Pfizer

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

Patient at the clinic for their first COVID-19 Pfizer vaccine today. Patient, sister and their mother were scheduling their second dose appointment when the writer heard a "thump" on the ground. The writer turned around to see the patient laying on the ground underneath a chair on her stomach with her eyes closed and not responding to voice command at approximately 1520. The writer and another nurse immediately rolled the patient to her side, a nurse moved the patient's hair from her face and the patient began to open her eyes. Patient began to become alert after less than 30 seconds of the episode. Patient remained laying down for approximately 2 minutes and stated she was embarrassed. Patient began responding to verbal commands and questions. Patient then began to go from a sitting and then to a standing position. Patient and her family escorted to the recovery room and assessed, refusing wheelchair transport. Patient's mother stated no history of this adverse event previously. Vitals taken x2 (See flow sheet). Nurses performed a head-to-toe focused assessment. Patient A & O to person, place, and time. Pupils equal and reactive to light. Patient asked "what day is it" and responded " The 18th." Patient asked "where do you go to school" and responded appropriately with school location. Patient asked "what is your mom's name" and responded. Patient asked "what is your name" and patient responded with her name. Patient asked "how old are you" and responded "12." Nurse assessed the back and both sides of the patient's head and witnessed no bumps, bleeding, or swelling. Nurse noted redness and slight swelling on the right eyebrow approximately an inch in length. No laceration or bleeding noted. The patient's mother touched the site and the patient stated that it hurt. Nurse advised the patient to place an ice pack on the site and the patient declined. Patient denies any neck pain, headache, nausea, dizziness, lightheadedness, or trouble breathing. Patient skin warm and pink. Nurse offered ice, animal crackers, and juice and patient declined. Nurse offered EMS evaluation to patient mother and the patient's mother declined. Patient's mother and the patient educated on the s/s of a head injury and allergic reaction and instructed to call 911 or go to the nearest ER. Patient and mother also instructed to follow up with a PCP and inform them of today's episode at their next visit. The patient and the patient's mother also instructed to ask to be given the vaccine in the recovery room for the second dose at the next appointment. Patient and family remained at the clinic for 30+ minutes. Patient stated that she felt ok and the patient's mother stated she felt ok to take the patient home. Patient left in the company of her mother and sister in stable condition without transport assistance out of the clinic. Patient's mother informed that a VAERS report will be filed and that they may contact her for further follow-up.

Hives developed on both arms on Saturday, Diphenhydramine 25 mg given by PO, Reduced swelling/redness, but hives did not completely disappear. On Sunday 5/23 hives became much more prominent in the afternoon. Spreading on arms, covered 25% of the surface of her back, and legs. Hives are raised, red and warm to the touch.

No immediate adverse event, but 2 weeks later (5/28) pt was seen for abdominal pain and referred to ER. Workup showed acute appendicitis, pt was admitted and underwent laparoscopic appendectomy. At time of follow-up (6/1), pt reportedly recovering well.

05/16/21 - vaccine administration 05/21/21 - small rash on inside right knee around 5pm; by 9pm, rash all over body. Administered 1 Benadry tablet at 9:30pm. 05/22/21 - rash progressed; called pediatrician; administered 1 Zyrtek tablet. 05/23/21 - rash appeared to start subsiding. Child reported some numbness in fingers and toes. Administered 1 Zyrtek tablet. 05/24/21 - rash subsided significantly. Swollen fingers and toes. Administered topical itch cream. 05/25/21 - fully resolved.

17 hours post dose, pt started with low grade fever, chill and nausea. 22 hours post dose she began vomiting and complaining of on and off stomach pain. 36 hours later on Sat June 6, she presented with severe lower right quadrant pain and we went to ER. Diagnosis was perforated appendix requiring emergency appendectomy and treatment for 72 hours with IV Cipro and Flagyl. She was discharged from hospital on Tues, June 7th on Cipro 500 mg BID po for 3 days.

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

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

Patient developed a large, painful lymph node in the lower part of the anterior chain on the right 12 hours after receiving the Pfizer COVID vaccine in the right arm.

Fever, arm swelling, arm tenderness, body aches, and rash on legs lasted 2 days. Rash on legs is what prompted reporting of symptoms.

Beginning Thursday night, fever onset reached 101. Patient reported extreme fatigue but aches and sore arm made sleeping difficult. By 2 am on Friday, June 11th, vomiting and diarrhea began. Patient was given 200 mg of Tylenol and 25 mg of Benadryl. Arnaca gel was applied to the rash that formed on the vaccine site. The rash was approximately 3 cm wide and 5 cm tall oval shape. It was bright red and painful to touch (like a sunburn). Arm was also swollen from shoulder to elbow. Patient slept from 4 am - 8am on 6/11. All day on 6/11 patient had trouble keeping down fluids (tried water, juice, gatorade, and broth) and patient refused food (tried popsicles, rice, bananas, scrambled eggs, and plain noodles). Patient complained of throbbing pain in left arm. Patient refused to massage the area and would screen in pain and cry with tears if mom touched it at all. Cold packs and warm packs brought no relief. Patient continued to receive Tylenol every four hours. Fever would reach 102-102.5, break with sweats. Patient reported feeling very cold and then very hot. Fever break would last 30 min - 1 hour before climbing again. Sunday 6/12 continued the same as 6/11. Patient began alternating Advil 200 mg with Tylenol every four hours. Advil didn't seem to help any more than the Tylenol did. Parent called consulting nurse and was advised to take patient to urgent care where she received anti-nausea medication. Monday 6/13 patient continues to have difficulty with food and drink. The phenergan meds help with nausea but make patient so tired, there's little chance to get patient to eat or drink. Vomiting has stopped but diarrhea continues.

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.

Started vomiting 2hrs after vaccination. Went to ER who initially obtained CBC with stable Hgb and sent home with Zofran. Patient continued to have bloody emesis so presented back to ER where they did CXR which was normal, gave IVF bolus, zofran, repeat CBC with Hgb 12.4 and transferred to another hospital for higher level of care. At the hospital, Initially made NPO and placed on IV fluids in preparation for possible endoscopy. Repeat labs showed stable hemoglobin compared to outside hospital. GI consulted and determined that hematemesis was most likely due to Mallory Weiss tear. Recommended carafate before meals, chloraseptic spray as needed for sore throat, continuing IV Protonix and IV zofran as needed, and gradually advancing her diet. On HD#3, she had another episode of hematemesis after eating solids. Overnight, tolerated liquids and solids without any further episodes of emesis. Tolerated transition from IV to PO meds and maintained hydration off of IV fluids. Due to symptom improvement, GI did not recommend endoscopy at this time and recommended that she be discharged on 1 week course of carafate, 2 month course of omperazole, and zofran as needed with plans for GI follow-up in 1-2 months. Had another episode of hematemesis at home after discharge. Went back to hospital and admitted again. The patient underwent upper endoscopy which showed no source of upper GI bleed. ENT was consulted and performed a nasopharyngolaryngoscopy which was negative for an ENT source of bleeding. She remained stable without an identifiable source of bleeding. Mom was comfortable with her being discharged home with close follow up by PCP. Pt seen on 6/7/21 at pediatrician's office for ER F/U. Pt reported she was still vomiting, 2x so far that day. The day before vomited 4x during the day and continued until the night. No more bright red blood in vomit. Describes vomit as blue and pink colors now. Pt does take a light green tablet that is her levothyroxine. Threw up the blue colored vomit immediately after taking this medication. Instructed to take zofran when feeling nauseous. Seen again by pediatrician on 6/10/21- Currently, per mom pt is still vomiting. Last time she vomited was last night. Pt is taking omeprazole. Pt vomited 5-6x yesterday. Decreased appetite, but has been eating some crackers and rice. Complaining of stomach pain after eating and vomiting. Pt used zofran once and it helped a little. Pt denies self induced vomiting. Pt has ben observed by family when vomiting and they do not report any self induced vomiting. Pt denies trying to lose weight. Pt never vomits up food, always liquid. Vomit is different colors, can be pink or blue. No more red color in vomit, only pink. Pt drinks water and gatorade. Pt denies feeling any burning before vomit, but feels burning sensation after vomiting. Pt has been having BMs, not regularly and hard. Taking one capful of miralax at night. Instructed for next five days, instructed to take zofran pill 1hr before dinner. F/U with GI. Seen again by pediatrician on 6/15/21- Per mom and pt she is still vomiting about 5-6 times a day. Pt went to GI yesterday, given lansoprazole 30mg qd and told to continue zofran.. Pt is now able to eat all her meals, takes zofran 1hr before dinner. Pt has vomited 1hr after dinner and has only vomited liquids. Hematemesis has resolved. Still has some blue colored vomit, most likely from levothyroxine medication she takes daily. Stopped taking Miralax 3 days ago. Pt had a soft BM earlier this morning. Pt states she has occasional stomach pains after vomiting, takes a while to calm down but then resolves. Described as lower abdominal. Pt has nausea before vomiting, after vomiting takes 15-30mins for nausea to resolve. Pt states she had a headache with a heavy sensation when vomiting. No headaches at night, but does vomit 3-4x overnight. LMP: 2wks ago. Recommended to go to ophthalmologist to r/o papilledema. WIll contact hospital to get results of any bloodwork done inpatient (reviewed - only CBC done inpt).. F/U in 1wk. Ordered MRI brain w/contrast. CMP. lipase, amylase, celiac disease panel. All results pending.

6 days after her first dose, she developed a rash on her knee. It was swollen and painful.we didn?t realize it was related until she developed a similar rash after her second dose. 4 days after her second dose she developed a rash on her left arm and hands. Looked the same as the one she had on her knee- raised, swollen and her arm hurt.

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

She exp swollen squishy lump on left side(between neck and shoulder). I contacted the doctor regarding a reaction to the vaccine within 24 hours. He wanted to rule out a tumor was informed the swollen lump would probably be there for another month or two.

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

Red ring and bruising at injection site 12 after vaccination lasting about 2 weeks. other symptoms included lymph node swelling, fatigue, headaches and stomach for a day or two after vaccination.

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.

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

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

Patient presented with positional chest pain that developed 1 day after the vaccine was administered. Was found to have mild elevations in inflammatory markers and with T wave flattening on EKG. Admitted for observation for presumptive pericarditis. Did have URI symptoms w/ runny nose on admission and siblings with cough/runny nose at home

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

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

June 26th- started getting a painful vesicular rash on her left arm- finger- spread up arm to axilla and then to L scapular area. + axillary lymphadenopathy. + fever and headache started 6/30/2021. Had a Dr. visit 6/30/2021. Diagnosed with shingles and started on acyclovir. No other areas of rash. No other symptoms. Fever and headache resolved mid day 7/1/2021. Rash on L arm continues- painful. Also had + rapid strep test that office visit on 6/30/2021- no throat pain- but still placed on antibiotics for strep- penicillin.

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.

Localized hematoma/swelling on dorsum of right foot. Hurts when walking. Also had nausea and abdominal pains. No fainting and no vomiting.

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.

Swelling in face. Swelling is minor and not causing any discomfort. Symptoms started approximately 48 hours after the injection. Today is 96 hours post injection and the swelling is almost gone. It was not severe enough to seek medical treatment. One dose of Childrens Benydryl was given and that seemed to help. We spent all day in the sun after receiving the injection, and I'm guessing this minor reaction is a result of that. We just wanted to report that she did have a reaction. Thanks!

Approximately 3 days after the vaccine started with abd pain and vomiting, this lead to dehydration and hospitalization

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.

Pt developed swollen lymph node in underarm in the axillary area of the right arm. Lymph node was still present 3 weeks later when getting 2nd dose of PFizer Covid. Pt went to see MD. MD stated common with shots and cleared for 2nd dose . Swollen lymph appears to be getting smaller

24 hours after receiving the vaccine, my daughter experienced chest pain. Per the recommendation of her doctor, we took her to the ER. She had a rash on her back and chest. After 48 hours, a low-grade fever of 101 (lasted 1 day) and a swollen lymph node on her right armpit.

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

Fever, eye redness, body pain starting 1 day after vaccine cough, nausea, abdominal pain 3 days after vaccine 1 episode of emesis 5 days after vaccine - Admitted to hospital with suspicion of MIS-C - As per ID and Hem/Onc, Started on IVIG and aspirin (5/23/21) - currently still admitted for management of MIS-C

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.

the day following vaccination she described worsening of chronic fatigue, headache, chest/rib cage discomfort, swelling of left arm and left face, hives under eyes and left face

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.

Same arm, rash and hives whole arm and top of hand. Mild onset 24 hrs after injection. Increased swelling, rash and itching at 48 hrs, spreading to hand.

Redness and swelling of arm after injection; Redness and swelling of arm after injection; This is a spontaneous report from a non-contactable consumer. A 13-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced redness and swelling of arm after injection on an unspecified date. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

The morning after the vaccine she had a fever for 1/2 the day, a headache for two days, and body aches for two days. Then, on Thursday, May 27th she had a swollen and painful armpit on the arm that the injection was in. The pediatrician thought it was probably swollen lymph nodes, but just did a teleconference with her, so she didn't see the swollen armpit. Patient took ibuprofen for the pain and swelling, put heat compresses on it occasionally, but it still stayed that way for All of Thursday and through the weekend. The swelling began to go down on Monday, May 31. Then on the morning of June 1 she had a sore throat, later developing a fever, headache, and congestion that lasted two days. She is a bit improved today, June 3rd, just still congested and has a cough but all other symptoms are gone.

Face is swollen/face was puffy; complaining of pain in her throat glands/Glands under throat are painful; sleeping a lot; didn't really eat much; Very Lethargic; vomited once or twice/Vomiting; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for her daughter (patient). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 13-years-old via an unspecified route of administration on 15May2021 15:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included ongoing reaction to bread. Concomitant medication included an unspecified anxiety medication. It was reported the patient received the first dose of the Pfizer COVID-19 vaccine on 15May2021, and the next day, 16May2021, she was sleeping a lot and vomited once or twice, didn't really eat much. This morning, 18May2021, she vomited and noticed face was puffy and complaining of pain in her throat glands, they will be taking her to her HCP this afternoon. Shee mentioned that she has had a reaction to bread, possible gluten intolerance, maybe yeast, and was asking if is there is yeast in the production of the vaccine. She got the vaccine on Saturday at 1530. It was further reported that for the first day or two she was very lethargic and vomiting on 15May2021. States they thought it was just a normal reaction. The reporter stated that today her daughter isn't in school again because she is vomiting, her face is swollen, and her glands under her throat hurt. States she is going to the doctor this afternoon. The patient did not recover from vomiting, was recovering from very lethargic while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

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.

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

Daughter stated she had diarrhea for 3 weeks while we were at the hospital on 6/2 for IV fluids and severe dehydration. Her poop was mushy, and not diarrhea, however for her it was much softer than normal. She collapsed at home and was unresponsive, 911 was called, ER doctor determined she was severely dehydrated and administered 2 bags of IV fluids to stabilize her blood pressure.

Lymph node on left side (same side as shot) was very painful and swollen. Swelling reduced in 24 hours, but still painful. Low-grade fever.

heart swelling or inflammation; heart swelling or inflammation; maybe she has a swollen lymph node that is putting pressure on a nerve.; arm pain in the opposite arm of vaccination/ left arm pain that has progressively gotten worse; get worse/ left arm pain that has progressively gotten worse; swollen lymph node; excruciating pain all the way down to her hand; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 13-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8736; Expiration Date: Jul2021) via an unspecified route of administration in right arm on 13May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient did not receive any vaccination within 4 weeks prior to covid vaccine. The reporter stated that the day the vaccine was approved [for her age group] she got her initial vaccine. She received her first vaccine dose on May 13th in her right arm, several hours later she began having left arm pain that has progressively gotten worse. She reported that after running her arm was in excruciating pain all the way down to her hand. She further enquired if left arm pain a common symptom of the heart swelling or inflammation of the heart following vaccination or is left arm pain something people have when they had heart swelling or inflammation. She further stated that hadn't happened the exact same day she wouldn't connect it so much. The vaccine was given in the right arm, but it is her left arm that is hurting. she called her pediatrician, and he is thinking it is coincidental or thinking maybe she hurt herself, but caller states she doesn't know but maybe she has a swollen lymph node that is putting pressure on a nerve. The patient took Tylenol for the reported events. Outcome of the events was reported as unknown at the time of reporting. Information on Lot/Batch number was available. Additional information has been requested

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.

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

Lymphadenopathy- Posterior cervical. Enlarged one day after first dose of vaccine, Improved over time, but then worsened again after second dose which was given in the same arm on 6/3/2021.

Patient started experiencing moderate-severe abdominal pain one week after the first vaccine dose. Abdominal pain subsided over 2 days. Patient has never had any issues with constipation or gas, cramping, menstrual pains. This was the first time she experienced so much abdominal pain.

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

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

Right groin 2 CM lymph nodes swelling 2 days post Pfizer vaccine. Headache and muscle soreness at injection site few minutes after the vaccine

Patient received covid #2 vaccine and developed a lump above the collarbone area with swelling and painful to touch. Diagnosed as left supraclavicular lymphadenopathy.

Mother called clinic reporting daughters face began to swell at around 10:00 Pm after receiving the first dose of Pfizer vaccine in the late afternoon (4:00 PM )at clinic.

Patient came into pharmacy on June 22nd, 2021 stating she had swelling underneath her left armpit after receiving her second COVID vaccination on June 19th, 2021. The swelling began on June 20th, 2021 and has gradually decreased in size over time. The pharmacist, counseled the patient that there have been reports of lymphoedema following COVID vaccination. She recommended the patient follow-up with her primary care provider for further evaluation.

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

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.

left supraclavicular and axillary lymphadenopathy on ipsilateral side of injection, normal labs, resolved over next month

Patient had a very bad allergic reaction to her 2nd dose of vaccine of pfizer on 7/6/21 . her reaction occured on 7/7/21 she broke out in bubble hives as well as her feet fingers and eyelids swelling up. today marks 4 days. I did take her to her primary on 7/8/21 he prescribed her benadryl . the next day got worse , so I took her to the hospital on 7/9/21. doctor drew a blood sample to check her organs she said everything looked ok. So doctor said she was gonna report it and I was to do so as well. Symptons have not gone away and we are going on day 4 so doctor said it should be gone in 3 days. So if shes not bring her back into hospital. I am very worried, and am up through out the night settting my alarm every 2 hrs to make sure shes not flaring up.

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

Patient received her first Pfizer dose at 4:06pm at 4:20 mom brought patient over to me to tell me she was feeling like her neck and leg felt swollen, we all discussed that it could be swollen lymph nodes and they choose to go and check out up front. At 4:30 Mom brought patient back to the pharmacy and said she was feeling strange. Patient said her throat felt weird, she felt dizzy and was having ear pressure, but was not having difficultly breathing. I offered Benadryl and to call 911, Mom denied her needing that at the time. While we were asking patient questions her eyes started to roll and flutter and her head would fall back, but she was alert and talking and stated that she was seeing spots. I told Mom that we were going to call 911 at that time so they could come and check her out. I also go an ice pack and we placed it on her neck, her face was flushed and I took her temperature it was 99.2 at 4:42pm. Ambulance arrived at 4:45pm and they did her vitals and she walked out to the ambulance with them to be checked out. I called Mom at 6pm to check on patient and she was doing much better and did not have to go to ER.

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

Patient reported to clinic 1+ hour post vaccination with complaints of itchiness and swelling to face. Patient denied any discomfort of the throat or tongue. Vital signs were within normal limits. Consulted with Pediatric Dr. who consented the administration of a 25 mg oral capsule of Benadryl. Patient began to feel slight discomfort swallowing. Oxygen levels remained within normal limits. Consulted with Dr. and per his assessment patient stable and no need for further intervention. Patient was observed for a total of 30 minutes following administration of medication. After 30 minutes patient reported that her symptoms were resolved.

Patient got up from receiving shot and fainted on the ground-patient hit his head. EMS was called. Patient turned very pale and nausea, patients arms was swelling. Patient started to return to conscience but remined unwell. EMS did an evaluation. Father took son to hospital

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

Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Weakness-Severe, Additional Details: patient started feeling hypotensive, sweating, lethargic post covid 19 vaccination. paramedics called due to low blood pressure. patients symptoms resolved gradually and didn't necessitate ER trip.

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

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

On Thursday 5/27/21 her right eye swelled spontaneously while in the classroom. Both the upper lid and lower lid. No ocular involvement, or visual changes. Resolved with time and ice. Assumed that it was contact dermatitis. No other symptoms or complaints. The next morning 5/28/21 she woke up covered in hives on trunk/legs, minimal facial swelling. Lips/tongue/mucus membranes not involved. No SOB, dyspnea, cough or wheezing. No chest pain/pressure, no GI complaints or other complaints. I gave famotidine and levocetirizine. No worsening of symptoms noted and she attended school with close monitoring.

Within 5 days of immunization, developed fever, abdominal pain, headache, elevated inflammatory markers, DDimers, ferritin and BNP and coagulopathy. Admitted to Hospital and evaluated for MIS-C. Observed and treatment recommended for MIS-C with IVIG and steroids.

-arm felt immediately warm after receiving vaccine (has felt similar after previous vaccines) -within one hour, arm was red and swollen -within two hours, left arm broke out in rash -over the next few hours, the rash spread down left arm and onto right leg -rash persisted for two+ weeks

On the outset: There is no proven link of the vaccine with what happened, but I am filling this just in case you see a pattern emerge: She was vaccinated (pfizer, 1st dose) on Saturday, May 15 2021. A couple of hours later she started experiencing mild symptoms (moderate headache, which we thought as a normal reaction). These persisted on and off until Wednesday, May 19th, when patient started having swollen and painful glands at the back of her mouth. Long story short, after testing first for strep, followed by blood work, patient's blood test came back positive with mono on Monday, May 24. The reason for this report is that I have read that mRNA vaccines, great as they may be, may trigger a virus response for viruses that stay within a person - like shingles or herpes etc. The way I understand it, mono also stays with a person. Patient had never been diagnosed with mono before, but mono sometimes does not have symptoms. So, is it possible that she had mono sometime before the vaccine, and it got re-triggered due to the vaccine? Again, just in case you see a pattern, I am just reporting if helpful. Patient also developed a mono rash on Wednesday, May 26; treated with topical benadryl cream.

She was not feeling well when she got up on Saturday morning. We went to the neighbors house and were outside for maybe 15 minutes (it was a warm day) when she passed out momentarily. We immediately got her some water and got her in the AC and she did fine since then. She did have mild finger swelling on the distal joint of both index fingers after the first injection on 5/14/2021(same lot #). We are not sure if the finger swelling was related to the vaccine. It started about 5 days after first vaccine.

Facial swelling, left side, maxillary and mandibular areas. No pain, no redness, no increase in temperature. Mild pain on pressure on the area of swelling. No palpable lymph nodes

Immediately following first does of covid vaccine patient became unresponsive, diaphortic. Pt did have a pulse and spontaneous breathing. Pt responded to ammonia capsule by opening her eyes . She complained of sudden onset of chest and abdominal pain . Pt states she became dizzy, lightheaded immediately following the injection. Then developed chest tightness and abdominal pain and nausea . Pt rated abdominal pain 10 0n 1-10 scale. Pulse 88 resp 36 Tx at mobile clinic: Ammonia capsule, benadryl 25 mg PO Pts weight 40.1 kg Tx in ED: Prevacid , Tylenol with great relief ,symptoms resolved

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.

Patient received 2nd dose of pfizer covid vaccine on 06/03/2021, next day noted supraclavicular lymph node.

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

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 days of left upper quadrant abdominal pain and fever (starting 6/7/21), and splenic infarctions visualized on CT abdomen/pelvis on 6/14

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.

lymphoproliferative disorder; Enlarged lymph glands supraclavicular; This a spontaneous report from a Pfizer employee received from a contactable pharmacist. A 14-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: ER8735) via intramuscularly administered in left arm on 22May2021 15:00 as single dose for COVID-19 immunization. Medical history included prior heart transplant and patient had known allergies to Amoxicillin, tree nuts/peanuts. Concomitant medications within 2 weeks of vaccination included Cyclosporine, Prednisone, Azathioprine and among other supplments. On 09Jun2021, the patient experienced lymphoproliferative disorder and enlarged lymph glands supraclavicular. The patient was hospitalized for both the events for 6 days. The outcome of the events was recovering. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab) was negative on 04Jun2021. The patient had enlarged lymph glands supraclavicular in addition to lymph tissue in chest based on CT scan. It was reported that the events may have started prior to vaccine administration however reporting this as vaccine was administered in the weeks prior to enlarged lymph being reported by patient. The most recent COVID-19 vaccine was administered at public health clinic. The patient receives no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient visited Emergency room/department or urgent care for events. Outcome of events was recovering. Information on batch/lot no. were available. Further information has been requested.; Sender's Comments: Based on temporal relationship, there is reasonable possibility of causal association between the event Lymphoproliferative disease and Lymphadenopathy and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

lip & face swelling; lip & face swelling; This is a spontaneous report from a Contactable consumer. This consumer reported for Female patient. A 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date(at the age of 14 years old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient historical vaccine included 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 on an unspecified date as 1st dose, single dose for COVID-19 immunisation and patient had no reaction on previous exposure to Vaccine. On an unspecified date, the patient experienced lip and face swelling 7 days post second dose of Pfizer COVID-19. Event was occurred after use of product. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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

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

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

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

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.

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

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

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

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

facial swelling especially around the lower eyelids, subsided through the next 48 hours and is the swelling is now gone, pictures available

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

Swellenband painful lymph nodes behind ears. Fever rash over 100%of body . Started day two after vaccine it is now day 7post vaccine rash getting worse

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

Supraclavicular lymph nodes in the left shoulder swelled up. It may have appeared sooner, but we didn't notice until two or three weeks after the first dose of Pfizer Covid19 vaccine.

Face swells up; Turns really red and itching; Face swells up and turns really red and itching; Really sick the day after she got her second dose; This is a spontaneous report from a contactable consumer (patients mother). A 14-years-old female patient received bnt162b2 (Pfizer covid vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 12Jun2021 (at the age of 14-years-old) as dose 2, single for COVID-19 immunisation. Medical history included asthma. There were no concomitant medications. The patient previously took BNT162B2 as first dose on 05May2021 or 06May2021(NDC, Expiration Date, Lot: Unknown) administered in left upper arm. On an unspecified date, the patient experienced face swells up, turns really red and itching, face swells up and turns really red and itching, really sick the day after she got her second dose. Patients mother stated she had to take the patient to the emergency room first time this happened, this was already the third time it was happening again and stated the patients face was swelled up and turned really red and itching. Patient mother added it looked like an allergic reaction, but she thought it was not an actual allergic reaction from what she read, she guessed it was her body trying to fight off this and the patient was really sick the day after she received her second dose and thought it was just going to end there with that, as she seemed to be ok for a week or two, and now yesterday and the patients mother gave another Benadryl, because the patient said, the same thing was happening to her face. Patients mother stated that she was calling to report about her daughter has been going though since she had been vaccinated, the patient having adverse reactions and confirms the product was the COVID vaccine and stated she had only a few minutes to go through the report, she was at work, when queried by agent. Therapeutic measures were taken as a result of face swells up, turns really red and itching, face swells up and turns really red and itching. The outcome of the events was unknown. Information about batch/lot number has been requested.

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.

1436 felt dizzy, was diaphoretic, pale, b/p 90/40, pulse 60 RR 40 99% 02 sat., MOC present. 1437 assisted to floor placed in Trendelenburg position feet elevated. 1439 B/P 110/p, pulse 80, RR 30 02 sat 99 %, alert and oriented , able to verbalize feeling better. No longer diaphoretic, skin color pink. 1444 assisted to sitting position in chair B/P 98/68 RR 32, 02 sat 100%, pulse 76. 1500 B/P 102/64 99% 02 sat 75 pulse respirations even and unlabored, per MOC stated she is feeling better, pt verbalized the same no longer requiring medical care, left with MOC, educated and encouraged to contact Primary MD if symptoms should return, verbalized understanding.

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

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

Redding, warmth to the left of the injection site. Approx size of a penny. Next day, Redding, warmth in same area but larger approx half dollar size. Not in shape, but just in size.

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

Site: Bruising at Injection Site-Mild, Systemic: Patient developed Left side mastitis after recieving vaccine-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: Pt developed left side mastitis according to her doctor and pt had gotten the COVID vaccine in the left arm just 2 days prior. Pt is only 15 and there is no other origin possible according to her dr.

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

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

Received vaccine 5/22/21 - had some local arm swelling & pain which resolved that night. 5/23 had fever, chills, nausea, diarrhea x2 days with complete resolution. On 5/29, developed urticarial rash on legs & arms - no improvement with OTC Benadryl. No new foods/obvious exposure to other allergens other than family had tried a new scent of their brand of fabric softener. 5/31, developed nausea, vomiting, hand/feet swelling, & had a pre-syncopal episode. Presented to ER; tachycardic with symptomatic orthostatics though vitals otherwise normal. Received IV fluids, Pepcid, Decadron with improvement in HR/symptoms. Continued to be orthostatic with some extremity swelling so received IM Epinephrine - subsequent improvement in rash, nausea. Hospitalized for monitoring. Orthostatis/nausea resolved, vitals remained stable. Some intermittent itchiness/hives present that came & went still present at the time of discharge from hospital.

tenderness at needle site location two days post vaccine, lymph node swelling on left side between breast and underarm

Patient received second COVID-19 vaccine on 06/06/2021 and on the next morning of 06/07/2021 she woke up with a headache, large swollen bump on her left axillary that was red, warm and painful to touch and no fever.

Patient received her second dose of the Pfizer COVID-19 vaccine Friday, June 4th, 2021. One day after the second Pfizer Covid 19 shot, (Saturday, June 5th, 2021), Patient experienced fever, fatigue, weakness and swollen lymph nodes. Two days after the second Pfizer Covid 19 shot, (Sunday, June 6th, 2021), Patient still had those symptoms in addition to the break out of several painful genital laisons. She visited her pediatrician Tuesday, June 8th, 2021, and the laisons were tested for the herpes virus. Patient was also prescribed oral antiviral medication, and topical steroid creams. The results for the herpes test came out negative. Today, June 11th 2021, the laisons are still present and painful, and continue to be treated.

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

she had low grade fever, chills, headache, but next day she complain of pain on the left side of her body (not just the arm) I was told this was normal and to give her Tylenol or ibu. she has swelling in her left axilla. on Sunday she notice some blister on the inner corner of her mouth. I have messaged her PCP with no response

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.

Enlarged and tender lymph node in the axilla: The left axilla has no erythema, no rashes, but is notable for a tender, visible well circumscribed 3.5 x 4 cm sub q nodule - most c/w enlarged lymph node. started 2 days after the second dose of covid vaccine. no therapy, we are just monitoring

5/18 - received Pfizer COVID Vaccine dose 1. 5/19-5/20 - very tired 5/20-5/21 - overall did okay 5/24 - woke up extremely nauseous, vomiting, fever to 100.6F -> increased to 102.5F, chills, near syncope in shower so ambulance called and went to Emergency Department 5/25 - similar symptoms as the day prior but also had headache, continued extreme fatigue. Fever continued. 5/26 - diarrhea started, vomiting resolved, continued headache and fatigue. Fever continued. 5/27 - last day of fever. Headache resolved 5/28 - diarrhea resolved.

Rash that started on arms (started on the 9th days after her second vaccination). Woke up the next day with rash and facial swelling. Rash itches. Tried Benadryl on first day. No soa. No cough. No sore throat. No difficulty breathing. No vomiting. No new soaps/lotions/hair products or makeup. Was at amusement park the day it started to break out. Had also been in the woods in the past few days.

Experienced a headache that has not went away. She is very fatigue, chills, enlarged lymph nodes behind her ears and under armpits, dizzy spells, sensitive to light.

After 10 minutes of vaccination, patient reported to pharmacy that she was not feeling good and assume that her neck was swollen. I check the neck area, no swelling, and asked if she was breathing fine, and patient was ok. I offered to give epi pen in case she is allergic to any, but refused. EMS showed 2 minutes later and took over.

Patient developed chest pain 3 days after her 2nd covid vaccine and was found to have elevated troponin consistent with myocarditis. She had sub sternal chest pain that lasted for about 5-7 days after her vaccine. She had normal vital signs and exam on the day she was seen in clinic and through out her course.

12 hours s/p vaccine The patient developed fever to 102.5 taken orally. She had body aches, Headache, nausea and vomiting. By the second day the patient developed mild facial swelling bilaterally, this responded well to Zyrtec. There was no SOB, or dyspnea. There was no swelling of lips or oropharyngeal structures. Her symptoms persisted for 48 hours. Patient was treated at home by her mother, who is a pharmacist, with apap alternating with ibuprofen. She was also given Zyrtec as noted. The patient was seen by me this afternoon and was improved with no fever evident. However, Mom had given her 1 gram apap 1 hour prior to her visit.

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.

Blistering rash on side of face. Resulted in infection and swelling on right side of face and under eye. Blister was swabbed and cultured by attending physician and came back as Herpes. Patient was put on antibiotics immediately and Valtrex after culture diagnosis was returned.

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

Patient passed out, resulting in her to fall and hit her head on the stove on her way down. She was pale and came back to within less than a minute. She stated she felt dizzy before she passed out. Once she was able to sit up we applied ice to her head due to a lump from hitting her head and only two minor scratches on her scalp that we cleaned well. We gave her something to eat and drink when she was able to sit up and we knew she was alert enough to eat. She began to feel better after this.

Pt developed fever, ST and presented to office with hives and edema of hands/feet> Pharynx red. Strep neg and started on prednisone for presumed angioedema. EBV titers neg when ST persisted, inflammatory markers very high. Clinically did well and by day 3 steroids much improved. Of interest pt did have COVID in Jan 2021 with chest pain after that was evaluated with normal troponin and EKG/ECHO by cardiology and normal, though to be anxiety

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.

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

Patient 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.

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.

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.