Pfizer

First time seizure 6 days post vaccination GTC w/ post ictal state. Unknown duration of seizure. Back to baseline in ER

clear fluid was accompanied with some blood thereafter; some of the vaccine leaked out of her arm; some of the vaccine leaked out of her arm; held the needle too long at the arm; This is a spontaneous report from a contactable consumer. This consumer (mother) reported for a 12-year-old female patient (daughter) that. A 12-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0185),via an unspecified route of administration, administered in Arm Right on 18May2021 17:00 as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18May2021 the patient experienced clear fluid was accompanied with some blood thereafter, some of the vaccine leaked out of her arm, some of the vaccine leaked out of her arm and held the needle too long at the arm. Caller called for her 12 year old daughter who received her 1st dose of the Pfizer COVID Vaccine yesterday at 5:00pm MST at a Pharmacy. She mentioned that 5 out of 6 of them in the family were over 16 years old and had no problem with their vaccination as they received it at a different Pharmacy branch. She mentioned that the branch she went to yesterday for her daughter was very unorganized. The vaccination was held at a drive-thru in which she noticed that the Pharmacy Technician held the syringe too long on her daughters arm and when he pulled out, some clear fluid flowed out and ran down her arm and she started bleeding. She already went up to the Pharmacist and they mentioned that they will call Pfizer within the week. She is called for herself just to make sure and seeked recommendations for events such as these because she is doubtful that her daughter even got enough of the 1st shot. She is wondered if she should restart the dose, how long should she wait if she restarts, or just proceed with the 2nd dose. Consumer called about Pfizer COVID-19 vaccine who reports her 12 year old daughter supposedly received her first dose yesterday at a pharmacy at 05:00PM MST. Agent reports that caller also mentioned that 5 people in their family above the age of 16 received doses at another pharmacy and had no problems, but her daughter who took her first dose yesterday at a drive thru of a pharmacy had a problem. Agent reported caller said that yesterday the tech who administered the first dose held the needle too long at the arm and when they pulled it out some of the vaccine went out, some clear fluid leaked out of her daughter's arm, and was accompanied with some blood thereafter. Agent reported that caller was advised to consult their physician and let them know Pfizer Medical Information's number so they can contact and discuss options. Caller said she would say that she was not very far from her daughter's arm when it happened since she was sitting next to her. She said she saw a fat drop of clear liquid run down her daughter's arm, and then after that came down, after it came a drop of blood that leaked down into it, so that it was clear at first then became pinkish. She said the person who gave the injection to her daughter had to grab something to wipe it because it was traveling down her arm. Caller said that there was no treatment done to her daughter's arm other than when he wiped it off and slapped a band aid on it, and then he didn't make eye contact with her and didn't want to talk about it. She understood that things like this can and do happen sometimes. She said she should have taken her daughter to a doctor but she didn't. Said her daughter did not have any other vaccinations yesterday or any other vaccinations in the last four weeks. The clinical outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.

Anaphylactic shock; This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old female patient received BNT162B2, (COMIRNATY, lot #: EL3302), via an unspecified route of administration, administered in Arm Left on 25May2021 14:17 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not received other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced anaphylactic shock on 26May2021 22:00, It lasted for about 30 hours for her daughter and got worse over time until her entire body was red and swollen on May2021. Caller stated they went to the Emergency Room and her daughter was given an epi pen and steroids because antihistamines were not helping. Caller mentioned later in the call that her daughter went to her doctor on 27May2021 at 1300 for this, to Urgent Care on 27 May2021 at 2100 for this; and finally to the Emergency Room today 28May2021 at 0200 and was treated in the emergency room and not admitted to the hospital. Caller stated her daughter was improving since being treated at the Emergency Room. Patient went to physician Office. No relevant tests was reported. Outcome of the events were not recovered. Follow up needed, further information has been requested.

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.

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

Diagnosed with acute promyelocytic leukemia within 48 hours of vaccine administration. Developed fevers immediately after vaccine, thought to be appendicitis, but diagnosed with leukemia. Currently undergoing induction chemotherapy.

Patient started having bilateral arm weakness on 6/13. She was evaluated in emergency room and found to have markedly elevated CPK to >7000 and mildly elevated AST (195) and ALT (70), and was diagnosed with rhabdomyolysis and admitted to hospital where she was treated with IV fluids. Her CPK peaked at 11,400. She improved on IV fluids and was discharged home on 6/16. On follow up visit in clinic on 6/19 her CPK had improved to 1151, her liver enzymes were trending down and her symptoms were completely resolved. Hospitalist felt rhabdomyolysis was due to activity as patient had been training for a black belt, but parents report no recent change in training schedule or intensity and concerned that this may be effect of vaccine given timing of onset of symptoms

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Mild

Within minutes after receiving 1st dose of Pfizer-BioN Tech covid Vaccine 0.3 ml IM, patient complained of dizziness and fell to the ground. Patient was very pale and cold to touch, not being responsive well. Patient was losing consciousness and having difficulty keeping her head up. Patient was moved to lie down on the floor with legs up. Cold water was offered and patient took a few sip. EMS was called. Patients eyes rolled back into her head and lost consciousness/possible anaphylactic shock and not being responsive. Epipen 0.3 MG IM administered. Patient regained consciousness. Nurse practitioner was called and vitals including BP and oxygen level was performed and found to be stable. EMS arrived in few minutes and vitals were checked again by EMS personnel and patient was transferred out to nearby ER. After 3 and 1/2 hours at the ER for observation, patient was discharged.

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

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

Fever onset day after second vaccine dose, associated with gross hematuria, proteinuria and rhabdomyolysis (metabolic crisis due to Very long chain acyl carnitine dehydrogenase deficiency VLCAD). Admitted to the Hospital on 6/12 with hypertension and elevated creatinine. Renal biopsy c/w IgA nephropathy. She was discharged on 6/23 on prednisone 60 mg daily with plan for slow taper. Acute kidney injury, proteinuria, rhabdomyolysis and hypertension improved at discharge. She had 2 additional admissions for elevated CK on 6/29 and 7/6. CK improved with IV hydration and glucose, and both admissions were <48 hours. Of note, patient had transient episode of gross hematuria in 1/21. Creatinine normal, BP normal. Proteinuria and hematuria resolved spontaneously on repeat testing of urine 3 weeks later. Also of note, patient had multiple episodes of rhabdomyolysis as young child due to VLCAD, with most recent episode in 2016. Trigger was viral illness or fasting. Previous episodes had higher max CK >20,000, no prior history of acute kidney injury during these episodes.

Pt developed ITP and anemia 4 days after second vaccination. Mom also states that a few days after initial vaccination, pt had some red spots on skin, but no ecchymosis

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

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

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.

Presented to ER with R sided chest pain during football practice. In ER, abnormal EKG with possible LVH, elevated troponin. Observed overnight. Her troponin normal by next day. She did have platelet 142K, not repeated (I have ordered). CTA showed incidental R sided pneumonia (she had no fever or cough at presentation). Cardiology consulted. They felt EKG was normal. Discharged on Amoxil. Follow up with cardio ordered, will need stress test.

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

Patient has Pericardial Effusion and pericarditis and required a pericardial drain. This even happened 3 weeks after the vaccine and the symptoms the patient had following the vaccine were persistent fevers.

Patient presented to the ER at 630 am with acute onset of generalized hives , itching and vomiting x 2 and was treated for anaphylaxis . SHe was given OM epinephrine and Benadryl with improvement .

anaphylaxis; This is a spontaneous report from a contactable Nurse reported for (patient). A 13-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 07Jul2021(age at vaccination 13 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient visited emergency room for reported events. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced anaphylaxis on 07Jul2021. The outcome of event was unknown. Information about lot/batch number is requested.; Sender's Comments: There is a reasonable possibility that the event Anaphylactic Reaction was related to the use if suspect product BNT162b2 based on known drug safety profile and the close temporal relationship.

patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.

Immediate syncope lasting about 15 seconds with 5 seconds of tonic-clonic activity and brief emesis. Normal mental status within 30 seconds. Initial heart rate 50, and BP 90/60, recovered to normal with BP 100/60 and heart rate 70 within 30 minutes. No signs of allergic reaction or anaphylaxis. Taking fluids and felt well upon discharge.

Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Immediately after administering vaccine, patient bled quite a lot. I wiped the area 2 times times and applied pressure for ~1 minutes. Applied a cotton ball under a band-aid. Within 1 min of the vaccine, the pt developed a pump that appeared to be filled with blood under the surface. She stated that the site felt like "when you initially get poked with a needle". I recommended to take ibuprofen 200-400mg q4-6 hours until the swelling decreases, to apply a cold compress, and call md if worsens.

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

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 reports cough and fever since 5/22. Was seen by pediatrician in clinic on 5/25, diagnosed with pneumonia and prescribed azithromycin. Parent reported compliance with medication but reported that patient started to have coughing fits and fever of 104 at home. This prompted ER evaluation and subsequently admitted to hospital for observation. During admission, patient was treated with IV Ceftriaxone x 3 days and PRN Mucinex for pneumonia. No oxygen requirements, so no further intervention was needed per MD.

The patient developed a severe headache. Grandmother (guardian) helped her sit in the car seat and she took 10 steps away from the car, when she looked back at the patient had began seizing. She was taken to the ER by rescue and diagnosed with having a grand mal seizure. Grandmother states her lips and around her mouth were blue and the seizure was severe. She was treated and released from the ER dept. The patient has been seizure free for 2 years.

The next day after vaccination the patient started having vaginal bleeding that lasted for 30 days. She was even bleeding out clots of blood

6/19/21 patient awoke with non-bloody, bright green emesis and abdominal pain. She endorses several episodes of nonbloody diarrhea with continued abdominal pain. She endorses starting her menstrual period 3 days ago. Mom endorses fever at this time, T-max 102.9. Presented to an urgent care for further evaluation where they obtained a rapid strep test and COVID-19 swab that were both negative. 6/21/21 she presented to an ED for continued and worsening symptoms. She received a dose of antibiotics and saline boluses during transfer to another hospital. In route, she became hypotensive with minimal response to fluid resuscitation. She required vasopressors to maintain blood pressure. A CT of the abdomen showed nonspecific findings for enterocolitis. A urinalysis had 5-15 RBCs and 51-100 WBCs. She was started on antibiotics. She required ICU admission initially, but improved and became hemodynamically stable after about 16 hours in the PICU. Her urine culture grew 3 different organisms with low colony counts so antibiotics were discontinued on 6/22/21. An ECHO demonstrated normal biventricular size and systolic function (LFEF 62%), mild tricuspid regurgitation estimating mildly elevated RV pressure (30-40% systemic), mild flow accelration across normal appearing trileaflet aortic valve and borderline small aortic root and sinotubular junction, normal ascending aorta, no pericardial effusion, normal right, left main, and LAD coronary artery diameter z-score, and mild outpouching in the left main coronary artery that may represent an early appearance of an aneurysm. A repeat ECHO the following day revealed normal biventricular size and systolic function, mild tricuspid regurgitation estimating RV systolic pressure of 30mmHg, left main coronary artery appears slightly prominent but measures within normal limits. LMCA measurement is similar to previous, normal measurement of the proximal RCA and LAD, and trivial pericardial effusion. The patient also had an elevated CRP of 18.8 mg/dL, fibrinogen of 408 mg/dL, d-dimer of 0.98, and nt-pro BNP of 309. SARS CoV2 IgG was positive and IgM was negative. She received IVIG 100 gm on 6/23/21 and was started on rivaroxaban. CRP decreased to 8.2 mg/dL on 6/23/21.

Patient experienced fever and chills day following vaccine. On day two after receiving vaccine, patient developed chest pain and presented to ED. Work up concerning for myocarditis due to chest pain in the setting of ECG changes and troponin elevation. Chest pain resolved prior to discharge from the hospital and patient was back to baseline.

Patient presented ~2 weeks after 2nd pfizer vaccine with chest pain and tachycardia diagnosed with myopericarditis course complicated by pericardial effusion and hypotension which improved prior to discharge.

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

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.

Generalized rash, weakness, swollen lymph nodes, general malaise, fever, chills, one episode of diarrhea and vomiting and headache.

Patient received dose #1 on 5/14/21 and dose #2 on 6/4/21. On 6/30, began to develop petechiae and easy bruising. Presented to urgent care on 7/3 after biting cheek and a large bruise/hematoma developing on the inside of her cheek. Thrombocytopenia identified on labs, resolved in 4 days without intervention.

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.

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.

Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological events; Tics; Tremors; Confusion; Inability to speak or walk or use restroom on own; Inability to speak or walk or use restroom on own; Fine motor skills deficit; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0876, Expiration Date: not reported), via an unspecified route of administration in left arm on 15May2021 at 15:00(Age at the of 14-years old)as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at time of Vaccination. Medical history was none. Known allergies was Nka. The patient received unspecified medications within 2 weeks of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 17May2021,the patient experienced nausea, vomiting, severe body aches, headache, moderate - severe neurological events, tics, tremors, confusion, inability to speak or walk or use restroom on own, fine motor skills deficit and tonic-clonic seizures. Adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized for 4 days. Hospitalization was not prolonged. The patient received treatment and stopped suspected interacting medicine. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0191, Expiration Date: not reported), via an unspecified route of administration in left arm on 06Jun202114:00 as dose 2, single for COVID-19 immunization. The outcome of the events was recovering. ~~ No follow-up attempts are possible. No further information is expected.

experienced a seizure/tonic clonic seizure; she was very confused; This is a spontaneous report from a contactable consumer (mother). A 14-year-old female patient (daughter) bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04Jun2021 (Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation. No medical history included. Concomitant medication included ascorbic acid (VITAMIN C) taken as vitamins from 2021 to an unspecified stop date took one time a day for three weeks). The patient previously vaccinated with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 13May2021 (Batch/Lot Number: EW0168; Expiration Date: 30Aug2021) right arm as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. It was reported that the patient experienced AE after Pfizer COVID-19 vaccine. The reporter stated that the patient received two doses, and then experienced a seizure. The patient was was seen by practitioner, who referred her to call today. The patient got her first dose 13May2021, which was given during the day, before the evening, and injected in her right arm. The second dose was given 04Jun2021, and was LOT: ER8735, with EXP: 31Jul2021 about the same time of day in the same place on the same arm. It was stated that the second dose was given 24 days after (as reported) the first dose. The patient had no side effects of getting the vaccines for a day or two afterwards, nothing. Had no seizures before, which is why they were concerned. It was added that everything was normal they tested in her blood work and everything else. The patient had her seizure on Sunday 11July2021, and they rushed her to the emergency room at 10:00AM. She says her daughter was asleep when it happened, and the seizure lasted about a minute. She says it was given to us by the emergency room that it was a tonic clonic seizure. She says for treatment they did blood work and kept her daughter for observation because she was very confused. She says that they gave her daughter no medications, and she ended following up the next day with the pediatrician, because it happened they followed up Monday with the pediatrician, and they have an appointment with a neurologist 18Aug2021 for a CT scan and EEG. She says all of her patient's blood work came back normal. The patient had no other vaccinations recently and had started no new medications, she only started taking about a month and a half ago vitamin C, just over the counter from and only took it one time a day and she took it 3 weeks, that was it. The reporter added that the has had no previous reactions to vaccinations. The reporter also stated that the patient has kind of recovered, she hasn't had any, she has been checking on her and checks on her at night when she sleeps since it happened when she was sleeping. She says she is fine, they are following up to see what triggered it. The reporter also says that they went home that day they went to the emergency room and they were at the hospital for 3 hours and didn't stay overnight. The reporter added that they got the lab results in today, the office has the blood work results already, but she doesn't have them. The reporter then asked, if after they see the neurologist in August if they need to call back with neurologist information, and results from CT scan, or if they will get back to her to follow up on this? It was added that the Seizure lasting about one minute. Time of Onset was 10:00, 11Jul2021. The Seizure require a visit to: Emergency Room and Physician Office Visit. The patient was not hospitalized. The outcome of the events was recovered.

Patient received her first dose of the Pfizer COVID19 vaccine at approximately 12pm. Patient felt fine immediately after the vaccination and was instructed to sit and wait for 15 minutes. The immunizer, watched the patient sit down in a chair. A few minutes later the mother of that patient began screaming help, help. Patient had fainted, falling on the floor and hitting her head. I ran our to assist patient, I instructed my technicians to call 911. Patient was on the floor, shaking. I assisted her in rolling over. When she came to I helped her control her breathing and take deep breaths. I used I gauze pad to stop the bleeding on her head. I made sure she was lying flat on the floor. We gave her an ice pack to help with the numbness and tingling in her hands. The paramedics arrived and took patient to the hospital.

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".

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.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Turning very pale, passed out and unresponsive, sweating-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: After 5 minutes of vaccination, mom called for help in the waiting area. The patient passed out for a few minutes and responded after we both called her several times. We called 911. She was feeling nauseous. She sipped a little water and was looking very pale and was starting to become unconscious again. Mother thought it was an allergic reaction and asked for Epipen. Epinephrine was administered, and patient became alert and less pale. EMS came and took her away due to low blood pressure

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.

This 15 year and 11 month old female developed fevers, abdominal pain, diarrhea and constant wrenching. She was seen in the ED and noted to be hypotensive and meeting SIRS criteria so was admitted to the PICU and started on norepinephrine pressor support. She had fevers to 39 degrees C and about a day into hospitalization developed acute mental status changes.

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.

Pain at injection site, sore throat, fever, nasal congestion, runny nose, lose of taste and smell, shortness of breath, high level blood clotting factor, pneumonia. Doctor visit on 5/26/21 OSF Virtual visit 5/27/21 , prescriptions prescribed consisted of: Montelukast , Levocetrizine DHCL , Azelastine HCI Nasal Spray , Fluticasone spray (was not administered because insurance would not allow scripts to be filled until 5/28-5/29/21). ER visit on 5/27/21 Treatment on 5/27/21-5/28/21 consisted of steroid via IV, Inhaler, antibiotic Prescriptions prescribed: Albuterol Sulfate , Azithromycin, Prednisone

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.

Very heavy period began, 2 weeks ahead of schedule. Much heavier bleeding began after about 12 hours and has continued for 3 days. This level of bleeding is not typical. Many blood clots have also been passed.

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.

Purpuric Rash started post vaccine day 5 lasted until post vaccine day 23 with first dose. Second dose caused rash to appear within 24 hours. Thrombocytopenia was revealed on day 3 post vaccine dose 2 and continued to drop for the next 48 hours.

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.

4-5 days after dose # 1 she started with heavier than usual vaginal bleeding, passing clots, persisting in the 10-15 days following with dizziness, HA, fatigue, heart racing

15 Year old patient presenting chest pain 4 days after de 2nd dose of the COVID-19 Vaccine. Patient had to be hospitalize, elevated troponin levels, electrocardiogram with normal functions, mild FR, trace MR, thickened pericardium. Normal function Cardiac MRI. Pericardium effusion.

Patient had always had regular periods. Had completed her last period May 22-28. Received the first vaccine on May 30th. Started with vaginal bleeding 6/7-6/11 and again 6/18-present.

Bleeding excessively; It was 4 days early and was the worse period she has experienced in 3 years; Extreme cramps; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female (non-pregnant) patient received 1st dose of BNT162B2 (lot#EW0196) on 30May2021 11:00 AM, vaccine location=Left arm at single dose for COVID-19 immunization. Relevant medical history was Asthma. No any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination included salbutamol (ALBUTEROL), paracetamol (TYLENOL) as needed. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps on 02Jun2021. We thought maybe it was a coincidence. She is only 15 yrs old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun2021 and I pray it was not as bad as last month after the shot. Outcome of reaction/event at the time of last observation was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts needed. No further information is expected.

patient received first Pfizer vaccine and starting 1 day later developed easy bruising and petechiae found to be thrombocytopenic with platelet count of 30 then further progressed along with hemolytic anemia ADAMTS13 activity 0% , clinical picture consistent with acquired thrombotic thrombocytopenia purpura (TTP) requiring therapy with high dose steroids, plasmapheresis and rituximab

Abnormal menstrual cycle started on June 25, the day after dose 2; she already had a period June 10-16. This involved increasingly heavy bleeding, with large blood clots. My daughter became very pale, weak on the morning of Mon, June 28, she fainted, then vomited. Made dr appt and got bloodwork. Started her on iron supplements. Dr said the hemoglobin was at 10.6, but had us get blood checked 3 more times, lowest hemoglobin was at 7.3.

Abdominal pain the evening of July 10th. Vaginal bleeding during the night of July 10th, 2021. Menstruation not expected for 5 days (not until July 15th). It (vaccine) may be coincidental and not the cause. Abdominal pain subsided the night of July 10th (lasted a few hours). Two nurse lines were consulted the morning of July 11th. Both recommended reporting to VAERS. Bleeding continues.

Symptoms began with pain on side on 6/17/2021. Reports feeling heaviness on chest that same night. Was taken to ER and had x-ray where PE was detected. She was transferred to another hospital and admitted for 5 days.

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