Pfizer

Approx 6-7 min after receiving vaccine in left arm. Patient's mother expressed concern about her daughters reaction. She complained of headache, stomachache, weakness in her legs and her eyes rolled back in her head and her head dropped.

Started having symptoms of fever and bodywide muscle aches. Fever reached 102 F. Sought care at medical clinic.

On 5/15, at 4:00pm while in the shower, patient had a pre-syncopal episode with dizziness, and heaviness in her arms and legs. Before she fell I was able to assist her to a sitting position. Her skin was pale and clammy, pulse thready 90bpm, bp 80/50. Symptoms improved after 15 minutes. On 5/21, at 10:00am was outside at a school sports activity. She began to feel slightly dizzy. She ran a short race and the dizziness was worse. She was pale, hr 120, bp 100/60. She drank fluids and rested but still felt unwell and a headache started so she came home. The headache evolved into a severe migraine with several episodes of vomiting. She also felt heart palpitations, which is unusual with her migraines. Hr was 100 and regular. Bp 100/60. Discussed with pediatrician, who patient had seen 5/20. Appointment scheduled with cardiology 5/26

The patient is a healthy 12 year old female with no medical history or problems, she received the COVID Pfizer vaccine #1 on Wednesday, May 19th at 4pm and was asymptomatic at that time. Within about 5 hours, she began to experience extreme lethargy. By the following day, May 20th, she experienced profound lethargy that lasted 36hrs. During this time, she was asleep but arousable with effort, she described general myalgias, moderate left arm pain at injection site, mild headache, no other symptoms. Her profound lethargy lasted through midday on May 21st, upon which time she was able to keep her eyes open and began to regain her strength. By the evening of May 21st, she was fully recovered.

Within 3-5 minutes, she was asking for water and feeling hot. Her back was sweaty. Her eyes looked like they were glazed- not responding; didn't look bright. She got some water and an ice pack on her back and removed her shoes and put her feet up. After drinking the water and keeping the ice pack on for the rest of those 15 minutes. Nurses were there watching her. And she was able to walk out of the clinic on her own power. It had looked like she maybe would have passed out without the intervention of water, ice pack and getting her feet up. She had muscle pain in her arm (of injection site) that day and into the next day. The muscle pain in her arm lasted for about 24 hours.

She was taking Claritin for the few days before this event. She normally takes it every fall and every spring. She had seasonal allergy symptoms on the days leading up to this event- she had sore throat, runny nose, a little headache and congestion and developed a cough; on the day of this symptoms she spiked a low grade fever - 100.5. I did a rapid test for COVID at home which was negative for her. Sudden onset: A bunch of knives poking her on the inside of her stomach - pokey from hips to ribs. She started to double over and bend over. Within 10 minutes, she couldn't stand up. She was telling me that something was really wrong. This isn't her character so I knew it was very wrong. I took her to ER. I was still concerned about appendicitis or COVID. This episode lasted for 90 minutes and then it came and went for the rest of the night and then after that - she had runny nose and congestion (normal allergies after that). She was better before they gave her the medication but it didn't seem like she really needed them. She was improving before she got either of the medications: Zofran; Levsin. They gave her a dosage of each there and sent home with a prescription but we never had them filled as she was feeling better. - As it started to improve - it ( being the pokey pain) it was located closer to her ribs and breastbone.

She started to get a sore throat and drainage the day after the first dose of the vaccine. That day she had headache, sore arm with earache and joint pain. Those symptoms continued for several days with some loose stools which lasted for two to three days with abdominal pain which persisted for a little over two weeks. We visited the doctor because of ear and throat pain and nausea. All tests were negative, but the symptoms improved slowly but they are totally resolved right now.

Fever of 101.5, chills, -body aches, stomachache, headache, high blood sugars 400-500 for 24 hours, sore throat, tired, and sore muscles.

She broke out in hives on June 4, they haven't cleared up yet. She was experiencing intense joint pain this morning (June 9) and we had to take her to the ER. They did blood tests, stated that her blood test for inflamation was mildly high.

Neck pain and spasming - sharp shooting and progressing to ear and temporal pain. Initially occurring a couple times a day and now more frequent. Also, originally started on just the left side of the neck and is now occurring on both sides.

After the second dose she had immediate pain at the injection site and over the next 24 hours she developed: A fever of 101.4 severe abdominal pain and chest pain that made her feel like her heart was being pulled out painful electric shocks down her neck and spine that made her walk hunched over numbness and swelling in the arm she got the shot pain in her fingers and toes that turned white and were ice cold to the touch Over the next 2.5 months her abdominal, muscle and nerve pain became unbearable plus she developed new symptoms: Fatigue gastroparesis, nausea and vomiting Eventually she couldn?t even swallow food or liquids without immediately spitting it up. An itchy rash on her arms peeling skin on her feet Her menstrual cycle lasted a month with large clumps of blood She had unexplained painful cysts vision problems headaches erratic blood pressure and heart rate memory loss, mixing up words and brain fog Dizziness, fainting and then nonepileptic seizures that we suspect were from lyrica verbal and motor tics loss of feeling from the waist down, muscle weakness, abnormal gait and eventually she wasn?t able to walk at all urinary retention From the day she got her 2nd dose to today we took her to the ER nine (9) times and she was admitted to the hospital a total of 3 times totalling 2 months. The last time she was admitted to the hospital she could not walk, was unable to feel or move below her waist, threw up anything she tried to eat or drink, had tachycardia and her blood sugar was at 47. Once she got an NG tube and was stable they transferred her to Inpatient Rehabilitation and she was just discharged on June 1st. Today she is able to walk with a walker and take care of herself but she still has little to no feeling below her waist. She still has an NG tube for nutrition and continues to have GI and urinary retention problems.

Status epilepticus in adolescent with well-controlled epilepsy, last seizure 9/2020. Seizures began 31 hours after second dose of Pfizer Covid vaccine. Headache, chills, myalgias, fatigue began 15 hours after second dose. Tylenol had been given to manage headaches about three times before seizures began. Fever to 101 was noted by EMS and in ER, no fevers had been noted before then.

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

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.

My daughter experienced on day of her 2nd vaccine, feel nauseated in the evening time, then the second day. Felt very lethargic, fatigue, laying in bed all day, sleeping. She still had nausea also experienced chills, highest temp 99.8F. Her arm pit on the right side where she got the vaccine was really sore. She basically like within a couple of days she started her period cycle again and it was very heavy and lasted one week and half almost two weeks. On 06-08-2021, at about 10pm, she was brushing her teeth when she saw black spots and she went to tell me. At about 11:30pm that night, she squatted to pat our dog and when she got up and she felt really dizzy, lightheaded so I got concerned. Her symptoms persisted and I scheduled an appointment with her pediatrician on 06-15-2021. The pediatrician ruled out anemia. Her pediatrician said she has Postural orthostatic tachycardia syndrome. Her pediatrician said that this is something manageable, she needs to strengthen her calf muscles and drink lots of water. They monitored her heart pressure and blood pressure. Her heart rate had increased to 40bpm. I also gave her Ibuprofen medication after the vaccine. Leading to today she has been having dizziness and light headiness every single day. My daughter is still experiencing symptoms, dizzy and light headed today. For her 1st vaccine- within few days after her 1st dose, she experienced when using the treadmill, she would feel very dizzy. I did not think anything of it at first and this happened three times then it stopped. She also had a sore arm.

Mild chest pain starting day after shot (w fever, swollen lymph nodes, muscle pains). Went to ER, told she was ok, then phone call next day telling us her ekg had abnormalities (borderline high qtc and other non-specific findings). Told to follow up w cardiologist. Went to cardiologist on 6/30, qtc had normalized but other non-specific ekg findings remained. Echo normal except for occasional extra heart beat. Told to avoid exercise, was given 24 hr heart monitor (we are still waiting on results), and come back for new ekg on 7/7/2021.

She got a fever, muscle aches, severe headache. Then she started getting small patches of a raised rash. It started near the injection site, then on her wrist (same arm) then on her chin, same left side. After a few more days she started getting them all over: legs, chest etc. They itch her like crazy and burn when she tries not to itch.

Meningitis pain; she woke up and said her face felt funny; pressure on her chest; pressure behind her eyes; muscle pain; she had not slept,; fever; headache; the chills; sore throat; nauseous; Caller states she was assuming hives; inflammation stayed around awhile; body aches / pain through her head and back down her neck; trying to push her eyeballs out and it is really painful; she was slumpy; swelling from the digging and scratching; her hands began to swell yesterday; she was just not feeling right; couldn't walk by herself; lip swelling and numbness; lip swelling and numbness; itching on face, hands and feet / Caller states then her daughters hands and feet began to itch; This is a spontaneous report from a contactable consumer or other non health care professional. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EW0178; Expiration Date: 31Aug2021), dose 2 via an unspecified route of administration, administered in Arm Right on 08Jun2021 16:00 (age at vaccination: 12 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, meningitis from an unknown date and unknown if ongoing at 7 years old. The patient's concomitant medications were not reported. The historical vaccine include COVID-19 Vaccine on 18May2021 for COVID-19 Immunization (1st dose Expiry Date of Covid 19 vaccine: 31Aug2021, lot EW0168 ,anatomical location: Right arm) and had she had itching on the hands. And other vaccine includes flu shots (she does the flu shot every year) for immunization. The patient experienced Meningitis pain on unspecified date, lip swelling and numbness, itching on face, hands and feet / caller states then her daughters hands and feet began to itch in Jun2021. She has pressure on her chest on 09Jun2021. She had pressure behind her eyes, muscle pain,she had not slept, fever, headache, the chills , sore throat, nauseous, caller states she was assuming hives, inflammation stayed around awhile , body aches / pain through her head and back down her neck, trying to push her eyeballs out and it is really painful , she was slumpy, swelling from the digging and scratching, her hands began to swell yesterday in Jun2021. she woke up and said her face felt funny on 09Jun202. she was just not feeling right and couldn't walk by herself on Jun2021, Caller relays her daughter will be (withheld) . HCP: Caller states she called the pediatrician office and 1 was by phone and she was seen by this provider yesterday and she encouraged her to reach out to us as well. Mom states she was aware of the possible symptoms to occur and her daughter came home Tuesday perfectly fine and went to bed and woke up with the typical symptoms, she had not slept, fever, headache, the chills, sore throat, nauseous and had all the symptoms pretty much. States she didn't have anything weird going on during the observation time the day of the vaccine. Caller relays her daughter didn't have anything weird after her 1st dose. Caller states she took a nap Wednesday about 24 hours after her 2nd dose and she woke up and her lips had begun to swell and she woke up and said her face felt funny and it was itchy. Caller states she was assuming hives. Caller states that there was nothing concerning as it wasn't in that initial 15minutes to 4 hour and that this occurs 24 hours after and that was a concern. Caller states then her daughters hands and feet began to itch and that was kind of along the same lines and said hives and she would itch itch itch and there was swelling from the digging and scratching. Caller states she has numbness in her lip with the swelling. Caller states the other symptoms that are bizarre is more yesterday and it started some on Wednesday she had a pressure in her chest and this was a child, her daughter was very strong, she got up yesterday and tried to do school and had a fever of 102 and Wednesday evening was so sick with symptoms and she still tried. Caller states the pressure in her chest is concerning and told them yesterday and she needed to be seen. States her daughter described it to the doctor that it felt like someone was sitting on her chest sort of pressure and on a scale of 1-10 she was a 7. Caller provides that not at any time did she experience trouble breathing and she never saw her lose or get weird coloring. Caller states she called her doctor Wednesday afternoon and talked to another doctor, that she called the help line after hours as they close 4:30 or 5pm. States she was told it was good news that she did not have trouble breathing but to have it at this point was weird and no one knows what to expect and everyone is different. States she was told to do Benadryl and continue with pain medication for fever and discomfort. Caller states her daughter was miserable the rest of the evening. Caller relays that the swelling subsided and the inflammation stayed around awhile and yesterday she woke up better with no nausea and the common symptoms are better and she still had the fever. Caller relays that at about 9:00 she began to have a problem where she said that behind her eyes she had significant pressure and that scared the caller what with the brain and swelling. Caller states her hands began to swell yesterday, like her lip and her fingers are itchy and swelling and it's constant itching and the pressure on her chest yesterday, that those 3 things freaked the caller out and she called the pediatrician and they said to have her checked out to make sure as nobody wanted to rush her to the ER as she was not struggling to breathe she was just not feeling right. Caller states the pediatrician did her research about heart inflammation and listened to her heart a couple of times and said her best observation for rubbing sounds was she did not hear any. Caller states when her daughter was younger she had meningitis and went through a whole lot with that and caller states she does not immediately rush to the hospital as that brings back emotions with that. Caller states the doctor said she didn't see any immediate distress and would do an EKG or they could wait and see, that she thought the pressure might be like body aches and her daughter had laid in bed all day the day before and had a time with it. Caller states she couldn't walk by herself and she was out of it. Caller states she could do the EKG or wait until today and they chose to wait. States that today she seems better and the only thing today is the continuing pressure behind her eyes that her daughter described as it felt like someone had 2 spoons and was trying to push her eyeballs out and it is really painful. Caller relays her daughter has been through meningitis pain and has pain through her head and back down her neck and the concern is swelling. Caller states it could be a weird reaction and the doctor thinks it is a weird headache she is having and is still doing ibuprofen. Caller relays that her chest is not nearly as heavy today and she has taken Benadryl again for itching and swelling. States the doctor says they don't know what did it because the risk was there and the benefit and don't want to get reactions. Caller states she had no problem with getting the shot, that weird things happen and the pediatrician is saying it can happen but doesn't know. States it is kind of scary. Caller states they checked her out and they checked her oxygen and blood pressure and that made the caller feel better. States that 9:30-10 last night after she got home she was slumpy and her head was hurting and she had chest pressure. Caller states with the hand swelling, that the caller herself went through reaction and hives and the doctor had asked if her daughter had anything new introduced and no nothing was and her daughter didn't seem concerned to share this but after her 1st dose her hands itched and she didn't pay it any mind. States she had no face swelling. Caller states she is wondering if those little hand itches after the 1st dose she didn't tell about till now was that a little bit of a sign that something else was there. States she didn't mention it after the 1st dose and was good to go. States after the 2nd dose she said mommy my hands itched after the 1st dose, her lip didn't swell and she told the doctor it's not conditions on the list of symptoms and she didn't have breathing issues. Caller states it's a non severe reaction and is assuming to dose and said yesterday if she gets a booster what does Pfizer advise. Caller states they have all intention of getting what she needs in the future. Caller states she wants to make sure she doesn't have worse and the lip swelling was freaky. Caller states she thought her daughter was out of the woods after the 20 minutes waiting and was home and then turned. Caller states it was pretty straight forward and knew what the expected symptoms were and they were fine and knew she was having the exact ones on the list and was not feeling well and had a fever. States she was thrown for a loop when others came up and the fact that they were 24 hours out, that she got the 2nd dose 4-4:15 on Tuesday and these evolved well after that time. Caller said they said to report this and her hope is that they can help if someone else has this issue. States when she said she was laying there my hands did itch after the 1st but not like this to this degree. States she never said anything and caller didn't know. States she knows as a parent there are certain questions to ask and warning signs of potential allergic reactions. Caller states she is assuming this is some sort of allergic reaction, not the worst kind but pressure in the chest and other concerns about her heart having some sort of issue she knows have been reported.Caller states that today she could have done the EKG for more information but based on her listening and what she wanted to thinking the body aches and extensive issues with that she is glad she waited. States she was laying in bed at 6:30 and asked her if she wanted to get the EKG and she said she was afraid of going to the hospital and it's not fun but would give answers if there is something else and she laid in bed until 9:30-10 and gave her more Benadryl and Ibuprofen and continued with that for the discomfort behind her eyes and the doctor is thinking it's body aches. States the fever subsided yesterday.Caller states she would like to share that her daughter is a tough kid and tough kids can be taken down too and may not pay attention. Caller states she doesn't over react but she is aware and if she had told her about her hands she would have thought allergic reaction, mild one and brought her to the doctor or at the 2nd vaccine and she didn't say anything until after the fact. Caller relays her daughter has never been through hives and the caller has and has a lot of seasonal and environmental allergies and the caller was that kid. Caller states with her daughter not having seen her lip swell and her eyes started hurting and she started thinking the worst. States the doctor pushed on her and checked her lymph nodes and did a thorough exam that lasted about 30 minutes and nobody knows. States she appreciates all that Pfizer and the other companies have done, that we need this.Caller states her daughter goes to the pediatrician in 2 weeks for her annual check up. States the doctor yesterday said her body responded and had a hard time with it. States she does the flu shot every year and this was weird and she wanted us to know and hopes this report can help. Caller states her daughter is a tough kid nobody knows and today she is better, she has a headache behind her eyes still there.Caller relays that Friday she had her annual eye check up and it's not a vision thing, that was fine until Wednesday and other other stuff and yesterday with pressure and she is sure it's residual and her body adjusting and if she can help with letting other people know.Caller relays if it comes back she is going to do the EKG, that she is not the parent to say it is nothing and will follow through with Pfizer also. Caller states she didn't have anything weird for heart beat and no rubbing sound and no signs and she thinks it was issues from body aches and hopefully she is on the up and up and nobody will have to leave and go to the doctor today. And didn't think because it was not an immediate issue with her breathing and nothing like that and didn't think it would be an issue with a booster. Caller states it could be that instead of sitting for 20 minutes they keep her longer and that when she fills out the sheet if was not an option, she knows there is severe reaction listed, she will make notes and make the person giving the dose aware that she had the delayed what they are believing to be allergic reaction and make sure, that she may never have it again and it could have been her system was so under attack. Caller states she doesn't understand vaccines and knows it's the body's job to do something and she is not reluctant helping her be immune and she understands what to do in the event and doesn't have an epi pen and her daughter has no allergies and no reactions to anything. Caller states she didn't have the worry, that there is always a chance and you worry when something foreign goes in the body that there is a chance to react. Investigations: Caller states they listened to her heart and took her vitals and tests with her fingers checking her eyes to make sure her pupils were dilating correctly and move her eyes with a moving finger. Caller states she doesn't know the medical term but the basics and let them know she was not in dire straights to rush to the hospital immediately. The patient underwent lab tests and procedures which included blood pressure measurement, body temperature: 102 fahrenheit, electrocardiogram, oxygen saturation, vital signs measurement was unknown and unspecified date. Therapeutic measures were taken as a result of lip swelling and numbness, itching on face, hands and feet / caller states then her daughters hands and feet began to itch, pressure on her chest , fever, swelling from the digging and scratching. The outcome of the events was unknown.

Patient received her second Covid immunization on 6/27. On 6/28, she developed fever, myalgias, headache, and vulvar pain. On 6/30, she was diagnosed with acute vulvitis, which evolved by 7/2 to acute genital ulcers.

Patient is a 12-year-old female who presents with rash, back pain, and pain with deep breaths following her COVID-19 shot today. Patient has a history of having COVID-19 in September 2020. Mom states she is a long-haul her and has had migraines and developed POTS following having COVID-19. She is currently in enrolled in a study and has been seen and followed up there for the symptoms. It was recommended that she obtain a COVID-19 vaccine. Today she got her second vaccine and within 10 minutes she began having headache and then developed a generalized red rash with facial swelling about an hour later. Mom gave 25 mg of Benadryl and rash seemed to improve. Patient was complaining of pain to her mid back. She stated she had worsening pain when she took a deep breath. She denies any frontal chest pain. No shortness of breath. She did not take any Motrin or Tylenol at home. Mom states she also got a rash with COVID-19 shot. Patient denies any vomiting. No diarrhea. No cough. No difficulty breathing just pain when she takes a deep breath. No drooling. No difficulty swallowing.

Had routine reaction immediately post vaccine (pain, redness, nausea, muscle aches, fever, etc) that recovered. Then, on 7/12/21, she started to experience pain, redness, and some swelling again but this time there was some pain on the right side as well. Pain originating from deltoid and radiating through arms and shoulders. On 7/16/21 the pain was worsening and she was no longer able to perform daily activities as well as would cry if her arms were even slightly touched. she was referred to the Urgent Care who did testing for illness and muscle conditions which came back normal. She was screaming through trying to get bloodwork due to the pain which is atypical for her and they sent us to the ER for pain with unknown origin. ER physician said all neurological processes were normal and was concerned for Complex Regional Pain Syndrome so he wanted an urgent follow-up with Primary Care. on 7/19/21 Primary Care suggested delayed response to the vaccine and referred her to Neurology. On 7/22/21 Neurology decided it was a delayed immune response to the Covid vaccine and prescribed Prednisone to start today 7/23/21.

Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient's father reported that she had not eaten or drank much, if anything, prior to the vaccination appointment in the afternoon. Patient is a premenstrual, young girl, of thin build and small stature, who just turned 12 the prior month. She expressed anxiety about shots and needles. Immunizing technician and father noticed that she slouched dramatically a couple minutes after the shot. But her face became ashen, she slouched more rigidly, and jerked. ~5-10 seconds later she was back to normal

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.

Late at night patient began having chills and extreme muscle pain all over her body, sore throat, nausea, extreme fatigue. She also had a fever of 102.

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.

On Sunday 5/23/2021 my daughter woke up to swelling, redness & pain of the 1st metatarsal of her left foot. One Monday 5/24/21 the swelling and symptoms in that region had resolved however throughout the day her right hand started to swell, become red and hurt. This the throughout the thumb and pointer finger region of her right hand. The swelling and redness spread further and could be seen on both palms just below the pointer finger as well as the top of her left foot. A visit to the doctor was completed on Sunday evening 5/24/21. The provider we saw believes it to be some for of reaction but it couldn't be determined if it was environmental, antibiotic or vaccine related. She was given 2 Benadryl 25 mg tablets after the medical appointment. As of this morning 5/25/21 I administered anther 25 mg Benadryl and instructed her to take a second dose around 11am at school. She is reporting there is still swelling in her hand but it doesn't hurt as bad as it did yesterday. Her PCP contacted my via phone today and is discussing her case with pediatric rheumatology as she also feels it could be a sign of allergic reaction but since much of the swelling is near joints she has reached out to them and I am waiting to hear back.

RN reported that patient became flaccid after her vaccination, then became rigid, crossed her legs, and lightly slammed her head back against the wall. He reports that she fainted but had some seizure-type activity, but minimalized. She was monitored by both RN and myself. She was lowered to the floor to lay on the floor, was fanned, and her BP and pulse were monitored by RN. She was accompanied by her mother, and her mother declined having EMS contacted. Once patient regained consciousness, she was alert, laughed and talked to us, and regained a sitting position. We then gave her cold water to drink, and she was able to get up into a chair. After sitting for several minutes, she was able to walk out of the room and into one of our monitoring cubicles for an extended monitoring timeframe. We kept her here for 30 minutes for further observation, then left accompanied by her mother. Due to RN's report of the seizure-type activity, mom is going to contact patient's pediatrician to see if further treatment is needed.

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.

Patient is a 13 year old female who presents to the clinic today with her mother for a follow up ER visit from 5/30/21. Patients mother reports that patient had received her first Pfizer COVID-19 vaccination on 5/26/21, and developed a headache on Thursday. On Friday, mother and patient report that she had a very active day at school, and in Phy-Ed she did a cardio work out, followed by a 10 minute run and then golf practice after school. Patient reports that she does not frequently go running. Saturday, mom reports that patient was fatigued and rested most of the day. Sunday, she was up at 5am and was working by 6am until noon at the family restaurant. Her mother reports that it was very busy at the restaurant. Later in the afternoon on Sunday, the family went to their lake house in New Auburn, MN. Mother reports that the patient ate a good supper and the patient was asked to take the dog for a walk around 8pm. Patient took the dog for a walk for about 5 minutes, and then came back and went to her room, and her older sister found her lying in her room with her arms flexed and legs extended. Mom reports that she was drooling, staring and her muscles were stiff, and she wouldn't bear weight on her legs. This lasted approximately 10 minutes and she was transferred by ambulance to the Bloomer ER for evaluation. Initial ER workup in Bloomer showed leukocytosis at 11.4, a CK of 333, and an alk phos of 263. Her CBC, Comp, CRP, Lactate, pregnancy, lymes, COVID and UA were all within normal limits. A head CT was negative as well. Given her symptoms, she was transferred from Bloomer ER to St. Mary's in Rochester to the general pediatric floor early Monday morning. Peds neurology consulted and diagnosed her with dissociative (non-epileptic) attack, and discharged her home around 5pm on Monday evening with family. Since discharge, she reports that she is still experiencing fatigue, a mild headache, and her quadricep muscles feel weak and ache. Mom reports that she has been monitored by family since discharge and she has not had another episode since. For pain, she is taking tylenol and ibuprofen with minimal relief. She has started her menses, her onset of menarche was January, 2021, and she did not have a menstrual cycle in February, March or April, and she began her menses on 5/24 through 5/30. Clinic recommends oupatient testing for an EEG, Echo, EKG and MRI and follow up with neurology.

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..

She woke me up in early morning - and she felt feverish and she had a headache. I gave her Tylenol and she went back to sleep. When she woke up around 08:00 a.m. she felt like she had the flu - terrible headache, chills, 100 degree fever, body aches and nauseous and really restless. By the morning, her left arm at injection site was also sore. We gave Ibuprofen at 10 am to help with aches and pain. About 20 min later, she threw up a lot. I called the doctor and talked to nurse. Told me to wait four hours before giving pain meds again. We gave her Pedialyte. at 02:00 pm, I gave her a dose of Tylenol and in within 30 seconds after giving it to her she threw up again, a lot. I called the doctor again. Nurse said to give her more Tylenol when she was able to feel better. She took a bath and drank some Pedialyte and that helped rehydrate her and then we gave her Tylenols when she was feeling up to it. On Sunday, when she woke up, she had swollen and painful lymph nodes on armpit on her left side and those are still persisting - not as swollen but painful a bit. She was tired still on Sunday but feeling a lot better. Tiredness, sore arm and pain in lymph nodes under her left arm were what persisted on Sunday. She still has pain under her left arm with swollen lymph nodes but did go back to school today.

At 4:30 PM, the patient received the first dose of the COVID-19 vaccine in her right arm at facility. She developed a headache, along with dizziness and pain at the injection site. She also reports that her arm began tingling and felt heavy. She waited for an hour without resolution to her symptoms. Around 5:30 PM, she began having intermittent episodes of shaking her limbs. There was no seizure activity. She reports that she has had these episodes since the beginning of the school year, but hadn't told her Mom. She reports that it mostly happens when taking a test at school. The episodes are worse today since taking the vaccine. Vitals: HR 110 BP 134/75 Sat 99% on RA. An RRT was called and she was taken to the ED.

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.

Myalgias and low grade fever on first day. Chest pain requiring ER visit on second day. Exam, ECG, lab work, echo consistent with pericarditis

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.

Headache,dizziness, shoulder ache. Transported to medical screening via wheelchair for evaluation by paramedics. Per medic, vitals within normal range. Left in stable condition at 12:35 p.m. Recorded by RN. Paramedic.

She woke up Sat with headache, body aches and muscle aches. Around 10:30 pm night she was became dizzy passed out fell down the stairs. I took her to the ER she required stitches (chin) and had some test to rule of chest pain.

On Day 3 evening, one hive appeared, with redness/swelling just below injection site. On Day 4 evening, multiple hives (around 20) appeared, then merged into one larger mound (around 1.5" x 2"). Previously, on Day 1 evening, soreness of arm and fever started. Fever reached 103.4 degrees. Fever lasted 2 days but lower grade - 101 degrees or so. Day 2 saw bad headache and armpit pain. Day 5 seems to have recovered from hives, but will continue to watch.

13-year-old otherwise healthy female presents to ED by ambulance for chest pain. Patient received her second dose of the Pfizer vaccine on 6/18. The following day, patient had generalized fatigue, sore arm, and one episode of nonbloody nonbilious emesis. Yesterday, patient began to have intermittent midsternal chest pain which radiates to the back. Patient reports symptoms worsen with movement, walking, and deep inspiration. She denies any shortness of breath, or palpitations. She denies any headache, lightheadedness, fevers, chills, diarrhea, abdominal pain, or dysuria. No cardiac family history per mom. Patient did not have any symptoms after her first Pfizer vaccine. Differential Diagnosis: Chest pain, costochondritis, myocarditis secondary to vaccine.

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.

Pt had a CBC done to evaluate weight loss and possible celiac dz since December. Labs 6/18/21 WBC count was low 2.62 with ANC of 843, platelets low at 171. Referred to hematology/oncology who rechecked labs on 6/22/21 and WBC normalized to 4.63 but plts still low at 159. normal physical exam no new symptoms.

Only had arm pain initially.; Bilateral knee pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration, on an unknown date (reported as: 2 weeks ago, as of tomorrow) (at the age of 13 years old)as 1st dose, single dose for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced Pain in arm initially, Knee pain started about 2 weeks after getting vaccine, it was like bilateral knee pain mostly with exercise. She did not have it the first few days of the shot like she would expect she normally would. She did not have it until last week. It was only when running last week and now she is still having it. Reporter reported that she was concerned about getting her daughter the second dose of vaccine and would like to know if this has been reported. Reporter does not know whether this was related to the first vaccine. She does not know how to know if it was related to the vaccine. Reporter stated that she does not know, and how does somebody know if it was related or not. Reporter also stated that her daughter was not having problems before and she does not know. Reporter stated that she would like to wait at this time and see, she was not sure she should report this or not. The outcome of the events was not recovered. It was reported as the Reporter stated that she thinks that she was not sure if it was related to the Covid vaccine or not Information on Lot/Batch has been requested.

Shortly after vaccination client felt intense pain in the right side of her neck radiating down her arm. Client was at the vaccination site in the observation lot at this time, and the Nurse called the ambulance to come assess the client. The client was transported to the ER with the consent of the mother.

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.

Headache, chest pain, body aches, tired. Chest pain, in the ribcage area just started 33 hours after the 2nd dose

Patient received second dose of Pfizer vaccine on 6/10/21. 12 hours after administration she developed fever (Tmax 103F), chills, myalgia. On 6/13/2021, she developed vaginal mucositis prompting hospital admission for evaluation and pain management. She was originally discharged with supportive care (Tylenol/ Motrin for pain) and if needed triamcinolone 0.1% cream. Per chart check, she was seen by PCP six days later and had not yet started triamcinolone cream and still in pain. PCP prescribed topical clobetasol, and oral prednisone 20mg BID for 5 days based on dermatology recommendations for treatment of Lipshutz ulcers.

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.

Developed rash and joint swelling the next day. Also with swelling of the lips. No fever. Rash was itchy and on arms and legs. No joint swelling resolved after 48 hours. Still with pain of feet with walking on 7/9/21

Day of vaccination (Monday) - arm sore, Tuesday - body aches, muscles sore, headache, Wednesday- muscles less sore, headache, Thursday - symptom free

Dizziness, weakness in legs, claimed loss of vision by patient. Events occurred ~15 minutes after receiving injection. Patient transferred to emergency department for evaluation

Starting at 0300 5/16/21 Pt was awoken with pain in R arm, R arm pit, and along back. Pain kept waking Pt up, she slept fitfully. Pt stayed in bed until around 1300 5/16/21. She had a project for school due- had to video tape making a recipe. She was standing up videotaping the ingredients when she felt very dizzy. Pt then reported that she lost her vision- everything turned black. I had to rush to her to catch her- she had loss of consciousness for about a minute. She was very pale- lips turned blue. She had a pulse the whole time, BP was 117/60- when I checked it about 5 min later. Her temperature on a ear thermometer was 99.7. After she awoke, she was still very dizzy and stayed in bed most of the day. 5/17/21 AM- she woke up for school 0600- and was feeling better. No more dizziness, color was back in her cheeks, was able to eat and left for school.

Patient was given her first Pfizer Covid shot in her LUA at 3:15. After the shot one of the school nurses notice during observation that she stood up and looked lie she wanted to pass out. The nurse accompanied the patient to a nearby cot where she laid her down. The patient c/o lightheadedness, dry fuzzy throat. Patient's extremities were cold to touch, eyes rolling back, hand posturing (stiff and cold), shaking., 62 pulse. No problems breathing or swollen throat. Blood pressure was 119/67 at 3:25 and pulse was 80. Nurse elevated patient legs for about 10 minutes, patient felt dizzy, shaking, apparent panicking eyes still rolling back. She was able to respond to simple commands. Still fuzzy throat. Administer 50mg IM in RUE at 3:34p.m. Blood pressure 116/71 at 3:35. Patient's face cheeks started to look red and warm. Blood pressure 123/76 at 3:39p.m. We called 911 at 3:46p.m. Blood pressure 117/78 at 3:52, temperature 97.5 degrees. Paramedics arrived 3:54p.m. Blood pressure taken by paramedics:142/86, O2 saturation 70%, started oxygen via nasal canula at 3:56. Gave epinephrine 0.5ml IM in left upper thigh. Started IV line at 4:00p.m. Red tonsils, lungs diminished but clear. 4:02p.m. transported by paramedics to Hospital.

immediately after the injection, pt appeared to have fainted, eyes closed, still breathing, body stiffed and jerked for a brief moment then became slouchy on the chair. we called 911 - as we waited for ems, pt opened eyes, said very sleepy, i kept her awake by taking about greys anatomy - ems arrived - mom wanted pt to be monitored at a facility - ems took pt away on stretcher.

Fever 101 for 4 days, weakness in right arm started on day 4. Difficult to hold pencil doing homework, right handed.

I administered the vaccine, got one side of the band-aid on and that is when her head fell back. Her eyes rolled into the back of her head; she then leaned over the right arm of the chair. Her body stiffened next. I held her head and body with the help of a colleague. This happened for about 10 seconds, then she woke up and snatched her mask off with a confused look on her face. We asked her questions to see if she was aware. She was, then she went back out falling over to the side. I called 911. When she awakened the second time after about 7-10 seconds her face turned pale. We then moved her to the floor and propped her feet up. Patient said she was nervous and felt like she had to use the restroom. Her skin was clamy; patient said clamy skin is nothing new for her. The fire truck and ambulance arrived on scene. The workers began to assess patient. Vitals were good. She did not go in the ambulance, but stated her vision were blurry. She went home with grandparents.

pt fainted/had seizure 50 to 10 minutes after covid vaccine. pt did not fall, dad held her.head and eyes rolled back, shaking and stiff for 2 seconds per dad. pt alert, breathing, and movement looked normal when I saw pt . pt mom called 911 and pt was taken to hospital . no history of fainting or seizures per dad

Patient immediately felt dizzy, broke out in hives on bilateral arms from elbow up, chest, neck, mouth area, muscle weakness in bilateral lower extremities. Increased heart rate from 110 at lying to standing at 146 bpm. Administered 25 mg of Benadryl By mouth with water. Within 20 minutes hives on face disappeared but remained in all other areas and none of her symptoms went away. Called 911 had her transported on a stretcher in an ambulance for further observation.

sharp pain in her neck and shoulder; sharp pain in her neck and shoulder; arm was hurting/arm pain; This is a spontaneous report from a contactable consumer (patient's mother) via medical team. A 14-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 14May2021 (at the age of 14-years-old) as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sharp pain in her neck and shoulder and her arm was hurting/ arm pain on 17May2021 night. The reporter was concerned because the pain appeared after a few days and not within 24-48 hours. She asked is this could be an indication that the vaccine was placed in the wrong place like not in the muscle. She asked if this is normal or when the patient should have this checked. The reporter stated that her and her husband did not experience any side effects. Outcome of the events was unknown. Information on the lot/batch number has been requested.

patient was given pfizer vaccine and was sitting in the chair for post vaccination waiting for about 5 minutes. Suddenly I looked up, I noticed her body stiffened and her eyes closed. she tumbled to the floor and hit her head on the ground. Paramedics were dispatched immediately. patient woke up right away, we checked her pulse, forehead for fever, and back of her head for any possible bleeding. She answered all questions that we asked of her correctly (such as her name, her age, etc.) Paramedics arrived, took her blood pressure, oxygen level (both normal), blood sugar (normal). Parents decided to take her to hospital for further evaluation. I called and spoke to Dad 5 hours later, dad stated that she is doing fine.

Patient experienced of weakness and pain in left arm. Left index finger pain upon movement. Patient's vitals normal otherwise and patient declined to have transported to the hospital by ambulance and transported patient to the Hospital.

Patient had no reaction from her first Pfizer vaccine. A few minutes after her second dose, she stated itching on her injection arm and in her legs. 10 ml of Benadryl was administered at around 2:45 pm. She stated headache and pain in her neck and head, but no difficulty breathing. She took ibuprofen (given to her by her grandmother). She was monitored until 3:30 pm and indicated her symptoms had resolved and she was feeling much better. Counseled her grandmother to monitor her closely this evening and to administer another dose of Benadryl if needed.

I have pictures I can upload. She had severe hives - flat, red rash on legs and arms. Very itchy; swollen ankles and swollen wrists and hands. She could barely move her feet they were so swollen. That happened within 12 hours. And at the doctor's appt online, she said to give her a double dose an antihistamine - I think it was Zyrtec - and Benadryl at night and to be on Cortosteriod cream on the swollen parts. We did that for about three or four days until it was bearable and it stopped. About three days after it stopped and she wasn't taking meds she had another break out - it almost looked more like blisters - on torso and on arm. We did the same treatment with meds and cream and it went away within 24 hours. I showed to Pharmacist and the Pharmacist said to give an extra week for the next dose of vaccine to give body a chance to rest.

Arm soreness, fever of 100.2, muscle aches in the legs all starting at 2am on 06/11/21. Administered Tylenol and it didn?t help

12 hrs post - severe headache, 100.5F fever, chills. Gave advil. Worsened over night. 6/10 vomited, nausea, 101F fever despite advil, body aches, severe headache, left arm pit/axillary lymph node pain, chills, shivering, muscle pain, continued advil and tylenol alternating, severe fatigue. Temp 101.6 at 8pm 6/10. 6/11 temp 99.4, headache improved, chills improved, able to eat 6/12 discontinued advil/tylenol, mild back ache, mild pain behind eyes, otherwise returning to normal

9:52 Within 1 minute of being vaccinated, while seated in chair stated "I'm really lightheaded". Eyes were wide open and became unresponsive to verbal stimulation 9:53 Arms stiffened, no response, diaphoretic, pale 9:54 More responsive, groggy 9:56 Placed in supine position on floor mat with legs elevated. Stated she "could feel nurse holding me up" 9:58 BP 96/50 HR 70 laying flat 10:00 Call placed to mom 10:03 Mom arrived 10:05 Sitting up, eating snack with bottle of water 10:07 Felt "shaky" and laid down 10:09 BP 96/52 HR 80 10:15 BP 98/52 sitting up, HR 80 10:26 Seated in chair eating another snack. feels "a little lightheaded"10:25 Feels OK. DC with Mom

6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; This is a spontaneous report from a consumer (patient's mother). A 14-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified rout of administration on the left arm on 05Jun2021 at 09:00 (Lot number: ew0178) at 14-year-old as single dose for COVID-19 immunization. Medical history was none. Prior to the COVID vaccine, the patient didn't received any other vaccines within 4 weeks. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Known allergies was none. Concomitant medication included ascorbic acid (VIT C), ibuprofen and cetirizine hydrochloride (ZYRTEC ALLERGY) within 2 weeks of vaccination.The patient previously took the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13May2021 (Lot number: ew0169) at 14-year-old as single dose for COVID-19 immunization. On 06Jun2021 at 17:00, the patient experienced arm pain which radiate across muscles in upper back/shoulders. The reporter was aware the evening of 06Jun2021 and reported 07Jun2021 morning. The patient received ibuprofen as treatment. The outcome of events were recovering. No follow-up attempts are possible; no further information is expected.

14 years patient received BNT162b2 vaccine; Second Dose: pain under arm around arm pit area; left arm, same one she received the shot in; Second Dose: Left Arm Injection Site Pain; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a 14-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (Batch/Lot Number: EW0196; Expiration Date: Sep2021) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history was reported as none. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187, Expiration date: Aug2021), via an unspecified route of administration in the left arm on 17May2021 for COVID-19 immunization and expereinced left arm injection site pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No investigation assessment was provided. Caller stated the patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time. Caller stated it lasted about 2 days after her first injection, so 17May2021, 18May2021, and 19May2021. Caller stated this time with the second dose, the injection site pain was less than the first time, but now she has pain under her arm at the arm pit area. Caller stated after the second dose the injection site pain was just that day, so just one day, it wasnot bad. Pain under arm around arm pit area; left arm, same one she received the shot in. Therapeutic measures were taken as a result of second dose: pain under arm around arm pit area; left arm, same one she received the shot in and second dose and left arm injection site pain with Advil. The outcome of the event second dose: left arm injection site pain was recovered on 07Jun2021; event second dose: pain under arm around arm pit area; left arm, same one she received the shot in was not recovered and unknown for other event. Lot/batch no. detail are available. Additional information has been requested.

Extreme weakness in her arms and legs; Really bad cough; painful in arms and legs; not been feeling well; This is a spontaneous report received from a contactable consumer (Parent). A 14-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration in right shoulder on 23May2021 14:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. Family history was reported as none, they were basically a healthy family. Patient was not vaccinated within 4 weeks and no additional Vaccines administered on same Date of the Pfizer Suspect. On 23May2021, the patient experienced extreme weakness in her arms and legs, really bad cough, on an unspecified date in May2021, she had severe pain in her legs and on an unspecified date in 2021, she was not been feeling well. Patient's father called on behalf of his 14-year-old daughter who received the first dose of the Pfizer COVID-19 vaccine about two weeks ago and had extreme weakness in arms and legs, 2 weeks ago, on Sunday 23May2021. She had not been to school since then, she went for a couple hours and then they send her back. His daughter also said that it had been painful but caller states that he does not know exactly what his daughter means by that, she said that her legs hurt her, that started probably 24May2021 or 25May2021 with the bad cough also and not been feeling well. Had all leveled out the past 10 days. Had blood work and the results came back Friday. Thought there was an outside chance based on the blood work that it was strep related. Her doctor had suggested that the parents call Pfizer to see if this type of reaction had been reported in her age group after receiving the Pfizer COVID-19 vaccine. She never really had a fever. This started the day after the vaccine, and they are not sure if it was related to the vaccine or not. A couple of results were off. The Streptolysins were 468. The antinuclear antibodies were 1 to 160, which was off. Everything else was negative. The patient underwent lab tests and procedures which included antinuclear antibody: 1 to 160, streptococcus test: 468. Patient received therapeutic measure to treat adverse events, they tried Amoxicillin, which had no impact, they thought maybe it was just a virus. They also tried Tylenol and Advil, which also had no impact. Stated that the Amoxicillin was 875mg twice a day and that the Tylenol and Advil were from different packages lying around the house. Patient was scheduled for the second dose this coming Sunday but they were holding off until she was better. The outcome of events was unknown. Information on the lot/batch number has been requested.

On sunday night, about 36 hours after vaccination, she started to have numbness of her lower jaw and tongue. She started to have an incredible amount of drooling and could not swallow. She then started to have epigastric cramping and sharp abdominal pain that moved into the right lower quadrant. She had pretty severe headache that started the same time as numbness and drooling with photosensitivity. No fever. No vomiting but she was nauseous. she went to the ER late on 6/13. She was then transferred to the hospital for furthur care. She had a neurology consult that thought perhaps her headache, numbness and drooling could have been an atypical migraine-this resolved as of 6/14. Her abdominal pain resolved after appendectomy and now she just has muscular pain related to surgery.

Got the Vaccine on Sunday. On Monday had chills, fever, muscle aches. Tuesday started to feel vaginal pain and swelling of vulva. On Wednesday had more chills, episode of fingernails turning blue. Extreme vaginal pain. Thursday went to Gynecologist- diagnosed with ulcers. Sent pictures to dermatologist and diagnosis of Lipschutz ulcers was made. On Friday went to rheumatologist and ruled out any auto-immune disease. Monday- 6/21/21 seen by Dermatologist who confirmed the diagosis of Lipschutz ulcers, believes it came from the covid vaccine. No current treatment available, only supportive care available.

Got the Vaccine on Sunday. On Monday had chills, fever, muscle aches. Tuesday started to feel vaginal pain and swelling of vulva. On Wednesday had more chills, episode of fingernails turning blue. Extreme vaginal pain. Thursday went to Gynecologist- diagnosed with ulcers. Sent pictures to dermatologist and diagnosis of Lipschutz ulcers was made. On Friday went to rheumatologist and ruled out any auto-immune disease. Monday- 6/21/21 seen by Dermatologist who confirmed the diagosis of Lipschutz ulcers, believes it came from the covid vaccine. No current treatment available, only supportive care available.

6/14/2021-6/17/2021 1. Spots on body, itchy. (ER 6/15/21 am - Hives, not poison ivy) 2. Both hands hurt, swollen, red, very painful, hard to bend fingers or hold things. Left hand worst. 3. Feet swollen, left heal hurt for a while 4. Both wrists hurt, left wrist worst. 5. Red swollen streak down spine. Swollen 1/2" or more raised off spine. 6. Left face swollen. Right jaw hurts so bad that it was hard to open mouth. *** Took benedryl 25mg every 6 hours, zrytec twice daily, continue normal pepcid pill. Everything cleared up 6/18/21 7am. Showed daily pictures to Dr. at follow up ER appt on 6/18/21.

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.

Pt had a witnessed fall post vaccination. Per mother, pt complained of being dizzy and fell. Staff witnessed patient falling from standing to ground, and hit her head. Pt was awake and alert upon RN reaching at side. Pt was following commands. Pt stated she was dizzy and nauseated prior to syncopal episode. Maintaining C-spine precautions d/t posterior head and midline neck pain and tenderness. Team alert was called. To ED via stretcher with medics

patient presented about 30 minutes after receiving her second dose of Pfizer covid vaccine with sharp pain in the left elbow. Patient was provided with a cold compress and rested for about 10 to 15 minutes and reported improvement in symptoms. patient left.

Within minutes of patient receiving her first dose on Pfizer Covid-19 she became limp and her head fell on her mother's shoulder. Her mother stated she was having a seizure. When the pharmacist came to her, she was conscience and alert. She stated she felt weak and she was given some water. EMS then arrived and she did not leave with EMS. She left with her mother who stated the next day that she immediately took her to ER where it was determined she had "an allergic reaction."

After vaccination, patient stood up and walked around the room. She started bouncing and acting a little nervous. I asked if she was feeling light headed woozy, she said a little bit. I sat her back in the chair. After about 30 seconds she fell sideways to the arm of the chair then slouched forward. I caught her before she went all the way to the floor and leaned her back into the chair, she then seized for approximately 3-5 seconds. Grandpa (legal guardian) was in the room and helped me get her to the floor where she came out for a few seconds and opened her eyes for 5-10 seconds passed out again then seized again for 3-5 seconds. She then woke up on the floor and was alert and looking around. She was very pale, I elevated her feet for a while and had her lay on the floor for 7-10 minutes. I then had her sit up on the floor and provided a bottle of water and put cold compress on the back of her neck. She stayed seated on the floor for about 5-7 minutes before I had her move to the chair to sit again with back against the back of the chair. She continued to sit there sipping water and talking for 7 minutes or so. Learned at this point that patient had not eaten breakfast and has passed out after a vaccination in the past (had not marked on the intake form). After 7 minutes or so, had the patient try to stand. She said her legs were wobbly, so I had her sit back down for several more minutes. Her coloring was much better at this point. After another several minutes we tried standing again and she felt better at that point. Had her just stand in the room for about 3 minutes before walking to the waiting room. Had her then sit in the waiting room for 5 minutes then she walked out with grandpa. They were going to get breakfast. Grandpa was going to call MD to discuss the events and follow up as necessary as well as to discuss plan going forward concerning the second dose.

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*.

Lipschutz ulcers; episode of fingernails turning blue; vaginal pain; swelling of vulva; chills; fever; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0178), via an unspecified route of administration, administered in arm left on 13Jun2021 (at the age of 14-years-old) as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0183) via an unspecified route of administration, administered in arm left on on 23May2021, 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 and since the vaccination the patient was not tested positive for COVID-19. It was reported that on Sunday 13Jun2021 the patient received second dose of vaccine and on Monday on 14Jun2021 patient had chills, fever, muscle aches and on Tuesday 15Jun2021 started to feel vaginal pain and swelling of vulva and on Wednesday 16Jun2021 she had more chills, episode of fingernails turning blue and had extreme vaginal pain. On Thursday 17Jun2021 she went to Gynaecologist-diagnosed with ulcers and sent pictures to dermatologist and diagnosis of Lipschutz ulcers was made. On Friday 18Jun2021 she went to rheumatologist and ruled out any auto-immune disease. Monday on 21Jun2021 seen by Dermatologist who confirmed the diagnosis of Lipschutz ulcers and believes it came from the covid vaccine. No current treatment available, only supportive care for pain management was available. On an unknown date in Jun2021, all blood tests came back normal, no other known cause for the ulcers. The outcome of the event vulval ulceration was unknown and patient was not recovered from rest of the other events.

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.

Shortly after vaccination (~15-20 minutes) patient became very faint and nauseous. Was pale in the face and vomited. Patient was seen by several firefighters that happened to be in the store at the time. She mentioned to them having fuzzy hearing, heavy arms, and sweating. They checked vitals and gave oxygen supply. Patient was then taken via ambulance to hospital but was feeling much better.

Approximately 10 minutes following the injection, patient was in observation area when she became pale and slumped over in her chair. The vaccinating nurse, along with the help of her parents, lowered the patient to a supine position on the floor and I elevated her legs. . We applied ice packs to her neck and forehead and within 10 seconds, was able to respond appropriately to verbal stimuli. Approximately 10 minutes later, the patient felt well enough to sit up and drink water . We continued to monitor the patient for another 25 minutes until she felt well enough to stand. The patient was stable and discharged from the facility at 11:48 am in custody of her parents. The patient ambulated without difficulty. No further complaints of dizziness. Skin pink, warm and dry.

pt. received injection then went to sit down in chair for observation, pt. fell to floor, stiffened body lasting about 5-10 seconds. Pt. was rolled to her back and then pt. aroused, and was tearful. small abrasion noted to bridge of nose, Pt. does not recall incident. Pt. states she has history of "passing out after shots"

numbness, tingling, and weakness of arm. Started immediately after vaccination. Got worse over the next couple of weeks and then has slowly started to get better without intervention

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.

Myocarditis Presented to ED with 2 days of chest pain, back pain, and nausea and vomiting 1 day after receiving Pfizer vaccine. Patient initially had back pain starting the night of 7/24, sudden onset. The next day she began to complain of stabbing chest pain that radiated into her left arm. Outside ED found elevated troponin of 2.93 and transferred to the hospital. Patient was COVID negative on admission and remained afebrile throughout her hospital stay. Patient was given IVIG on 7/27 which was well-tolerated, did not require steroid treatment. Cardiac markers downtrended over course of admission and was discharged 7/29 after normal Echo with Cardiology follow up.

She got her vaccine, she was sitting in the chair and 4-5 minutes after the shot she started telling her grandfather that she felt nauseated. She then started feeling dizzy and looked like she was going to pass out and he caught her and he laid on her on the floor on a pillow. There was a off-duty paramedic to assist her and they suggested to call 9-1-1 and they showed up 5-6 minutes later. She was then taken to Hospital. They ran a lot of laboratory tests, urinalysis and everything was negative. Her white blood cell count was high and her URC's and UBC's were high. Her albumin was also high. She was then released from the ER and was told to FU with PCP within 2 days. She is still having the symptoms of headache, sore throat, and achy bones, the typical flu-like side effects. She is taking Tylenol for the symptoms, as well as cough drops for her throat.

In her eyes, patient felt tingling and fluttering; we could not see her eyes moving at all. She also felt tingling in both arms, both hands, her face, and torso; she also had a lot of pain in her back. She felt that her face was hot but to the touch it was not. After about 20 minutes of these sensations her fingers cramped in gnarled positions that she was unable to straighten. Her right hand fingers was more rigid than her left. This lasted about 30 minutes and then she was slowly able to straighten her fingers. By the time she went to bed, around 10 pm, she felt basically back to normal.

Day 6 post vaccine patient began complaining of bilateral anterior ankle pain, and L hip pain. She had a low grade fever of 99.8 at that time. The following day Day 7, she had general fatigue, bilateral angle pain, and malaise. On Saturday, Day 8 she was unable to stand for periods of 15 minutes or longer due to pain in both ankles, and her knees, and elbows began to hurt. On this day she was given advil 400mg without relief, she then took Tylenol 650mg and the joint pain decreased from a 9 to a 6. We have had to continue alternating tylenol and advil since Saturday and she is unable to stand or walk for prolonged periods.

- Typical sore arm and fatigue in Day 1 & 2 - 4 days of severe headache from Day 1 through Day 4 - Day 4 severe diarrhea - Day 4 & 5 foggy "brain" - Muscle aches and weakness Day 2 - 4 - Potential menstrual period interruption

She felt muscle pain from upper-left arm to left chest like an electric current is running. She took a painkiller. One week has passed since the vaccination, and the pain has gradually subsided, but it still remains.

Very strong nosebleed; Little pain in her shoulder; Inappropriate age at vaccine administration; off label use; unapproved population; This is a spontaneous report received from a contactable consumer(mother) or other non hcp. A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration in Arm Left on 19May2021 12:00 (at the age of 15-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks, prior to the vaccination and adverse event following prior vaccinations. Caller was a consumer (Consumer daughter) calling regarding the Pfizer Covid-19 vaccine and his daughter was the patient, who will be 16 in 2 months got the Covid-19 vaccine on Wednesday, 19May2021. Caller reported that the patient didn't feel anything bad other than a little pain in her shoulder. Next day on Saturday, 22May2021, the patient got a very strong nosebleed in the morning. Caller stated that he doesn't know if the patient's nose-bleed was related to the Covid-19 vaccination and maybe it's not related. Caller reported that the patient's second dose of the Covid-19 vaccine is already scheduled. Caller reported that the patient strongly believes that her nosebleed was not related to the Covid-19 vaccine. Caller stated that he does not know honestly if the Covid-19 vaccine was related to the patient's nosebleed, but he does not want the patient to get the second dose if she had this kind of reaction. Caller inquired what they should do. Caller didn't know the patient's exact weight. Caller declined to provide his address and that he did not have the patient's primary care physician's information. The patient experienced just slight pain in her shoulder later in the day on 19May2021. Caller reported that the patient was done after 2 days with the arm pain and patient got the nosebleed on the morning of Saturday, 22May2021. Caller reported that he doesn't remember the patient having any nosebleeds in the last 5 years. Patient's nose bled just the one time and nose stopped bleeding within half an hour and an hour later the patient felt fine. Caller reported that the patient's nosebleed was pretty bad. The whole sink was covered in blood from the patient's nose. Caller unable to provide product details for the patient's Covid-19 vaccine as he does not have the patient's vaccination information with him at time of call on 24May2021. The patient Didn't any AE(s) require a visit to Emergency Room and Physician Office. The outcome of the very strong nosebleed, little pain in shoulder was recovered and unknown for other events. Information on lot/batch number has been requested.

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.

fever; nausea; vomiting; diarrhea; mild arm soreness; mild swelling at injection site; mild to moderate chills; mild to moderate muscle aches; This is a spontaneous report from a Pfizer Colleague from a contactable pharmacist (patient parent). A 15-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported via an unspecified route of administration on 04Jun2021 (at the age of 15-years-old) as single dose for COVID-19 immunization. Patient did not have known drug allergies. Patient did not have any chronic medical conditions. Patient's medical history included the first dose of bnt162b2 vaccine. The patients concomitant medications were not reported. In Jun2021, patient experienced mild arm soreness, mild swelling at injection site, mild to moderate chills, mild to moderate muscle aches, and having a slight temp the day after her vaccine. On 07Jun2021, the patient started experiencing fever, nausea, vomiting, and diarrhea. The clinical outcome of all events was unknown. Information about batch/lot number has been requested

Henoch-Schonlien Purpura. Abdominal pain, rash covering legs and torso, abdominal pain, joint pain leg pain

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.

2nd Dose given at 830 am on June 5th. At 5pm sameday pt. Was having weak legs,dizzy, slight headache trouble standing . By 9 pm pt. Was very weak, chills and she felt as if she had fever but temp was 97.3 , by 10pm she could not get out of bed because she felt so weak and achy,, her arm was so sore I couldn?t even touch it & she couldn?t lift it , had severe chills but also started to run a fever of 101.3. She could not sleep and was quite scared. I slept in her room with her to make sure she didn?t stop breathing. Gave sips of Gatorade and at 1130 gave her 1 pill tylenol rapid gel release for pain/fever sips of Gatorade through the night

Fever, vomiting, diarrhea, fatigue, sore muscles developed within 12 hours of vaccine administration and were improving at approximately 24 hours later.

Headache starting that evening, chills, fatigue, nausea, muscle soreness/weakness, sore throat, muscle aches

15 yo F , previously healthy, received the Pfizer covid vaccine on May 15. within a week, she developed non-tender swelling in her L UOQ of chest. the swelling worsened and became painful after second covid vaccine on June 5. seen first by me for this on June 8. recommended symptomatic care and saw her again for f/u appt today, June 14. clinically pt is back to baseline. no swelling and tenderness has resolved.

Woke up with chills, muscle pain through out whole body, fatigued and just flu like feeling. Felt like that, all day. Around 6:30pm she came outside to get some fresh air, trying to feel normal & got suddenly dizzy & then fainted. Her body kind of, rocked. She came to, after she heard her sister, calling her name a few times. So she was out for less than a minute. But she's never fainted before!

Technician (licensed to vaccinate) administered vaccine to patient near pharmacist. 20 seconds or so after administration, patient stated felt dizzy and immediately became unresponsive and head dropped to chest. Technician stated he then lifted the patients head because he heard a "snoring" sound indicating airway may be constricted due to positioning. Technician stated the patient's body twitched and became ridged, throwing her belongings. He called pharmacist (myself) for assistance. I immediately checked for breathing and pulse, both of which were evident. I observed pt vitals for about 20 seconds before the pt opened her eyes and was responsive and able to talk to me. Blood pressure was 120/69. Pt remained in the pharmacy waiting area for 30 minutes after. Patient said that in the past she has nearly passed out from piercings she has had, but has never fainted before and has no history of seizures.

Numbness ,tingly sensation, weakness, pain on left hand palm that started at 130am and traveled to the forearm by mid morning and shoulder. Went to ER on 6/15/21 , several tests were done, all was normal. The pain continued the next day 6/16/21, we went to Hospital ER , more tests done, all was normal once again and we were told to follow up with primary care doctor for Neurology referral

IN ER VISIT: history from patient and mother: Immediate onset lightheadedness, dry throat, intermittent neck and leg pain, then blurred vision. In ER rapid twitching of eyelids and rapid eye movements, not consistent with nystagmus. Exam otherwise normal, except lying in chair with eyes closed, answers appropriate but brief. Abated with ativan and zofran. Seen at 1912 PM in ER, came by private vehicle with mother. Discharged from ER at 2300 alert ambulatory and improved.

Symptoms: low fever, back and chest pain, mild nausea - started 6/4/21 and get worse over 4 days. Urgent care seeked on 6/8/21, EKG shown normal, no treatment received. Symptoms abruptly disappeared on 6/10/21

This is her 2nd medical event within the month of vaccine, previous VAERS reported Seizure activity appearance on 6/27/21 witnessed by parents. Started with yawn facial expression, drooling, pale, unconscious, shaking, called 911, normal appearing once they came, brought to facility and normal eval and EEG

Patient was vaccinated on June 5, 2021 , one week later she developed fever and myalgia and on June 27, she woke up with bruising and petechia on the legs and arms. she also had hematomas over the oral mucosa and subconjunctival hemorrhage. On June 27, she was seen in the ER, platelet count was 1000. She received IVIG on June 28 and 29

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.

Full body rash; full body itchiness; swelling of the skin, toes, fingers and lips.; swelling of the skin; swelling of the skin, toes, fingers and lips.; Joint pain from minimal movement.; swelling of the skin, toes, fingers and lips.; This is a spontaneous report from a contactable consumer (patient). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unspecified) via unspecified route of administration in the left arm, as dose 2, single on 10Jun2021 for COVID-19 immunization (at the age of 15-years-old). The patient medical history was not reported. The patient received birth control medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. There were no known allergies. On 12Jun2021 16:00, the patient experienced Full body rash, full body itchiness, swelling of the skin, toes, fingers, and lips. Swelling goes up at night and down after waking up, Joint pain from minimal movement. The events led to emergency room visit and hospitalization for 2 days. The patient underwent lab tests and procedures which included nasal swab and results were negative on 13Jun2021. Treatment received included benadryl, motrin and atakin, no imaging or steroid medication given. The outcome for the events was not recovered. Information on Lot/Batch number has been requested.

Bells Palsy - Paralysis of left facial muscles - difficulty smiling & blinking with left side. No treatment. Spontaneous recovery started 12 day after onset. Muscle weakness continues.

Around 9 AM, my daughter came downstairs and said her legs felt heavy. She sat down and then she said she was really hot. She was also sweating and pale. She said that she felt like she was about to pass out and that she couldn't see. She also said she couldn't focus, that she was seeing stars, and everything looked black. My husband and I told her to lay down on the couch. We gave her a rag to put on her head to cool her down and we got her some water to drink. She said she had a headache and we gave her some Tylenol.

Patient has had severe muscle and joint pain since her second vaccination. The pain started in her legs and knees and then moved to her shoulder then her wrist, then her back and back to the wrist and then shoulder. The pain was so severe that Motrin wouldn't even help. She ended up having to get on steroids starting July 4th. The prednisone helped quite a bit, but as soon as she ended her steroids the pain came back. We are now over 5 weeks from the injection and she is still in pain.

severe aches and pains in muscles and joints; severe aches and pains in muscles and joints; it hurt to pee; in tears from the pain; throwing up; This is a spontaneous report from a contactable consumer (patient). A 15-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0168, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 25Jun2021 at 10:00 (at the age of 15-year-old) as a single dose for covid-19 immunisation at Center. The patient had no medical history and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included Colecalciferol (VITAMIN D), birth control and anti-depressant medications received within 2 weeks of vaccination. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Jun2021 at 10:00 (at the age of 15-year-old) as a single dose for covid-19 immunisation. The patient was fine at first from the day of vaccination, on 30Jun2021 at 07:00, (after 5 days of vaccination) she started having severe aches and pains in muscles and joints. No one could touch her. She thought it was the vaccine and then she mentioned that it hurt to pee. Patient was taken to urgent care to rule out UTI infections, which they did and then referred her to the E.R (emergency room) because no one could touch her. She was in tears from the pain, and she was also throwing up. Patient received pain medications through an IV (intravenous) and anti-nausea medication as a treatment. The events resulted in emergency room/department or urgent care. The reporter assessed the events as non serious. The outcome of the events was not recovered. Follow up needed, further information has been requested.

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.

12 hrs after vaccine administration reported chest pain upper retrosternal area with radiation to jaw .back with dizziness,feeling warm with chills and muscle aches and joint pains for next 36 hrs Admitted to Hospital 7/16/21 Symptoms resolved 7/18/21 at 10 am

Patient developed ipsilateral arm swelling which progressed to polyarthritis on the elbow and wrist. Within a few days, similar symptoms developed on the ipsilateral leg including knee and ankle. Also with arthralgias and myalgia in this distribution. No real improvement with ibuprofen. Was admitted to hospital for these symptoms and arthritis resolved with NSAIDs, but still with significant arthralgias. No fevers throughout, but on NSAIDs.

Patient returned from trip and began having bilateral leg tightness and weakness, difficulty walking, tingling and numbness in hands and feet, low back pain. Got progressively worse over 2 weeks, she was requiring assistance to be carried to the bathroom. Denies other symptoms or illnesses, no fevers. On exam, 3/5 lower extremity strength throughout, absent lower extremity deep tendon reflexes, upper extremity strength 4 or 5/5 with 2+ reflexes, sensation intact throughout, right sided facial nerve weakness with asymmetric smile, other cranial nerves intact, tremor with finger to nose bilaterally, shuffling unsteady gate with inability to lift legs high.

About 30 hours after receiving the 2nd does of the Pfizer vaccine (6pm, June 24), my daughter started experiencing severe neck pain concentrated around the base of her head and eventually extending down her neck and shoulders. Her neck was very stiff and she had a constant severe ache. We treated it with moist heat (wet hot towels) and when that failed to work, gave her Advil even though we usually avoid it given her single kidney. The Advil provided temporary relief. The pain subsided on its own after about 3 days. My daughter also got her period off cycle two days after receiving the second Pfizer dose (June 25.) She is on a BCP for acne and was taking the active pills at that time so did not expect her period. It lasted nearly 2 1/2 weeks even though she was on the active BCPs the entire time. The flow was never as heavy as a typical period but it was more than spotting.

She started with a fever 102, chills, headache, body pain. As of today she still exp sinus pressure, ear pain both sides (side going down gland to neck), headache and body pain. She was taken to the doctor informed to give Tylenol and Ibuprofen.

Rash and swelling on face, feet/toes, arms, fingers, and a little on back; Tonsils slightly swollen; Rash and swelling on face, feet/toes, arms, fingers, and a little on back; swelling on face, feet/toes, arms, fingers, and a little on back; swelling on arms, fingers; This is a spontaneous report received from a contactable consumer (patient) or other non hcp. A 15-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-COVID-19 VACCINE, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jul2021 13:30 (at the age of 15-years-old) as dose 1, single for covid-19 immunization.Medical history included urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication(s) included cefalexin taken for urinary tract infection, start and stop date were not reported.The patient previously took azithromycin for drug hypersensitivity and experienced rash, azithromycin for drug hypersensitivity and experienced swelling. On 13Jul2021 at 06:00 the patient experienced rash and swelling on face, feet/toes, arms, fingers, and a little on back, tonsils slightly swollen, joint swelling, swelling on arms, fingers. Adverse event resulted in patient visited Emergency room, department or urgent care. patient received treatment with Zyrtec.The patient did not tested for covid before and prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date: 14Jul2021.The outcome of the events was recovering. Information about lot/batch number has been requested.

My child experienced dizziness and fainted within 24 hours of receiving the covid19 vaccine. That night, she experienced chills, fever and muscle aches. By the following morning (about 36 hours post vaccine), she was back to normal. No problems since then.

Presented with right arm redness and swelling. Ultrasound evaluation reveal DVT. Underwent heparinization and thrombolysis. Underwent post thrombolysis venogram. Patient is a 15 year old previously healthy female with unprovoked thrombosis located in right upper extremity, per the Admission Note specifically at the right distal subclavian through axillary vein as well as a DVT in the basilic and proximal brachial vein. Associated symptom was sensation of pressure on right arm "like blood pressure" cuff. Duration as of admission of these symptoms and presumably underlying clot was three days with onset of these symptoms was Sunday 7/18/2021. Timing was cyclical with discomfort in the arm worse in the morning than in the evening. Context of this thrombosis was healthy female who does not smoke, does not use hormonal contraception, is not active in sports where upper body workouts are emphasized, and was not injured.