Pfizer

Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe

Small raised, red bump that appeared immediately after injection at injection site. Patient also experienced itching and small red dots that started to appear around injection site seconds after injection. Administered 50mg po Diphenhydramine following injection. Itching subsided and no additional redness or swelling occurred.

She has measles like bumps it started below injection area didn't notice till she got home on both arms and legs and hands. She still has them and they are itchy and red.

Macular erythematous, blanchable rash on bilateral palms. Non pruritic and non painful. Patient first noticed the rash ~50 hours post vaccine administration. Anticipatory guidance and supportive care provided. No further interventions required.

headache, lightheadedness, fatigue, and a fever of 100.4 - site of vaccine has a slight redness/tenderness (mom reports mild - consistent with vaccine localized reaction). Sxs have persistent through from 5/16/2021 to 5/18/2021, temperature has slightly improved at 99 with Motrin, but headache/fatigue persisting, and then patient woke 5/18/2021and vomited x 1. day 3 with slightly elevated temp, persisting headache, fatigue, and new onset sx of vomiting today. Motrin for fever, fluids, rest, and monitoring at home.

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.

Client complained of itchiness to throat, right arm, left foot, abdomen, and right temple. Denied any difficulty breath or shortness of breath. Able to drink water without difficulties. Offered Benadryl IM. Vital signs stable. B/P 110/56 HR 74 RR 18 O2 Sats 100%. No distress noted.

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

Female patient with 12 years of age had a cutaneous reaction in both arms after fifteen minutes of observation. Presented itching in the punctured area.

Swelling of the upper left lip on 05/20/2021 noticed when she woke up at 7am. No signs or history of trauma. Gave Benadryl 25mg liquid orally and iced the area. A second dose of Benadryl was given at 1pm as the swelling had not subsided. By evening her lip was normal. When waking up on 05/21/2021 she noticed a approx 1cm ulcerative type lesion on her inner upper lip. The lip was swollen again, but slightly less so. Repeated Benadryl 25mg three times that day at 6 hour intervals. Started on triamcinolone 0.1% cream prescribed by her pediatrician that evening. On 05/22/2021 the lip was not swollen and the ulcer appears to be healing on the upper lip, but a small portion of her lower left lip now shows an approx 1-2mm ulcerative lesion. Triamcinolone 0.1%cream applied 3x daily. She noticed a irregular confluent red rash approx 4cmx2cm on her right mid abdomen on Tuesday after swimming, but unsure if this is related. She had her regular maintenance allergy shots (one shot in each arm) on Tuesday at 12:15pm.

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

The night after her shot, patient had a hard time sleeping. She experienced "crazy dreams". She's had a fever, chills, headache, tiredness, pain at injection site, and a feeling of overall discomfort. She has been resting and sleeping all day.

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.

Systemic: Fainting / Unresponsive-Severe, Additional Details: upon exiting vaccination room pt fell forward. it is unknown if she fainted or tripped, mom was standing behind her and was unsure as well. pt bumped head and had a welt on her upper right eyebrow, also her nose began to bleed. ice pack was given/applied to head/eye, paper towel given to stop nose bleed. also water/starburst given. 911 was called. dispatchers came and quetsioned if she felt dizzy when she left room to which pt responded no, ambulance took pt.

I just saw a 12 year old in the office who has an odd rash that started the day after she got her first COVID vaccine (Pfizer). She started with the two on her right ankle the day following the vaccine, then the two on her left ankle started the next day, followed by one more on her distal left arm over each of the next three days. She says the burn slightly when she touches them but no itching, not otherwise painful. They look to me like burns or something similar. I wonder if they are self-inflicted but she denies causing them or anything new recently aside from the vaccine. She has been using neosporin occasionally since they were noted, no other treatments. Other vaccine reaction noted: fatigue and slightly sore arm. She just completed a course of clinda for strep on 5/5. Otherwise just takes vitamin D daily. No recent open water swimming, etc.

First Dose of Pfizer red welt (COVID arm) at the vaccine site, burning and itching. Lasted about 4/5 days.

Pt is a 12 y/o female, a&o x4, accompanied by mother. Within 5 minutes of vaccination the patient complained of stomach cramping and nausea. On further assessment both of the patient's arms appeared red and she developed a rash on the neck and right side of cheek. Pt spit clear fluid x2. Pt vital signs were within normal limits. Lung sounds were clear. The patient was administered 25 mg of diphenhydramine hydrochloride IM. Last vital recording was at 1:50 pm 111/77, HR 88, Spo2 98%, when EMS arrived.

Facial rash: Dry and flaky. May or may not have been related to vaccination. In retrospect had also started differin gel which may have caused the rash.

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

It was within 5 minutes, she started having hives that went down her arm and spread to other arm, face, trunk, legs, stomach. I went and got a nurse and she called a pediatric team - three nurses and one doctor - they took her vitals and gave her some Benadryl - 30 ML (children's). They had her sit and drink a bottle of water. We watched to see if the swelling and the hives would shrink and go away. It was probably about 20 minutes later where they went away, but she developed a headache and she was nauseated. We administered Benadryl (gave her regular 25 mg tablet every 6 hours) for the next 24 hors in the dosage times. She was nauseated the first day and she had headache for two days. The hives went away by the time she went to bed the evening of the vaccine.

developed a rash whole left arm; Feeling dizzy; dizziness was kind of severe dizziness where felt like everything was moving around; weak; Shaking; Chilling; Does not feel ok; half an hour lying down; This is a spontaneous report from a contactable consumer reporting for their daughter (patient). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at 12-years-old intramuscular, administered in arm left on 16May2021 (Batch/Lot Number: EW0177) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that within 5 minutes after taking the vaccine on 16May2021, the patient started feeling dizzy, weak and little bit of shaking, chilling. Dizziness was kind of severe dizziness where felt like everything was moving around her. They took her to urgent care center because she does not feel ok after half an hour lying down there. The doctors were there and they gave medications as an injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed (treatment). The patient got the reaction at 1145 am within five minutes feeling dizziness. After 30 minutes waiting were advised to take her to the urgent care. She was prescribed Promethazine 25mg, Ondansetron 4mg, Meclizine 3 times a day for next five days. Reports adverse event (unspecified) still maintains. Then later developed a rash, whole left arm on an unspecified date. Therapeutic measures were taken as a result which included injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed. The outcome of the events was unknown.

About 5 minutes after the shot, patient's mom said that she didn't feel good. Patient was dizzy, sweaty, nauseas and really hot. The arm that got the injection was also really hot. I had the patient lay down, and gave her an ice pack for her neck/arm. After a few minutes patient said that she felt better. I had her lay down for about 5 minutes. She then sat up and said she was much better. Wasn't dizzy or nauseous anymore. Arm felt better too. I had the patient sit and wait in total 30 minutes. Mom wanted to leave sooner but I asked if she wait so that we could make sure she was ok. THey waited 30minutes and left . patient was fine.

Headache for 3 days, arm pain at injection site for 3 days, fever 24hrs, chills for 2 days, general not feeling well, soar throat on 2nd day.

She had a rash after school - she noticed it about 2:00 - she started getting a headache and around 03:00 - she noticed a rash (red marks - no bumps) on her knees and upper and thighs. About 3:20 - her right arm and a little bit on her left arm were almost like hives (bumps) - they were a little bit itchy off and on. The next morning, could still the bumps but not as bad, but on 19th after school it was back just like the day before. We gave Benadryl to see if that would help. In the morning it goes away - on her arms, she can see a little a bit of where the lumps are - not as bad; on legs it's just almost completely gone, and by afternoon it's back to full scale of where it had been the night before. Could see where the bumps were in her arm but it is not as bad as it was. Today, as far as I know from the last time I asked her, she said there are still some on her arms but not on legs.

I received hives for 6 days. It was everywhere on my body. I was very itches. I did take claritin and Benadryl as needed.

Patient began developing rash 2 weeks after initial dose of Pfizer COVID-19 vaccine. Rash started with an oval, salmon-colored plaque followed by numerous similar but smaller lesions on trunk. Rash evaluated in my office 06/03/21 and felt to be consistent with Pityriasis rosea. Referral to Dermatology for confirmation.

Patient developed pruritic rash 10 min after vaccine administration. She was given antihistamine with improvement in her rash, and symptoms. She was discharged home from the vaccination site in improved condition.

2nd pfizer covid vaccine....Fever the morning after that lasted only about 8 hours (and came down w/ tylenol, but after 2 rounds of that, it never returned). Hives on the feet and ankles appeared the night after (about 36 hours after) and persist now that we are 48 hours out. Raised skin, redness and slight yellowing of the skin w/ the hives. Somewhat itchy hives. Administered Benadryl orally every 4 hours and topical hydrocortisone cream. It is still there, but not an emergency or causing problems. We will monitor and call the Dr. in the morning if it persists.

Patient experienced strong localized reaction including itching, burning, and swelling at the site of injection. This patient and 11 others received undiluted Pfizer COVID-19 vaccine. No other adverse events were reported from the incident.

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.

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

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

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

Swelling and redness at the injection site that was around 1 1/2 inches in diameter, warm to the touch, felt itchy and painful at times ; we treated it with ibuprofen and a cold compress/freezer pack

Patient started breaking out with minor rash on May 21 on our way to vacation four days after her Covid Shot. Her mother and I thought it may be the sheets she slept on in the motel or maybe something she ate. She was treated with Bendryl pill and cream. the next few days at or destination the rash got worse and worse itching was incredible and a bad headache. On Tuesday evening Patient started swelling on her feet and hands her feet were somewhat blue We got extremely concerned and called our Health Care Provider nurse Line. With everything we provided to her relating to Patients symptoms she felt like calling 911 immediately would e best for her. The Island we were staying on is very small and the hospital was 2 miles away my daughter just took her. The attending physician treated her for a severe case of hives She said that it was due to an unknown origin. Patient just received her 2nd Pfizer Covid shot on June 7 and on June 8 started breaking out with hives we now know the shot was the culprit. Hope this is helpful information

Vital Signs: BP 92/61 HR 80 Resp 18 O2Sat 98 Skin Signs: Warm and dry Circulation: Cap refill <2sec Initial Treatment: Brought to triage for eval, C/O burning at injection site. No swelling or discoloration present. 3:20 PM Vital Signs: BP 92/64 HR 86 Resp 18 O2Sat 98 Skin Signs: Warm and dry Ciculation: 1 Respiratory: Breath sound clear bilaterally Follow up Treatment: Ice pack to injection site. Arm more comfortable. Notes: D/C home with mother. Will monitor and f/u if no improvement.

Shingles in L V1 distribution (Left forehead/scalp). Symptoms started 6 days after second vaccine dose.

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.

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

She complained of a headache developing soon after receiving the shot on June 11th until June 13th. She was tired most of the day on June 11th. On June 13th, she showed me where a red circle had developed around the injection site. On June 15th, she complained about sneezing a lot, a sore throat and having a headache throughout the day. Later that evening around 9:30 pm, she started vomiting (2 episodes) and stated her throat pain was an 8 out of 1 to 10. After vomiting her throat pain dropped to a 7.

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.

Vaccine received 6/12 in L deltiod. On 6/14/2021, she noted a burning pain from mid-upper arm (distal to vaccine site) to mid lower L arm. It only occurs when

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.

This was my daughter's 2nd dose of the vaccine. After she got up on the morning of the 12th, I heard her in the shower and went to check on her. Her face looked gray and she said that she needed to sit down. After sitting for a bit, she was able to stand up, but then proceeded to fall forward, as if she were passing out. I was able to steady her and sat her back down. Her eyes looked like they were staring off into space. She said that she couldn't see me and everything was "purple and yellow." This lasted a few minutes and then I was able to get her out of the shower and dressed. She then began to regain some normalcy and was fine after that. She ate breakfast and rested. She didn't have any more episodes after that, but I could tell that she wasn't as perky that day. This episode was definitely not normal for my daughter, so I felt that I should report it.

pain at the injection site, pain in the left arm - since after the injection - lasted for 2 days tiredness, fatigue, low grade temp - 99.6 F orally - started on day 2, resolved on it's own by following morning.

Wednesday night she got hives all over her back and face. It was itchy. I gave her Benadryl and she took her Zyrtec. The next day, I called the allergy doctor and and they told me to have her take 2 Zyrtec in morning and 2 at night. I think she took Benadryl that morning too and then Friday morning it was clear/she was fine. Wednesday you could see the hives everywhere; Thursday she complained of still being itchy and Friday she was fine.

Patient loss consciousness for a few seconds, vomited, hot to the touch at first then cool to the touch. 911 was called and vitals were checked by the paramedics. Patient did not go to the hospital and vitals were within range.

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.

Pain and a hurting sensation present at site of vaccination at 1405. Pt waited 15 minutes in the EMS room with an ice pack and then left vaccination clinic. Pt stated she was feeling better, however, pt returned with guardian and stated that burning sensation was still present. Pt was provided a second ice pack for site of vaccination. Nurse administered PO 25mg of Benadryl with guardians consent at 1430. Pt states at 1440 that she feels better. Minimal pain and burning sensation present. Pt has a history of needle phobia and anxiety.

itching on the hands; This is a spontaneous report from a contactable consumer (parent). A 12-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0168; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Right at 4:10-4:5pm on 18May2021 as SINGLE DOSE for covid-19 immunisation. Reporter states the patient got 1st dose was 18May2021, lot EW0168, in her right arm before tennis practice at 4:10-4:5pm that on the sticker she had to wear it said 4:35 to leave after dose. States the expiry date is 31Aug2021. Caller does not have the NDC or dose to provide. Medical history included meningitis at 7 years old. she had meningitis and went through a whole lot with that and doesn't think that has a bearing on this. There were no concomitant medications. Patient had not taken other products. Patient's historical vaccine include Flu shot. Patient does the flu shot every year. Vaccines administered on same date of the Pfizer suspect reported as none. Patient was not received any other vaccine prior four weeks of vaccination. On an unspecified date the patient experienced itching on the hands. Reporter states her school gave her the 1st dose on 18May2021. Caller reported with her first does of the vaccine, she had itching on the hands but didn't thought about it and perhaps that was a sign after the first dose. Reporter relays her daughter didn't have anything weird after her 1st dose. After her 1st dose her hands itched, and she didn't pay it any mind. States she had no face swelling. Reporter states she is wondering if those little hand itches after the 1st dose she didn't talk 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 reporter that her 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 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. Patient visited to physician's office for the events. The outcome of the events was reported as unknown. Follow up attempts are needed; further information was requested.

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.

With the first dose: Headache (came and went frequently) dizzy(2-3 days) nausea (2-3 days) sore arm (3-4 days) gave ibuprofen for about 2 days and most symptoms went away. She continued to complain about a headache every once in awhile. About a week later I noticed her eyes seemed a little yellow but it didn't seem to get worse and thought maybe she just need to drink more water and get some sleep. After second dose: Bad headache (3-4 days) dizzy and nauseous (3 days) gave ibuprofen for 2 days. Two days after the vaccine she was fully jaundice. Hadn't notice because she was feeling bad from the vaccine so I just let her sleep mostly. Next day we got into see her primary care dr who ordered stat bloodwork and stat ultrasound. That same day she got some blood work back and told us to go to the er because her platelets were really low. At the er they diagnosed her with autoimmune hemolytic anemia, which explained the jaundice. She was admitted and put on steroids. Her hemoglobin got as low as 5 and they cross matched her incase they needed to do a blood transfusion. They were concerned that there was a possibility that her immune system would attack the donor blood since it seemed to be attacking her platelets as well. Luckily the steroids started working and he levels creeped up a little. She also recieved 3 vitamin k transfusions and pain meds. When she was switched to oral steroids and her numbers were still rise they released her. She is still taking steroids and has weekly follow ups with Dr. . We are also in the process of getting a rheumatology referral to see if there is an underlying condition we didnt know about.

The day she got her shot the had lots of pain in the site of the shot, and got a red rash that same afternoon. This past week it looks like a bruise on the left side of her neck all the way across to the right side. It also is going down the back of her neck looks dark in color.

Pt's mother described an injection site reaction that was swollen and hard to the touch, as well as red and raised above the skin. Did not describe any other pain outside of regular arm soreness nor any itching. Diphenhydramine oral or topical was recommended by the pharmacist on duty whom she described the reaction to.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient reported severe dizziness and nausea about 5 minutes after receiving the Pfizer vaccine. She ended up vomiting few times. Patient was given water and crackers. She did not end up feeling better even after resting for 15 minutes. The family called 911 and Emergency services took her to the hospital

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: PATIENT REPORTED ARM PAIN AND PASSED OUT BRIEFLY (ABOUT 15-20 SECONDS) - GAVE WATER AND MONITORED FOR 30 MINS. TOOK BP 105/78 WHICH MOM REPORTS AS NORMAL FOR PT. FULL RECOVERY EXPECTED

Red splotchy rash occurs when out in the heat or body temperature is elevated from physical activity. Slightly itchy occurs all over the body - abdomen, legs, shoulders, arms, but not so much in the scalp, face or feet. Rahs lasts anywhere from 5-15 minutes and generally dissipates with some slight splotches remaining a little longer.

2 weeks after the patient received the COVID vaccine in her left arm she developed an abscess in her LEFT breast requiring ultrasound and treatment with antibiotics. She started with left breast pain then developed redness and warmth of the breast. She was seen in the office for evaluation then sent for an ultrasound. The ultrasound indicated a 10mmx10mmx8mm abscess. She was then referred to a breast surgeon that day for surgical intervention. The surgeon did not feel that surgical incision and drainage necessary at that time and agreed with the plan to treat initially with antibiotics.

She received the Pfizer COVID vaccine and within 2 hours got hives . They continued to worsen and right now is receiving treatment with steroids to try to counteract the allergic reaction.

PATIENT EXPERIENCED REDNESS DOWN ENTIRE ARM, ITCHING AND BURNING IN FACE WITHIN 5 MINUTES OF INJECTION.

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

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.

Immediate excessive pain in right arm/ infection site, fever 12 hours after dose 2. Around 24 hours post vaccination, Nieve fainted and hit her head. She did not have prior dizzy or fainting spells. The emergency room physician diagnosed her with vasovagal syncope- fainting: vagal reaction, possibly caused by the pain in her arm. As of 7/3/21, Nieve has not gained again but still feels lightheaded, dizzy, and headache.

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

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.

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: Dizziness / Lightheadness-Mild, Systemic: VOMITING ONCE-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild

Bilateral hand rash. Symptom onset on day 3 (June 25, 2021) with progressive worsening. Itching and soreness. Treated with Clobetas 0.05% cream - 2x daily beginning on July 2, 2021 through July 8, 2021.

hives all over her body/hives/rash; hives/rash; This is a spontaneous report from a contactable Other Health Professional. A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left at the age of 12-year-old on 28Jun2021 (Lot Number: EW0191) as single dose for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. The patient previously took first dose bnt162b2 (Lot EW0186, First administered in the Left Deltoid) at the age of 12-year-old on 04Jun2021 for COVID-19 immunisation. The patient got the first dose of the Pfizer covid vaccine and after the first dose had broken out into hives from head to toe, she is wondering if it is safe to administer the second dose to the patient. Caller states that a patient received her first and second dose of the Pfizer Covid-19 vaccine, but after the second dose, the patient had hives all over her body. Caller asks, ''if a booster shot is proven to be needed later in time such as in the fall, should the patient not get it?'' When queried first dose date of the patient, at first the caller states that she is not sure, one of her other representatives put second covid vaccine dose as 28Jun2021 and because of that she is not sure. Caller is aware that the hives/rash began a couple hours later after she had the covid vaccine and she has had them all day. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. ''Later on in the call, caller is able to confirm first and second dose. Caller asks for this age group is it just 2 doses or do they require a booster? Caller confirms that the first dose was given on 04Jun2021 and the second dose was given on 28Jun2021. Caller states the reason she was asking if its okay to give another is because the parent of the patient was asking if she would still get the next dose. Caller states that since the patient has already received 2 doses she is not sure why the parent was asking about another dose, caller then asks if this age group will need a 3rd shot as a booster? '' Caller is aware that the hives/rash began a couple hours later after she had the covid vaccine and she has had them all day on 28Jun2021. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. Therapeutic measures were taken as a result of events. The outcome of events was not recovered.

after the first dose had broken out into hives from head to toe; This is a spontaneous report from a Pfizer sponsored program. A contactable Other Health Professional reported for a 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left deltoid on 04Jun2021 (at age of 12-year-old) (Batch/Lot Number: EW0186) as single dose for covid-19 immunisation. There was no medical history. The concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine and after the first dose had broken out into hives from head to toe. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. The outcome of the event was not recovered.; Sender's Comments: The causal association of the event urticaria in relation to suspected drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be totally excluded based on known drug safety profile. 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

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.

Hyperthyroidism or some sort of autoimmune disorder. No one in our family on any side, has hyperthyroidism. We are trying to figure it out. It mimics hyperthyroidism. Has the same symptoms as Grave but Graves? disease was negative. Dr. said ?she?s not textbook?. He?s been doing this for about 30 years. Started losing massive amount of hair within a couple weeks of second dose. She has less than a third of the hair she had before the vaccine and is losing more daily. When put on methimazole for treatment, she reacts with extremely painful, deep mouth sores. Which isn?t typical. She?s never had mouth sores before. I?m wondering if it?s related to the vaccine. Her thyroid numbers were ? a little high but not bad? before the vaccine. But I?m wondering if the vaccine has something to do with it.

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

second dose, when the nurse took out the needle from the injection site there was blood.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient's mother). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number and Expiration date not reported) intramuscular on 19Jun2021 (age at vaccination 12-year) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) as dose 1, single on May2021 (at the age of 12 years) for COVID-19 immunization. On19Jun201 the patient experienced after the second dose, when the nurse took out the needle from the injection site there was blood. The nurse said that she might have nicked a vein or a blood vessel. The nurse cleaned it up with alcohol and band aid to stop the bleeding. Re-porter was concerned it may affect the vaccine although patient did seem fine. Reporter was also asking if there was a danger on the vaccine going into your blood stream or if the vaccine will still work. Reporter said that patient was vaccinated from a vaccination site and they cannot talk to the nurse. Reporter called about the Pfizer Covid-19 Vaccine. She has a question because her 12-year-old daughter received her vaccine back at the end of May and in June for the second dose. The clinical outcome of vaccination site bleeding was recovered on an unspecified date in 2021. Information about lot/batch number has been requested.

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

High fever that lasted two days (even with acetaminophen and ibuprofen), extreme chills with uncontrollable shaking, face and neck rash.

About 20minutes after receiving the vaccine, the patient's mom stated that the patient was complaining about itching on her legs (around her ankles-(under her socks) and her upper thighs). I gave the mom one 25mg diphenhydramine capsule to have her daughter take

Patient waited 15 minutes at the pharmacy after the dose and left. Mother states that after 10 minutes on the road in the car patient started to feel dizzy and had a visible rash on chest area. They came back to pharmacy where patient seemed to want to faint, we called 911. Ambulance came within 10 minutes and took her to ER.

Patient experienced a rash at injection site. The parent was not aware of the time frame post vaccine when rash started.

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

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.

Chills; Vomiting; Headache; Nausea and stomach cramps; Nausea and stomach cramps; Sore arm at the vaccination site that was also a little bit warm; Sore arm at the vaccination site that was also a little bit warm; This is a spontaneous report from a contactable physician (parent). A 12-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm left on 19May2021 16:00 or around 15:15 pm (Batch/Lot Number: EW0185, Expiry date: unknown, Age at the vaccination: 12-years) as single for covid-19 immunization. Medical history included ongoing allergies, seasonal and environmental. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) (she had been taking for a while), pseudoephedrine hydrochloride (SUDAFED 12 HOUR) (she only took it once) taken for hypersensitivity, ibuprofen (ADVIL 12 HOUR) (she had taken it here and there once or twice, not all the time) taken for an unspecified indication, fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF) (she did not take it the day of the shot, but she took it the entire week prior) taken for hypersensitivity, seasonal allergy and azelastine (she was supposed to do one pump of spray twice daily per nostril) taken for an unspecified indication, start and stop dates were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was mentioned, additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect and prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was mentioned as none. When she was young, she had a fever after one of her shots. It was a high fever, only once. The reporter stated that his daughter got the vaccine on Wednesday in the afternoon at 4 pm, or around 3:15 pm. She was 12 years old. She had not been feeling well since then. On 19May2021, the patient had sore arm at the vaccine site that was a little bit warm, it was a little bit warm all day yesterday. It was still a little sore but maybe a little better. Left arm. It was quick it happened after the injection. On 20May2021, he stated that his daughter had chills started last night, Thursday night it was about the same, and just a lot of nausea and vomiting during the day along with stomach cramps. And now, it was Friday. She vomited like a dozen times and it was still going on. She had headache all day yesterday, it was better today. Relevant tests reported as none. Treatment in regard to the events was Advil for the headache, Pepto for the stomach, Pepcid for stomach discomfort, Benadryl to sleep, and rest. The outcome of event headache was recovered, vaccination site warmth and vaccination site discomfort were recovering, and other events was not recovered. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Pt had a vasovagal reaction after receiving the first dose of the Pfizer vaccine. Pt was transported by wheelchair to a cot and assessed by the site paramedic. Pt reports feeling much better after eating crackers. 1448 Vitals: BP 108/64, HR 74, O2sat 99%, RR 18 Sx: pale/moist skin, re-assed 5mins later and found to be warm, dry PMH: Asthma Medications: Albuterol prn, Xyzal prn Allergies: Penicillin

Patient accidentaly received a dose of 0.3ml of concentrated vaccine instead of reconstituted vaccine. At the time the error was caught, we contacted Pfizer who said that it is not harmful but that they are more likely to experience pain in the injected arm and should be monitored for symptoms. A claim was filed with rite aid corporate and the patient was contacted. At that time she was reporting pain at the injection site. The patient's pediatricians office was contacted and when the pediatrician spoke to the family they reported arm pain as well.

pain above injection site, mild below distal extremity. no swelling or discoloration. Pt. tensed up during the time of the vaccination. Ice pack applied

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

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

10 minutes after her first dose she had been sitting in a chair & developed diaphoresis, warm skin, loss of vision,& low blood pressure. Pt was initially not responsive, when transferred to a wheel chair to take her to a gurney, left arm & left leg jerk twice. Took her to lay down and check her blood pressure. En route, in the wheel chair within about 5 to 10 seconds, she became responsive and said she could not see. Her vision returned to normal within a minute. Her initial blood pressure was 97/64 with O2 Sat 100% on room air. Her skin temp was 95.5, and her HR was 95. She continued to be responsive with excellent oxygenation and When the EMTs arrived she had a blood sugar of 90 and improving blood pressure with a regular rate and rhythm. Her diaphoresis resolved, and she continued to improve, tolerating water. Had similar reaction last year to flu shot, no hx of seizures

patient was with mom and mom reported an hour after vaccine patient's hands had red spots around knuckles and red hands. no trouble breathing, patient mom said redness of hands stayed from Friday to Tuesday which is when she called, she did state allergy pill she gave daughter helped the redness go away patient mom says will find a doctor but otherwise patient is experiencing no other symptoms

Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: 3 CM edematic rash at injection site-Medium, Additional Details: Shot may have been given lower than should have in arm as well

pt had fever the night after taking the vax. The next day she when she woke up her entire right side of the body was sore and had diarhea. She had fatigue and developed a rash on her left arm. Three days later she still has a rash, sore arm, slight fever and diarhea. Pt will be going to urgent care today for treatment.

Patient reports swelling at the injection site. there is a small bump noted. Reports pain in the left arm and it is difficult to raise arm due to pain level.

Immediately began bleeding, which ran down arm from injection site. Approximately 4 minutes later, back of entire arm that received injection was numb from underarm to pinky and ring finger; warm hives on front of both arms down to wrists; warm, rosy cheeks and cold hands/fingers; tickle in back of throat. Benadryl given at clinic. 2.5 hours later, numbness in arm reduced to upper arm only; hives on arms have reduced; tickle in throat gone. Continues to have pain at site of injection.

patient was given shot and fainted and started rash at site lips turned blue also shot was given at 10:23am and at 10:26am adverse event started epipen was given at 10:26am paramedics called and patient was taken to hospital for followup

Urticaria for which I have used oral antihistamines and topical steroids. Yet the symptoms still persist.

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

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

Child's mom calls on 05/24/2021. States her daughter developed a rash to her torso and had a fever of 101.0 F post vaccination. States they visited her physician today and their physician said it looked like a viral rash, but, recommended calling and reporting the event to the health department (VAERS Reporter). Went to physician office to get started on birth control. Mom says she just decided to mention the rash to the physician, but, wasn't concerned.

Pt received vaccine (1st dose, Pfizer lot #EW0185) at 9:42 am and was seated in observation area. Patient raised hand and told observation/charge nurse her stomach hurt and she wanted to use the restroom. When asked to describe pain, pt stated she felt a little nauseous. The pt also stated she felt sick before getting the vaccine. The nurse accompanied to the patient to the restroom, and pt used the toilet. When pt came out of the stall, the nurse asked if she was feeling better. Pt stated her stomach still hurt, and she wanted to go to the school nurse's office. Charge nurse escorted pt to school nurse's office. The nurse stated "oh, we know her," and told charge nurse pt had frequent abd pain. Charge nurse left pt in care of school nurse and returned to vaxxing area. Nurse who administered vax to pt stated to charge nurse that the pt told her her stomach was hurting when she asked if she was well, and that it was an "ongoing thing," and she was getting an ultrasound for it Friday. Pt had no fever and no other complaints, but stated she was "only getting the vaccine because my grandmother wants me to." One-half hour later, school nurse came to auditorium asking if charge nurse could speak to pt's GM. Per school nurse, pt's GM had picked pt up from school d/t stomach complaint and now was on the phone with a question about vax SEs. Charge nurse spoke with GM on the phone. Per GM, pt had vomited x 1 and her ears were "very red." GM stated pt had recent issues w/ vomiting, but was concerned that pt's ears were red. GM denied any itching, rash, SOB, voice changes, dizziness, redness or weals anywhere else, or other symptoms of concern. Advised GM to give pt benadryl following dosing instructions on bottle, give her small sips of water and bland food as tolerated, and monitor pt at home. If pt's condition worsened, GM should take pt to UC/ED immediately for assessment. GM agreed w/ plan of care. At 2:30 pm, the school health director emailed the school site coordinator and told her the "student had an adverse reaction after today?s vaccination. She is currently in the emergency room and the docs believe it is definitely an allergic reaction to the vaccine. ....She did speak with your NP who was on-site this morning after she was dismissed to home, and advised to take Benadryl. Symptoms worsened and she went to ER where she received 2 doses of epi." Charge nurse reached out to school health director for information on where pt was treated to call for a report of symptoms prompting the epi intervention, but had not received a reply at the time of this report.

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.

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Patient stated she felt weird.-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Per the father, patient reported arm pain/soreness on 5/17/21, body aches on 5/18/21, and on 5/19/21 patient reported waking up with a mild headache and mild tingling of leg.

Immediately after the injection child experienced a severe headache, pain at injection site, and some fatique. The severe headache has continued for 3 days. Over the counter advil has not helped. Headache is so severe that child is crying from pain. Noises above a normal tone (including the sound of a piano playing) triggers the headache and worsens it.

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

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

Patient had a rash/hives on her lower left leg shortly after receiving Pfizer-BioNTech Covid-19 vaccination (5:45 pm). Patient, along with her parent, was monitored for 30 minutes. After 30 minutes, patient's mom stated that the rash seems to have improved and that she was contacting pediatrician to see if any further treatment was necessary. Patient's mom indicated that patient is also allergic to Benadryl. Patient and her mom left at 6:20 pm, stating that they thought the patient was fine and was okay to leave.

She had an upset stomach and was feeling really tired. Then the next morning, she had a rash - itchy and bumpy - torso, back arms and face. Went to the Doctor and she said it looked like an allergic rash. She told us that based on my daughter's genetics and her asthma - (I (her mother) had an anaphylaxis with my second Moderna shot - my entire body was giant hives.)- That he did not recommend her to have the 2nd shot. My daughter still has some of the rash - a little on her left cheek, stomach and back still. The itching is gone. She did take Benadryl for it.

Site: Swelling at Injection Site-Mild, Additional Details: recieved request for medical records, pharmacist is not contacted regarding adverse events

Started to develop a rash a day or two after vaccination. Rash continued to worsen and peaked at about 10 days. Seen in ER and then by myself (Pediatrician). Normal bloodwork. Rash consistent with pityriasis rosea, ? related to the vaccine. Being treated with antihistamines and oral steroids. Rash is itchy, but no signs of trouble breathing.

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.

Prolonged Fever (over 103), ringing in ears, dizziness, rash over entire body and face. Some soreness in legs but that went away.

After vaccinated and seated in the waiting area, patient turned red and became unconscious briefly. Patient came back conscious and became very pale. Patient was breathing fine.

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.

Pt accompanied with mother to receive first dose. Pt tolerated well at the time of vaccination. Pt had dizziness and 'feeling hot' while at the observation area. Pt brought back to an exam room to be examined by Dr Dr. and MOP confirmed that this issue was because pt didn't eat anything today. Vitals taken at 1255 are B/P: 91/56, P: 92, SPO2: 100%. Pt states pain is localized to the site of injection and was minimal. Dr. required vitals every 15 minutes for the next hour. Vitals at 1310: B/P: 110/73, P: 77, SPO2: 99%, pt reported no dizziness at this time. Vitals at 1325: B/P: 117/72, P: 79, SPO2: 100%. Vitals at 1340: B/P: 108/73, P: 85, SPO2: 98%. Vitals at 1355: B/P: 111/75, P: 86, SPO2: 98%, pt denies dizziness, pain or nausea. Dr. reviewed vitals taken and assessed pt prior to discharge.

Had petechiae of opposite arm 4 hours following COVID vaccination. Petechiae took over a week to resolve.

13 y/o received dose 5/27/21 at 9am. On 5/30/21 noticed red blotches on her trunk and extremities that worsened overnight and became itchy and profuse by 6/1/21. Parents treated her with Benadryl twice and she took cool showers to minimize itching. Double abx ointment applied. Child was taken to an Urgent Care 6/1 in the afternoon and dx with Contact Dermatitis with prescription for a 5 day steroid tapered dose. Reaction is resolving. Father states three other people in the household have received this vaccine, 15 y/o brother at the same clinic, and none have had adverse reaction. Advised to f/u with PCP and determine if second dose should be given. At this time father states she will not be getting the second dose.

Shingles outbreak T4 distribution ~10 days after injection in otherwise healthy 13 year old. Treated with Valtrex. Rash is itchy but not painful.

Patient broke out in rash on neck and arms, May 17th 2021, two days after 1st covid vaccine. The rash lasted 2 days and went to the walk-in clinic on May 19th, The rash was diagnosed as allergic reaction and treated with oral steroids and an anti-histamine. Patient had a liver transplant 2 years ago and still is a patient at facility. She had a visit at Facility this past Monday, May 31st 2021. They are aware of the rash and the reaction to the first vaccine but told patient she must get the 2nd dose (strongly recommended). I discussed with her and guardian signs and symptoms of allergic and when to seek immediate medical attention. They understood the risks of an allergic reaction with 2nd covid dose and what to do.

About 5 minutes following immunization, parent came to alert pharmacist that patient was experiencing nausea and light-headedness. Pharmacist observed that patient had a drowsy appearance and her eyes would periodically roll to the back of her head. Patient was also warm to the touch. She was given a cold pack which we placed on her wrists and she said that seemed to help. Patient remained under observation for about 20 minutes before she felt comfortable to leave the store.

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

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.

Patient was vaccinated at 1631 6/3/2021. She came to observation room with many allergies in the past and history of serum sickness. She was to be watched in the observation room for 30 min. She developed nausea and abdominal pain (6/10) She was flushed and itching. 1645 Benadryl 50 mg given per mom's OK. 30 min later she was still the same but with dizziness too. Given gatorade to sip on and vitals taken. 125/76 Mean 95, HR 90, RA pox=97%. Continued to watch with no improvement despite interventions . RRT called ultimately. Patient taken to ER with Mom at patient's side.

Rash like bumps on arms and nose and cheeks. Not red just small all-over bumps that are itchy and painful

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

13 yr/o female with a history of recent second Pfizer COVID 19 vaccination presenting for a delayed urticarial reaction.

At 11:05 voiced complaints of tingling in the bilateral jaw. Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. Attendee assisted to the cot to lie down. 11:08 - HR: 83 BP: 110/72 O2Sat%: 98 11:11 – Benadryl 50 mg administered. 11:15 – Tingling getting better. 11:18 – Slight jaw tingling. HR: 78 O2Sat%: 100 11:40 – injection site slight discomfort. Jaw no longer tingling. 11:45 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with their mother.

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

Patient had a single hive on chest after pfzier first dose. Pt given liquid cetirizine 10 mg orally. Pt observed for an additional 30 minutes. Patient had no complaints of shortness of breath, no distress noted, no other hives noted on body. Patient left with mother feeling OK and mother advised to take daughter to ER or call 911 if she has sx/sx of anaphylaxis. Mother and patient educated on the sx/sx of anaphylaxis.

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.

5/13 vaccination, 5/14 Woke up, her bottom lip was swollen and darkened in color; almost purplish. Her upper lip had a rash between the lip and the nose. That night, I gave her children's Benadryl. 5/15 administered benadryl again. 5/16 She seemed better but as the day wore on, her rash got worse, she complained that her lips were itchy and that they hurt. 5/17 same symptoms. Her mouth got progressively worse and sought medical attention. The dr. stated he didn't really know what was happening, if it was related to vaccine? 'just keep monitoring', keep with the zyrtec morning and night, don't delay 2nd shot. 5/20 symptoms disappeared.

erythematous rash on hands b/l with skin burning sensation of posterior-lateral index finger extending to thumb b/l. Erythematous rash on nose and cheeks that is also w/ skin burning sensation. Skin burning sensation w/o rash on abdomen that is intermittent

5 days after COVID vaccine, a tender 1 cm subdermal nodule was felt inferior to the left clavicle, consistent with a lymph node. Nodule remains as of 06-09-2021, although tenderness has resolved.

Woke up exactly 12 hours after vaccine with the following symptoms: Fever 99.5-100, red cheeks, shaking, body aches, nausea, headache, couldn't lift her arms much. Symptoms lasted 24hours and as fast as they came on, they went away the same. A severe headache remained the second day.

Noticed a bump on patient's left shoulder by the neck about a week after her first vaccine injection. It slowly started to dissipate after almost two weeks but was still slightly visible. Her pediatrician examined her and informed us this was a reaction to the vaccine and to report this via this link.

Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness of left arm(vaccination arm)

Pt complained of dizziness & lightheadedness after 1st pfizer injecction, brief period of syncope today. Skin warm & dry, mom says her daughter has passed out previously after lab work injection. BP 94/63 P68 RR16 O2 sat 100%. Symptoms quickly resolved after a few minutes of laying down. alert/oriented, left with her mom ambulatory/ stated she was feeling better, skin warm & dry, no cyanosis noted per nurse.

Crescent shaped ecchymoses and induration oinferior to external lower lip, abuts vermillion border. No other ski changes or rash, no oral/airway angioedema.

Patient following administration of the vaccine became lethargic and pulse slowed down. Epinephrine was administered and patient was responsive. She did vomit and was hot to the touch and mildly sweaty.

At first I was real tired and had headache. I notice my arm and leg was hives. When I went to doctor my arms and legs had hives. I did not have hives on my feet and hand. I had took some Benadryl and next morning I had Claritin . It lasted for 24 hours.

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

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

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

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

Rash in the form of small raised bumps and hives on torso, itching appeared 2 days after vaccine was taken, after fever broke. Antihistamine (children's zyrtec) was administered for 3 days. Rash did not change in appearance, but itchiness went away.

She is itching all over and it's bad itching.; Started to break out in hives all over her body/ Hives was reported as worsened; Ear was puffy and itchy; Ear was puffy and itchy; This is a spontaneous report from a contactable consumer (patient grandmother). A 13-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left upper arm on 27May2021 12:30 (Batch/Lot Number: EW0182) as single dose for covid-19 immunisation at the age of 13-year-old. Medical history ongoing depression. Concomitant medications included dimenhydrinate (DRAMAMINE) taken for an unspecified indication from an unspecified start date to 23May2021; fluoxetine (FLUOXETINE) taken as antidepressant therapy from an unspecified start date and ongoing. Her mom says she takes allergy pills Benadryl, clarified to be the CVS Allergy relief brand (Lot# P123696, Exp date: Jan2024). The consumer reported her granddaughter received the COVID Vaccine yesterday at 12: 30. Last night her granddaughter started to break out in hives all over her body. It is on her arms, legs, belly, back, all over. She came in her room last night saying her ear was puffy and itchy. Her granddaughter is itching all over and it's bad itching. she applied Hydrocortisone Cream to the spots to help the itching and the itching is better. The hives have gotten worse. She mentioned she has recently done her grand-daughters laundry and washed her bedding/clothing in Tide. Caller contacted the patients mom and found out she normally does not use Tide. Therefore, she does not know if its from the shot itself or the change that occurred with the use of Tide. The outcome of itching all over was recovering. Outcome of other events was not recovered.

The vaccine compromised her immune system and she presented with Shingles. After examination at the hospital's emergency room, she was prescribed an antiviral medication. Treatment also consists of alternating doses of Tylenol and Motrin for severe nerve pain.

pt bled after the vaccine. I applied pressure with a cotton ball and the bleeding stopped. The patient left the counseling room and her father returned a few minutes later saying that she had turned white. I met the patient at the higi machine where she was breathing and talking but was saying she felt out of it and was thirsty. The father thinks she fainted at some point.

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

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

COntact dermatitis that started a few hours after vaccine- spread all over body. Prescribed steroids 2 days out.

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

PT HAD HIVES DAY AFTER THE 1 ST DOSE . THEY DID NOT MENTION ANYTHING TILL WHEN THEY CAME IN FOR SECOND DOSE . RECOMMNDED TO CHECK WITH PRIMARY CARE PHYSICIAN BEFORE GETTING SECOND DOSE AND TO GET IT AT THE DR'S OFFICE IF DR STILL DEEMS NECESSARY

fainted, grey color, cool/clammy skin, thready pulse, not responsive. EMS on site who attended her. She become responsive while the assessed her. Their dx was vasal vagal and advised her mom to take daughter to urgent care. Mother's name is.

Pt had body aches, then back from shoulder blades to waist broke out in hives. Mom applied ice. Called Dr's Office. Ice and ibuprofen given throughout day as needed. Hives eventually decreased, left w rash, that too had faded by night time.

Approximately one week after 1st dose of Pfizer covid19 vaccine, patient developed a rash all over torso. Today, 3 weeks post vax#1, rash is still present. It is pruritic, covers entire torso (ant/post) from base of neck to pelvis/buttocks. Lesions are variable from small (5mm diam) raised, erythemic lesions to large (2-3cm diam) hives. Lesions on the back are coalescing to cover entire back. Pt's mother stated the individual lesions are coming together-rash worsening over past 2 weeks. OTC Topical cortisone helping with itch, but not with lesion resolution. Enc pt to reach out to PCP-Pediatrician and discuss possible systemic treatment such as PO anti-histamine or steroid taper. Pt rescheduled for dose #2 which will continue to be delayed until rash is completely resolved. Suggested 30 minute observation at next vaccine appointment.

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

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

Patient said she felt immediate, strong pain in her arm from the jab the nurse gave her. She said the needle was in her arm a lot longer than when she received her first shot. I also watched patient receive her first COVID shot from a different provider, different facility, and I was surprised by the force of the jab of this second COVID shot, and length of time the needle was in her arm. After the nurse left us in the room to wait 15 minutes, patient became more and more uncomfortable, hot, sweaty and nauseous. Within 5 minutes, she was lying down on the exam table - at which time I alerted staff at the nurse's station in hallway that patient wasn't well and we needed help. She said she would get "the provider" and be right in. When I walked back into the room, patient was curled up in a ball on the table, pale, clammy and not able to speak. I yelled down the hallway for help right away, and stepped back into the room. Patient then began to vomit. At least two nurses entered the room, and began to assess her vitals. Her blood pressure was low, but she was breathing fine. 'The provider" (I don't know his name) came in and I told him about how hard she was jabbed, and that she began to feel badly immediately afterward.

Raised, hard, red rash on upper arm, approximately 2 inches long and 1 inch wide. Began day of vaccine and still present 8 days later.

Patient complained of bilateral arm itching about 14 minutes after vaccine. No respiratory distress noted. No rash noted. O2 sats were 98% on RA throughout event. She was given Benadryl 25 mg PO liquid. Instructed to call 911 if she has further distress at home.

Developed generalized pruritus 5 minutes after receiving the vaccine. Received 25mg of diphenhydramine with resolution of symptoms. No rash. No other symptoms.

Rash that covers her whole body, more prominent in hands and feet. Swollen shot area that looks blistery, about 3 inches big..

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

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.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: PATIENT REPORTED SMALL RED DOTS ON HER EXTREMITIES (ARMS AND LEGS) ON DAY 2, BY DAY 3 SHE WAS HAVING THEM ON HER CORE (FRONT AND BACK). BY THE 4TH DAY SHE REPORTED THEY STARTED TO BREAK OUT ON HER FACE AND IN HER EAR. SHE REPORTED SOME OF THEM RUPTURED WITH A LITTLE PUSS. WHEN SHE CAME TO THE PHARMACY, IT LOOKED LIKE SEVERE ROSACEA OR ACNE

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

"Incoming TC from patient's mother, reporting possible COVID-19 side effects / adverse reaction: Mother called to report side effects from daughter's Pfizer vaccine. Patient denies emergency symptoms at time of call. Only reporting side effects from last week. 5/16 1st dose Pfizer @ pharmacy. Reports minor dizziness and body rash. Called PCP, states to take Zyrtec for 3 days. Symptoms gone after 1 day. Advised to take Zyrtec night before and morning of 2nd dose. Patient received 2nd dose at EVC 6/08 Pfizer. 10mins after injection pt reported dizziness and was observed for 30 mins at testing site. Pt was taken later to urgent care by her mother, was also seen by PCP. Pt later developed body rash limited to face, bilateral arms, neck and stomach area. Denies any other symptoms. Urgent care advised to take Zyrtec, symptoms gone after 3 days. Pfizer 1st dose 5/16 Lot# 0177 at pharmacy Pfizer 2nd dose 6/8 Lot# ER8735

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient presented about 10 min after vaccination as lightheaded and nauseous. Patient vomited one time. EMS was contacted, when they arrived the patient's BP was 90/60 and HR was 88 bmp. Parent of patient refused hospital transport after EMS gave all clear, and patient was able to talk, stand, etc on her own. Mother stated that patient was very anxious before and during the vaccine.

Injection site reaction 2 days post vaccination after second dose. 3.5 cm x 5.5 cm injection site erythema; Injection site reaction 2 days post vaccination after second dose. 3.5 cm x 5.5 cm injection site erythema; This is a spontaneous report from a contactable other hcp. A 13-years-old female patient received second dose of BNT162B2 (Formulation; Solution for injection; Batch/Lot number: unknown), dose 2 via an unspecified route of administration on 02Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Not known allergies. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 03Jul2021 the patient experienced Injection site reaction 2 days post vaccination after second does. 3.5 cm x 5.5 cm injection site erythema. AE resulted in emergency room/department or urgent care. The patient received treatment with Diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information related to batch/Lot no. was requested.

had napped 2-3 different times, which was unusual for her daughter.; Her daughter immediately had right arm injection site pain; Her daughter was really tired for 24-36 hours afterwards/Her daughter was really exhausted for 24-36 hours afterwards; This is a spontaneous report from a contactable Nurse. This Nurse (patient's mother) reported for a 13-year-old female patient (reporter's daughter) that: A 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Right on 24Jun2021 at 13:21 (at the age of 13 year) as single dose for covid-19 immunisation. Medical history included ongoing heart disease congenital diagnosed prior birth, ongoing irregular heart rhythm. Patien''s family history includes her daughter's grandmother (patient's mother's mother) & her daughter's aunt (patient's mother's sister) all have holes in their hearts & they all have implantable defibrillators. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Patient not received additional vaccines on same date of the Pfizer Suspect. Patient was not received any other vaccine four weeks prior vaccination. She stated her daughter (patient) didn't have an implanted defibrillator at this time & her daughter's doctor was waiting until her daughter was older. She reported her daughter's irregular heart rhythm had a genetic component, but she did not know if the irregular heart rhythm was related to her daughter's congenital heart disease. Patient's mother reported her daughter received her first COVID-19 Vaccine dose on 24Jun2021 at 01:21PM in her right arm, and immediately had right arm injection site pain on 24Jun2021. She said her daughter, was really tired and exhausted for 24-36 hours afterwards on unknown date in Jun2021. She said she was not sure if her daughter tiredness and exhaustion started on 24Jun2021, but her daughter took a nap that evening (24Jun2021), and on the next day (25Jun2021) had napped 2-3 different times, which was unusual for her daughter. She reported she offered her daughter Ibuprofen and an ice pack for her right arm injection site pain, and her daughter refused. Patient not visited to physician office or emergency room for the events. The outcome of the events her daughter was really tired for 24-36 hours afterwards/Her daughter was really exhausted for 24-36 hours afterwards was not recovered and had napped 2-3 different times, which was unusual for her daughter, her daughter immediately had right arm injection site pain was unknown. No follow-up attempts are possible. No further information is expected.

Pt passed out after 2nd vaccine 2 minutes after administration she started to loose consciousness. RPh helped lay her on bench, eyes remained open patient was sweaty and answered immediately when her name was spoke. Arms were turning red, 911 was called. Assessed her breathing and pulse. Took blood pressure which was low, and took pulse ox; which was normal. Breathing was fine and color returned soon after. No swollen lips or tongue. Pt stated that she didn't eat anything all day and it was around 5pm. Mother stated that she has hx of syncope after any use of needles. EMS cleared pt, gave her a glucose tablet and he left on her own accord with her mother.

She developed a rash within 24 hours of the vaccination. Itchiness. This continued for about 5 days. It was sporadic from chin and neck area to buttocks. Still some remaining patches and red welts on top of the skin.

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 .

Site: Pain at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient reported signs of feeling faint and lips turning white. temp was stable at 96.7 and breathing was normal. Parents refused 911 so I instructed them to seek medical attention immediately. Parents drove to hospital themselves. Called parents later in the evening and mom said daughter was doing ok and was told px reacted to pain of getting the vaccine and not the actual vaccine and she should continue vaccines series on 8/10/21. All vitals wore normal and she's being monitored at hospital

Swollen lips after 4-6 hours Discoloration of top lip (purple in color) with redness on skin above. Started peeling 2 days after, still with purple discoloration of top lip but improved. vomiting for 2 days after - vomiting that evening. With headaches which also resolved after 2 days.

Vasculitis of hands. Patient presented redness, pain and itching of hands and palms intermittently starting approximately 4 weeks post-vaccination.

Eczema on cubital fossa and surrounding area on inside arm (opposite of elbow) redness, spotting, itching, change of pigmentation or "pinking" of pigmentation symptoms are continuing to exist as of now. Starting a daily regimen of hydroxyzine 25mg and desonide cream .05% (too early to tell results)

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.

Pt came to my office today for evaluation of itching and swelling around mouth starting 1 hour after getting her first dose of Pfizer Covid 19 vaccine. She did not have hives but rather papules. In the office her rash had resolved with the exception of mild erythema. She also complained of an itchy throat but had onset of rhinorrhea and sneezing yesterday. She took benadryl yesterday which made no difference. She had no cough, wheezing, difficulty breathing, hives, vomiting or diarrhea.

After about a minute or so, Pt. felt pretty warm/hot in the room and started saying that she could not see/vision was blurry and she started turning pale/yellow. The room was stuffy so we moved from the vaccination room to the waiting room but the symptoms (vassalage syncope) seemed to progress so we brought her into the pharmacy where there was enough room for her to lie down. We had a fan run directly on her & within a few minutes the EMTs were present and they checked her out initially & they decided to bring her to the ambulance & checked her vitals. They asked her mom if she wanted to bring her to the hospital as her vitals were all normal. Mom decided to bring her just in case to make sure everything was okay and get her checked again as a safety precaution/parental concern.

Patient was sitting in 15 minute observation, after patient read over vaccine pamphlet and got to ingredients. She stated that she was allergic to sodium chloride. Patient had erythema on chest. Patient was given Cetirizine ( Mother stated that Benadryl does not help ).

Patient presented with copious rash on the left arm, more prominent around the injection site that occurred 10 minutes after the administration of the vaccine. 25 mg of diphenhydramine IM were administered. Patient recovered after 15 minutes after the diphenhydramine was administered. Patient was observed for 1 hour.

Minor pt has mild hives on arms and legs. Mother allowed dosing of 25mg Benadryl x 1 dose. Pt waited another 15 min thereafter; hives subsided. Faxed MD to notify of this minor rxn to the 1st COVID dose

Pt. developed a skin rash on chest. Denied any difficulty breathing. Benedryl 25 mg was administered. Vitals were wnl. Rash diminished and pt was cleared to leave.

My daughter was fine that first 30 minutes. When we got home she had chills and had a rash on both her legs above and below her knees. I bundled her up and within 20 minutes was okay. I monitored her and there was no other issues than diarrhea later

Patient started to get hives around the cheeks of the face within the 15 minutes of waiting after the shot. Patient was advised to take Benadryl to prevent it from further spreading/anaphylaxis.

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

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

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

Vomiting second day morning followed by rash on face around eyes. Rash subsiding but left eye has blood hemorrhage ( blood shot eye). 24 hrs later second eye also blood shot. Tightness of chest also started third day but now improving. No discharge from eye, no discomfort as of now.

Patient states she received the COVID vaccine on 5/13/2021 at 4:00pm, on 5/14/2021 around 10:30am or 11:00am patient started to have dilated eyes, hands froze and where purple with white Raynaud's, stuttering, twitching of the left eye. Patient is still having left eye twitching but other symptoms are better.

Within minutes of injection patient developed redness at injection site. Redness and itching progressed down left arm and into left hand in patches. Administered 50 mg diphenhydramine 10 minutes after vaccine administration.

Adverse Event: Hives, redness and itching around chest Treatment: Benedryl, Allergy Medicine, Tylenol Outcome: Stopped itchiness

patient reports numbness at the vaccination site. site assessed, no swelling, no rash. patient was able to move arm without any difficulty. i observed patient for 20 minutes, was fine.

Client c/o itchy chin. Hx of Peanut allergy and carries an epi pen. EMS evaluated. Itchiness went away in 5 min. No swollen tongue or face. No respiratory distress, no hives noted. Mother came and brought child home. Mother wanted to know if daughter should have 2nd dose. Instructed to talk to child's allergist for advice.

Itchy rash on right side chest. Treated with over-the-counter Cortizone, no signs of rash the following morning.

8PM PT. STARTED BREAKING OUT WITH HIVES, HAVING SEVERE ITCHING, CALL PLACE TO OFFICE (OFFICE HOURS CLOSED) S/W DR., ADVISED TO MEDICATE WITH BENADRYL. ONLY HAD TO BE MEDICATED ONCE.

Child had hives on all 4 extremities, no flank or head. No additional body system complaints. VVS except for elevated pulse of 118. Pt was assessed in the presence of mother. They agreed to administer Benadryl 25mg po - brought to site by mother, given at 1710. Child remained for full 30 minutes, rash subsided but did not disappear. No additional complaints/concerns noted. Pulse decreased to 103 with no discomfort or distress. both reviewed indications for calling PCP and/or EMS. Mother noted that pt's sister has anaphylaxis allergies and the family is well versed in management and has EpiPens. Pt's MD was contacted following day and advised parents that she may receive the second dose of Pfizer. Her symptoms have completely resolved with no adverse effects.

Patient had syncopal episode with seizure. Diaphoretic and hives noted after regaining consciousness.

Itchy uncomfortable rash on chin for 1-2 days about 2-3 days after 1st Pfizer COVID vaccine. 2 pictures available for review Resolved on own without intervention.

Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Pt received vaccine, spoke to her shortly after and decided to shop around the store. Shortly after walk pt started feeling light headed, and dizzy and fainted. Mom stated that this had happen to her before. Monitored patient for 30 min, gave water and a snack. Mom decided against calling 911.

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

Pfizer Covid vaccine administered at 1401 on 5/26/2021. 1413 - in observation room, pt noticed a rash (red/blotchy) around injection site. No pain/itching at site. No other symptoms reported. Pt monitored for 30 minutes by 2 RNs following vaccine administration. By the end of 30 minutes, rash improving without intervention.

Initial complaint at 1353: Lightheaded, hot, cold, headache on right side, diaphoretic to the touch 1406 BP 110/70 HR 64 Denies SOB, tingling throat. Ate at 12 noon fruit and chips 1410 BP 122/72 HR 66 Worsening of headache on right side of head, room spinning. Hot/Cold flashes have passed. 1413 Spinning has stopped. Everything is bright. Clamminess has subsided 1417 R side of face numb. symmetrical grimace/smile 1419 Sitting up. Reports dizziness. Feeling melting down right side face. ***Documentation provided stops here.

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.

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

Immediately after the shot... Felt like passing out, red rash developed around her neck and was red all over neck - front and back. Rash was also on chest and a few places on her stomach. Redness from her left shoulder down arm to elbow. The next day she felt itchiness under her skin in muscles and joints and this lasted for 7 days. It gradually got better until it ended after 7 days.

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

-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

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

SEVERE PAIN AND BURNING. RASH APPROXIMATELY 2INCHES WIDE AND 5 INCHES LONG. STARTING ABOUT 11 AM THIS MORNING AND AFTER ICING IT CHANGED AND WAS MORE APPARENT. WENT FROM LIGHT RED TO DARK RED AND PURPLE

small dots on skin that look a bit like Petechiae. This is on her left mid-thigh. She also had very itchy nose and ears.

Bruising on both inner arms (not outer arm where vaccine was given), about 3 inches from armpits, looking like a series of several dots in a cluster about 2 inches long.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild

patient stated she had itching on both arms 5 minutes after receiving the vaccination and a sore throat, no further progression after 25 minutes. . there was no rash. Customer then took 50mg diphenhydramine liquid by mouth. 5 minutes after the diphenhydramine, the itching started to decrease. patient was observed for 40 minutes total.

About 5 hours after receiving her 2nd vaccination, developed "covid toes". She has raised purple patches on top of her feet near her toes and on top of her toes. It is more prevalent on her right foot. They are not causing her pain or discomfort at this time.

Site: Bruising at Injection Site-Mild, Systemic: Weakness-Medium, Additional Details: pt was anxious and light headed she fainted on the floor gradualyl no bursing or hurt. pt was able to walk to car to head home and rest

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

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

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.

Within a minute, we had sat down and I looked over and I thought maybe she had gotten a sunburn - but then place where sun wouldn't have hit - were getting very red; it was looking like - hives - back, arms, legs, face - all over her body. Rash didn't start the injection site - it was her other parts of the body. Warm to the touch and spreading. By like 10 minutes, it had reached full body. She didn't complain of itching. Nurses took her vitals - described heart as "tacky" -but as she calmed the heart was coming back to normal. She wasn't in any stress until I pointed it out and she looked and saw she had an issue. The nurses had been give her Benadryl that I had brought - gave her 27.5 dosage of it - two pills. 1/2 hour after taking the Benadryl everything had subsided and we left. There were no further symptoms with her skin. She still had congestion etc but no further skin issues. I called her Primary care doctor to alert her but they said they didn't need to see her.

Note: pt had vaccine administered at an outside facility; she thinks on 5/21 but not certain of the exact date. Reported 2-3 days later, had localized pain and swelling at injection site. On 6/2, reported she had worsening pain ("like a bee sting,") swelling, and discoloration. Saw me for this concern in my office on 6/3 at which point she had minimal discoloration and no swelling, but site was still very tender to touch. I am reporting this because it is a local site reaction that occurred/persisted later than the expected timeline of 1-2 days after vaccination.

baseball sized red circle at the injection site that was sore but not swollen, still present when seen by doctor on 6/9 told it was not infected and to go ahead and get second dose when ready

child reports had low grade fever (99), injection site pain/swelling, developed red/blanchable wheal like annular patches/plaques on sides of both feet of various sizes (1 cm to approx. 2 inch diameter) - describes as painful, denies itching

patient received first covid pfizer vaccine on 5/15. On/around 5/29 patient developed a red, bumpy, painful rash. Patient was evaluated on 6/1, culture of rash sent to lab.

PATIENT RECIEVED VACCINATION. NO ISSUES DURING MONITORING. THREE HOURS LATER SHE DEVELOPED RASH W/ERYTHEMA MULTIFORM SPREAD TO WHOLE BODY. MILDY ITCHY, BUT OTHERWISE ASYMPTOMATIC. BENEDRYL GIVEN WITH NO EFFECT. ISSUE RESOLVED ITSELF.

Hives developed 3 days post-vaccination #2 in two large areas of extremities--one left UE and one on Right LE. Resolved with Benadryl. Non-recurring.

Full body macular papular rash that began within 24 hours s/p dose #2 and lasted for ~ 7 days. Not reported to be pruritic, no urticaria.

Terrible red rash like hives on both hands and part of wrist. Skin color turned very dark (looked like a burn).

patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient's mother) reported for a 14-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0187 and expiry date: Aug2021, patient was 14-years old at the time of vaccination), via an unspecified route of administration in Arm Left on 17May2021 as a single dose for COVID-19 immunisation. The patient's medical history and family medical history reported as None. The patient's concomitant medications were not reported. Patient took Pfizer covid vaccine to hopefully not get Covid, no other product and history was reported. On 17May2021, the patient experienced patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time. This report related to a study or programme. Reporter seriousness for First Dose experienced Left Arm Injection Site Pain was unspecified. Patient received treatment with Advil for the event. Reporter reported on behalf of her daughter, who is 14 years old and was scheduled to get her second dose, then states, no she got her second dose of the Pfizer Covid Vaccine on 07Jun2021, and she is complaining of pain under her arm around the arm pit area and wants to know if that is okay or if that is an adverse reaction? Reported that the patient had a sore left arm at the injection site with her first injection and it was worse than the injection site pain this time which lasted about 2 days after her first injection, from 17May2021 to 19May2021, but this time with the second dose, the injection site pain is less than the first time, but now she has pain under her arm at the arm pit area, after the second dose the injection site pain was just that day, so just one day, it wasn't bad. Second dose was received on 07Jun2021, LOT: EW0196, Expiration: Sep2021, also provides the Saline Lot Number for the First Dose of the Covid Vaccine: Saline Lot Number: 21099DK Expiration: 22Sep2021. Vaccine was not administered at Military Facility. Patient not visit emergency Room and physician Office for event. Patient had no prior Vaccinations (within 4 weeks) and not AE(s) following prior vaccinations. The outcome of event was recovered on 19May2021. Information on lot/batch number was available. Additional information has been requested.

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

10 days after the first shot of Pfizer Covid-19 vaccine, around June 4th 2021, patient started to notice accelerated hair loss. A few days later, she noted a bald patch on the right side of her head, behind her ear. Today (June 18) hair loss continues and hair seems to be thinning out. She is stressed out. Not sure what to do and would like some guidance before we get the second shot. Multiple people on VAERS have reported accelerated hair loss post second shot. Patient had developed Pneumonia last year when she had been diagnosed with covid-19 (around April-May 2020)

Between 12-1am on 6/18/21 Complaints of extreme hypersensitivity of skin, felt ?weird? for her clothing of bed sheets to touch her resulting in uncontrollable crying. Also fever of 101.3 Administration of ibuprofen by mouth for fever once able to calm the emotional reaction. Water intake & sleep. Awoke after 9am on 6/18, fever reduced, symptoms resolved except for tiredness.

Rash on both arms: circular and red around the elbows and bumps going down the forearms. Very itchy and red. Did not respond to hydrocortisone cream. Started approximately 3 days after the shot and Went away on it?s own approximately 5 days later.

14 year old female patient accompanied by her mother. Patient reports swelling on injections site arm. At the moment of evaluating patient she appears calm, breathing without difficulty. No observation or palpable edema on extremities, no redness. Reports mild discomfort when touching injection site. Cold compresses intermittently placed. She is kept in observation for 30 minutes. Vital signs BP 140/90 P 107 R18 Sat 98%.

16:06, patient went into syncope x3. 911 was called. Blood sugar: 116, RR-14, O2SAT-98%, heart was 45 bpm. When patient awoke heart rate would stay above 80 bpm but would drop back down to mid 40's, then she would become unconscious. Patient's speech was sluggish. Skin was pale and warm to the touch. Constant communication was given to try to keep patient awake. Airway remained. Patient showed no signs of inflammation. 16:10, patient was awake. Alert and oriented to person, place and time. O2SAT-98%, heart rate 82, RR-20. 16:22, patient was taken by ambulance.

she feels like her legs are hurting; when she sits her knees has bruises on both legs/bruising on her left knee; This is a spontaneous report from a contactable consumer (patient's sister). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route of administration in arm left on 08Jun2021 at 18:00 as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration in arm left on 18May2021 as a 1st dose, single dose for COVID-19 immunisation, LOT# (First dose): EW0186 (When clarified as EW0176, reporter confirmed the same, contradictory information hence not captured in tab). Age at vaccination was 14 years. The patient had no prior vaccination within 4 weeks, just Pfizer. On 12Jun2021 at 14:16:17, the reporter wanted to report a Covid vaccine side effect was called on behalf of her 14-year-old sister. Stated that, she filed a report with yesterday and they gave her the Medical Information contact information to further discuss her sister's adverse reactions. The reporter stated that, her sister was 14-years-old and she got the 2nd dose of the Covid vaccine of Pfizer on Tuesday this week, on 08Jun2021 and began having bruising on her left knee, after a day on 09Jun2021, the patient felt like her legs are hurting and when she sits her knees has bruises on both legs. Stated that, the patient had got the first vaccine when she was 14 (further not clarified hence, not captured in tab). Stated that, on her research she has found that could be a rare side effect and wanted to know if they had any further data or report of this side effect. Stated that, the reporter had read all about the side effect and saw lot of scary things, it seems like rare condition to have, so the reporter concerned, was that really bad, do they had to run any test or something. Stated that, the reporter was calling and got disconnected so, she called in again. Stated that, the reporter was in the middle of filing a case about COVID vaccine side effect. Stated that, the reporter has concerns because her sister does not have a primary healthcare provider or insurance so she was unsure of what she should do. Stated that, the reporter was provided with the number of health department and she got the questions so, she wanted to call them tomorrow, it's Saturday so when they were working. Everything was good regarding this case right. Response included was advised caller, Pfizer cannot make independent patient recommendations and that she would have to seek further medical advice from a primary care provider. The dates and seriousness for the events were unspecified. The reporter stated that, the patient did not take any treatment yet. The investigation assessment was reported as no. The outcome of the events was unknown. Follow-up actions are needed. Further information is requested.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Error: Wrong Dose of Vaccine - Too Low-, Additional Details: First dose administered was just air and immunizer then informed m,other she was going to issue vaccine the vaccine. Patient was injected with air on first injection and then given correct dose of vaccine.

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.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: NO EMS needed, pt felt on her head

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.

On the night of 6/29/21, developed hives in random places on abdomen, back, legs, backs of arms. Applied calamine lotion and hives were gone in the morning.

burning and itching rash on hand and wrist (same side as injection); burning and itching rash on hand and wrist (same side as injection); This is a spontaneous report from a contactable physician. A 14-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, age at vaccination 14 years), via an unspecified route of administration on 15Jun2021 as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. The patient experienced burning and itching rash on hand and wrist (same side as injection) on 16Jun2021. The patient was treated with topical steroid for events. The outcome of the events was not recovered. Information regarding lot/batch number has been requested ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Itchy rash and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events Burning sensation and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Shortly after the vaccine, she lost color in her face, she said her vision went blurry, then she vomited. Just a few minutes after vomiting, she said she felt fine. She waited around with her grandmother for another 20 minutes, then left, feeling well.

Rash developed below injection site on upper left arm. Rash was 2 inches by 2 inches in size. It presented with bruise like sensations and has progressed to a slight itchy sensation. It appears to be the ?COVID arm? .

Redness, itching, warm to touch and stinging at site of injection 2 days after the shot. No fever and no other systemic symptoms

My daughter developed a rash that has persisted for over 3 weeks now. She was originally misdiagnosed as having poison ivy and was given 2 steroid shots. That helped for a few days. She then saw the regular Dr who said it was a virus and was given 5 days f oral steroids. The rash has persisted coming and going regularly in different locations all over the body. My daughter has also been much more tired than normal. The regular Dr has referred her to dermatology but she can?t get in to be seen for several weeks.

patient got very dizzy, with an almost "grey" color to skin. She had not eaten anything before vaccine. Given a coke to drink by dad and monitored for 15 minutes. Patient had full color back when she left and felt so much better

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

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tinnitus-Mild, Additional Details: patient fint for 2 minutes but recovered consciousness

Red circle appeared RUA at injection site, itchy ?under the skin? on Friday,. Saturday it was about 1 inch round. Probably grew to about 2 inches round at 4 days post injection. Started getting smaller/better on day 5 (Tues)?1 week after injection red spot is small and more like a bruise., but still a little itchy. We treated it with Tylenol, Ice to site, benadryl for itching.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted within 15 minutes of receiving first dose of pfizer covid vaccine. patient immediately gained conciousness

Patient developed an itchy rash on torso and upper body. They were red almost like pimples and very itchy. Also developed a fever of 102, and arm was throbbing. Father alternated Ibuprofen and Tylenol for the fever , and Benadryl for the itchy rash. Today she is doing much better but still has a itchy rash on the arm. She no longer has a fever and seems to be much better.

Patient received vaccine at approx 9am and around 2:15 pm she started developing itchy eyes, swelling of eyelids L>R, redness of cheeks. No shortness of breath, no difficulty swallowing, no hoarseness of voice.

Site: Pain at Injection Site-Severe, Additional Details: patient is to follow up with a neurologist due to numbness in her arm from elbow down

Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium

Patient's mom called on the 20th day after patient's covid vaccination. Per patient's mom, patient complained about feeling "sensitive" on and around injection site started 3 to 5 days after vaccination. The pain level gradually elevated over the last 2 weeks. Today is the 20th day after vaccination and patient still feels the pain. Per mom, there are no "bumps" around or under the arm or close to injection site.

Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: passed out for 3-5 seconds-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: she passed out for 3-5 seconds, came to. Was very pale, maybe 5 minutes later threw up. Then she regained some color and was less confused. She was very anxious about getting the shot prior to getting the injection.

By the following day after getting shot 1 in the covid series Pfizer, she started breaking out in a rash all over her body that itches and hurts. We went to the Dr and she was given hydrocortisone that doesn't help. Its been 4 days and the rash is still slowly spreading

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

Large rash on arm spreading slightly onto back. Will be calling to see pediatrician tomorrow first thing if not showing improvement.

per mother, developed dizziness and had low BP 100/60. Symptom started on 6/11/21. Child only had soreness at sight prior to development of dizziness. Saw medical care physician on 6/15/21 due to persisting dizziness and low BP. Symptoms lasted for 2 weeks then resolved.

Pt reported a reaction that developed days after receiving the vaccine. She said she had a reaction on her arm, leg, and back. She did not report any swelling. She took a picture of it and I didn't see any redness, but it looked like there were some bumps that developed on her arm. It may have been more than a week after getting the vaccine and she is not sure the vaccine actually caused that reaction. I made the decision to counsel her on signs and symptoms of anaphylaxis reactions and to seek medical attention if needed and gave the second dose. I saw her mother 5 days after she got the second dose. Her mother said she hasn't had any reaction to the second dose.

Patient w/history of past allergy to egg, peanuts and strawberries. PMH significant for asthma. Tympanostomy tube placement in 2009. The mother called regarding advice regarding second dose on 7/12. The mother reports that about 1 hour after receiving her first dose of Pfizer vaccine she developed a rash consistent with hives all over her body. She did not have associated shortness of breath, vomiting or diarrhea. Unknown time course for resolution.

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.

Came up with this bubble like on her skin; maybe like it get burned or something; skin blisters; Came up with this bubble like on her skin; maybe like it get burned or something; skin blisters on right arm at injection site; This is a spontaneous report from a contactable consumer (parent). A 14 years old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot Number: EP7534, Expiration date, NDC number and UPC number: Unknown), via an unspecified route administered in Right Arm on 30Jun2021 at 11:45 AM (14 years old at vaccination) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history was not reported. No known allergies were reported. Patient did not receive any medications in 2 weeks. The patient did not take any other vaccine in four weeks of vaccination. The patient did not have Covid-19 prior to vaccination. Patient took the vaccine and about a day or so after, on 01Jul2021, patient had this bubble like on her skin. If it could visualize what kind of thing, maybe like it get burned or something 'and' her skin blisters on right arm at injection site. Since vaccination, the patient was not tested for Covid-19 infection. The patient did not receive any treatment for the events. The outcome of the events was not recovered.

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

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

Itchy rash to arms and legs that immediately resolved with 25mg IM Benadryl. No airway issues. No swelling, no nausea. Observed and Father drove home.

Pt and mother came back saying that pt felt itchy. (Mother said same thing happened to her and asked pharmacist if remembered. Pharmacist did) RPh inspected injection site and looked red with scratch marks. Pt mom also showed a couple of spots that daughter thought might have been mosquito bites but mom said could be hives because there were multiple spots on thigh above knee above ripped jeans on right side. Mom also said pt had a spot on her back. Rph offered patient liquid diphenhydramine orally (50mg) (20mL of 12.5 mg/5mL diphenhydramine). Pt took orally and was asked to wait an additional 15 minutes. Afterwards pt said she felt ok. Mom said she would give her more benadryl at home if she needed it and would watch closely and if anything happened would take her to ER.

Pt. sitting with mother and sister in observation area. Mother signed for assistance. Pt reported feeling hot and having blurred vision. Able to state name throughout event. Pupils dilated, skin hot. Pt instructed to remove mask and breath deeply, cool pack applied to back of neck. After several minutes patient reported vision retuning to normal. Patient incontinent during episode. Pt transferred to private room. Water, peanuts, and fruit snacks provided. Sister very tearful and anxious. Water and snacks provided. Family remained 30 minutes. Verbalized feeling okay, reported slight headache. Mother made appointment for patient to see pcp today, family left clinic.

Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: 5 Minutes after the vaccine, pt lost consciousness for a few seoncds. pt showed some jerking motion. Pt was given water and benadryl. About 30 minutes after the shot, pt fully regained consciousness and back to normal

Site: Pain at Injection Site-Medium, Additional Details: Patient was given one dose of Pfizer vaccine in two separate injections. Needle and Syringe failed to administer dose during first injection. Patient was stuck again to administer dose. Magellan 25G 1" hypodermic safety needle was used.

Horrible itchy rash over the entire body, including back of neck, scalp, torso, legs. Lasting for days.

15 year old female found in supine position with feet elevated in vaccination area. Pt had a left upper lip injury (non-bleeding) , redness and slight swelling to left lateral eye area. She also had a less than dime sized abrasion to right knee. Pt was recovered from dizziness (syncope) and then placed into a wheelchair and placed onto a cot in the observation area with her feet elevated with a chair. VS 107/73 66 24 and an O2 sat of 99% on RA Pt timid and somewhat afraid of passing out again. Chair was later removed and then pt sat up in bed with apprehension. She ate a bag of doritos and drank a half bottle of water ( about 250 ml) She then stood up and denied any dizziness but insisted on sitting and/or lying down. She did sit back down for another 10 minutes and later stood up , denies any symptoms. Pt then ambulated to BR without help, MAEW, NAD, steady gait. She was a + o x 3, VS at 1431 111/69 74 22 with O2 sat of 99% on RA. Pt and mother given directions to change positions slowly allowing 30-60 seconds per position change. They both acknowledged this. Pt discharged home with sister and mother with direction to f/u with pcp as needed and to increase sodium and water intake today and tomorrow. No medical history Denies taking any medications Denies any allergies (name), site supervisor aware of situation. Vaccination Site

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

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

Ovoid rash about 7cm diameter at injection site, as well as itchy, erythematous rash on back and bilateral arms. Rash appeared 1 day after vaccination, and has continued for several days; however patient reports rash was initially raised but is now flat. No medications given yet.

3 days of severe abdominal and pelvic pain that was debilitating. Patient was hardly able to walk - she had extreme pain with urination and defecation. She also had headache, fatigue, arm pain, fever and rash - hives, with pruritus of scalp.

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".

Patient began to feel light headed and asked her mom for water. Patient then fell to the side and hit her head as she fell to the floor, then had a seizure lasting 30 sec. patient was Alert and oriented x4 when we got to her. Patient stated she felt like she was falling asleep and dreaming then remembers everyone standing over her. Patient has small bump on upper left of head. Patient was taken to medical center for treatment and observation.

pt presented with a thin red line from injection site down the arm to the wrist that was itchy at the wrist approximately 5m after administration. approx 10 min later patient stated that she was itchy all over, no sign of rash or hives though.

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

Pt received vaccine and was standing outside of immunization room with her parents waiting for her brother to receive vaccine. She felt dizzy and fainted. She hit her head and collapsed. She was seizing/ shaking on the floor. She was conscious with no visible bleeding. She was able to say her name and DOB correctly. Mother reported no history of epilepsy or seizure. Called emergency services and pt was taken to Clinic for further evaluation. A 1.5cm laceration was noted behind her left ear. Pt received 2 staples in the lacerated area.

Patient returned to the site of vaccination 4 hours after being vaccinated with bilateral forearm hives and erythema. This area was mildly pruritic. Treated with Diphenhydramine 25mg and VS were normal. She was observed and left without incident in the care of her mother.

Patient developed diffuse urticarial rash 1 week after first dose of Pfizer vaccination. No other known triggers. No prior similar symptoms in the past. No recent illnesses. Lot# for vaccine was EW0169.

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.

Spoke with clients guardian about adverse event. Guardian reported nurse calling her after she went back to school after vaccine due to a rash on chest, lower abdomen, and from inside of arms from elbows to wrist on client. Mother took client to ER to be checked out. Per report of Guardian, ER doctor said, "this rash shouldn't stop client from receiving second vaccine." Guardian also reported ER doctor prescribing Prednisone for 5 days and Benadryl as needed. Guardian did not say what ER doctor ended up diagnosing the rash cause. Guardian reported client reporting rash was itchy, but Guardian reported she did not see client actively itching. Guardian also reported client very nervous about vaccine and was being told mixed messages about vaccine from peers from school. Per CDC guidelines instructed Guardian to have client evaluated by allergist before receiving second Covid-19 Vaccine. Guardian reported client is doing well now.

Event: About 2-3 minutes after the vaccine was administered, the patient had an erythematous warm rash, initially to the left deltoid and left antecubital fossa area (vaccine was administered in the same arm). The rash was flat and blotchy, some areas were slightly raised. After about 5-7 minutes, the rash had spread to the patient's upper chest/ torso, clavicle areas, and upper back. Patient stated the rash was not pruritic, just that the areas felt hot. No respiratory distress or wheezing, patient did not seem anxious. She denied previous similar reactions to medications, food, vaccines, or blood draws in the past. Treatment: an ice pack was applied to the vaccine site on the left deltoid and left arm area. Since patient did not have any rash to the face/ lips, and no respiratory distress, it was determined that she was not in need of IM Benadryl or Epi. We do not currently have PO Benadryl pills on site. Patient was instructed that she could take 50mg of Benadryl when she gets home. Education was provided to the patient that if she feels any throat closing, difficulty swallowing, tongue or lip swelling, or difficulty breathing at home, she should call 911 immediately. I also discussed with the patient that she could consider taking 50mg Benadryl prior to her second COVID-19 vaccine appointment if she prefers. I discussed with her that if the rash was persistent tomorrow, she should consult her family/ primary care physician. Patient's mother speaks another language, and patient translated this information to her mother, and patient and mother had no additional questions or concerns. Patient's mother was present with the patient in-person during the vaccine visit, as patient is a minor. Outcome: patient was observed in the observation area for 30 minutes to monitor for worsening of rash, and to monitor for any new developing symptoms. Rash was largely resolved after 30 minutes with the ice pack, just a faint area of flat erythema to the left upper arm area around the biceps.

Prior to arrival, the patient received her first COVID vaccine at the clinic, after which she suddenly felt dizzy, described as lightheadedness, and felt warm. She was noted to be hypotensive with SBP at 67. She subsequently drank water with some improvement. No syncope, severe headache, numbness, tingling sensations, or focal weakness. Mother was concerned and brought the child to the ED for further evaluation. Currently the patient feels better. No similar symptoms in the past. The patient denies any chest pain or pressure, shortness of breath, or abdominal pain. No recent fever or cough.She is otherwise healthy and has a normal cardiopulmonary exam and reassuring EKG. The description of her symptoms and the environment which happened is very consistent with vasovagal syncope and she does not have any stigmata, and acute neurologic or cardiac emergency. I believe she is safe and stable for discharge home and she was discharged with return precautions and follow-up instructions.

Patient mom called in regards to daughter, she stated her daughter got the vaccine on Monday 5/17 around 6pm and the next day in the afternoon she started to itch and notice a rash on her shoulders and then under bra, cheeks, around mask, neck and even on legs. She states the rash is all over body and looks like little bumps. Patient is extremely itchy. Mom applied cortisone on the patients arms and she states it might have helped a little and also gave her Allegra which she states it didn't work. Patient's mother gave her daughter Benadryl on 5/25/21 at round 10:30pm and it helped.

Extreme redness/swelling/pain at injection site. Treated with ice and ibuprofen ? lasted for approximately one week after symptoms appeared.

5/13 vaccination 5/14 Woke up with mild case of hives. Was on her elbows and knees. 5/15 She got up and the hives were all over. We gave her Benadryl. It took about 60-90 minutes to take affect. We took her to urgent care, the rash had started to fade (I do have pictures if needed). They prescribed Prednisone with ongoing Benadryl. *2-3 days where the rash was all over extremities; itchy. *Every morning when she wakes up, she has hives shortly after she gets up. *5/18 PCP appt. The dr. didn't feel the prednisone was affective. The doctor stated to have full dose of Benadryl and to get over the counter Zyrtec. *She felt the Benadryl was enough but it has not made the hives stop occurring. **Appt with allergist; waiting for a cb for date & time. *2nd vaccination scheduled for 6/3/2021 *infectious disease doctor wants her to have appt with allergist before the 2nd vaccination

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

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

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt had dizziness, confusio, drop in BP and HR. called 911 and transfered to ER; pt did not receive any medication only monitored; pt had an anxiety attack and vegal reaction per ER staff-Severe, Systemic: Hypotension-Severe, Additional Details: pt had low BP and HR in 50s

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.

lethargic; sore throat; radh; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 15-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunisation . The patient's medical history was none. Patient's concomitant medications were not reported. Patient had no known allergies. On17May2021, 3 days after vaccine, she had a very sore throat, radh and was lethargic. Patient treatment was unknown. It was reported that most recent COVID-19 vaccine was administered at Public Health Clinic. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test and strep: negative on 19May2021. The outcome of all event was recovering. Information on the batch/lot number has been requested.

underlying autoimmune disease that caused the vascular reaction; rash; underlying autoimmune disease that caused the vascular reaction; This is a spontaneous report from a contactable consumer (Patient Mother). A 15-year-old female patient (Reporter's step-daughter) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in left upper arm on 15May2021 18:00 as single dose for vaccination. The patient medical history and concomitant medications were not reported. No patient family medical history relevant to AE. No prior Vaccinations within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient broke out with a rash the following Monday evening, 17May2021 causing multiple visits to the Emergency department and Urgent Care Clinics. Reporter and patient are driving to patient's primary care physician's office now. Patient did not get admitted to the hospital. Patient has been to urgent care, and the emergency room a few times. The doctor from the emergency room believe that patient had a vascular reaction to the covid vaccine. The doctor asked reporter to call Pfizer to get some guidance. The doctor thinks that patient has an underlying autoimmune disease that caused the vascular reaction. The doctor put patient on a course of steroids because of patients reaction for whatever is going on. Reporter was looking for guidance about the second dose of the covid vaccine, since patient had this reaction. Reporter is not sure if prednisone will take away the effect of the covid vaccine. Reporter is asking what to do and where to go. Patient was told that she may have had a vascular reaction secondary to a possible underlying immune condition not yet identified. Mom stated that the child was prescribed Prednisone to counter the rash. Mom wanted to know if her child should go ahead and get the second dose of the Pfizer Covid vaccine given the side effects. Patient broke out with a rash was reported as worsened. The patient was advised that she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of this vaccine had a severe allergic reaction to any ingredient of this vaccine. People with a weakened immune system, including people receiving medications that weaken the immune system (immunosuppressants) were not in the clinical trial for the Pfizer-BioNTech COVID-19; that may have a lower response to the Pfizer-BioNTech COVID-19 Vaccine. The outcome of rash was not recovered and outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of autoimmune disorder,vascular disorder,angiopathy cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

itchy; hives all over her body/welts/Multiple whelps; This is a spontaneous report from a contactable nurse (patient's mother). A 15-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16May2021 (at the age of 15-years-old) (Lot Number: EW0161) as single dose for covid-19 immunisation. Medical history included mensuration cramps. Concomitant medications included ibuprofen (MOTRIN) taken for mensuration cramps; paracetamol (TYLENOL) taken for mensuration cramps; ibuprofen taken for mensuration cramps. She was taking Motrin and Tylenol. Motrin was 200mg and she was taking, she didn't start Motrin until Wednesday, that would have been 18th and in 24hr. On Tuesday she took 400mg Motrin for the whole day and Yesterday she took about a 1000mg of Motrin in the 24 hour period. So she took it may be 3 times, so each pill is 200mg. She had her period and she was getting mensuration cramps, so that's why she was taking it. It's a gel cap. The Tylenol she was taking, she took on Wednesday that would have been the 17th she was taking Tylenol, so she was taking about a 1000mg coz they are 550mg per tablet and she was taking two times, may be three times. The patient received first of the vaccine on 16May2021. Last night 19May2021 around 11pm she was very itchy with hives/welts but then went away. Then at 4am extremely itchy on thighs stomach back, and then again today on wrist as well on thighs, stomach and back, down to her knees. She had been taking Benadryl and Zyrtec. She also got her period on 16May2021 and had been taking mostly TYLENOL and some ibuprofen. She usually took MOTRIN during her period and had no problems. The nurse stated "My daughter took the Pfizer vaccine on Sunday, 16May2021 and last night 19May2021 she developed multiple whelps, hives all over her body, her abdomen, her legs, very itchy and it still continued on today. Now, she's 15, I have not taken her to doctor but I do plan to do that tomorrow but since you have a calling number for adverse reaction then I'm thinking this might be a delayed reaction to the vaccine, I'm not sure. Does that spell familiar?" Nurse stated "I have given her Benadryl and Zyrtec, only 25mg she got one last night that may be 5 in the morning and then she took another one about an hour ago 25mg. Two Benadryl 25 & 25 today and last night and she took one Zyrtec. The Benadryl is in 25mg tablet orally. She took Zyrtec now, she took one its 10mg oral." The outcome of the events was not recovered. For Causality, Nurse stated, "That's what I'm thinking. She has not taken anything out of the normal, that the only thing I can think of. It could be."

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: pt was given 0.3ml of sodium chloride instead of pfizer vaccine but was called back to get the correct dose and vaccine from immunizer. no compliants from pt and no visual adverse effect seen-Mild, Error: Diluent Administered Instead of Vaccine, Additional Details: Mother is requesting antibody test for her mother on cvs account to ensure that her daughter did get the second dose of the pfizer vaccine and not just the sodium chloride. spoke to mother around 12:30pm after the call with dr, also called the pharmacy manager and he is aware of the situation. when talk to to mother she was told no follow up is needed per dr but can call for clarification.

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: pt was given 0.3ml of sodium chloride instead of pfizer vaccine but was called back to get the correct dose and vaccine from immunizer, no compliants from pt and no visual adverse effect seen-Mild, Error: Diluent Administered Instead of Vaccine, Additional Details: Mother is requesting antibody test for her mother on cvs account to ensure that her daughter did get the second dose of the pfizer vaccine and not just the sodium chloride. spoke to mother around 12:30pm after the call with dr, also called the pharmacy and is aware of the situation. when talk to to mother she was told no follow up is needed per dr but can call for clarification.

Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Immediately after I gave her the injection I looked at her face and her eyes rolled up and her pupils were dilated and I said to her Are You OK and that was when her head fell back and and it hit the back of the wall. I looked at the top of her head and it was red and she was sweating. Patient was still sitting and we called 911. Paramedics came and checked her out. She became aware and responsive within minutes. She stayed about 30 min.

Patient is a 15 year old female who presents following administration of the second dose of Pfizer COVID19 vaccine in the left deltoid. Patient states that she developed a tender, pruritic, red rash at the site of the injection about 10 minutes following the administration. She relates that she also developed smaller red rashes on the left distal portion of the arm. She states that this did not happen with her first dose of Pfizer vaccine. She states she also feels slightly dizzy, but relates that she only at a grilled cheese for lunch and minimal water intake. She denies a history of anaphylaxis and denies allergies to medications, foods, other vaccines. She affirms a past medical history of low vitamin D (currently treated with supplemental vitamin D gummies) and low iron (untreated). She further relates that she had her tonsils removed about 1 year ago. She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting. Exam (update as needed): GEN: Alert and oriented x 4, NAD. HEAD: NCAT EYES: PERRL, EOMI ENT: Ears normal, Nose normal, OP normal with exception of no tonsils noted, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: Skin warm and dry. 0.5mm ecchymosis noted 2 cm below the AC joint and in the correct anatomical position for IM injection. Roughly 5cm of erythema and edema of the left deltoid injection site. The area is mildly tender to palpation, but nonfluctuant. Two 0.5cm erythematous macules located on the left forearm that are nonfluctuant and nontender to palpation. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Vaccine site reaction. Vital signs within normal limits. Physical exam otherwise normal. Gave patient 10mg OTC Zyrtec from her personal supply. About 30 minutes following administration, the vaccine site was significantly less erythematous and edematous. Patient did not develop any other symptoms. Patient felt comfortable leaving the site. Advised patient and parent that patient should take 25mg diphenhydramine PO once, once they arrive at home. Instructed patient to consult the patient?s PCP regarding the post-vaccination reaction. Patient instructed to go to emergency department should she develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, worsening skin rash, or cramping abdominal pain with nausea/vomiting. Patient and parent demonstrated understanding of post-vaccination instructions. Medications administered: Patient self administered 10mg of Zyrtec. Disposition: Home

5/25 vaccine; 5/27 menstrual cycle began; 5/28 much heavier menstrual bleeding, 5/29 mild epistaxis noted, sister sick with viral URI symptoms, 5/31 patient began to have cough, congestion, body aches; later noted bruising to right upper arm and right hip with no known trauma; 6/1 petechia to lower extremities; 6/2 started new oral contraceptive pack; 6/3 continue w/ menorrhagia & noticed many clots (very atypical, usually menstruation ceases at this point) 6/4 seen by PCR, CBC w/ platelet count 2,000, sent to hospital

5:20 Pt had syncope episode. Taken to Observation area via w/c to lay down. BP 80/52 P62 R20 5:35 BP 90/62 P 60 R 16 No nausea. skin warm & dry. 6:05 Sitting up drinking juice. 6:35 Pt left with parents w/o assistance.

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.

She had her vaccine at 10:30 a.m. around 5 p.m. we noticed a few small red bumps on her left knee. We thought at first they were mosquito bites. We administered some Benadryl gel. The next day around 6 p.m. she woke up from a long nap and noticed she had several raised bubbly itchy bumps on her hands, legs, and feet. I immediately gave her one benadryl tablet. After taking to the triage nurse around 7 p.m. I gave her another benadryl tablet plus two Advil Dual Action tablets. She awoke the morning of June 8th and all the symptoms she had the earlier night were gone.

Patient received 2nd dose of Pfizer vaccine today. The patient's mother asked for assistance as daughter was "having a reaction." Vitals/assessment at this time: 62, 16, 82/54, 99% on room air. Patient looks pale, diaphoretic, says "my vision is blurry". Questioned mother and patient, mother said "this is the first time this has happened." When asked about if she had anything to eat, she said she had not eaten breakfast. OJ given. Patient awake, alert, oriented X3. Sitting in chair. Skin warm to touch/ looks flushed. Vitals Reassessment- 72, 92/59, 95% room air. Repeat vitals taken x 2. Patient noted feeling better. Patient drank all orange juice, moving extremities, talking, walking with steady gait. Home with parent.

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

Patient developed about 1.5 weeks after receiving the vaccine rash on face, chest, back that is pruritic and burns with application of emollient. She was seen on 6/4 and determined to have a dermatitis. No change in ADL or new products to suggest cause of the rash. She is being treated with oral antihistamines, topical steroids, vanicream.

Pt left office @ 1130 after receiving vaccine, Mother Called office back d/t to pt having hives on her legs @ 1230 pm,. Pt in office has significant hives on legs. Only reaction , 25mg of Benadryl given to pt.

large rash on neck area initially; rash spread to back and legs; hives on arm of injection in the middle of the night Took Benadryl which seemed to clear it up but rash came back in morning. Threw up in morning. Went to urgent care. No respiratory issues and rashes cleared up. Instructed to monitor and continue Benadryl as needed. If hives come back and Benadryl does not clear it up then go to urgent care or ER. Benadryl did seem to work but rashes continued for several days.

Patient presented to the observation room with her mother to schedule 2nd appointment and be observed after vaccination. Patient lost consciousness and was caught by the observation staff and lowered into a chair. Staff states patient lost consiousness for approximately 30 seconds. Once patient came to she knew her name, where she was, and the date. She still felt very dizzy. Patient's pulse and O2 saturation were immediately taken showing a pulse of 45 and O2 sat of 100%. Unable to get pulse up, lead of operations called for ER support. Patient was gray in color, very weak, and still complaining of dizziness when ER staff arrived. Unable to walk due to weakness, patient was transferred to cart and taken to ER

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

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

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

After patient received vaccine, she walked to the Moderna side to wait for mother to get vaccinated. While waiting for mother, patient started to feel "dizzy." She was assisted to chair by staff. Upon assessment, patient was warm to touch and pale color was noted to face. Patient was alert and oriented. BP 100/74, P58, SpO2 99% on room air, water given and cool compresses applied to neck. Extended monitoring in recovery area done. Patient states, "I feel much better." Patient ambulated from facility, with mother, without any difficulty. No s/sx of distress noted.

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

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

Pt received Pfizer COVID-19 vaccination at a COVID Vaccine Clinic held at Hospital on 6/12/21. She received the vaccine approx 9 am and had c/o of L arm pain but didn't notice bruising welts/rash until approximately noon same day. She presented to ER same day. Photos of rash were taken in ER. Swelling, tenderness, joint pain and rash noted to left upper extremity (LUE). Parent reports 5-6 "bruised welts" to LUE were noted prior to ER visit. Pt took cetirizine for rash and Tylenol for pain.

Caller stated her daughter getting a little rash and as days went by the rash started getting big. Rash has spread to both arms and is very itchy

Client received her first dose of the Pfizer Covid-19 vaccine (Lot # EW0187 Exp. 08/2021) at 12:38 PM on Wednesday 6/16/21. EMTs and Lead RN responded to the incident. Lead nurse signaled over EMT at approximately 12:44 that she needed the gravity bed for a client. The client was found lethargic when EMTs arrived with a gravity bed. The client was a 15-year-old female with a chief complaint of dizziness. Client?s older brother was present during incident. Interpreter translated information between EMTs/RN and client/client?s brother. The client was alert and tracking to voice. Per the lead nurse, the client was complaining of dizziness after the administration of her first Pfizer vaccination. The client had no known allergies or medical history. The client also did not take any medication. The client's brother stated that ?she had chicken nuggets and a smoothie? to eat at approximately 10:00. The client's brother also stated that ?they had been standing at the border crossing under the sun? for an extended period of time. The client's airway, breathing, and circulation were intact. The client was negative for hives, swelling, shortness of breath, or other signs of anaphylaxis. The client was nauseous, dizzy and complained of numbness on both arms. The client was unable to bear weight and not following simple commands before she was assisted to gravity bed by EMT and RN. The client then briefly lost consciousness for less than a minute before becoming alert to person, place, date, and event. EMTs assessed vital signs every 5 minutes for a total duration of a 45-minute observation. Vital signs were taken by EMT with client lying supine immediately after losing consciousness (12:45) and were reported as follows: Blood Pressure (BP) 92/64, Pulse (P) 66, Oxygen Saturation (O2) 99%, Temperature (T) 98. Skin was intact, pale, and cool to touch immediately following patient regaining consciousness. Patient remained lying flat on gravity bed for approximately 10 minutes before she was assisted to a seated position. Patient was in a high-fowlers position when she was given a juice and granola bar. Client then stated that she was ?feeling better?. After an additional 10 minutes sitting on the gravity bed in high-fowlers position, the patient was assisted by RN and EMT from vaccination station to EMT/observation station. The client remained seated in the EMT/observation station for an additional 15 minutes. Vital signs were taken every 5 minutes during this time by EMT. They were reported as follows: 12:51- BP 112/78, P 69, O2 97%, T 98. 12:55- BP 108/78, P 77, O2 99%, T 97.9. 13:00- BP 104/78, P 66, O2 98%, T 98.1. 13:05- BP 96/62, P 83, O2 95%, T 98.1. 13:10- BP 92/68, P 76, O2 98%, T 98.1. 13:20- BP 90/70, P 92, O2 99%, T 97.6. 13:28- BP 92/72, P 93, O2 99%, T 97.9. After a 45-minute observation, client stated her condition was improving and was observed walking normally. Client?s skin color returned to a pale pink and became warm to the touch. Client denied dizziness or any other symptoms. Lead RN educated the client about what to do if symptoms returned. The client was provided with the V-Safe form and EUA form with highlighted portions pertaining to symptoms to be mindful of. The client was also instructed to call 9-1-1 if symptoms of anaphylaxis, also known as a severe allergic reaction, presented. These symptoms include difficulty breathing, shortness of breath, hives covering body, facial swelling and more. Client and client?s brother acknowledged understanding of information. The client?s brother stated that he would ?drive her straight home?. The client then left facility at approximately 13:33 with her older brother in positive disposition with steady gait.

Injection site pain for a week with swelling and redness. The site (now 8 days later) is sill raised and red but not swollen.

Patient presented on 6/14/2021 for Rash that began a week prior. No new foods or meds introduced during this time frame. Only difference prior to rash family could think of was COVID vaccine. Patient being treated Cetirizine and hydrocortisone 1% OTC

A 15 yrs old female patient complained she could not see anything 10 minutes after receiving Pfizer vaccine. She seemed sleepy,and her face looked pale.She was responsive and conscious, She denied difficulty of breathing, She was hot to touch and asked for water. After approximately 5 minutes, her vision was back to normal,and her face color changed to its normal complexion. the patient has not received anything during this period. She was encouraged to be calm and breathe in and out slowly.Vitals not recorded. EMS arrived and patient went to the ER for further follow-up. Patient's mom confirmed patient remains stable an hour after the incident.

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

High fever 102.7 to 103,2; general full body malaise; Chills; extreme soreness at injection site; Nausea; Headache; body aches; This is a spontaneous report received from a contactable consumer (patient). A 15-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217 and expiration date not provided), via an unspecified route of administration, in arm left, on 04Jun2021 15:45 (at the age of 15-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were reported as "none". Patient had no known allergies. No other medical history. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264 and expiration date not provided), via an unspecified route of administration, in right arm, on 14May2021 15:45 (at the age of 15-year-old), at single dose, for COVID-19 immunization. On 05Jun2021 02:45, the patient experienced high fever 102.7 to 103.2, general full body malaise, chills, extreme soreness at injection site, nausea, headache, and body aches. The patient underwent lab tests and procedures which included body temperature: 102.7 to 103.2 on 05Jun2021 02:45. Since the vaccination, patient had not been tested for COVID-19. No treatment received for events. The outcome of evens was unknown.

Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium

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.

At 1443 EMT observed client leaning forward in chair and approached for further assessment. Client mentioned feeling dizzy. PHN arrived at 1445 and observed client sitting upright in chair, alert and oriented x4. PHN asked EM to bring anti-gravity chair. Client able to transfer to anti-gravity on her own. First vitals by EMT at 1445: blood pressure 148/86, pulse 92, oxygen sat 100%. Grandmother present with client. Client reported feeling dizzy and nauseous. Client denied headache, blurry vision, shortness of breath. PHN observed hives on neck, bilateral arms, chest and upper left back. PHN offered Benadryl, Grandmother accepted and stated she would go get Father who was outside. Father denied client having allergies, no pertinent medical history or current medications. At 1448 PHN administered 1ml/50mg Benadryl IM on right deltoid after checking dosage table and verifying weight with client. PHN called 911 at 1449. At 1452 client reported new onset of tingling on both hands. Client appeared pale and diaphoretic. Vitals at 1452 by EMT: blood pressure 150/90, pulse 108, oxygen sat 100%. Hives on bilateral arms improving, hives on upper left back resolved. Flushing of face and ears. 1456 PHN and EMT observe edema of lower lip. PHN on phone with 911 operator asked client if she was having trouble swallowing. Client unable to fully describe, drowsy, but was speaking in full coherent sentences. At 1456 pulse 95, oxygen sat 100%. Paramedics arrived at 1458 and assumed care. Client transported to

1st shot, no reaction. 2nd, fever, vomiting, headache, site redness and swelling . Took Tylenol for 48hrs and ibuprofen, alternating. Sips of water, but no food. By the 3rd day, she was if nothing happened.

Patient was anxious to get shot but seemed healthy otherwise. Shot was given at approximately at 1:40. By 1:45 she showed signs of being queasy and eventually passed out. Her father caught her, so no physical injuries were reported or seen. Blood pressure was taken roughly 3 minutes after collapse. In prone position on her back since loss of consciousness, her BP was 93/69 and pulse rate was 82. Although ashen at first contact, her coloring was improving as EMS showed up 15 minutes after my arrival. Total incidence time was roughly 20 min.

Hives - itchy head started day of vaccination, then developed hives to chest, back, neck, face the days following. No SOB Also had fever, chills, body aches the day after

Headache; lethargy; aches in large limbs; fever; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp. A 15-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, in left arm on 16Jun2021 at 09:45 (Batch/Lot number: Not reported) (at the age of 15-years-old) as 2nd dose single for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included oxymetazoline hydrochloride (CLARITIN ALLERGIC) for seasonal allergy. Patient had no known allergies. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular in left arm in May2021 as 1st dose single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Jun2021 at 23:00, the patient experienced headache, lethargy, aches in large limbs, fever and injection site pain. Patient did not receive treatment for the events. The outcome of the events was recovering. Information on the batch/lot number has been requested.

My daughter has developed a rash on her stocking; having high fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother). A 15-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 08Jun2021 at 15:00 as dose 2, single (at the age of: 15-year-old) for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in right arm. Medical history included migraine and asthma. The patient's concomitant medications were not reported. No other vaccine administered in last four weeks. The patient had diagnosed with COVID prior vaccination and not diagnosed post vaccination, patient had not tested with COVID. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 10Jun2021 at 15:00 The patient experienced she has developed a rash on her stocking and having high fever. Therapeutic measures were taken as Tylenol and benadryl as a result of she has developed a rash on her stocking, having high fever. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The outcome of all event was not recovered. Follow up attempts are needed, Information on lot/batch number has been requested.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: tingling sensation on the arm that got the vaccine-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: as soon after giving vaccine, pt fainted. Woke up after 1-2 mins, pt was positioned flat on her back with legs elevated. Pt took apple juice and 25mg benadryl @7:30pm, watched pt for another 15 mins and took blood pressure before leaving. BP was low but mom states she always has low blood pressure. Followed up next day around 1pm, mom states pt has pain at the injection site, headache, no fever, and sleeping

AFTER vaccination and patient attempted to stand and fell backwards in seat. Patient was incoherent, hot, sweaty, loss color to face and lips and unresponsive. Blood pressure was check 100/46 65 heart rate and temp less the 85degrees. Patient was unresponsive for about 10 minutes. EMS was summoned and the patient was given water and juice to drink. Patient slowly returned to a normal state after about 30 minutes but was still slow to respond.

Patient woke up the morning of 6/25/21 with a rash on both of her hands. Throughout the day, the rash did spread to her upper thighs and lower legs. The rash continued to spread to her feet. The rash was bilateral on her body, and appearance was similar to a viral rash. She did complain of her body being sore and achy as well. The rash did not itch. We gave her ibuprofen and antihistamine during the day which seemed to help with comfort. The next morning (6/26), patient woke up and the rash was almost gone. She still had a little bit of the rash on her calves and feet. By the end of the day and next day, the rash was gone.

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

Sore left arm two hours after the vaccine was administered. on 6/21. Soreness subsided the next day. On 6/27 hives were noticed on both arms with mild itchy symptoms. 6/28 hives appeared on both legs with mild itchy symptom. Hives are still noticeable the morning of 6/30 on both legs and arms, Benadryl was given at 9:00 am.

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.

urticaria that started 2 days after the second dose and has continued intermittently for the last 3 and a half weeks. treatment is cetirizine 10 mg PO Q24. Referral to Pediatric Allergist placed.

Pt w/ hx of severe allergy to nuts. Hx of Fainting/feeling hot w/ allergy testing @ age 9. Pt c/o flushing/sweating and dizziness 5mins after vaccination BP 114/70, HR 88, RR 16, O2 Sat 98% RA -- > 120/68, 86, 18, 100% RA. Pt VSS, extremities warm to touch. Pt stable and released from vaccination site ~35mins after vaccination. Pt transferred via wheelchair w/ Dad as a precaution.

Hives/rash started soon after the first dose. Comes and goes all over the body. Rash was blanching and looked urticarial. Only one time there was a petechial rash. Had the second dose on 6/6. On 6/12, to relieve discomfort, a doctor prescribed a short course of dexamethasome and famotidine, and also started her on Zyrtec. She is still taking the Zyrtec daily. The rash disappeared while taking the steroids but starting coming back when she stopped. The Zyrtec helps but the rash still comes and goes.

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.

Blood work done on 06/21/2021 came back with Platelet level @9. Blood repeated 2-3 times on 06/22/2021 and platelet level came back being at 6 -8. Dr. advised to give IViG INFUSION with Steroid to avoid immediate risk of Internal bleeding. Patient was showing signs of Petechiae on her lower legs when at the hospital. Subsequent blood work on 06/25/2021 after IViG showed a boost in platelet to 138. Weekly blood work has been ordered to check platelet levels and impact activities have been restricted.

Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient had slight rash posterior base of neck to mid back.

Lip swelling over the 1st day after shot. Then persistent hives which have not resolved for nearly 1 month.

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

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

Left hand pain, tingling and numbness for last 5 days following injection. After injection left arm was painful from injection site to hand. Arm pain resolved 2 full days later, but hand pain remains.

the bend same arm she got the injection, it is a little bit a colored that's almost like a bruise but it's not a bruise.; This is a spontaneous report from a contactable consumer (Patient's parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0181), via an unspecified route of administration in deltoid left (left upper arm) on 20Jun2021 (at the age of 15 years old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated trying to figure out, her daughter got her first dose Pfizer vaccine on 20Jun2021 and she scheduled to get by next sunday to get her second dose but last night or now this morning on 03Jul2021 she has like a knot or spot on her arm right towards the bend same arm she got the injection, it is a little bit a colored that's almost like a bruise but it's not a bruise. Not at the injection site it's further down and today marks the second week she got it on two weeks ago and again it just popped up this morning and again don't know if we need to be concerned or not. Reporter was worried about that color on her arm. Reporter had no idea about treatment received for the problem. The outcome of event was not resolved.

Developed rash on 06/30 that started on her abdomen, then spread to behind the knees, up her legs, with a mild amount a rash on her back and her forearms, left greater than right. Rash is not itchy, peaked around 7/9 and is slowly improving.

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.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: After receivig vaccine, patient felt lighthead, blurry vision. Mother said she has a fear of needles and had not eating anything proior vaccine. SShe had some apple juice and ems came and check her out and was fine. did not go to hospital

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.