fluid bolus --first doses of vancomycin, Zosyn started; Pt reported flushing and pruritis with vancomycin administration Currently hospitalized

6/13 Sunday she was tired and achey, T 100. 6/14 Monday, she said her stomach hurt and headache at the end of the day. 6/14 during the night she woke up her Mom and said her chest hurt. She has mild exercise induced asthma. She said her chest felt tight, and it hurt to breathe. She went back to sleep in Mom's bed. She got up very early 6/15. She took a shower, and it helped. She does look like she has laboured breathing, she does seem uncomfortable or unhappy. No fever today, not checked, but does not feel warm. She does have an inhaler, she did use it, but didn't help. She did eat and drink 6/15. She ate cold cantaloupe, and it helped her feel better. Is not complaining of burning. She has not done anything strenuous at camp yesterday. She does not have a history of seasonal allergies. Not in distress. No runny nose, she has had a little cough, when she breathes deeply. No rash on her body. She did feel nauseated 6/15. No diarrhea. Evaluated at PCP's office . Chest pain/difficulty breathing resolved on 6/16

Called by pharmacy staff to patient who was feverish and non responsive in a chair in the aisle. Patient was lied on the floor, ice pack applied. She came to and wanted to sit in the chair. Was offered apple juice. After a few sips, she slumped and became unresponsive. Her breathing was shallow. Mother said she had not eaten or drunk anything today. She was lied on the floor again and remained non responsive and then said she was extremely tired. 911 was called, ice was continually applied. Patient did become responsive and drank 6 ounces of apple juice before EMS arrived. She was taken by stretcher by EMS for evaluation.

Shortness of breath, near syncope, decreased hearing, fever 101.7 degrees F, fatigue, imbalance in standing but dizziness, soreness to right upper extremity( injection site), pallor lips and face Denies palpitation, nausea, headache.

tired; chest heaviness; asthma like cough; shortness of breath; aches; sweating; shivering; feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night; dizzy; her heart feels really fast and pulse this morning; fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am; She was up a lot of the night; headache; This is a spontaneous report from a contactable consumer (Patient Mother) reported for a 13-year-old patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 09:30 (At the age of 13 year) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included, thrombosis (blood clots but not DVT's), mast cell activation syndrome (mast cell activation stuff especially near her periods), device malfunction, she also has a VP shunt. There were no concomitant medications. The patient previously took first dose of BNT162B2 for COVID-19 immunization. It was reported that Consumer calling on behalf of her 13-year-old daughter, birthday of DOB, who received the second dose of the Pfizer Covid 19 vaccine yesterday at 9:30am. She reports the following side affects her daughter has experienced: headache that started within an hour of getting the vaccine, by lunch she was tired, chest heaviness, an asthma like cough, a little bit of shortness of breath but her pulse ox is 98%, aches started when going to bed last night, sweating, shivering and feeling like she was "thinking really weirdly" like she was "dreaming but awake" during the night, very dizzy, head feels like it has a heart beat in it, her heart feels really fast and pulse this morning was 130 on the pulse ox, right now standing her pulse is 150, fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6am. It was reported that "She was up a lot of the night but did not want to bother us. It was reported that She has a history of "blood clots but not DVT's, mast cell activation stuff especially near her periods and she also have a VP shunt. Reporter want to know Is this an allergic reaction or could it be. Post Covid vaccine is anyone reporting pericarditis or chest heaviness, when would pericarditis occur. The patient underwent lab tests and procedures which included body temperature: abnormal Fever at 6am this morning 101.2. Now down to 99.7 after taking tylenol at 6 am, oxygen saturation: abnormal pulse this morning was 130 on the pulse ox, right now standing her pulse is 150. The outcome of events was unknown.

Super high fever. Severe chest pain. Trouble breathing. Patient taken to emergency room. X rays taken. Patient was given tylenol

Shortness of breath on the day of the shot. Then symptoms went away. About a week after she had chest pains for 1 day. On Sunday, June 13, she had chest pains and she couldn't eat or sleep. Symptoms continued for 2 days. Took her to the doctor who ordered blood tests, EKG and x-rays.

chest pain, palpitations, and headache starting at 9am on 6/18 after receiving 2nd dose of pfizer vaccine on 6/13; noted to have a fever on arrival to ED, admitted to hospital and was noted to have sinus tachycardia without arrhythmia; underwent several tests including CT angio, echocardiogram; no clear identified etiology but per discussion with cardiology, suspected transient myopericardial or pleural inflammation from vaccine, improved with motrin

13 year old previously healthy female presenting with chest pain. Per patient, chest pain started this AM on 6/18/21, described as substernal, pleuritic, unable to describe what it feels like. Was constant, sometimes radiating superiorly. Also reports light-headedness when standing quickly that preceded the chest pain. associated with shortness of breath. Had isolated low grade fever to 100.2 the night before, otherwise afebrile without cough, congestion, abdominal pain, N/V/D, rash, or leg swelling. Of note, patient received 2nd COVID vaccine 2 days prior to symptom onset (6/16/21). Patient seen at Hospital, got EKG which was normal. Troponin elevated at 0.83, elevated CK 701. Was transferred for concern for myocarditis, in the setting of recent 2nd dose COVID vaccine 2 days ago. Hospital (on 6/18/21): CBC WNL. Electrolytes WNL. AST, Bili mildly elevated. ESR, CRP elevated. Troponin 19. EKG normal. COVID neg. Received Tylenol and Motrin x1.

13 y/o F with hx of exercise-induced asthma BIB mom for dizziness and chest pain s/p Pfizer COVID-19 vaccine received yesterday. Pt endorses nausea, HA, chest pain and SOB. No fever. Chest pain currently. Pt took albuterol 1.5 hours PTA. Pt usually only needs albuterol with physical activity. NO PMH/PSH. Vaccines UTD. NKDA. Differential Diagnosis: vaccine reaction, myocarditis, pericarditis, costochondritis. After assessment and treatment, pt is well appearing, explained to mom on reassessment symptoms have resolved, no chest pain currently. Explained symptoms likely secondary to vaccine reaction, explained normal heart enzymes and normal EKG, strict return precautions given including chest pain and fever.

She had chest pain in her middle chest and to the left of middle. At first the pain was moving, it was up higher and down to ribs and is not upper chest, center chest and left of center of chest. hurts when breathing. She went to ER hour and half after pain started and then her leg, upper thigh, started hurting. elevating her leg helped the leg pain. The leg pain has gotten better. She also had a bad headache the first night and the night after the vaccine but the headaches have gotten better since.

Syncopal Episode after shower. Patient developed new onset nausea and dizziness and woke up on the floor. She felt unsteady on her feet for a few hours after the incident. Also experienced shortness of breath about 2.5 hours after the incident.

On day 3 after the second dose, she began to develop a rash on her face and arms around 8 pm. This progressed over the next several hours to the next morning to include swelling of the face and neck, tightness of the throat and chest, and progression of the rash to involve all of the arms, chest, and legs. The rash was a fine maculopapular rash that was itchy. Over the next 3 days the symptoms did not progress further, but they also did not subside. On day 7 after the 2nd dose, she was placed on a Medrol Dose pack. The swelling of the face and sensation of tight throat began to ease by the next day. After completion of the steroid regimen, her skin is dry and flaky with mild tightness in the skin of the face. However, most of the rash has gone and the tightness in the throat is absent.

1st night couldn't sleep 2nd day headache that wouldn't go away along with dizzy/light headedness 3rd day about an hour after her evening peanut immunotherapy dose of 4 peanuts her skin got very itchy, burning hot, red with some hives. She said her throat felt swollen. A couple hours after a double dose of benadryl and ice packs she began to improve. 4th day she was much better. We spoke with her allergist over the phone, and he said it was reasonable to chalk the reaction up to extra stress on her body due to the vaccine/her bodies response to the vaccine. We only did half her peanut dose. 5th day she was normal.

Chest pain Shortness of breath Feelings of having a fast-beating, fluttering, or pounding heart

A few minutes after the injection, she smelled a strange smell, started to sweat, felt like throat was closing and couldn't breathe, and started panicking. An epi-pen was administered and 911 was called. The EMS team took her to the hospital by ambulance where she was monitored for a few hours until released.

Dysfunctional uterine bleeding causing symptomatic anemia requiring hospitalization and transfusions. Onset of menarche 4/2021. Received first shot 5/18/2021 and 2nd shot 6/8/2021. Third menses onset 6/7/2021. Started becoming symptomatic with DOE, lightheadedness, and pallor 6/17/2021 (day 10 of menses). Hospitalized on 6/19/2021. Still bleeding as of date of this form (7/1/2021)

severe chest pressure; shortness of breath/cant breathe / not breathing normally; unable to dance or even walk; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Right arm on 05Jun2021 at 13:00 at the age of 13-years-old as dose 2, single dose for covid-19 immunisation. Medical history included Bechet's disease from an unknown date and unknown if ongoing, allergy to sesame seeds, she also carries the antibody for crest syndrome but does not have the disease or diagnosis (crest syndrome) from an unknown date and unknown if ongoing. Concomitant medications included colchicine (COLCHICINE) taken for an unspecified indication, vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, iron; vitamins nos (IRON; VITAMINS NOS) taken for an unspecified indication, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication on unspecified date. The patient previously took Omnicef omni-pac, and first dose of previous vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Eq0170), via an unspecified route of administration, administered in Left arm on 14May2021 at 16:00 at the age of 13-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. On 13Jun2021 at 8:00 AM, 8 days post vaccination, the patient had severe chest pressure and shortness of breath. Previously she was significantly athletic and danced 30-40 hours a week, now she was unable to dance or even walk without feeling like she cannot breathe. ER in said they have had 2 other cases with similar symptoms 8-10 days post vaccination. Her labs checked out okay, but she is not breathing normally. The patient received treatment for adverse events with Mortin, Tylenol, steroids and breathing treatments. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care was not specified. The patient underwent lab tests and procedures which included labs (Investigation): okay on an unspecified date and Nasal Swab (sars-cov-2 test): negative on 16Jun2021 (). Device Date: 18Jun2021. The outcome of events was not recovered.

severe chest pressure; shortness of breath; This is a spontaneous report from a contactable consumer (patient herself). A 13-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ew0180; Expiration date: unknown) via an unspecified route of administration, administered in Right arm on 05Jun2021 at 13:00 PM as Dose 2,single for COVID-19 immunization. The patient's medical history included behcet's syndrome, crest syndrome antibody, allergy to plants. Concomitant medications included colchicine (COLCHICINE), calcium carbonate, colecalciferol (VITAMIN D 2000), iron (IRON), cetirizine hydrochloride (ZYRTEC ALLER-GY) taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Eq0170; Expiration date: unknown) via an unspecified route of administration, administered in Left arm on 14May2021 at 4:00 PM as Dose 1,Single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. It was reported that, 8 days post vaccination on 13Jun2021 08:00 patient had severe chest pressure and shortness of breath. Previously was significantly athlethic and danced 30-40 hours a week, no she was unable to dance or even walk without feeling like she could not breathe. ER in said they have had 2 other cases with similar symptoms 8-10 days post vaccination. Her labs checked out which was okay but she was not breathing normally. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of severe chest pressure and shortness of breath as patient had received mortin, tylenol, steroids and breathing treatments. The patient underwent lab tests and procedures which included SARS-COV-2 test which was negative on 16Jun2021. Since the vaccination, has the patient been tested for COVID-19. The outcome of events was not recovered. Follow up attempt is excepted. Further information is requested.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021739775 same reporter/drug/AE, different patient

Pain in chest, burning sensation in chest, shortness of breath and tired with normal walking and talking.

Tolerated #1 COVID-19 vaccine well. Recieved #2 vaccine and the following morning has significate chest pain and a bit of shortness of breathe. Was seen at Hospital ER. Heart rate 110-130, EKG normal, labs were normal except Ddimer was elevated. Nuclear study to r/o pulmonary embolism was negative. Given IV fluids and chest pain resolved. Discharged 8 hrs after arrival.

Patient is a 13-year-old who was transferred from another hospital for chest pain in the setting of Covid vaccination. She received her second dose of Pfizer vaccine on Tuesday, June 29. On Wednesday she developed fatigue chest pain shortness of breath weakness, nausea and mild abdominal pain. She also had a fever to 102.5 Fahrenheit. mom is a nurse and took her pulse and felt that it was 30 and fast. She then took 1 with her home equipment it was in the 120s. She called her neighbor who took her pulse and it was in the 130s. She then transferred her to another Hospital for further care at hospital her vital sinus evaluation was a temperature of 37.4 pulse 119 respiratory rate is 15 blood pressure 106/62 satting 98% on room air. On exam she was well appearing with tenderness to palpation of sternum heart rate normal rate and rhythm lungs clear bilaterally and abdominal exam benign. they obtain CBC with white count of 4.8 hemoglobin 12.9 Camm that was unremarkable LFTs are within normal limits troponin that was negative BNP 223 with a normal upper limit of 125 ESR 2 D-dimer 0.697 with upper limit of normal 0.5 and a CRP of 9 with upper limit of normal of 8.1. UA bland. She was given Toradol for chest pain EKG with sinus tachycardia . She was given 1/2 L normal saline bolus ondansetron Toradol and started on maintenance IV fluids of D5 NS. She was then transferred to another hospital for further care . Upon arrival here she notes improvement in her energy level and all of her pain except for her chest pain. She describes it as a pressure on top of her chest that is right in the center and is worse with movement and deep breaths. Of note she had a appendectomy a few years ago that was complicated by surgeons making the bowel and then required her to have a bowel resection. She has no dietary restrictions and eats by mouth, no GI complications in the long-term. PMH: as above PSH: No significant past surgical history FH: Reviewed and noncontributory to current presentation SH: Lives with caregivers Meds: None Allergies: No known drug allergies Immunizations: UTD Review of Systems Constitutional: fever, no chills, no sweats, fatigue Skin: no rash, no lesions, Eye: no redness ENMT: no ear pain, no sore throat, no congestion, no hoarseness Respiratory: + shortness of breath, no cough, no wheezing Cardiovascular: + chest pain, no palpitations, Gastrointestinal: + nausea, no vomiting, no diarrhea, no GI bleeding Genitourinary: no dysuria, no hematuria, Musculoskeletal: + muscle pain, Neurologic: no headache, no dizziness, no numbness, no weakness Psychiatric: no sleeping problems, Allergy/Immunologic: no recurrent infections, Additional ROS info: All other systems of a 10 system review are negative. Briefly, patient is presenting with chest pain, myalgias, and fever in setting of recent covid vaccine (2nd dose Pfizer 2 days ago). Seen at an outside hospital where labs were notable for mildly elevated BNP and D-dimer, negative troponin, normal LFTs and chemistries. Chest x-ray reportedly negative. EKG with T wave inversions in V1 through V4 (read as nonspecific ST changes by their physician), but otherwise normal. Given the possibility of post Covid vaccine myocarditis or PE, transferred for further management. Patient states that after Toradol that she received the outside hospital all of her other symptoms have resolved but she continues to have chest pain. My exam showed: Gen: tired but nontoxic appearing, no acute distress, alert and active; HEENT: PERRL, EOMI, normal conjunctiva, neck supple without LAN; Chest: significant reproducible chest pain; Card: RRR, no murmur, good perfusion, brisk radial pulses bilaterally; Lungs: CTAB, good air entry, no increased WOB; Abd: soft, non-tender, non-distended, no masses; Ext: warm and well perfused, moving all extremities; Skin: no rashes Chest pain. Overall well appearing with normal exam with reproducible tenderness. Given recent Covid vaccine, must consider myocarditis, although only mildly elevated BNP and negative troponin at the outside hospital are reassuring, especially given reproducible pain and reassuring EKG. Symptoms then may represent musculoskeletal etiology such as costochondritis or myositis related to vaccination. Less likely pneumonia or pneumothorax, but possible. Low suspicion for PE given lack of persistent tachycardia (tachycardia improved while in ED, currently HR 80s) or hypoxia. EKG obtained which showed T wave inversions in V1-V4 (normal for age). Bedside ultrasound with normal global function and lack of pericardial effusion. Labs obtained in BCH ED notable for negative BNP and troponin, along with reassuring lipase given abdominal pain. Thus, unlikely to be true myocarditis, more likely musculoskeletal etiology such as costochondritis or chest wall pain. Cardiology will discuss with mom for reassurance. Final Diagnosis 1. Chest pain R07.9 2. Fever R50.9 3. Fatigue R53.83 4. Shortness of breath R06.00 PLEASE NOTE: Since the patient is not from here, we do not have access to her vaccination records and cannot supply lot number, etc.

Approximatly 10min. after patient recieved her vaccine she was seen slumping over onto her mother and hyperventilating. RN was then notified and arrived to help coach patient to slow her breathing down and to take even breaths. Vitals were taken at 0950:BP-110/70,HR-90,RR-20. Skin was pale and diaphoretic. Patient then was given water and crackers and transferred to lay down in a non-stimulating environment. At about 1015 her vitals were retaken:BP-115/80,HR-100,RR-18. Skin was normal pallor and non-diaphoretic. After a few minutes in the sitting position, then standing and soon she was ready to leave. mother was advised on when to seek medical attention for signs and symptoms of anaphylaxis.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium

abdominal cramping; throat started hurting and started tightening; throat started hurting and started tightening; This is a spontaneous report from a contactable consumer(patient). A 13-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number not provided), via an unspecified route of administration on 20May2021(at the age of 13-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.it was reported that Complainant hung up abruptly/transfer incomplete. Reporter stated that I am just reporting a reaction my daughter had to the shot. It was the Pfizer Covid vaccine. On 20May2021, she had abdominal cramping and then her throat started hurting and started tightening. Her weight is approximately 135 pounds and she's probably 5'5. Product details and pharmacy details could not be probed as the caller hung up abruptly. Call back was done to gather further information however it was unsuccessful. Hence limited information available over the call. The outcome of the events was unknown. Information about lot/batch number has been requested.

Within 15-20 seconds of receiving the injection, my daughter who has NO history of seizures or health issues of any kind, , began having seizures. Her skin color becamee gray, her lips turned blue. The seizure last approximately 20 seconds and when she came out of it she was able to breathe but said her throat felt funny, scratchy, smaller - but she was still able to breathe. She was nauseous, head hurt and was very disoriented for approximately 20-30 minutes. The pharmacist called 911. 911 arrived and took her blood, did a multitude to tests which all came out ok. We opted not to take her to the hospital as she was breathing ok, and her color was returning.

Around 7PM on June 19th, she had chest pain and chest pressure. She also had a mild headache. She was taking a walk in the neighborhood and had to come home because she was experiencing shortness of breath and having difficulty breathing. She described it as an electric shock/shooting pain in her chest area, on both sides. I took her (the participant) to the ER. While at the ER, she started to feel experience pain and tingling in her left thigh. It would feel better if her leg was elevated. The leg pain subsided by the 20th. On the 21st, she was taken back to the ER because the chest pain and shortness of breath was not subsiding. They did another EKG which showed no abnormalities. Blood work came back with the same indication of virus/inflammation. They gave her a pain med (not sure of the exact name, but it is used for patients after surgery) and an IV. Also given a prescription for 27ml of ibuprofen with Tylenol in between. Two days later, on the 23rd, she had an appointment with the pediatrician. The doctor checked muscle tone and listened to her chest. My daughter gets fatigued by going up a single flight of stairs. Doctor referred her to a pediatric cardiologist. Later that night of the 23rd, she began to get a tingling sensation in her left arm that went down to her hands and lightheadedness. She was not able to move and had to lay down. Being upright made the pressure in her chest worse and she had to take shallow breaths. I took her to the ER. They did a chest x-ray that showed no abnormalities. Referred her for an echo cardiogram on the 24th. She was doing better after that until July 5th, when the pressure and pain started getting worse again. I took her to the pediatrician again and they referred her to rheumatologist on the 11th of July. The rheumatologist prescribed a steroid medication to calm her immune system. She said her immune system was activated and was inflamed, which is why she was experiencing the shortness of breath and pain. She prescribed her colchicine and Aleve. Since she has started to take the meds, she is doing better but she is still experiencing pressure at a lesser level. The pain is the same level that feels like static shock.

At first, waking up with difficulty breathing (around 4:30 AM), pain when breathing (throat), Chest pain. Headache. Very fast heartbeat. Took a lot of effort to walk, especially down stairs. Took Tylenol (around 5:00 AM) , went back to bed. After 7 hours of sleep, had no appetite. Headache. Symptoms faded after a couple more hours.

Patient had the normal injection of first dose in the series of Pfizer COVID-19 vaccine. The patient waited in the facility for the standard 15 minutes when fainted (syncope). I rushed over within 10 seconds to turn the patient onto her back. I checked for a pulse and breathing. There was a faint pulse and breathing initially, which seemed to stabilize after about 2-3 minutes. She became conscious again after about 2 minutes of unconsciousness. Patient was diaphoretic with shallow and rapid breathing. EMT was called and arrived about 20 minutes later. Blood pressure read by the EMT: 105/56 about 30-40 minutes after the injection (20-25 minutes after the syncope). Patient was not given anything for treatment besides purified water. Patient was told to follow-up with primary care doctor for the second dose if required.

yesterday 7/26/2021 Patient experienced an asthma attack - she resorted to her emergency inhaler for immediate relief while she does have a medical history with asthma, she HAD NOT had any episodes in at least 5 years.

acute onset of cough, chest tightness and shortness of breath starting 3 hours after vaccination. Presented to urgent care facility. Took albuterol every 4 hours which improved symptoms. Developed body aches, nasal congestion in the following days.

Patient DOB on first dose was documented under 01/05/1990, today patient came in for second dose and DOB is filled out as 12-21-2006

Pt. stated she felt like her throat was closing and was having difficulty swallowing. Assess patient, ausuclated lungs and cleared in all fields, O2 saturation 99%, HR 108. Zytrec 10 mg po given. Continue to monitor and patient recovered quickly.

Patient received vaccine at Health dept 5/13/2021 at 4pm. Presented to our office 5/14/21. seen by Dr 3:09 pm, complaint that had facial burning 1-2 hours after first dose COVID vaccine. School nurse called and reported face swollen and throat itching took Benadryl and did not help. no cough or wheeze, throat itchy called and spoke allergist who stated did not expect allergic run to last that long and people will idiopathic urticaria can have reactivation of urticaria- VAERS Report filed yesterday Patient returned to Saturday walk in clinic today 5/15/21 and saw me- woke up at 2 AM c/o difficulty breathing but didn't want to bother parents on arrival 09:29 P130 sat 98%- nurses state not in distress at arrival at my arrival in room 10:20 AM noted to have frank stridor and fair to good air movement- patient seems to have worsened while here 0.3 mg Epi given IM and felt better sent to ER by ambulance - Hospital for additional monitoring? in case more epi needed

Within 10 minutes after the vaccination, there were some body tremors and dizziness, then she lost vision, hearing and ability to speak for a few seconds, followed by difficulty breathing and a feeling of her heart ?jumping out of chest.? Eventually, she recovered, but her right hand (not the injection arm) still has involuntary tremors, which has not gone away.

Frontal Headache and Throat Tightness for 20 minutes. Symptoms resolved after mom gave Benadryl 37.5mg orally.

Vaccination was on Saturday, within 10 minutes of the vaccination, my child reported her ears felt like they were popping, she felt dizzy, tight throat and jaw pain. On site nurses gave her apple juice and crackers. She reported feeling unwell, dizzy, light-headed, jaw pain and short of breath the following day, on Sunday. On Monday, we took her to urgent care for same symptoms - unwell, dizzy, light-headed, jaw pain, short of breath. Rapid COVID test and strep test were negative, EKG was normal. Urgent care doctor says it is vertigo.

Slight throat tightness and itchy eyes about 15 minutes after vaccination. Slight cheek warmth without rash or hives. Benadryl 50 mg PO administered with mother's consent. Symptoms did not progress and slowly resolved over a 1 hour observation time at CVC. No SOB, wheezes, tongue thickness, or hives at any time. BP, pulse, O2 sats were all normal. Initial BP - 118/78, pulse-84, O2 sat - 99%. No orthostasis at dismissal. Home with mother with precautionary instructions.

Patient reported "not feeling right", throat is tight, hard to swallow, light headed. Patient was put in the exam room at 6:00pm VS take, WNL. Doctor examined patient, lungs clear, airway clear. No swelling, redness, rash. Patient was given 25mg cap of Benadryl, monitored for 25min. Repeat vitals taken, improvement in HR, otherwise WNL. Patient given prescription for Albuterol inhaler, Benadryl, Loratadine. ER precautions advised to parent

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild

Patient stated that she felt her throat was closing. Heart rate was assessed no interruptions in breathing. Examined throat no inflammation or redness noted. Patient had normal chest rise and fall through entire assessment. Was observed an additional fifteen minutes after initial thirty minute observation due to patient's allergy to cats and diagnosis of Celiac's disease.

Patient was administered the first Pfizer Covid 19 vaccine per protocol and was seated for observation post administration. She became faint. Pharmacy staff broke an ammonia inhalant to help the patient recover. She responded quickly, but did require additional whiffs later. When questioned, she stated that she was having no difficulty breathing, swelling in throat, and no obvious rash. She was accompanied by her mother, who declined emergency medical care/911 assistance. The patient was not wearing constrictive clothing, so no adjustments were necessary, but she did recline further in the chair. She was also provided with cool, wet, paper towels for her forehead and neck. When she was feeling better, she had a few sips of water. Although offered a motorized cart to leave the store, she left with both parents walking with no assistance. On 5/20/21 we reached out to the family and spoke with her father. The patient did have a minor headache the evening of her vaccine administration, which has resolved. She does have a sore arm, which is a common side effect of the vaccine, Her father has reached out to her pediatrician to see whether she should get the second dose or not. He has not yet received a response.

Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium

pts neck started swelling after taking the vax. she was having a hard time breathing due to the swelling. she went to Hospital ER. pt was triaged and then left due to the situation at the hospital. Pts mother gave her Advil and was monitored all night. The swelling seemed to be better the next day. She had fatigue that lasted about 3 days. Parents called the Pediatrician. They were advised to call her Endocrinologist. They recommended her back to Pediatrician due it being a immune reaction. They called an infectious disease specialist which recommended her to an allergist. Pt has follow up appts next week for thyroid.

is a 14 y.o. female who has a history of Hashimoto's followed by Endo. also has no known allergies. She received the COVID vaccine on 5/14/2021 at 10AM. Per notes, 10- 12 hours later, she developed throat swelling and trouble swallowing. She went to ED, but left without being seen. There is no description of skin, mucous membranes or gastro-intestinal involvement. There is no description of respiratory distress following the events. There are no vital signs listed following the event (BPs, oxygen saturation, etc). She was given advil. The neck swelling "got better" the following day. will be getting an USS of the thyroid to assess.

8:50AM- patient started exhibiting symptoms of anaphylaxis (difficulty swallowing, difficulty breathing, lip tingling and tenderness. 9:30AM- Benadryl was administered (25mg chewable POx1) 9:30AM vital signs: HR 115, RR 22, O2Sat 98% on room air, BP 123/95, 9:33AM- EMS arrived 9:34AM- Epi pen administered . Patient tolerated well, school nurse notified. 9:45AM- Breathing appears better, still having difficulty swallowing 9:45AM vital signs: HR 120, RR 22, O2sat 95% on room air, BP 132/74 9:53AM EMS administered 10mg dexamethasone IM left deltoid, tele monitor placed on patient

Dizziness reported ~5 minutes after injection. Water and juice provided, LE elevated. Shortness of breath reported ~45 minutes after injection. After 1 hour of observation at Vaccine Clinic, patient transferred to Urgent Care per family request.

Patient complaints of dizziness and shortness of breathing. Provider on-site assessed the condition of the patient and was experiencing cold clammy skin. Provider recommended to give EPIPEN 0.3 and called 911

Pt received her 1st dose of the Pfizer vaccine in the right arm at approximately 2:45 PM on May 29 at pharmacy. Pt was recommended to sit for 15 minutes in the waiting area after vaccination for observation, but she and mom opted to go shopping in the store. At approximately 3:37 PM, pt and mom came back to the pharmacy to tell me (the pharmacist) that she had hives and showed me red bumps on her left arm. I had the pt sit while mom went to go buy Benadryl. After 5 minutes, I checked on the pt. She had taken one dose of Benadryl and stated that she was dizzy and feeling itchy all over. After chatting with mom for 5-10 minutes, the pt stated that she felt like her symptoms were not worsening and were stabilizing. The pt then said she wanted to rest at home. I recommended she sit for a little longer, but mom stated she would keep a close eye on the pt and had an epipen at home. They then left the pharmacy. I followed up with mom on May 30th at approximately 4:00 PM to see how the pt was doing, and she stated that they were at the ER because the symptoms were not getting any better, and the pt "felt like she was having an asthma attack." Pt's mom states that the pt is doing much better after receiving IV meds.

Systemic: Dizziness / Lightheadness-Medium, Systemic: patient cant control breathing; cant walk after 10 min administration-Medium, Systemic: Flushed / Sweating-Medium

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Medium

MOTHER REPORTED CHILD HAD REACTION TO FLU VACCINE IN THE PAST. PATIENT WAS REPORTED TO BE ALLERGIC TO EGG PRODUCTS AS A CHILD AS WELL. PHARMACIST CONTINUED WITH VACCINE AND OBSERVED PATIENT POST ADMINISTRATION. WITHIN 5 MINUTES, MOTHER REPORTED PATIENT FELT THROAT SPASMS AND SKIN SPLOTCHES. PARAMEDICS WERE CALLED FOR EVALUATION. PHARMACIST OBSERVED PATIENT. PATIENT CONTINUED TALKING UNTIL PARAMEDICS ARRIVES INDICATING AIRWAY WAS STILL FUNCTIONAL. PHARMACIST HAD EPINEPHRINE INJECTION AND CPR MASK ON HAND IN THE EVENT IT WAS NEEDED. PARAMEDICS/MOTHER AGREED TO HAVE PATIENT EVALUATED IN EMERGENCY DEPARTMENT.

Shortness of breath. Was not made aware of reaction until mother submitted a survey/feedback. I opened and read the feedback this evening.

Subject observed 30 min. post vaccine with no adverse reaction. Mother states pt called her and c/o itching, fine rash at 4 pm. Mother states that at 6 pm was taken to Emergency Room due to c/o chest tightness, SOB. ER physician administered EPI pen. Pt improved and was sent home. Physician reported "may have been due to vaccine, not sure". Mother reported this per telephone to school the next am (5-26-21), and was called back by RN for report. Mother will not give second dose vaccine. Contacted 5-27-21 and had no other ill effects.

HPI: Patient is a * year old * who presents following administration of the first dose of Pfizer COVID19 vaccine in the left deltoid. She states that immediately following administration of the vaccine, she started to feel lightheaded with ?fuzzy vision,? and pain with swallowing. She denies a history of anaphylaxis. She affirms seasonal allergies and confirms that she was feeling ?stuffy? this morning. She affirms that she ate and drank this morning without odynophagia. She relates that there was a big family argument that is causing her to feel stressed at this time as well. She affirms pleuritic chest pain, odynophagia, epigastric abdominal pain, headache, lightheadedness, and blurry vision. She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Exam: GEN: Alert and oriented x 4, NAD. Patient appears to have a developmental delay secondary to eye contact avoidance, slow to respond, and speech impediment. HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Shallow, guarded breathing at rest, but clear to auscultation bilaterally with deep inspiration, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry. No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Vital signs stable and physical exam within normal limits, however, patient continued to report odynophagia, pleuritic chest pain, abdominal pain, lightheadedness, and blurry vision, even after giving patient snack/drink and reclining her with lower extremities above the level of heart and head. EMS called to the scene for further evaluation. Instructed patient and parent to consult their PCP regarding the post-vaccination reaction. Patient and parent instructed to go to emergency department should she develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting. Patient and parent demonstrated understanding of post-vaccination instructions. Medications administered: None Disposition: EMS contacted due to patient not improving. Care transferred to EMS . No workup was performed by EMS and they instructed the parent of the patient to take the patient to ER via private car for further evaluation. Father was amenable to plan and signed form.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: patient was having given epipen then felt better but called 911 then they took her since epipen was administered but while leaving the pharmacy she was in good condition feeling better no need to administer 2nd dose of epipen

Approximately 11:10 am on 6/7/2021 Adverse event occurred during the 15 minute wait period following the vaccination. Pt c/o SOB, weakness , diaphoresis and pale. Pt stated that she could not see and it was hard to breath. Pt stated that she has not eaten or had anything to drink today. Hx: was taken. Pt had no known medical hx or allergies to meds

pneumonia; inflammation to the heart; Shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 22May2021 08:00 at age of 14 years old as a single dose for covid-19 immunisation. Medical history included pericarditis with inflammation. The patient's concomitant medications were not reported. The patient previously took vancomycin and experienced allergies. The patient experienced pneumonia, inflammation to the heart, shortness of breath, chest pain, all on 23May2021 07:00. The outcome of the events was not recovered. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events resulted in emergency room/department or urgent care. The patient received treatment for the events included Antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

Patient reported lip swelling, throat itching and a little hard to breath 30 minutes after injection. 1.5 hours later, patient developed itchy rash on arms/cheeks/neck. No intervention needed. Symptoms resolved a few hours later on their own at home. Patient did not report to MD until 6/7/21

COVID-19 Post Vaccine #2 Vasovagal reaction. EMS notified due to patients history of anxiety and increase in RR, patient stated she feels "shaky". Patient stated she feels better with legs elevated. Patient lowered to the ground, legs elevated and moved to the litter. VS taken and EMS notified.

Starting early morning after vaccine, approximately 15 hours after vaccine, patient developed severe chest pain, shortness of breath, and tachycardia. Her fever was high throughout the day (often 102.8 even after Tylenol and Ibuprofen). I am a physician and my husband is as well, we monitored her heart rate, oxygenation, temperature, and symptoms at home. We called her doctor and asked whether this could be myocarditis and whether we should go to the ER. She felt that we should just have her rest and monitor her vitals. I dosed her with two large doses of Ibuprofen (600 mg twice during the day), and by 6 pm on 6/4 her chest pain started to improve and her fever broke. The severe crushing chest pain lasted about 12 hours.

pressure in chest, shortness of breath, rapid/irregular heart beat, light headedness. Started afternoon of June 13 and continued to 6/15.

6/17: two episodes of shortness of breath and heart palpitations lasting approx 30 mins each first one around 5pm 2nd around 10pm. 6/18: 9am shortness of breath and palpitations started again lasted over 2 hours. Pediatrician evaluated patient and ordered chest X-ray which was normal. Pediatrician referred us to ER for further evaluation. At the ER they did blood work, EKG, urinalysis. EKG was normal. Labs came back showing elevated D Dimer so they ordered a CT scan of her chest which came back normal. They also ordered a coagulation profile which came back normal. We were released from the ER and told to monitor if symptoms continued. She had no symptoms of shortness of breath or palpitations while at the ER. As of today she continues to have very short episodes of palpitations but has not had shortness of breath.

Patient is a 14 yo girl with PMH significant for migraines who presented with one day of chest pain and nausea that woke her from sleep in the setting of multiple days of malaise. She states that after receiving the COVID-19 vaccine three days prior to admission she has not been feeling well. She reports subjective fevers and chills the day after receiving the vaccine, and intermittent feelings of her heart racing. She also has been feeling hot and generally unwell. + shortness of breath. The night of admission, she awoke from sleep with burning central anterior chest pain and nausea. She tried to stand up and felt generally weak, and then had tunnel vision and felt she was going to faint. Per mom, she was pale and diaphoretic at that time. The pre-syncopal symptoms resolved within about 10 minutes and the chest pain persisted for approx one hour. Parents called EMS and she was brought to the ED for evaluation. Of note, she reports a history of pre-syncopal sx however has never lost consciousness before. Also reports a history of intermittent palpitations. No hx chest pain prior to this episode. + fevers/chills as mentioned after receiving COVID vaccine three days PTA but no infectious sx prior to that. No cough/URI sx, no abdominal pain, no nausea. + diarrhea night of admission. No sick contacts. She is active in dance and has good exercise tolerance for that; does not spend much time outdoors. No known insect or tick bites. + FHx of sister with heart murmur as a baby that spontaneously resolved; unclear diagnosis. In the ED BP 94/62, T 97.4, P 84, R 16, SpO2 100% on RA EKG: sinus rhythm, no ST or PR changes CMP: unremarkable CBC: WBC 11.8, Hgb 11.5 Trop T 0.33 Bedside echo w/ reported good function UA wnl COVID neg CXR PA and lat unremarkable On arrival to the PCICU she reported feeling at her baseline and denied chest pain and shortness of breath.

Pt visit ER 3 days post 2nd Covid-19 vaccine on 6/18/21. SOB started following day, CP last night. Diagnosed with Myocarditis during ER visit. Discharged.

Pleuritic chest pain, emesis, shortness of breath, palpitations, epigastric pain - albuterol with improved shortness of breath f/u 6/23 all symptoms resolved except epigastric pain

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: After 3-5 min from the shot she was waiving her arms and unresponsive. I then gave her a epipen. Then a few seconds later she was breathing and talking. blue lips and labored breathing was noticed. 911 was called and assessed her. father declined taking her to er.

1 day after 2nd shot had fever, abdominal pain, chest pain, shortness of breath, tachycardia.. Was seen in ER. Fever. abdominal pain resolved in 2-3 days. Chest pain still present, and shortness of breath 5 days after

chest pain, trouble breathing, and heart palpitations - started ~48 hours after vaccination and lasted approximately 18 hours.

Received 2nd Dose on 6/22. On 6/23 & 6/24 she had "normal" reaction, for example- Headache, sore muscles, low grade fever, tired. On Friday 6/25 she woke up with chest pain and the headache was still there. She had a hard time taking in a deep breath and when she did it hurt really bad. The chest pain hurt all the time, but worse when taking the deep breath. We call pediatrician and they told us to go to ER.

Experienced lump formed in middle to base of throat and right cheek became swollen. Lump in throat was the size of a quarter but did not block her airway passage. Doctor checked her airway passage, heart, and pulse. Took one Zyrtec administered by mom, because she is allergic to Benadryl. The Zyrtec was given around 2:45 PM. After 10 minutes the lump in middle to base of her throat and right cheek did not reduce in size. She was able to drink water and her mom, and gave her another Zyrtec pill. This is an emergency plan for provided by her allergy doctor. This was an emergency event for her with all of her known allergies. After 20 minutes, she began to feel the lump in her throat slowly decrease in size. She was being monitored by Dr. and a Nurse, and additional nurses on staff. Dr. continued to check her heart, airway passage, and pulse. As the lump continued to reduce in size after 45 minutes to 1 hour after receiving the Pfizer vaccine, she was able to get up and walk around with a pulse monitor on her finger to monitor her heart rate and breathing. She did not have any concerns while walking nor while sitting in the office and was being watched by the staff. In the very beginning after giving her the Zyrtec she need to keep her mask off to ensure her breathing stayed under control. We were able to leave and did not need the EpiPen administered by staff nor by her mother. We were able to leave around 3:45PM. We received follow up calls from the Nurse at 4:54 PM and from Dr. around 5:30 PM to check on her. At 11:00 PM I did give her 1 Zyrtec before bed. I woke her up on June 17th at 6:15 AM and asked her to drink some water. After drinking water she noticed she had a lump in her throat. Her mom gave her another Zyrtec. She was watched closely throughout the remaining week and was in contact with her doctors office. Patient also experienced pain in her throat due to all the swelling/inflammation. Since receiving the vaccine, patient has noticed an increased difficulty in wearing her mask. This did occur prior to receiving the vaccine.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

24 hrs after first dose child developed difficulty breathing. 48 hrs later child had insomnia and chest pains x 30 mins.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe.

1st dose Pfizer vac at 3:16pm L arm. w/mother/sibling in attendance. Attendee directed to observation area but immediately had reaction after receiving injection. Became pale, faint,dizzy. Stated anxious, fear of needles. Legs elevated while sitting. 3:26pm drank water. Encouraged to stabilize breathing. Skin pinkish, warm, dry. Mom distracted her. After sibling done with vaccine, Attendee walked unassisted to observation area. 3:40pm went to observation area check on her laughing and talking with family. Took pulse ox 99% and HR: 63. Gave mother home discharge/adverse reaction instructions to contact Primary doctor/UC prn. Attendee discharged to home w/her mother approximately 3:50pm.

The differential diagnosis for this patient's chest pain includes PE, ACS, Dissection, Pericarditis, Pneumothorax, Pleurisy, Pneumonia and musculoskeletal strain. Given the above history, physical exam and ancillary tests, the patient's symptoms are most consistent with: Acute myopericarditis. Should be noted the patient is post 2nd COVID 19 vaccine by 3 days ago. Case reviewed with the pediatric emergency medicine physician at healthcare facility who will accept the patient in transfer. Because this is highly likely a post vaccination myopericarditis will hold on aspirin or other treatments at this time. Patient was given Motrin 400 mg p.o. in the ED for pain.

Client received second dose of COVID19 vaccine at 2:28pm. While sitting in observation room with her mom, she became dizzy, light headed and nauseous. Nursing staff evaluated client. She stated she had only had a muffin for breakfast. Staff provided juice, water and nutri-grain bar. Due to nausea, only able to drink a small amount of juice. Moved client to cot. EMS was called. Provided cold compress for forehead. She continued to drink the juice. Pulse ox was taken and was 98 continuously while she was on the cot. Nursing staff evaluated her for symptoms and improvement. She state she was still dizzy, lightheaded, and nauseous. She also stated her throat hurt/felt tight. EMS arrived. Interpreter used during event.

Vaccine was administered on 7/7/2021. On 7/9 pt woke up feeling like something heavy was sitting on her chest and said it was hard to catch her breath. She would get winded walking up a flight of stairs. Symptoms worsened throughout the day and was taken to the ER around 2am on 7/10/2021. Upon arrival at the ER, she rated her chest pain a 6/10. A CXR and EKG were completed and returned normal. She was diagnosed with inflamed tissue around her sternum and told to continue to take Motrin at home.

She began feeling badly the day after 2nd dose. Sore throat, runny nose, sneezing, headache, fatigue. Today is 4th day after 2nd dose and she feels pretty awful. Started running low fever and complaining of *chest pain* and *pain in back and shoulders* and pain upon *deep breaths*.

myopericarditis with SOB 2 days after vaccine. diffuse ST elevation EKG. troponins 8-20. echo with mild function decrease.

Pt. called me crying in pain saying her stomach hurts and she's having trouble walking. She said she has her menstrual cycle and it has never been this bad. She said she didn't get it last month at all. Prior to this, she said her cycles were normal. She also had pain in her thighs and trouble breathing which resulted in her needing her rescue inhaler. At this time she has been given ibuprofen and is resting with a heating pad. I as pts. mom am concerned that this may be related to vaccine.

24 hours after vaccine, she had a fever of 106. A week after, she began having breathing problems (no history) and chest pain. Symptoms have continued still, and not getting better. We have been to urgent care, ED, pediatrician, and going to cardiologist soon. Now has 2 inhalers and OTC pain meds. I firmly believe the problems are connected to covid vaccine.

Pt had Pfizer covid vac this morning at 10:25 am. She tolerated injection well, waited 15 mins and left w/o symptoms. Her uncle drove her back to clinic at approx 11:13 am with pt stating she was SOB, throat felt like it was closing and her lips felt numb. Epi autoinjector pen 0.3mg was administered at 11:14 am and RN arrived on scene at that time and VS were taken: 134/89-104-99%. Pt verbalized less difficulty breathing, and no longer feeling throat closing. RN and Dr. arrived and MD provided assessment. Pt was taken to treatment room via w/c and placed on table. Pt was monitored and transported to ER when EMS arrived.

Pericardial effusion on 6/19 s/p percardiocentesis. Ongoing hospitalization, associated complications including pleural effusion and new pericardial effusion on 7/16. Initial rpesentation also with somnolence, decreased respiratory drive thought to be due to Onfi overdose. Was intubated now on room air.

Patient had an syncope episode following a pfizer covid 19 shot. She had shortness of breath and appear to have a seizure afterwards. Gave 1 dose of an epipen and patient vitals was stable.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PATIENT IS STILL FEELING CHEST PAIN AND STILL HAS RASH.

The patient presented to the ED with Shortness of Breath and Chest Tightness which started 24 hours after she received her first dose of the Pfizer Covid vaccine. The patient received diphenhydramine IM for treatment of the adverse reaction. Her symptoms improved and she was discharged from the ED.

Fevers over 100; chest pain; hard time breathing.; Sore Joints; This is a spontaneous report from a contactable consumer. A non-pregnant 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for inejction), dose 1 via an unspecified route of administration, administered in left arm on 23Jun2021 13:00 (Batch/Lot Number: EW0217) as dose 1, single (at the age of 14 years old) for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. The patient experienced fevers over 100, chest pain, hard time breathing and sore joints on 23Jun2021. The patient received TYLENOL. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.

Patient reported difficulty breathing. Vital signs within limit after the initial assessment: RR 14, BP 110/60 (parent stated that the patient usually runs a low blood pressure). No swelling of the throat, face, or mouth, no signs of respiratory distress was observed. Over the course of 15 minutes patient continued to report difficulty breathing. Paramedics was called, arrived at the scene and transported the patient at 10:55 am per parents request.

Migraine, facial numbness and tingling central to nose and mouth area. Feeling like she was unable to breathe when ascending steps that resulted in hyperventilating which lasted 18 minutes. Normal breathing rhythm returned after 43 minutes. Right arm extremely tender. Oxygen and heart rate at 23 min were 98 for O2 and heart rate 73 BPM.

Patient received a first dose of Pfizer vaccine around 10am on 05/16/2021. Around 6pm on 05/17/2021, patient's mother called and stated that her daughter feels difficulty breathing, SPO2 at 94, heaviness in chest (she describes like an object was sitting on her chest) and chest pain (on scale 0-10, with 10 is the most intense pain, pt reported 8/10). In addition, pt has been experiencing chills since the day of the vaccination. Parent gave the child ibuprofen before calling pharmacy. Pt 's mother reported that her daughter dose not take any medication nor any herbal supplement. The daughter has a history of heart murmur. Based on the severity of the symptoms, we advised the mother to take her child to emergency care.

Tongue swelled up and her throat felt tight, itchy, and closed up. I have a dose of Benadryl within minutes, it didn?t seem to help. I gave a second dose of Benadryl and increased the amount and that helped. I also called the nurse line.

Patient experienced difficulty breathing and felt throat was closing within 3 minutes after administration of vaccine. Also complained of change in vision ( temporary loss of vision) and skin tone changed in tone ( face turned pale). Epi-pen was administered and 10 ml of liquid Benadryl.

Pt was very anxious before shot given. Mother had to physically hold pt down for her to receive the shot. Afterwards, pt reported headache, dizziness, and sore throat immediately after the shot. Pt was hyperventilating so I encouraged deep breathing and hydration. HEENT and Pulm exam were normal, as were the vitals. Pt eventually recovered without any other intervention. Pt waited for full 30 minutes after dose.

Pt had syncope x 1 postvaccination followed by seizure x 2. Pt recovered spontaneously after 3-5 seconds. No labored breathing. Alert and oriented x 3. Pt brought to ER.

Pt received vaccine with mother present at 1419, c/o dizziness, lightheadedness, blurry vision, difficulty hearing, at 1439. Pt states she did not eat lunch. Nursing team intervened by taking vitals, placing wet towel on forehead, lying pt in supine position with legs elevated. Pt VS stable, pulse in 80s, BP(120s/80s), 99% on RA, RR 16-18, no respiratory distress, no s/sx anaphylaxis. Pt states she did not eat lunch. Gatorade offered to pt. Dizziness improves in supine position but returns upon sitting. At 1532 pt states she has facial numbness. EMS called at 1535. EMS arrived at 1557 and assessed pt. Pt?s BG is 93, VS stable. Pt reports feeling dazed, unable to focus, blurry vision and difficulty hearing. At 1602 EMS informed pt that they will take her to Medical Center, pt immediately got agitated and started crying and hyperventilating. 1604 pt stated she had difficulty breathing and a light localized rash began to appear on her chest. 1605 EMS transported pt. Pt?s mother to follow.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling in fingers

Per Dr. 1.Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)? Yes. 2, Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol? No. 3, Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause? Yes. 4, Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine? No. Pt received COVID vaccine, Pfizer 1st dose. Approximate 5 minutes in the observation area pt complained of headache, throat discomfort, and stomach upset. She has a history of food additive allergy (dough additive), has an epi pen but has never needed to use it per mother at bedside. Initial VS: T 98.2 P 84 BP 119/70 RR 20 SpO2 99% on room air. She was monitored in the adverse reactions area. She was given Benadryl 25 mg oral x 2, and cetirizine 10 mg oral x 1. During observation period she had observed worsening oropharynx swelling, and stridor/inspiratory wheezing. VS prior to transfer was P 78 BP 102/69 RR 18 SpO2 100% on room air. EMS was called and pt transferred to ER for further monitoring, Tryptase level, and epinephrine if needed. Pt was recommended to see her pediatrician or allergist to discuss 2nd dose options prior to scheduling appointment. Signed: DO, 5/21/2021 2:59 PM".

15yo patient in observation parking lot c/o headache and laid down. honked horn because patient stated she had trouble breathing. RN's in observation area ran to the car. Patient tachypnic and couldn't talk, slightly pale with no signs of cyanosis. 911 called immediately and epi pen, 0.3mg administered at 1621. Patient layed down in the back of her car until ambulance arrived. BP stable, no pulse-ox available, respirations 66 bpm. Patient awake and alert, still unable to talk, lips pink, diaphoretic. Care turned over to Paramedics on site. No h/o allergies or anaphylactic reactions. H/O anxiety and on Prozac.

Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: pt's tongue felt funny, then her throat felt tingly, progressed to throat beginning to close. given 50mg benedryl and 20mg pepcid at pharmacy and she went by ambulance to ER. she will undergo further testing this week at allergist to see if she is allergic to polysorbate and peg.

Received her first dose of the Pfizer COVID-19 vaccine on Sunday May 16,2021 at around 2:50 pm. At around 7:20 pm on May 16,2021 she stood up to walk to the bathroom. She began feeling nauseous when she stood up. While she was washing her hands, after going to the bathroom, she began to have difficulty with her vision. She describes white and blue dots obstructing her vision in both eyes. She also began to experience loud tinnitus. She described hearing multiple frequencies. The problem with her vision and the tinnitus continued as she walked through our house to a couch where she laid down. The vision problem and tinnitus continued while she laid on the couch. Her breathing was rapid but she thinks this may have been due to the stress caused by her other symptoms. This episode lasted for several minutes and then the vision problem resolved. The tinnitus continued for several minutes after the vision problem resolved. The intensity of the tinnitus slowly decreased until it finally stopped. The following evening, she experienced tinnitus for a few minutes but it was less intense than it was the previous evening. She very rarely has experienced tinnitus in the past. She has very infrequently experienced brief episodes of orthostatic hypotension when she was dehydrated. When this event occurred, she felt like she was well hydrated. This event lasted much longer and she has never experienced this problem with her vision in the past.

After 15 minutes of observation Pt. went to car, en route to car pt. started feeling throat tighten and felt trouble breathing. Pt. was escorted to the back where she was monitored for an additional fifteen minutes. Pt. stated that she was feeling better. Pt. left the facility with no further incident and was speaking in full clear sentences without any obvious difficulty.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium

Dry, itchy throat with some throat swelling. Clamminess, dizziness and paleness. Local emergency services requested for assistance

About 30 minutes following vaccine developed arm pain and a sensation that her throat was closing and wheezing. Took a Benadryl tablet. Presented to emergency department the following day at 1433 at that time no feeling of throat closing. No swelling of the uvula or any tissues examined in the pharynx. No wheezing.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild, Additional Details: Patient felt dizzy and blackout/ fainted for less than 10 seconds. Vommiting and blood pressure on the low 96/64

PATIENT RECIEVED SHOT IN LEFT ARM BEFORE SITTING DOWN IN THE WAITING AREA FOR 15 MINUTES WHILE WAITING FOR 3 FAMILY MEMBERS TO RECIEVE VACCINATIONS. ABOUT 10 MINUTES AFTER RECIEVING THE VACCINATION, PATIENT STARTED WHEEZING AND STRUGGLING TO CATCH BREATH AND SAID SHE FELT THAT HER THROAT WAS TIGHT. AT 2:16PM, PHARMACIST ADMINISTERED ONE EPIPEN TO THE LEFT LEG. PARAMEDICS CAME AND CONTINUED THEIR ASSESSMENT BEFORE TAKING PATIENT TO THE HOSPITAL.

Sudden onset severe excruciating upper body pain including back, abdomen, chest, throat, neck causing difficulty moving, difficulty breathing, difficulty speaking, nausea. Severe pain lasted 20-25 minutes then slowly diminishing over next hour. After severe pain diminished, ongoing symptoms included severe fatigue, lack of fine motor coordination, brain fog, weaknesses.

Patient received c19 vaccine Pfizer - lot EW0178 at 1437 on 5/26/021 At 1443, patient was given 0.15mg Epi in left thigh due to reaction. BP 104/68 P: 63 O2: 97% RA (laying) BP 101/70 P: 88 O2: 98% RA (laying) Patient was seen with her head back in her chair, then sliding down the chair with her eyes rolled and unable to breath. RN assisted Patient mother at side Lab Mgr present Patient was kept on the floor until 911 arrived for EMS transport to Hospital.

Moments after the vaccine administration, pt started to experience difficulty breathing, lightheadedness, flushing of the face, swelling of lips. Epinephrine 0.3 mg IM was administered, 911 contacted. A few minutes after the epinephrine administration, pt started to breath better. EMT came in within 5-10 minutes. Checked pt's vitals, administered required care and took the pt to the ER.

Started having hives on chest, shoulders, then on my face and Waist. Then at 1:00AM on 5/29/21 I started to have a hard time breathing and feels Ng anxious.

Developed anaphylaxis with abdominal pain, nausea, vomiting, shortness of breath, chest pressure, hypotension and urticaria. Required IM epinephrine -> epinephrine drip as well as steroids and antihistamines.

Immediately got a shooting pain in arm with light headness. Got pale within 30 seconds. Started to have a seizure with uncontrollable arm and leg movement. Arms went limp broke out in a clammy cold sweat. Pupil got enlarged and were unresponsive. Patient blacked out and this continued off and on for 15-20 minutes post injection. Had very labored breathing. EMS arrived and attended to patient

After the patient was vaccinated, she stating feeling ill. She was lightheaded and with problems breathing. We gave her Benadryl but still reported she was feeling bad and asked for an ambulance.

Patient was a 15 yo female. She came with her mother to get the 1st Pfizer vaccine. She was fine the vaccination room. However, after 15 minutes after the vaccine, she started to having a shortness of breath. Her face started to turn pale, she ended up passing out for 2 second which also led to 2-3 seconds of seizure. Two minutes after the event, she still look tired, mother ask to call 911. Paramedic came and check on patient as well as conducting a series of questions. After roughly 15 minutes, paramedic left and patient's mother refused to transport to the hospital. Paramedic inform patient to check with pediatric as soon as possible. Patient looked okay and back to normal state.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild

Patient received vaccine dose around 13:20. At approx. 13:25 patient began to audibly wheeze, became pale, diaphoretic, and had mild circumoral swelling. Patient received 0.3 mg epinephrine via EpiPen at 13:26, and 911 was called. Patient lost consciousness at 13:27 and pt was lowered to floor from chair to prevent a fall. Patient immediately regained consciousness. Patient was transferred to a chair and vitals were obtained at 1330. BP 112/60, HR 86, SPO2 96% on rom air. Mild wheezes bilaterally over anterior bronchi, all other breath sounds clear throughout. EMS arrived, patient was still slightly pale and was transported to ED. Upon leaving, patient was AOx4, ambulatory, and without respiratory distress. Per ER note, patient was given Benadryl and solumedrol by EMS. At the ER, patient received NS bolus 1L, and Benadryl 25 mg orally. Patient was medically cleared by ED MD to go home at 17:58 pm on 5/21/21

tired; coughing; Breathing reaction; This is a spontaneous report from a contactable consumer. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23May2021 (at the age of 15-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included allergic to amoxicillin where it was a couple of times when she was little and she would get blotches and red; and has been vaping without her parents knowing. Concomitant medication included etonogestrel (NEXPLANON). On 23May2021, the patient experienced breathing reaction. The mother stated that her daughter took the vaccine, she was 15, she was aware of the normal side effect problems and heart problems as she has been hearing in the news, she was concerned because she just figured out her daughter has been vaping without her parents knowing. The mother stated that she was a family therapist, and many teens vape age 12-15, parents don't have a clue about vaping and the chemicals in the vape that can cause heart and lung problems. She was contacting Pfizer because she wants to make sure this was in the radar, because of side effects. They should consider asking these types of things prior to administering the product. The mother was concerned watching her daughters breathing reaction. Her daughter was better today. The mother was reading side effects on vaping and there was some link to heart and lung issues, some even have lead in the chemicals or nicotine. The mother stated that she has also realized, in general when people ask if they are taking medications, especially for women they don't say anything about taking pills, or combination of pills. Her daughter experienced a Breathing reaction after the first dose. She was better today, she took the shot on Sunday, she was tired and coughing on an unspecified date but was better now. Her main concern was the age group and the Heart problems for this group. Her First Dose was on 23May2021, she was worse yesterday but today she was better. The breathing reaction started on the 23rd. Yesterday her daughter was in bed all day. Her daughter has made no physician office visit or went to the emergency room because of this. Treatment: Not to her knowledge, Unknown for breathing reaction. The mother again stated that she just wanted to express he concerns with this age group. The patient was recovering from all events. Information on the Lot/Batch number has been requested.

Anxiety, hyperventilation-States "common when getting injections." (1st injection at AACO-DOH on 5/15/2021 EW0183) @14:23 HR=80 SPO2=100% BP=114/65 @14:32 HR=78 SPO2=100% BP=112/74 @14:35 Left vaccine clinic

Myasthenia gravis exacerbation causing respiratory failure and intubation. Today is day 12 of symptoms. She also has profound weakness from her myasthenia gravis. Treated with intubation, high dose steroids, and increased pyridostigmine.

The evening of the vaccine Maddison had slightly labored breathing, pins and needles feelings in feet and hands. Fever, body aches. The morning after while taking their temperature, Maddison said she couldn't see anything then fell into my arms. Her pupils quickly dilated, she made gutteral sounds while shaking slightly then lost consciousness. I couldn't see her breathing for about 15 seconds and she was confused when she came to. She couldn't hear, see or speak during the episode. We took her to the emergency room where a chest xray and ekg came back clear.

Patient got her 2nd Pfizer Covid-19 shot at 5:45 PM on Tues 6/8. She had some of the typical side effects the next day- a sore arm, flu-like body aches, a headache and fatigue. In the middle of the night Wed night/Thurs morning at 3AM she woke up with chest pain and difficulty breathing. In her words, her "heart really hurts and it is hurts to breath." I gave her 1 (500 mg ) capsule of Tylenol. This was the first pain reliever she had received post shot. She also applied Frankincense oil over her heart. Patient was unable to go back to sleep for a few hours because it hurt too much. She did finally fall back asleep in the early morning hours. Yesterday (Thursday 6/10) she reported that she was feeling a lot better. Her heart was still a little painful but by today, Friday 6/11, she says she feels fine. When I heard on the news about a number of other children between 12-15 who reported heart pain, I thought we should let you all know. I am a little worried that there might be some kind of long term complication for her heart.

itching all over, even in her ears; feeling short of breath; Chest hurting; itching all over, even in her ears; skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs; This is a spontaneous report from a contactable consumer (patient's grandmother/Guardian). A 15-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0167, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 19May2021 at 16:30 hours as 1st dose, single dose (at the age of 15-years-old) for COVID-19 immunization. Medical history included seasonal allergy and allergy to cats (from an unknown date and unknown if ongoing). Patient had no covid prior vaccination. Concomitant medication included clonidine extended release (ER) at a dose of 0.1 mg daily taken for an unspecified indication, start and stop date were not reported. Patient was not covid tested post vaccination. 0n 19May2021 at 19:45 hours (about 3 hours after receiving her shot), patient complained of itching all over, even in her ears, patient also mentioned her chest hurting and feeling short of breath. Patient was not sure whether her skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs, possibly because that was the area uncovered so she could see it. The blotchiness and chest pain resolved quickly, but the itchiness continued. Patient also complained of stomach pain, which occurred after patient's grandmother gave her a loratadine. The loratadine settled the itching down, but patient reported nausea the next morning and shortness of breath, as well. Patient received Claritin 24 Hr for the events as treatment. The outcome of the skin was red from scratching it, but thought it had been somewhat blotchy, too, on her legs and chest hurting was recovered on May-2021 and recovered for rest of the events in 2021 Follow up needed, further information has been requested.

Patient presented hyperventilating, tachycardic and eventually became apneic and required intubation; had COVID in the past; was COVID IgG positive; troponin normal; ECG sinus tachycardia; all other labs normal on 5/22 and 5/23

Has signs of myocarditis with pain near her heart and a pressure in her chest with breathing that feels a bit labored with deep breaths, but she isn't experiencing difficulty breathing. She complained of the symptoms on Thursday morning and then we saw on the news that night that this was a newly discovered side effect for younger patients receiving the vaccine. She has not met with the doctor yet because she didn't want to miss final tests at school and the offices were closed for the weekend. However, we have been monitoring her closely and had hoped it would disappear by now, but we will be seeking treatment tomorrow since it has not gotten worse, but it also hasn't improved after 4 days of rest.

About an hour after receiving the 2nd vaccine, she developed a pain in the upper-mid sternal area. She's not had any pain like this in the past. The pain remained constant ever since it started, and there don't appear to be any alleviating factors such as position changes. Deep inspiration makes it worse. The pain radiates at times across the upper chest and down the back. She's had some accompanying nausea. She's also noticed feeling a little short of breath as the day progressed, which is not necessarily related to the pain. She denies any palpitations or dizziness. No near syncope or syncope. The pain remained a maximum intensity of 10/10. She therefore presented to the ER. Diagnostic studies including labs, EKG and a CT pulmonary angiogram were performed. Troponin returned as elevated, but without EKG changes. She was transferred at the time to the Medical Center for admission. Echocardiogram was completed and normal. Vital signs remained normal. Troponin trended down. Pain improved and she was discharged home.

My daughter received her second Pfizer vaccinations at 2:15 pm. At 1230 at night she work up with stabbing chest pain in the center of her chest that lasted three hours. She initially said her felt faint and couldn?t catch her breath as well as initial nausea. Being an advanced healthcare professional, I spent five minutes of asking her questions: did she eat something bad, did she feel like she needed and inhaler, did she need to use the restroom, checked her pulse (100bpm with palpitations), no resolve. We live 5 minutes from hospital where we prefer to go, but my daughter didn?t think she could make the five minute ride there. We went to ER that is around the block from us and it was total chaos. 40 + people in the waiting room to be seen. My daughter was visibly in distress, crying and couldn?t keep still because of the intense chest pain she rated a 10 out of 10. Finally they did a 12 lead EKG. The rolled us to the back of the waiting room. After 15 minutes, I rolled back out to the front desk and no attention to her and her severe chest pain. Finally I announced we were going to hospital. The called back to us? ?Good Luck!? Got pt to hospital and the immediately did EKG, lab work, chest x ray, urinalysis. The chest pain became intermittent then final subsided. The doctors ruled out pneumonia, No PE, EKG WNL, lab work fine. The Doctor stated it was chest wall pain and gave us a NSAID prescription. I talked to my sister who is an nurse works in the vaccination clinics. She said she has had patients who have had bouts of pericarditis and pleurisy after the second shot. That motivated me to google second dose Pfizer reaction in teens. There is a rare side effect of myocarditis in the teen population after the second dose. The publication date was June 4 the day before my daughters reaction. I didn?t thinsk the ER physician was aware of the the possible rare side effect of myocarditis in teens. I was happy with the care we did receive.

Pt reports she had her first dose of Pfizer Covid vaccine on 5/17/21. The following week she had a very heavy period that lasted longer than usual with severe cramps and occasional lightheaded/dizzy spells. After her cycle ended, she continued having brief episodes of dizziness, usually when going from sitting to standing, usually resolved quickly (after a few minutes) with rest. Over the past two weeks, the episodes have become more frequent and intense, and over the past few days episodes also include s/s of seeing spots and having blurred vision with nausea, SOB, and palpitations/tachycardia. Tonight while at lacrosse practice, pt suddenly became dizzy and felt like she might pass out, became diaphoretic and pale.

Approximately 2 hours following the patient's first dose of Pfizer Covid-19 vaccine the patient experienced an anaphylactic reaction. She had hives, face swelling, and throat closing symptoms. She visited a local hospital emergency department for treatment including epinephrine.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: Patient had fainting/suncope 5 minutes after getting 2nd dose of Pfizer vaccine. Her BP dropped to 52/25/35 with shakiness. She recovered with full consciousness very quick after 2 minutes, but it took for 20 min for her BP back 97/75/96. Advised to go to Urgent Care immediately.

Tightening around heart and chest area. Heart feels constricted and squeezed/tightening. Have a hard time trying to breath deeply. Headaches, felt fatigued, and heart hurts,, which lasted for 2 days.

Felt tightness in chest and said it was harder to breath. Around two weeks after the shots started to have reflux like symptoms and started vomiting up food. She is having difficulty eating and has been gagging on her food. We are setting up a visit with a physician but she has not yet seen a doctor.

Two hours after the second dose of the vaccine my daughter developed a sore throat. The next day she felt better but her throat still hurt. On the fifth day she complained that she felt like she couldn't breathe so I took her to the ER. She was diagnosed with an Allergic reaction because her throat was swollen and she was prescribed some Prednisone. They gave her Benadryl and Steroids. It has been nine days and it seems to be a little better but her throat still hurts and she is very tired.

About 10 minutes after receiving the Pfizer vaccine patient thought she was having an allergic reaction. She said her throat felt tight and like it was closing and she could not take a deep breath. I told the patient to take sips of water but she said that wasn't helping. Her throat still felt very tight and she couldn't breathe. I gave the patient 1 benadryl 25mg capsule. I continued to ask her to sip water and take deep breaths. After about 10-15 minutes she said she still felt like someone was choking her. I gave her another 25mg benadryl. The entire time the patient's mother was present and consented to provide Benadryl. After 10 more minutes, the patient said she still did not feel well, but did not want an Epi-Pen. Another pharmacist called WellNow (in our parking lot) and they said the patient could go there to be monitored. WellNow said the patient was just tired and they did not administer any further medication.

acute pancreatitis ; Pt awoke at 4 AM day after her COVID vaccine with abdominal pain. Pain abided some and she was able to fall back asleep. When she woke up in the morning she had crampy pain in the epigastric abdominal area. Pain is constant, worsened some with laying down and improved with sitting up. She feels like she has some mild difficulty breathing when she is lying flat. She has not been able to eat much because eating makes her feel like her stomach is going to explode. She is barely keeping down much water due to pain. She denies any nausea or vomiting.

At around 9:25 am on Thursday, June 17th, 2021, a fifteen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at approx. 9:38 am. The Pfizer vaccine was administered at 9:45 am. Patient was one of the first minor patients of the group that complained of a severe headache to observation nurse. Observation nurse gave Gatorade to the patient and she took a sip of Gatorade and was calm afterward. One of the patient?s guardians instructed her to head back to the van with the rest of the group. At approximately 10:33 am observation nurse notified charge nurse that another minor patient was having a reaction to the vaccine in the parking lot area. One of our site specialists was the first to attend to patient. Site specialist stated that she saw the patient walking with one of her guardians in the parking lot and looked like she was about to faint. Charge nurse hooked up patient to the pulse oximetry and called 911 at approx. 10:34 am. The patient?s O2 level was 83 with a pulse of 107. The charge nurse observed that the patient was under a lot of stress and was hyperventilating and unable to verbalize how she was feeling. Shortly after, the patient fainted due to hyperventilation. Observation nurse advised the patient to calm down and take deep breaths but the patient did not comply and continued rapid breathing. The patient started to vomit and made some gurgling sounds in her mouth and the charge nurse with the help of site specialist laid the patient on her left side. Shortly after, the patient stopped breathing. Observation nurse administered the epi-pen on the patient?s right thigh. Immediately after administering the epi-pen, patient started to breathe again with an O2 level of 98 with a pulse of 110; but the patient was still unconscious and unresponsive. At approx. 10:36 am first responder paramedics arrived at the scene and took the patient to hospital for further evaluation.

Dizziness/lightheadedness; Nausea; Blurred vision; Terrible headache; a little palpitation; Clogged throat; this heaviness (not clarified); This is a spontaneous report from a contactable consumer (parent). A 15-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 16:00 (Batch/Lot Number: EW0182) as single dose for COVID-19 immunisation. Medical history included no other illness. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received Amoxicillin, Azithromicin, Cefdinir, Gardasil(Pf) and had allergy. The patient had Nausea that does not go away with Gardasil. She also received HPV vaccine previously and experienced nausea and the dizziness for a month. Reporter stated, "she did not have any allergic 'condition' (not clear) but she was allergic, she had always had a rash when she had this Amoxicillin this antibiotic. She was allergic to Penicillin." The patient had the COVID Pfizer Vaccine on 15May2021 and as soon as she had her first dose she started to feel nausea and dizziness and from there 5 days later she had, she felt a terrible headache, 'this heaviness' (not clarified), headache, dizziness, palpitation. The reporter took her to the emergency room, they did all the test and they didn't really see anything in the results. From there she cannot stop to have nausea and dizziness and clogged throat so the reporter had to give allergy medication to her every day. She did have, she never had an allergic reaction to any vaccine but the HPV vaccine (captured as unspecified vaccine in tab) what was similar to what she is experiencing now. She had nausea and the dizziness for a month that she couldn't stay in school and she has this nausea and dizziness and clogged throat she has to run for this allergy medication what normally she never needed. So, she doesn't want to take this second dose and the reporter was wondering if it is Pfizer because she was just like (Height), a (Weight) pounds if because the reporter understand the vaccine is one for everybody, isn't this strong for a kid with that height that weight, that you do not needed the second dose. The patient could not she said she will not because she goes to school and she feel the nausea and dizziness and so. The reporter would like to report it because it maybe Pfizer's that she was thinking that 1 dose would be enough for kids. When asked about the start of experiencing adverse events, the reported stated that "Well the nausea and dizziness, she was a little bit not sure about like headache right after like her we stayed there like half hours because the doctor said to stay there because she has her reaction to which but then we just the reporter felt the nausea and everything was so bright you know, the reporter had the same effect but her went away and the patient after we received she was, the whole day but not too bad, 5 days after then she but she was already with this nausea, dizziness and 5 days after she got the palpitation, bad headache, nausea, dizziness and then I took her to the emergency room." Reporter stated, "No they have improved, the only thing now left is every day she has this nausea, dizziness and then she said about dizziness and then nausea and then clogged throat and then the reporter gave her the 'allergic pill I gave that, to this allergy' (not clarified further) really she gave only 1 tablet a day." Reporter stated, "On 20May2021, they did a blood test, they did urine test, they did a ECG, so the hospital did all and the doctor too, nothing new." The reporter had lab test result on chart, she stated they put on her chart but she also had the copy of the results. Okay, here they put the result is a line on the chart. Okay here they put like linear line lab test complete, she get all the line because here they didn't put results but screen for metabolic and kidney disorder they did, they did an 'urinary tract infection' (not clarified) they have marked in the ECG. Okay you going to ask for specific (incomplete sentence)." The patient had no other illness but reporter need to know what Gardasil and Covid 19 vaccine have in common because the symptoms were very similar. Nausea that does not go away. She asked if it is the preservative or what ingredients. Never had a reaction to any other vaccine. She just wanted to call the Medical Department if she should have the vaccine on Saturday or not. On 15May2021, 4:30 AM, the patient experienced dizziness, nausea, lightheadedness, blurred vision, headache, a little palpitation (as reported). The patient received treatment Children allergy medication. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events clogged throat, heaviness was unknown and other events was not recovered.

PATIENT SHOWED UP FOR THE APPOINTMENT FOR HER 2ND DOSE. WHILE GOING THROUGH THE , EVEN THOUGH PATIENT (PARENT) MARKED NO ALLERGIES, I ALWAYS STILL RECONFIRM WITH PATIENT THAT THERE IS NO ALLERGY. PATIENT WITH HER PARENT (MOM AND DAD) PRESENT INDICATED THAT SHE HAD LOST LIP COLOR (PALE), VOMITING, DIZZINESS, SHORTNESS OF BREATH. PATIENT WENT TO THE ER AND HER BLOOD PRESSURE WAS LOW AND HAD IV GIVEN TO HER. SHE WAS RELEASED THE SAME DAY. PATIENT DID NOT CALL THE PHARMACY AFTER THE REACTION. PATIENT IS ALSO NOT SURE IF THE ER HAD REPORTED IT. FOR THIS REASON WE ARE REPORTING THIS EVENT.

loss of consciousness; nausea; vomiting; stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83%; Difficulty breathing; severe Headcahe; This is a spontaneous report received Support from a contactable nurse from Pfizer sponsored program via medical information team. This case pertains to patient 3 of 3. A 15-year-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: ER8727; Expiry Date: 31Jul2021), dose 2 via an unspecified route of administration on 17Jun2021 (at the age of 15-year-old) as a single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as a single for COVID-19 immunisation and had no reaction. On 17Jun2021, after 15 minutes of observation, the patient had a severe headache, difficulty breathing, loss of consciousness and stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83%. On an unspecified date, the patient also had nausea and vomiting. The patient pulse ox (documented as provided by caller) went down to 83%, she had severe headache, nausea, vomiting and she was unconscious. When she was unconscious was when her pulse ox was 83% and she stopped breathing intermittently for 10 to 12 seconds at a time. Then she started breathing again but was not responsive after she received the epinephrine then her pulse ox steadily rose again but was not responsive. She was like this until EMS took her away. The reporter stated that the most severe case was for this particular patient. She had already been vaccinated and had already gone through the 15 minute observation. All these kids came in a bus together, but this patient was sitting in the vehicle after the observation when the guardian brought her back to the nurses saying that she was complaining of a severe headache and at that point she had difficulty breathing and lost consciousness. The nurses reported that it appeared that she stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83%. At that time they administered epi (epinephrine) and called EMS. Her pulse ox and her breathing improved after the administration of epi, however she remained unresponsive when she was on the way to the hospital with EMS. The patient was taken to the hospital and she did improve. This was the 2nd dose, she had the 1st dose and did not have a reaction to it. The seriousness of the events severe headache, difficulty breathing, loss of consciousness, stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83% was reported as medically significant. The reporter stated that it was very serious. This patient reaction was a little more intense than just an anxiety induced reaction. She says with a pulse ox of 83% if they had not intervened then this would of been life threatening. It is medically significant but if they had not intervened then it would have been life threatening especially when you're talking about gurgling and a pulse ox of 83%. The reporter tends to think that with that severe of a reaction, with the pulse ox that low and her being unresponsive, she believes that this was probably a true adverse event. Outcome of the events was reported as unknown. The reported causality for the events severe headache, had difficulty breathing and lost consciousness, stopped breathing several times for multiple seconds and they described her to be gurgling when her pulse ox went down to 83% was reported as related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events respiratory arrest, loss of consciousness, dyspnea and headache and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

12 hours post vaccination she got a fever 102.9F, chest pain, chest tightness, shortness of breathe, headache and achy. Fever last 24 hours, chest pain/tightness with shortness of breathe for 12 hours. Headache, sore throat, fatigue, cough lasted 48 hours.

Patient presented with chest pain and pleuritic pain the day after receiving her 2nd COVID vaccine. Treated with ASA x1 and scheduled Ibuprofen. Pain improving

feeling like going to pass out; difficulty breathing; chest pain; Moderate headache; fatigue; moderate muscle aches; joint pain; This is a spontaneous report from a contactable consumer. A 15-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 06Jun2021 at 11:15 (at the age of 15-years-old) as dose 2 single for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), mood disorder, asthma, NKA other than seasonal outdoor allergies and minor lactose intolerance from an unknown date. Concomitant medications included methylphenidate hydrochloride (CONCERTA); oxcarbazepine (TRILEPTAL) and salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0185 and Expiration date: unknown), via an unknown route of administration, in left arm on 16May2021 at 11:00 (at the age of 15-years-old) for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. On 06Jun2021 at 12:00, the patient experienced moderate headache, fatigue, moderate muscle aches, joint pain, chest pain, difficulty breathing and feeling like going to pass out. Lasted for exactly 48 hours. The case was assesses as non-serious. Patient received Ibuprofen and steroid inhaler as treatment for events. On an unspecified date in Jun2021, the events were recovered. Follow-up attempts are needed. Further information is expected.

My daughter developed shortness of breath Sunday morning 6/27. She thought it was her asthma and took 2 doses of her rescue inhaler. That didn?t help and she said she had chest pain. We went to the emergency room at hospital. She was admitted for pericarditis and elevated troponin level.

client driven by mother, c/o sharp chest pain 8/10, visibly upset, grimacing during inspiration. paramedics on site were called and took vitals bp 100/65, 02 99%, HR 70. After about 15minutes, pain was 3/10 resting, 5/10 during inspiration. EKG conducted, WNL. Client and mom AMA to be taken to the hospital. Client stated she was feeling "a lot better" at 12p . Mom said that she will drive client home and will go to ER if condition worsens.

tightness/pressure in chest, hard to breathe, feeling of congestion, cough after a couple of days. All of this in addition to full body aches, headache, 4 days of extreme fatigue and fever. Chest pain last for days after all other symptoms cleared. (no reaction to first shot other than slight headache, soreness at injection sight and slight fatigue.)

She developed a fever around 10:46pm of 101.5 and a very fast heart rate over 137bpm. Shortness of breath and immediate chest pains..

At 10:30pm she developed fever of 101.5 , along with a very fast heart rate, and shortness of breath..

Patient developed fatigue 3 hrs post injection. The following day, developed fever to 103F, nausea and vomiting, dizziness and pleuritic chest pain, difficulty breathing. fever last for 2 days. Went to ED for evaluation on day 3 (7/1). Symptoms ultimately resolved, but then developed facial hives and facial swelling on day 5 post vaccine.

Beginning on the day after thee 2nd shot:severe stomach pain, fever, fatigue, bloody loose stool, fever went away after several days but digestive problems persisted. Elevated heart rate gradually beginning to be noticeable and bothersome with a feeling of being "winded". This also was totally out of character for my daughter who is a runner. She has never had any symptoms like this before.

PATIENT GOT VACCINE AND STARTED FEELING DIZZINESS AND VOMITING. PATIENT WAS HAVING DIFFICULTY BREATHING. CALLED 911 AND IN LESS THEN 5 MINUTES THEY ARRIVED. PATIENTS BP WAS 80/50 AND TOOK HER TO THE HOSPITAL

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium

Patient fainted approximately 5-7 minutes after receiving her vaccine. Patient was breathing rapidly, had tingling in fingers, felt warm, blurred vision

continues cough, heavy body pain ,shortness of breath, dizziness, low blood pressure, high heart rate, pain full boils on body, sore throat,

Began having tightness in the throat and difficulty getting a deep breath within 14 minutes of receiving the vaccine. Voice became hoarse. Later lips began to swell. IM Benadryl and epinephrine were given. Then she was taken to the Emergency Room. Symptoms continued and she was given Solumedrol.