Pfizer

Vaccine was given at 3pm. At 4:30pm patient had a tight chest so he used his inhaler. At 8:30pm he went into anaphylaxis---red from head to toe, swollen hands and feet, could not move fingers or toes, lips blue and swollen. He was transported to the ER.

PATIENT HAD RED BLOTCHES ON LEFT ARM RUNNING TOWARD SHOULD. LASTED FOR ABOUT 15 MINUTES BUT WENT AWAY AFTER THE PATIENT WAS GIVEN SOME BENADRYL.

pt received Pfizer covid 19 vaccine with mom in the room. Less than 5 minutes later, step dad reported that patient passed out and hit his head on the side. Pt was bleeding from the left forehead. A technician called 911. I wiped blood from the injury and applied a gauze and instant ice pack. pt was breathing and fully responsive. pt denied any other pain or discomfort other than the injury on the forehead and injection site pain in the arm.

The patient got the vaccine on 05/16/2021. Mom called on 05/17/2021 and informed that patient developed rash on inner thigh on the morning of 05/17/2021 .He was fine all day on 05/16/2021 and woke up with a rash in his inner thigh. Mom gave him Bendryl but he called mom again after few hours with a rash on his hand. Mom took the child to urgent care in the afternoon and the doctor was confused as to why he got a rash after more than 12 hours later. The doctor was not sure if it was due to the vaccine. The doctor advised Benadryl and gave a prescription of prednisone to keep on hand incase symptoms worsen.

Developed hives on trunk about 24 hours after vaccination that improved after taking Benadryl. The following day (2nd day after screening) developed hives on face that again resolved with Benadryl. No respiratory issues

Patient reported feeling hot, felt head and it felt hot to touch. Nurse on site was called to check BP -- which was 142/90 hr 101. pt was told to take off mask and relax and drink some water. After about 20-25 minutes, pt felt ok and BP was 124/83 hr 91. Patient was monitored longer and then sent home.

Redness on arms after injection, light-headed Vital Signs: BP 120/84 HR 107 Resp 16 O2Sat 97% Skin Signs: Cool and dry, clammy, diaphoretic Circulation: Cap refill <2sec 1sec Respiratory: Breath sound clear bilaterally Initial Treatment: Vitals taken. Patient felt better after given juice and sitting down. 4:09 PM Vital Signs: BP 110/80 HR 107 O2Sat 99% Notes: Patient heart rate was still over 100 bpm. Other vitals were in good range. Cheeks still rosy with potential rash. Follow up with provider recommended. Parent provided CDC link with information regarding hx of GBS and safety of receiving COVID19 vaccine. Patient discharged home with parent.

Pt had vasovagal reaction and emesis immediately post vaccine admin. NO ALLERGY to vaccine. Okay to receive 2nd dose. At 1:37PM, 6 min post receiving vaccine, patient told mom that he felt lightheaded and was having pain at injection site left arm. Rn assessed immediately and pt reported feeling "sick". He drank few sips of water. MD called to bedside. I assessed pt at 1:39PM, pt sitting chair, elevated his legs onto the footrests of wheelchair sitting in front of pt. +Facial and lip pallor, and complaining of nausea followed by 1 episode NBNB emesis consisting of what he ate for lunch 1 hour prior. Pt immediately reported feeling better post emesis. Lips appeared pink. Pt brought to triage area, lay supine on stretcher with legs elevated. Nausea and "lightheaded" sensation resolved prior to lying down. BP improved post emesis from 75/39 to 84/46 at 1:48 PM. Stayed lying down for 5 minutes after which time pt wanted to sit up. Upon sitting BP and HR increased 96/64 and 69, stable with no nausea or lightheadedness, only remaining sx "slightly weak". drank 12 oz apple juice and ate 2 graham crackers without any further emesis or symptoms. Observed for 15 more minutes and was ambulating without return of symptoms, discharged home with mom and brother with instructions to seek medical care if symptoms return.

Patient developed lines of hives on back which were very itchy about 5 minutes after vaccination. Gave a 25mg tablet of diphenhydramine with water. Watched for extra time (10 more minutes) and patient began to improve. Advised mother to continue diphenhydramine at home as needed and report.

5 days prior to admission on 5/16/21, he received a first Pfizer COVID vaccination. The day after the vaccine, he had neck pain and stiffness. He subsequently developed fever, diarrhea, and vomiting. The day prior to admission, he developed a diffuse popular rash. He was seen in clinic on 5/20 and lab work was obtained, which was consistent with MIS-C findings (elevated troponin, elevated fibrinogen, elevated CRP, hyponatremia, relatively low absolute lymphocyte count).

Thurs 5/20 4pm 1st COVID vaccine given Friday: tingly all day; 6pm developed diffuse erethema, scc alp brigh tred Sat 5/22: redness, hives worse, facial swelling started. Seen at Danbury ED. Given all supplental anaphalsix stuff, then epi. Discharged home Sunday: 5/23: Facial swelling returns, mom gives IM Epi, returns to hospital. Found to have ST abnormalities on EKG, sent to hospital for prolonged allergic reaction and eval of possible pericarditis. 5/24: continues to have urticaria, now with new petechiae/purpuric breakouts in areas where hives were, but most prominently in bilateral ankles.

Area around where the shot was injected has become swollen and itchy. It's an oval shaped area, roughly 2-3 inches in diameter. He hasn't had a similar reaction to shots before. It also didn't appear until about 9 days after the dose.

Several days after receiving the first Covid vaccine dose, developed a rash. The rash presented on both of his upper arms and both thighs. The rash was more pronounced near the injection site on his left arm. The bumps looked like small raised pimples without pus. They itched.

Patient received vaccine at outside institution so lot number is not available. PCP is also at outside organization so limited information available. Below is information from Emergency room visit. 12 y.o. male who presented to the emergency department for Rash that the patient noticed around noon today while at his friends house after a sleep over. Patient received his first COVID vaccine yesterday at outside retail pharmacy at 1030am. Mother states it was Pfizer. Patient states "noticed the rash last night when they went to and has no other symptoms such as fever, chills, runny nose, head congestion, difficulty breathing, swelling of the lips, tongue, mouth, throat. Denies nausea, vomiting, abdominal pain. Patient states that is very itchy and they have been spreading and more been popping up since he noticed them. He denies any history of eczema, sensitive skin, food allergies. Mother does state that 2 years ago, the patient had a severe to the influenza vaccine in which she describes it as 8 inch area of redness, hot to touch, swelling around the injection site. No anaphylaxis reaction at that time either. Discharged with oral decadron and benadryl. Follow-up with PCP next day.

Patient experienced unexplained episodes of petechiae (bleeding under his skin) for starting two days after the vaccine (and continuing since then).

On either side of his neck, h e got a red (not quite a rash) - it was not bumpy (like eczema) but patchy red. Lymph nodes were swollen on neck underneath those red patches. Itchy - On that Sunday, when I noticed it, the Pharmacist said to take: Oral Benadryl and topical Benadryl for adverse reaction. We did that for a week and it started to go away. I outlined the rash with sharpie - t did get bigger and started spreading down his shoulders. As of today, it's cleared up - you can see a dark mark where it was but it's fading away.

Inflammation of arm where injected. A lot of arm pain day after vaccine. Little nausea. Very tired. Night sweats.

Patient started to develop a cough on the second day of the vaccine around 6 pm. The cough was accompanied by shortness of breath, given his asthma we assumed this was some asthma related reaction to the vaccine. Nonetheless, that evening he started to complain about chest pain every time he laid back on his bed. This symptom is not common in previous asthma attacks. Sitting up alleviated the symptom, chest pain and shortness of breath lasted for 2 nights (Sunday and Monday evening), by Tuesday he felt better. We assumed this was an asthma episode, but recent reports of Myocarditis leads us to believe the had a mild myocarditis episode, given the chest pain while lying down. He also had typical COVID vaccine symptoms such as low grade fever (100F), pain in the vaccination site, congestion, and itchy throat.

He got a superficial blood clot in left arm ?He's got the shot May 21 and I noticed he had two hard knots on left arm and there was probably about a half inch between them and as hard as a rock on that following Monday may 24,2021 , he said it was sore some more when you touched it we was told to keep an ion it make sure it didn't get any worse, turn red, swell, feel hot to the touch, and then to put a warm compresses on it ??

Hives, body rash , still comes and goes after Prednisone treatment . Pt has an allergist appointment on 6/17/2021.

Diffuse body rash and facial swelling within first hour after injection. Rash resolved in 24 hours, with benadryl, facial swelling took 2-3 days. Mood swings and irritability also occurred, took a week to completely subside. No respiratory symptoms at any time per mom.

Sore arm at the injection site; whole body and muscle aches; fever of 101 degrees; whole body feels warm; nausea; fatigue and sleeping more than usual. Symptoms started at 4 AM the following morning, gave him some Tylenol to bring down the fever, and have him drinking lots of ice water. He has no appetite because he feels nauseous but he was able to eat a piece of bread which seemed to settle his stomach somewhat.

Patient developed a blanching rash and pruritus, beginning upper body (thorax, upper arms, neck, face, scalp). Administered benadryl 50 mg, and topical hydrocortizone 1% on affected areas. Patient reported difficulty breathing. Administered albuterol rescue inhaler multiple times. Overnight, patient slept poorly, self-administering albuterol. ------- 2021-06-06 morning, the upper body rash diminished, but moved toward the extremities (legs, forearms and hands, face and scalp). Labored breathing continued. Patient visited clinic. Patient continued benadryl and albuterol throughout the day. -------- 2021-06-07 morning. Patient reported better sleep the prior evening, with no albuterol required. Rash had largely resolved, with only minor spots. Patient reported moderate headache.

Rash formed on chin, jaw area. Reddish in color. Small and blotchy. Noticeable to him, but not painful or irritating. Also, appeared on his chest up to 10 days after. Nothing else in his life had changed...no new detergent, bed sheets, etc.

Started breaking out in hives, first on the arm that injection was received in, and the progressed to full body hives. Parents paged Pediatrician on call and gave Zyrtec, which was all they had at home. Benadryl was given around 11:30PM and hives resolved shortly after dosing with Benadryl.

Diffuse hives appeared on patients body several hours after receiving his first Covid vaccine. Dad not sure if was less than 4 hours after vaccination. He had no breathing issues or vomiting. The hives lasted for 2-3 days.

My son started getting hives on the arm and started spreading more after 24-48 hours on the arms and legs. I gave him a Claritin a couple of hours ago and it has started to improve.

Fever, tiredness, sore arm, giant red circle around injection site hot to touch appeared has a red border kinda middle is swollen.

Rash on whole body. Red, fine raised itchy rash on face, chest, back, arms Small amount in groin and on legs Face sl swollen

Hives developed over L arm, neck few minutes after vaccination, patient also felt tightness throat A/O x3. vital sign WNL Benadryl given 12.5mg at 11:15am

pt has enlarged lymph nodes and redness at site, says there is pain coming from the red site under the arm that makes it hurt to lift arm high , no pain in shoulder or top of arm per mother

Painful injection site later the same day. Following morning injection site very painful/sore. Headache. Fever.

Patient started to experience swelling, itching and redness at the injection site 1 day after receiving the pfizer covid 19 vaccine. The site is warm to touch and is the size of is that of 2 quarters per patient's dad.

Patient's mother called to report a possible adverse event. Start date is approximate but she thought it was within a week of the first vaccine dose. Patient developed an itchy rash on his buttocks and waist. Mom described the rash as small pinpoints. She thinks it lasted 1-2 weeks. Treated with OTC hydrocortisone, no medical care. Rash was fully resolved when patient received his second Pfizer dose on 6/10/21 and he has not developed a similar rash; advised family to call back if he experiences the reaction again.

Pt got covid vaccine at a pharmacy Monday 06/07/2021. Started with a rash the next day 06/08/2021 which has spread all over trunk & extremities. Rash is fine pink papules and itches. Rash is blanchedable. no hives

Erythematous maculopapular rash with wheals 1-2 cm in diameter primarily over the shoulders, neck and upper back with just a few scattered on the trunk and legs

Within two hours of receiving the vaccine, the patient developed a rash on his chest and abdomen. It moved to his back. This rash was small raised bumps and were itchy. 24 hours later, it looks more like hives on his abdomen. The bumpy rash stayed consistent, and the hives went away until a few days later a very red and inflamed rash developed on his neck, eyes, chin, cheeks, forehead. this has stayed consistent and the hives-like rash is back on his abdomen.

12 hours after the injection chills, fever, aches - treated with cool bath to reduce fever, advil and tylenol The 102 fever lasted 48 hours, and then a rash appeared on the knees and elbows The following day it turned into welts and began spreading all over the body. Treatment included benadryl, claratin and advil for the pain. Calamine lotion was also used for the itching, but nothing really controlled the pain and itching. The welts continued to get worse, until day 6, when the welts started to turn back into an all over the body rash

Fatigue, pain at injection site and soreness under left arm starting around 11pm on 11Jun2021; fatigue and underarm soreness and still continuing today (14Jun2021); dizziness starting around 6am on 12Jun2021 and still continuing today (14Jun2021); fever and chills starting around 8am on 12Jun2021 and subsiding by around 9am on 13Jun2021; raised, red/irritated skin around injection site, in shape of band-aid that was applied after injection, observed 13Jun2021 and still persisting as of 14Jun2021; increased dizziness and racing heart beat starting morning of 14Jun2021 and still continuing.

Headache starting that evening, chills, fatigue, nausea, muscle soreness/weakness, sore throat, muscle aches, red welt at vaccine site that is getting bigger by day.

Patient felt faint while standing and singing during church. Passed out for a few seconds. Skin was hot and sweaty. Removed his jacket, gave him water and fed him a donut. Patient recovered after about 10 minutes.

Low grade fever, pain at the injection site, severe chills, severe muscle and body aches, severe fatigue and tiredness, severe nasal congestion, severe runny nose, unable to perform normal daily activities for 3 days, continued with residual symptoms and mild to moderate activity impairment for 9 days.

developed patchy red rash in upper arm around injection site. Area size of orange was swollen; area with it was bumpy, itchy red rash

Mother of PT states her son got a rash after his first dose. Mother of PT states her son again experienced the rash after his second vaccine, which got worse. Mother of PT states took her son to see his PCP, and he told him it was a rash and it was a result of his Pfizer vaccine. Mother states his son still has the rash which is itchy with little red bumps, which his PCP told him that it may take one to two months to go away. Mother of PT does not know what vaccine site of body her son got the vaccine on.

24-36 hours after injection - fatigue and slept for an extended time. Pain in arm of injection. 3 days after 2nd injection, hives on arms, legs, back, shoulders, tops of hands and feet. Raised and looked like target hives. Very itchy.

Diffuse urticaria developed 5 days after second dose of pfizer without other obvious source. Treated with antihistamines and resolved within a few days.

Blister-like hives appeared on tops of ears, then upper back and back of hand; Sore arm; Nausea; Fatigue; Tremors; Headache; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 09:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously had the known allergies included hives developed after 1 dose of amoxicillin and Azithromycin, hives present after several doses of m (as reported). The patient did not have the COVID prior vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received Multivitamin and Probiotic in two weeks. On 14May2021 at 01:00 PM, after the 4 hours of dose the patient experienced blister-like hives appeared on tops of ears, then upper back and back of hand. Then, sore arm, nausea, fatigue, tremors, headache through night. Following day continued with hives, headache, fatigue, sore arm, plus vomiting. Felt much better by the second day post shot. Just hives and arm soreness continued. The patient did not receive treatment for the events. On an unspecified date, the events nausea, fatigue, vomiting, tremors and headache were resolved. The outcome of blister-like hives appeared on tops of ears, then upper back and back of hand and sore arm were not resolved. Information on lot/batch number has been requested.

Fatigue starting approx. 12 hours after second pfizer covid vaccine shot and lasting 24 hours; reduced appetite; fever from approx 24 hours after shot (maybe sooner) until approx. 36 hours after shot. Highest recorded temp was 102.2 at approx. 30 hours after shot. Fatigue interfered with daily activities from 12 hours after shot to 36 hours after shot. Mild soreness in arm where shot was given. Pulse and blood oxygen were checked each time temp was taken (approx 3 times between 24 and 36 hours after shot) and were within normal ranges each time; although pulse was on the higher end of the normal range for a 12 year old boy. Quick recover starting 36 hours after shot, when temp reduced to approx. 100. Appetite returned at this time. Fever was gone by 48 hours after shot and all other side effect seemed to have subsided by this point. No mediation was taken by the vaccine recipient. Vaccine recipient was offered usual foods and he consumed milk and water in smaller amounts than usual but also more frequently than usual to stay hydrated.

per mom, a few hours after vaccination, patient's left calf started to be come red, a little swollen, and warm to touch. mom kept an eye on it overnight and patient was still complaining following day. patient was taken to emergency room to evaluate. they checked for clots, no signs of clotting and said it was a reaction to vaccination. mom made pcp aware of reaction and it was advised not to received 2nd dose of vaccine.

Rash shingles onset 6/17/2021. Fever started 6/20/2021, headache started 6/19/2021. Seen by pediatrician 6/21/2021. Negative Covid and negative strep test. Diagnosis: shingles

My child began feeling tired and ran a temperature about a degree warmer than usual for the first three days after his second COVID vaccine on Sunday 13 June. (So Monday, Tuesday, Wednesday). Thursday he was extra tired and began to complain of itching under the chin in the evening. Friday morning he woke up and had what he described as itchy/painful raised, red patches of skin on his right collarbone, under his chin, across his face (right cheek, temple). His temperature was about 100* and he was, quite frankly, pretty miserable. These weren't little skin irritations, they were giant patches of inflamed tissue covering the better part of each cheek, his temple, under the chin and then in smaller spots on his collarbones and back. Saturday the rash moved to cover the left side of his face, and the left collarbone. (And no, for the record, I did not switch laundry detergents, change his diet or anything like that.) As of today, 6/21 condition has improved but not fully resolved.

Patient received COVID vaccine on 6-17-21 and HPV on 6-18-21. On 6-19-21 he developed a diffuse folliculitis type eruption on trunk and extremities. It is not itchy or reddened.

10 minutes after vaccine patient developed pruritis rash arms and legs . 25 mg of benadryl provided with rapid improvement of the rash and pruritis. Patient was discharged home, patient and family were advised to consider Benadryl prior to second dose administration.

12 year old healthy male who presents with chest pain 2 days after receiving second dose of COVID-19 vaccine (pfizer) on 6/14. Yesterday with tactile fever and headache, resolved with tylenol. This morning woke up with substernal chest pain, described as "heaviness on chest," worse with deep breaths. No SOB or difficulty breathing. Pain does not radiate. No diaphoresis. No nausea/vomiting. No lightheadedness. No fevers/chills, cough, rhinorrhea, conjunctival injection or sore throat. No rash. Normal PO. Normal UOP. Last stool yesterday, normal. No sick contacts. No recent travel. No family hx of cardiac disease, sudden death, or coagulopathy.

Headache; fatigue; aches in large limbs; fever; injection site pain-all mild to moderate; This is a spontaneous report from a contactable consumer or other non health care professional. A 12-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number was not reported), via an intramuscular route of administration, administered in left arm on 16Jun2021 at 09:45 (at the age of 12-year-old) as a single dose for covid-19 immunization at clinic. The patient medical history included ongoing seasonal allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for seasonal allergy (received within 2 weeks of vaccination). Since the vaccination, the patient has not been tested for COVID-19. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number was not reported), via an intramuscular route of administration, administered in left arm on an unspecified date in May2021 as a single dose for covid-19 immunization and did not experienced any reaction. On 16Jun2021 at 23:00, the patient experienced headache, fatigue, aches in large limbs, fever, and injection site pain- all mild to moderate. Patient did not receive any treatment for the events. Events did not result in hospitalization. The outcome of the events was recovered on an unspecified date in Jun2021. Information about batch/lot number has been requested.

Urticaria (full body). Still going on as of today. Has taken daily OTC Benadryl - switched to daily Zyrtec.

An hour after he received his vaccine, he began breaking out in large welts all over his body and got a headache. He has had a headache ever since he got his vaccine. He was seen at the pediatrician's office and was told he had an allergy to something in the vaccine and was not to receive the second dose.

Within 10 days of first covid vaccine, pt developed urticaria that has persisted x5 weeks and may go on to chronic urticaria. No angioedema, bruising or systemic symptoms. Likely idiopathic but due to time frame of vaccine, we considered it worthwhile to report it, as the vaccine continues to be studied.

After receiving the injection, within about 5 to 10 minutes patient felt dizzy and fell in his fathers arms. Patient did not pass out but was dizzy, clammy, sweaty and pain in his left arm at injection site. I called 911. 911 came within a few minutes since they are stationed across the street from us. The EMT took his vitals. Vitals initially low at 88/55 then climbed back up to 102/68. No fever. Patient started to feel better. EMT stated patient is ok and may have

6/16 woke up with spot under left arm. Thought it was a spider bite. By 6/29 full rash. On 7/2 diagnosed with shingles. Never had chicken pox. Fully vaccinated for varicella. I don?t believe there is a link between covid vaccine and shingles but I want to report.

RASHES DEVELOPED FROM THE LEFT SHOULDER THROUGH OUT THE WHOLE BODY, LASTED FOR MORE THAN 5 DAYS. DIDN'T TAKE ANYTHING FOR IT AND DIDN'T GO SEE A DOCTOR FOR IT, JUST DISAPPEARED AFTER 5 DAYS.

Allergic rash all over his body; This is a spontaneous report received from a contactable nurse (Parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0191), via intramuscular route of administration on 18Jun2021 at 19:00 (at the age of 12-year-old), as dose 1, single in right arm for COVID-19 immunisation. The patient's medical history was reported as none. Concomitant medications were not reported. On 21Jun2021, 2 days and 5 hours after the administration of first dose of vaccine, the patient experienced allergic rash all over body. The patient received vaccine on 18Jun2021, Friday and on 21Jun2021 night, he began to have rash, like an allergic rash all over the body. Patient never had this before and the reporter did not know if it was related to vaccine. Patient was taken to doctor at the urgent care, where he was prescribed with Prednisone 20 mg 1 tablet by mouth daily for 3 days and Benadryl 25 milligrams. Reporter attributed the events to vaccine because that was the only thing that was different since the rash broke out. Therapeutic measures were taken as a result of allergic rash all over body and no lab works were performed. Patient was due for his second dose on 09Jul2021. The clinical outcome of the event was unknown.; Sender's Comments: Based on known drug safety profile and close temporal association, the event of allergic rash is assessed as related to the product BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient received his second dose of the Pfizer vaccine today. He is accompanied with his mother. He had no issues with his first dose. Approximately 15 minutes after administration, patient developed mild itching to his bilateral forearms and on examination, he had a few scattered erythematous papules to his bilateral forearms. He had no other rash. No swelling. He had no other symptoms. No shortness of breath, wheezing, cough or chest pain. No angioedema or throat/tongue swelling. He was talking in complete sentences and eating/drinking without any issues. Lungs were clear. See vitals below. Patient took Claritin last night and Allegra this morning for a history of seasonal allergies. He was monitored for greater then 30 minutes. The pruritus had improved, the rash did not get any worse. Patient and mother felt comfortable going home and had no further questions or concerns. Patient will go to the ED with any severe/acute symptoms. Vitals 07/07/21 1147 07/07/21 1148 BP: 110/80 108/80 Pulse: 80 79 Resp: 16 SpO2: 98% 98%

Within two hours after having the first dose of the vaccine, he broke out in hives (small red bumps) on his back and upper arms. There were several bumps, but mostly concentrated on his upper back. He said it was itchy. We gave him benadryl. The bumps stopped itching within about an hour and were gone the next morning (we looked at around 8am).

pt complained of getting dizzy and having trouble seeing when talked to him after. patient had parent with him (father) pt was nervous. got vaccine and left room. father said he looked very pale and then pt sat down and started to throw up. patient wasn't hospitalized. mild redness at injection site. left the premises after 15 to 02 minutes feeling fine.

rash appeared 1 week after dose 1..got worse but then better by time for dose 2..gave dose 2 and by 3 days after 2nd dose could see it was getting worse again. Went to doctor and diagnosed with pityriasis Rosea. Currently 1 month after 2nd dose and rash has been getting worse over the past few weeks. Treatment is Claritin and Benadryl caps. Triamcinolone and oatmeal baths.

4 days following 1st COVID vaccine, pt developed erythema migrans vs cellulitis vs insect bite to left lower back. ? Lyme disease, treated with doxycycline, began resolving in 3 days after start of doxycycline. No other systemic signs and symptoms at that time.

About five minutes after receiving the vaccine in his left arm, the patient developed redness itchiness and rash at the site of the vaccine. No systemic symptoms. Received an ice pack to the area. Pt was monitored in clinic for 30 minutes, during which time symptoms had fully resolved.

Spreading rash that started in left groin. it spread rapidly down leg, up the side of the abdomen and into the armpit. Rash was very itch and very red/irritated. It also started to looking like it was bruising as it healed. Rash was unaffected by Benadryl or antibiotics. Was prescribed steroids and it cleared up after about 2.5 weeks.

Okay so on July 4th 2021, he was fatigued and cranky and I did not realize he was sick. On July 5th 2021 he woke up with a sore throat and not feeling well, on that night he had a 102+ fever, congested and ill. This continued and on Tuesday morning when he woke up, nose red and could not breath out of it. The fever broke on Thursday and he had been treated with Tylenol, Ibuprofen, fluids, Flonase and rest. I tried to help him with steam, to steam out so he could breath better. We did a rapid Covid test on the 6th of July which was negative. On the 9th and 10th he was still tired and had congestion, but on late on the 8th of July the fever did break. He was just miserable, he slept most of that week. He did not have body aches, so I don't think that he had the flu.

Pt returned to office at 4:30 today after starting to break out in a rash around 1440. Rash started on his left forearm initially and then spread to right forearm, both knees, and right flank. Rash is itchy. Pt denies any fevers, no shortness of breath, no sore or tickly throat. He does complain of right upper arm pain (HPV vaccine) and pain in both legs. He is ambulating without issue. No limp. Since leaving the office this AM he has eaten a steak quesadilla and SODA. He also took his zyrtec, singulair, flonase and flovent.Per mom he hasn't been playing outside over the past few days. Rash looked more red prior to entering the office (though they had walked from mom's workplace at and outside temps today are in mid to upper 80's Physical Exam- Areas of rash consist of erythematous, flat lacy appearance and are over the inner aspect of the right and left forearm, right flank, and above the left and right knees. No raised areas noted.. Lesions: no petechiae or rash. Pt given script of 25mg benadryl to take at night and 2.5% hydrocortisone ointment to apply to rash areas 2-3 times a day as needed. Mom to return to office tomorrow if rash is worse, spreading. Will also do allergist referral to ensure that second doses of HPV and COVID can be given per schedule

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient became lightheaded about 10 minutes after immunization. He presented as pale, shaky, and almost ready to faint. Patient was given pedialyte, ice, and chocolate after vomiting one time. EMS was contacted, they arrived and assessed the patient. He was cognizant and able to stand on his own. Mother refused transport to the hospital and the family left about 45 min after immunization was given.

Itching began after first dose on 05/17/2021 and then rash began after 2nd dose on 06/07/2021, rash and bumps are on upper arms, bumps are prevalent on back and other parts of body

Face Swelling to 3 times it?s size with painful rash Left Eye swelled shut and couldn?t open Slight rash on upper left arm

tiredness; weakness; head is burning; fatigue; drooling; hives; itching; redness; gained weight since the vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729; Expiration Date: 31Jul2021) via an unspecified route of administration, in left arm on 27May2021 (at the age of 12-years-old) as dose 1, single for covid-19 immunisation. Medical history included patient had an allergic reaction to penicillin before. The patient's concomitant medications were not reported. The patient had a meningitis vaccine a month before the covid vaccine. Patient's mother was calling on behalf of her 12 year old son. She stated her son received the first dose of the Pfizer COVID vaccine on 27May2021. On 27May2021,6 hours after receiving the vaccine the patient said he was very itchy and had hives on the left side of his chest. At first she thought the patient had poison ivy because it was like 3-4 inches across. The next day the patient said he was itchy when he sat up and it went up onto his neck and cheeks and that's when she realized it was hives. She called the doctor, applied cold compresses to the patient and gave him Benadryl. The hives resolved very quickly, the patient has never had hives or an allergic reaction before. By 2:30 the patient had the Benadryl and you couldn't see the red anymore. The patient could sit up but kept saying it itched and that went on for about 48 hours. You would have to look pretty closely to see the bumps. One week after the patient received the vaccine he was really weak and tired (on 03Jun2021). She stated her son also keeps having episodes of tiredness and weakness. It felt like the patient had been exercising and his legs were tired and his head felt like it was burning (on 03Jun2021). The patient's temperature was 97.7. The patient laid down and he slept pretty hard, and was drooling, for a couple of hours. When the patient woke up he didn't know where he was, the time or date and within a couple of hours the patient was fine. She didn't think anything of it the first time it happened. This event happened again 2 weeks after the vaccine. The doctor said they symptoms sound like mono but the patient's lymph nodes aren't swollen and he doesn't have a sore throat. The doctor thought the patient was having a delayed immune response to the vaccine because of the timing of it. The doctor said that by 3 weeks this should have resolved. The patient has had 2 mild episodes of this since, but he didn't go to sleep he just laid down. The doctor said to wait to get the second dose, so now it is 4 weeks since the first vaccine. The patient was at the 30th percentile for his height and average for his weight. The patient had gained weight since the vaccine but his mother didn't know if that was related to the vaccine. She was afraid of the patient having myocarditis with the second dose. The patient went to sleep after taking the Benadryl last time and she was afraid that the patient won't be able to tell her if he was having chest pain or problems breathing. She stated if his reaction was just hives she would give him Benadryl but with the risk of myocarditis after being given Benadryl he wouldn't be alert enough to tell her if something was going on with his heart due to him having fatigue as well already. The redness went away within 24 hours and the itching was gone in 48-72 hours. The redness was gone the evening of the 28th. The patient could still see and feel the bumps, the bumps were just white. The patient's head was burning happened the first 2 times he had these events. The patient's temperature was 97.7 and 98.1 fahrenheit when this happened. The other two times the patient said his head burned between his eyes and not like a headache. The doctor said that if the fatigue symptom continued he would recommend doing some blood work but since it has gotten better his mother may take him to an allergist. She thinks that the patient may be allergic to something in the vaccine. she was thinking of taking him to an allergist to see if he was allergic to one of the ingredients in the vaccine. She stated from the list of the ingredients the only ingredient she found that could be linked to the vaccine that could cause an allergic reaction would be PEG. She stated her son never had any allergies to medications or vaccines in the past. She stated she was not sure what advice should be given regarding her son receiving the second dose of the vaccine due to him having an allergic reaction to the first dose and tiredness and weakness. She stated she was not sure of the risks of vaccine versus him not being vaccinated. She would like to know if he should receive the second dose after experiencing side effects with the first dose. Reporter seriousness events was unspecified. Outcome of the events hives and itching recovered on May 2021, redness recovered on 28May2021, event tiredness and weakness was recovering and for other events was unknown.

Rash around neck / Have rash all body; Itchy all body; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in left arm on 29Jun2021 at 10:45 AM (vaccinated at the age of 12 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included atopic dermatitis from an unknown date and unknown if ongoing, allergic to apple and cedar tree, birth, Alder, Prennial Rye, sweet Varnal, Timochygrass. Concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. After taking the vaccine 11 am, on 29Jun2021 at 04:00 PM, patient got rash around neck around 4pm and all body except face around 12am -1am and took Benadryl to sleep. On next day, patient was still itchy all body and took Benadryl again to sleep. After the next day, patient went to ExerUrgent care and got steroids prescription creams. However, after 4 days now, patient still have not to get better and have rash all body. Therapeutic measures were taken as a result of the events with prescription steroids cream and Benadryl cream. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The report was non serious. Outcome of the events was not resolved.

Hives. Patient treated with zyrtec and benadryl; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Ew0185) intramuscular in left arm on 06Jun2021 (at the age of 12-years-old) as second dose, single for COVID-19 immunization. Medical history was reported as none. There were no known allergies reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Ew0185) intramuscular in left arm on 16May2021 (at the age of 12-years-old) for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021, the patient experienced hives. Patient was treated with Zyrtec and Benadryl. The outcome of the event was recovered on an unspecified date in Jun2021. No follow-up attempts are possible. No further information is expected.

Received vaccine at 3:30 pm on 7/15/21. By 4:00 pm, my son had complaints of sensitivity and soreness. Morning of 7/16/21, he woke with a significantly swollen arm with raised red area and extreme sensitivity. I took pictures due to the significance. Measurements 3" x 3", warm to the touch. Color, dark purple. By Day 3 - 7/18/21, the color faded to a blue bruise, size remains the same, still warm to the touch. Day 4 - 7/19/21, color is fading, but can still see the area affected on his right harm. Since it has been 4 days, we went back to pharmacy today 7/19/21 at 1:00 pm, to show them his arm, and the pictures I took. They referred to this as COVID arm, and immediately recommended I register with VSAFE to track his progress. *Note: VSAFE does not allow any registration for people born after 2005. So, I am tracking information here at VAERS

Loosing hair; This is a spontaneous report from a contactable consumer or other non hcp. A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8735; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 12-years-old) as DOSE 1, SINGLE, and second dose via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number and Expiration date was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. The patient experienced loosing hair on an unspecified date. Reporter was calling because her son got the vaccine the first dose on 17May2021(confirmed) had been noticing that he was losing hair, and didn't know if this might a be side effect of the vaccine, planning to take him to the doctor and calling on Monday to schedule an appointment but just wanted to ask if it could be a side effect of the vaccine. The suspect product was confirmed as Pfizer COVID-19 Vaccine. Reporter stated, thought the patient height was about 4 feet 9 inches. Reporter didn't know an exact date of event because reporter just noticed after patient took (incomplete sentence), not the exact date but reported as about a week. On the week of this report, reporter noticed after the shower and saw a lot of hair on the mat. For facility name, reporter stated, could not find the card right now but it was a hospital in. Anatomical site where COVID-19 vaccine was administered reported as right arm for both the shot. No treatment received in response to event. Reporter just noticed and was wondering that's why called to see if it might be a side effect a reaction to the vaccine. It was concerning, yesterday after patient took a bath, reporter noticed a lot of hair and that's not normal and will call the doctor to schedule an appointment but again wanted to call to ask. Patient took no other vaccine prior to the first dose. Reporter stated, it just if patient passes the comb through his hair you know the hair will come off and it's a lot of hair it's not one or two hair it's several, and stated reporter did not know the time event started. Clinical outcome of the event was unknown. Information on the lot/batch number has been requested. Additional information has been requested.

Patient reported that the vaccine injection site was red hot and feels hard. Appointment was not made for this.

a skin rash appeared on all extremities and trunk of body as well as neck. Rash in the form of welts. Very itchy.; a skin rash appeared on all extremities and trunk of body as well as neck. Rash in the form of welts. Very itchy.; Rash in the form of welts. Very itchy.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 12-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: Ew0181), via an unspecified route of administration in left arm on 06Jul2021 (at the age of 12-years-old) at 14:30 as dose 2, single for COVID-19 Immunization. Facility the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration on an unspecified date as historical vaccine as dose 1, single for COVID-19 Immunization. On 11Jul2021 at 21:30, the patient experienced 5 days after 2nd dose, a skin rash appeared on all extremities and trunk of body as well as neck. Rash in the form of welts. Very itchy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not received treatment for the adverse event. The outcome of the adverse event was recovering.

Broke out in a full body rash; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; This is a spontaneous report from a contactable consumer reported (reporter's son). A 12-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 08Jun2021 09:00 (Batch/Lot number was not reported) as dose 2, single (at age of 12-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. No known allergies. Concomitant medications included ascorbic acid (VITAMIN C); vitamin d nos (VITAMIN D). Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18May2021 09:00 administered in left arm (at age of 12-years-old) for COVID-19 immunisation. The patient broke out in a full body rash starting 2 days after the 2nd shot on 10Jun2021. Started on top of his feet and spots on his leg and by the 3rd day, was covering most of his body up to his neck. Red, warm to touch, itchy, it was not too raised, just slightly swollen on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Used Zyrtec and Benadryl per advise of doctor. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No Hospitalization Prolonged. Outcome of the events was recovered/resolved. Information on the lot/batch number has been requested.

Welt and rash on the left arm, 3 inches below the injection site. Itching and redness. Welt appeared days after vaccine.

Vomiting; Low blood sugar; unable to walk without help even sitting in wheelchair; Rash; had reaction to vaccine; Headache; Having hard time eating and drinking; This is a spontaneous report from a contactable consumer (parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Batch/Lot number was not reported), via an unspecified route of administration on 14May2021 (at the age of 12-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included Immunodeficiency and Gene mutation. The patient's concomitant medications were not reported. Reporter stated, her child had his Pfizer vaccine (COVID vaccine) on Friday (14 May 2021) and he was fine on Friday, Saturday and Sunday but on Monday patient experienced vomiting, took him to the Hospital of (withheld), he had low blood sugar, he had rash, (headache) and was unable to walk without the help even sitting up in the wheelchair and patient is having hard time eating and drinking as of now. The outcome of the events was reported as unknown. Information about Lot/Batch number has been requested.

Tiredness; Loss of appetite; lack of energy; Chills; Fever; Soreness at the injection site; Warmness at injection site; difficult to lift his arm; This is a spontaneous report from a contactable consumer (parent). A 12-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EV00191) via an unspecified route of administration in left arm on 22May2021 at 11:00 (age at vaccination 12-year-old) as dose number unknown, single for Covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were none. The patient previously took Flu vaccine, 2 years before, onset Age was about 10 years and experienced flu symptoms. Patient was healthy, no allergies and no medical history. Not even regular vitamins. Patient did not receive any other vaccines on same date of the pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Patient's mother was a bit concerned. He was doing great and then on 23May2021, Sunday onwards he had chills. Then he had a temperature of 100 and she gave him plain acetaminophen and Sunday onward 6 or 7 hours onward he kept getting chills. On 23May 2021, for six to seven hours, he had chills. There have been temperatures of 90 and she has to give him a blanket or heater. It was more or less the same today 26May2021 Attempted to clarify that the caller stated the intensity was a little less. Caller confirmed. She thought it was a normal reaction and waited patiently for 3 days. She was not allowing the temperature to go up as soon as he gets chilled and breaks into fever, she checked his temperature and it was always less than 100 like 99.9 or 99.7 Fahrenheit, axillary. Then he broke into a sweat and feels a little better. He also had tiredness and loss of appetite on 24May2021. She also reported that on 22May2021, his arm was sore and difficult to lift and then it disappeared in one or two days. He took the vaccine on 22May2021 in the morning and then by Monday symptoms were gone, the soreness, and warmness at injection site. Patient experienced tiredness on Monday 24May2021 in the morning after fever, the lack of energy and tiredness started. On 24May2021 patient experienced loss of appetite. His breakfast, lunch or dinner reduced to one fourth. On 22May2021 in the morning started in the evening, around 6 or 7 o'clock, patient experienced soreness at the injection site. On 22May2021 in evening, patient experienced warmness at injection site. The time range for adverse events was 3 to 5 days. 3 days of fever no one gives her answers. Pediatrician says wait and after 4 or 5 days they look into it. Adverse events did not result into emergency room visit and physician office visit. Treatment received for chills was gave acetaminophen every 6 to 7 hours. Treatment received for fever was Tylenol every 6 to 7 hours. Treatment received for tiredness and lack of energy was keeping him hydrated and his appetite was quite less and she was giving him lemon juice keeping fluids. Treatment received for event warmness and soreness at injection site was gave him ice and it helped a lot localized. Patient did not receive any treatment for event loss of appetite. The patient underwent lab tests and procedures which included fever was 99.9 and 99.7 Fahrenheit on 23May2021. The outcome of event chills was unknown. the outcome of event pyrexia, tiredness, loss of appetite and lack of energy was not recovered. the outcome of event soreness and warmness at the injection site and difficult to lift his arm was recovered on 24May2021. No follow-up attempts are possible. No further information is expected.

Swollen and very sore lymph nodes in left axilla starting the day after the injection. It has only been 2 days so I do not know how long this will last. You can feel the nodes are swollen and my son is complaining that it is very sore especially when he is lifting or using the arm.

Immediate reaction in left arm site of injection deep red rash, skin blotching non-itching . Neck and face rash. Deep purple rash in both feet and toes. Given 25 mg Benadryl po with resolution of rash in 3 hrs. C/O headache and nausea.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Additional Details: administered vaccine at 2:56 pm. within 5 minutes patient had loss of color, sweating and felt dizzy. Patient laid on the bench and was responsive the entire time. Called EMS at mother's request. Patient walked out of the store with mom and EMS and seemed fine. Spoke with father about 20 minutes after patient left and he said he was ok. He said he will follow up with us if anything changes.

Bruising in knuckles of both hands. Started on 5/18/21 No additional symptoms other than soreness at side of injection.

Patient had a syncopal reaction: skin became hot and clammy, patient was dizzy, upon asking him to repeat a command or do a simple action (like wiggling fingers, lifting arm) he was not responding and his eyes were rolling to the back of his head and would not vocalize (when asked if ok, or what his symptoms were, or if he was having trouble breathing) at which time we called 911 since he was not responding verbally or physically. Had him sit, take off his mask, gave him water to sip, took BP (102/60), within 5 minutes he started to come back around, was able to follow command (wiggle fingers) vocalize that he could breathe fine, and felt that there was water behind his ears. His temperature to touch seemed to start to go back down, and once paramedics arrived they evaluated him and released him as "ok" within 10 minutes.

Got the 1st dose of COVID-19 Pfizer vaccine and after 24hours, kid got rash on the stomach and left shoulder and it became worse day by day. Have seen the pediatric and after examination, she mentioned that it could be Pityriasis Rosea and advised to see a dermatologist and also report this event. I am reporting this as advised by the pediatrician. Not sure if this is the side effect of vaccine but believe it could be because this started after 24hrs of receiving vaccine.

Pt received vaccine in left upper arm. He was bleeding immediately more excessive than a usual bleed after shot. no medications history. he felt faint also. applied cold compress to head and mom applied pressure to arm with paper towel. bleeding stopped and he was feeling better . Checked in with mom on patient at home and he was feeling better

Fatigue, pain around injection side on the day after vaccine during the day. Nothing concerning but right before he went to bed he didn't feel good. My son thought he had to vomit but couldn't. He said his HEARTBEAT WAS SO MUCH FASTER than normal. I got so concerned that I slept next to him which I never did before. He fell asleep after 1 h and woke up the next morning and felt fine. I did not go to the doctor because he was feeling well the next day.

There is a bulge that has appeared below the injection site that sticks out and seems full of fluid. It appeared as soon as his arm stopped feeling sore and has been there for 2 days as of now.

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

His mother was present and told us he had multiple allergies to foods and sulfites, as well as asthma. He used to carry an epi pen but does not currently, also has a history of asthma for which he carries a rescue inhaler. He received the Pfizer vaccine at approximately 9:15am in his left deltoid, and about 2 minutes later Mom notified me and the school nurse that he was starting to get "hives". I noted a localized, small area of erythema on his left upper arm around the bandaid, approximately silver dollar sized, not raised. School RN removed the bandaid. He did not complain of itching and at that time stated he felt like he was breathing fine. The school RN gave him 50mg of Benadryl PO per the mom's request at 0920. The patient was in no distress, breathing and speaking normally. At 0922 he stated he felt like his throat and tongue were swelling, so I had him remove his mask, and asked mom if his lips looked swollen to which she responded "yes". He stated it felt like it was hard to swallow. We placed a pulse ox on the patient and his oxygen saturations were 96-100%, HR 85-90, RR 30. We administered an adult epi pen (0.3mg of epinephrine) into his left lateral thigh at 0923 and had the school office call EMS. The patient remained in no acute distress, and said the swelling in his tongue felt better after the epi, but that his throat still felt swollen. Lungs clear bilaterally, RR remained 24-30, HR 110-115, pulse ox 98-100%, erythema on left upper arm resolved. Fire department arrived at 0935- report given and they checked a pulse ox as well. Patient walked to parking lot to ambulance for transfer to Hospital with mother following behind.

nonspecific small raised red bumps on back that spread to pts trunk, rash was pruritic in nature as well

The evening of his morning shot he began to have back pain up between his shoulder blades. Describes it as burning, his "skin hurts" is uncomfortable when touched, leaning against a chair or even when his t-shirt rubs against it. Three days later and it still hurts.

Pt. has history of Lymphangioma. Pt. presented with lump on chest that became inflamed and red after 9 days of receiving Covid-19 vaccine. Pt. presented with itchiness, swelling, bruising, redness, fever, hot to touch and headache. Pt. used ice packs and Ibuprofen for treatment.

Hives started appearing 1 day after shot. By Wed (3 days after shot), red bumps all over trunk. Bumps have red circle the size of a dime with a yellow "head" in the middle. Spots look similar to varicella zoster, so he is going to get tested.

Patient developed all-over itching 10 minutes after receiving the vaccine dose. He was treated with Benadryl 50mg after it was determined that he was developing no other symptoms. He stayed in the office and was observed for one hour. His symptoms resolved within 24 hours and he did not develop any new symptoms within that time frame and did not need to seek out any further medical care.

rash all over his body including his eyes/rash all over his body including his eyes/still there on his toes; This is a spontaneous report from a contactable consumer (mother) via medical team. A 13-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) dose 1 via unspecified route of administration on 13May2021 as a single dose for COVID-19 immunisation (age at vaccination was 13 years). Caller was asking for guidance regarding getting the second vaccine dose after having a side effect following the first dose. She reports that her son received his first vaccine dose on 13May2021 and 4 days later on 17May2021 he began having a rash all over his body including his eyes. She reports that the rash lasted for about 6 days and is still there on his toes. She reports concern about what he may experience after getting the second dose, which is scheduled for 03Jun2021, and asks for guidance on if it will be safe for him to get it or not. Patient had a side effect after the first dose of the vaccine. Should get the second dose? Caller talking about her 13-year-old son, asking how much protection will my son get or what is the efficacy following 1 dose of the Pfizer covid vaccine? The outcome of the event was unknown. Information on the lot/batch number has been requested.

Complained of sob and chest pain on the same day of his shot, but resolved on its own, later that night started with new-onset fever/chills, headaches, myalgias, and a new onset rash spreading from face to trunk, early lesions described as red papules and eventually dry up, no dermatomal distribution, spread throughout, not itchy, refers some tenderness/burning feeling upon palpation. Only treatment received is Tylenol.

There was sweling at the site of injection and it hurt whenever the area was touched. The swelling and pain stopped after 2-3 days.

Site: Swelling at Injection Site-Mild, Systemic: blister-like protrusion on injection site - looks to be filled with fluid-Mild

the rash started about 2 - 7 days after the vaccination; probably related to a viral infection. Said it looks like pityriasis rosea; probably related to a viral infection. Said it looks like pityriasis rosea; This is a spontaneous report from a non-contactable consumer (parent) reported for a 13-year-old (same age during vaccination) male patient (son) that patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 15May2021 as single dose for COVID-19 immunisation. Patient s medical history and concomitant medications were not reported. Caller's son received the first dose of the Pfizer vaccine on 15May2021. Rash occurred a week later. Caller stated the rash started about 2 - 7 days after the vaccination. Caller stated, they went to the pediatrician, they think this may not be caused by the vaccine, probably related to a viral infection. Said it looked like pityriasis rosea. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Patient began experiencing hives within 5 hours of receiving COVID vaccine #1. Patient noticed hives on stomach, back, legs, and buttocks. Patient reported them being itchy. Patient's PCP was notified and a telehealth visit was performed. Patient's PCP recommended Benadryl every 4-6 hours. Hives would wane and return for the next 4 days. Hives were on arms, chest, back, buttocks, and legs throughout the five days. Patient began Zyrtec on Monday morning and continued Zyrtec through Wednesday. Allergy was e-consulted to discuss the second dose of the vaccine and if patient should receive it. Allergy recommended Zyrtec one hour prior to second dose and have PCP prescribe epi-pen in case of more severe reaction.

Large red circle at the injection area and he had a rash on his armpit area; Large red circle at the injection area and he had a rash on his armpit area; This is a spontaneous report received from a contactable consumer (parent). A 13-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0173, Expiration Date: Unknown), via an unspecified route of administration on 15May2021 (at the age of 13-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient's parent reported that the patient weight is around 65-70 pounds and height is around 5 foot (might be a little under 5 foot). On an unspecified date in May2021, the patient experienced large red circle at the injection area, and he had a rash on his armpit area where he received the vaccination. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Rash - all over front torso - only discovered on my son at bedtime, although he said it was present in the early afternoon. Will monitor, if still there in the morning will call pediatrician

He noticed a lump around his collar bone. Doctor diagnosis it as two swollen cervical neck lymph nodes. On the left side which is the same side of the body where her received the injection.

After second dose of Pfizer Covid-19 vaccine he received two days ago on Wednesday June 2nd around 5pm. Felt tired that night and into the next day with some local swelling and pain to the right arm at site of injection, and also into right armpit. Thursday evening, he was resting sitting on the couch and developed some mild chest pain. Can't really describe the location or severity very well. Did seem to be worse with inspiration. Hasn't reoccurred since that time. Still feels somewhat tired today with mildly sore right arm. No fevers. No chest pain today. IR showed second dose of Pfizer Covid-19 vaccine was given to the left arm but confirmed with CVS that it was given to the right arm.

Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Mild, Additional Details: Patient felt light headed, nauseaous with abdominal cramping and little confusion. He felt exhausted. Called ambulance and paramedics monitored the patient's vitals and send him after he felt better

Urticaria of lower (lumbar region) back 5 hours after vaccination. Pruritic. Improved the next day and resolved completely after 2 days.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium, Additional Details: patient was given 2nd dose of phizer covid 19 vaccine. patient was fine intially and became lifeless and pale after 5 minutes. Patient was disoriented , pale, and complained of blackened vision and huge sound in his ears. paramedics were contacted and patient was arousable. after 15 min patient was ok and documented color restored to complexion. paramedic deducted anxiety due to needles and patient was taken home by parents

8 hrs post vaccine- 6/3 -Site pain and fatigue 24 hrs post vaccine-6/4- stiff neck 48hrs post- 6/5 severe chest pain- went to ER, 6/5 20:00 Admitted to Hospital

Patient received vaccine on 6/4/21 at 2:30 pm. Patient woke up early (before 6 am on 6/5) and complained of headache and feeling tired. Patient had fever that reached as high as 101F at 2 pm. Patient felt chills and sweats while he had fever. Patient felt better by 9:00 pm with fever down to 99F. Fever was resolved by morning of 6/6/21. Patient also had moderate pain at injection site and swollen lymph nodes in left armpit (injection side). Patient slept during the day on 6/5 and drank extra water and fluids during the day. No other treatment was provided.

Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: MOM CAME IN LESS THAN 24 HOURS TO REPORT THAT PATIENT BROKE OUT IN RASH ON HIS TORSO AT 6PM THE NIGHT ON 5/5/21. HE RECEIVED THE VACCINE ON 6/3/21. THE RASH ALSO SPREAD TO LEGS . HE DID HAVE ITCHING . HE IS GETTING BETTER IN REGARDS TO RASH/ITCHING. I DID RECOMMEND MOM TO GIVE BENADRYL AND FOLLOW UP WITH PROVIDER REGARDING 2ND DOSE

Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: MOM CAME IN LESS THAN 24 HOURS TO REPORT THAT PT BROKE OUT IN RASH ON HIS TORSO AT 6PM THE NIGHT ON 5/5/21. HE RECEIVED THE VACCINE ON 6/3/21. THE RASH ALSO SPREAD TO LEGS . HE DID HAVE ITCHING . HE IS GETTING BETTER IN REGARDS TO RASH/ITCHING. I DID RECOMMEND MOM TO GIVE BENADRYL AND FOLLOW UP WITH PROVIDER REGARDING 2ND DOSE

Fever - up to 102 - lasted until yesterday - it was back down to normal yesterday. He has had a sore arm - at injection site; the arm also was hard - a lump that was a little bit palpable - which is gone now; - body aches - gone now, chills, difficulty swallowing. He didn't have trouble breathing, but he felt his throat tighten when he swallowed (still has this); upper right abdominal pain - that is the real bad symptom still. His eyes hurt when he moved them around. Fatigue. He's been glued to the couch since Friday. I had given Advil and Tylenol. After the prolonged fever, I eventually called into the doctor's office. The pediatrician said it was common and said to wait it out but seek treatment if it got worse. He is able to eat but is awful nauseous. He is eating what sounds good. The pain stays the same when he eats.

"Pfizer-BioNTech Covid-19 Vaccine EUA" Severe Soar Arm Pain In The Injection Area Fever Of 102.3 started at around 2 A.M

Next day, started with nausea in the M (8:00), then fever (12:00 PM), then chest pain (3:00 PM). Went to the ER to be monitored. On Sunday, said pain moved from injection site to under arm (small lump).

Rash on chest and back still present, gave antihistamine allergy medicine. Headache, stomach ache, body ache, injection site soreness, still ongoing

He had hives all over his torso and legs,. Gave him a dose of Benadryl and within a few hours the hives were gone. He continued to have soreness in his arm and felt achy and not well for two days following the shot.

Bad rash all over torso and both arms (not head or legs). Mild fever. Lethargy. Muscle pain -- especially neck and left ear. Rash was red bumps like Chicken Pox/Shingles -- about a hundred of them, not particularly itchy. Patient has had full course of all recommended childhood vaccines, but none recently. Symptoms started to subside on third day. Ibuprofen reduced aches. After fourth day, bumps are still visible but fading and causing no more discomfort.

inflammation in his intestines and his stomach; petechial rash on his legs, which is still getting a little bit worse; HSP; stomach pain/extreme stomach pain started again and so on/intermittent stomach pain/lower left abdominal pain; lower left abdominal pain and he doubled over in pain and started vomiting; Caller states again he had intermittent pain throughout the day; vomited about three times in total, it wasn't like excessive vomiting; didn't feel well/feel sick again; This is a spontaneous report from a contactable consumer (patient's parent). A 13-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0164, expiration date: 31Aug2021), at the age of 13 years old, in left arm on 14May2021 16:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was a normal 13 years old, he doesn't take anything, he's active. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The vaccines administered on same date with BNT162B2 was none. The previous immunization with the Pfizer vaccine was none. The patient previously received the flu shot every year and experienced no adverse event. On 16May2021, about 48 hours after the vaccination, the patient started having stomach pain in the middle of the night. It began 16May2021 in the evening and into 17May2021, the patient was having stomach pain and not feeling well. Reporter stated the patient woke her up. Reporter stated they thought it was some food he ate. Reporter stated they tested his covid antibodies and they also personally at home on 17May2021 night, they tested him with a home kit for covid just to double check because nobody really brought it up and it was negative also. Reporter confirmed the home covid test was done on 17May2021. Reporter stated there was no known exposure, they just did it to make sure he didn't have covid. The patient was taken to the emergency room on 18May2021. Reporter stated they were waiting because patient felt good during the day and they thought nothing was wrong, but then the extreme stomach pain started again and so on 18May2021, she took him to the local emergency room. Reporter stated they didn't do much other than push on his stomach, she was worried about appendicitis. Reporter stated they didn't worry too much, but she thought maybe it was his appendix. The doctor examined him and said he had a stomach issue and released him with medicine and that was the 18May2021. On 19May2021 and 20May2021, the patient would get intermittent stomach pain, again thinking it was a stomach bug or something. On 20May2021, the patient experienced petechial rash on his legs. Reporter called the pediatrician and again the patient was having intermittent stomach pain and kept having it intermittently. The patient would feel fine then feel sick again then on the 22May2021, the patient had more bad stomach pain and some vomiting so he wound up back in the emergency department, it was a different one than the first on 22May2021. The patient did a lot of blood work, his labs came back good, but he did not do a CAT scan, but reporter tried to do everything else, tested patient for covid, antibodies and everything and they sent him home again on the 22May2021. The patient had intermittent pain again throughout 23May2021 then on 24May2021, he went to visit the pediatrician just for a visit and they were thinking its Henoch-Schonlein purpura (HSP) which is an autoimmune response and they still didn't have a diagnosis for his stomach. Reporter stated patient was perfectly fine at the pediatrician, then when they got home, he started having lower left abdominal pain and he doubled over in pain and started vomiting. The patient vomited about three times in total, it wasn't like excessive vomiting. Reporter stated the pain would bring it on, he does have a rash, which is still getting a little bit worse. Reporter stated they took him back to the emergency room, they did a CAT scan and that showed he had inflammation in his intestines and his stomach so they kept him in the hospital. The patient was admitted on 24May2021 when he visited the emergency room for the third time. Reporter stated because patient was in pain, they admitted him to watch him. Reporter stated they were worried about the patient having intussusception with the bowel, where his bowel can go inside each other and can create a blockage, so they wanted to admit him to make sure that didn't happen. Reporter stated the worst of the stomach pain was on 25May2021, which would have been at 19:00. The patient had not had an episode since then, he hadn't had an attack like that since. The whole week before from 17May2021, or the 16May2021 when it started through 25May2021, it was very intermittent of a lot of pain. So far, knock on wood, the patient hadn't had it since 25May2021 at 19:00 and hopefully tonight it won't happen. Reporter stated it will be about 48 hours of not having the bad pain. Reporter stated he still has some pain, but not like where she had to rush him to the emergency room. The patient's vomiting ended on 24May2021 or 25May2021. He had recovered completely from vomiting so far. The patient was released on 26May2021 with a diagnosis of HSP, which was an auto immune response, and he'd never had this happen before. Reporter stated if she googled HSP, it said it can still get worse, but it was not the worst case of HSP. Reporter stated the patient has never had anything like this before, he was perfectly fine, they made it through covid and didn't get covid and he is a healthy kid so she thought Pfizer should know. The outcome of the events HSP, stomach pain, petechial rash was not recovered. The outcome of vomiting was recovered on 24May2021 or 25May2021. The outcome of the events inflammation in intestines and stomach, didn't feel well/feel sick, intermittent pain and lower left abdominal pain was unknown. No follow-up attempts are needed. No further information is expected.

Patient received vaccine and stayed in pharmacy building for 15 minutes. Around that time patient's parents came back up to pharmacy to notify staff that he had broken out into a rash in the back and his hands felt swollen. I asked if he had any trouble breathing and parents stated no. We followed the Adverse Event Action Plan. We called 911. Patient's parents then stated son is starting to have some breathing issue. I came out with EpiPen and was going to administer when mom stated son's symptoms has resolved greatly and she did not want me to administer EpiPen. Shortly after EMS arrived and evaluated patient and took him to hospital for observation.

Patient was hyperventilating before vaccine was administered. After vaccine was administered patient started to get dizzy and skin color changed. Patient lay down, vitals were being taken, and water was given. once patient smelled ammonia patient started feeling better. Patient stayed for 15 minutes to ensure he was stable to go home.

left arm deltoid injection site with red circular rash with well defined border; There was general swelling (puffy/boggy) of upper arm centered around the injection site that extended under the rash 4 inches in diameter with diffuse/tapered border.; The injection site was very tender to palpation w/ pain raising or using arm.; This is a spontaneous report from contactable consumer (patient). A 13-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 03Jun2021 at 10:30 as 2nd dose, single dose for COVID-19 immunization. Medical history included appendectomy in Feb2019, otherwise healthy boy. Patient previously took Amoxicillin and experienced full body rash. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the patient received within 2 weeks of vaccination. On 05Oct2020, patient had been tested for COVID-19 via Nasal Swab and resulted negative. Prior to vaccination, patient was not diagnosed with COVID-19. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 13May2021 at 09:15 AM as 1st dose, single dose for COVID-19 immunization. It was reported that, patient experienced on left arm deltoid injection site with red circular rash with well defined border that was not raised and about 2 inches in diameter. Does not itch. There was general swelling (puffy/boggy) of upper arm centered around the injection site that extended under the rash 4 inches in diameter with diffuse/tapered border. The injection site was very tender to palpation w/ pain raising or using arm. This was only a day following the 2nd injection (On 04Jun2021 at 14:00). No treatment was received for the adverse events. Since the vaccination, the patient had been tested for COVID-19 via Nasal Swab. On 07Mar2021, patient tested COVID-19 and resulted negative. The device date was 05Jun2021. The outcome of the events was recovering. Information about batch/ lot number has been requested.

Patient was examined by his pediatrician and cleared for physical exercise on 06/01/2021; 4 days before receiving his 1st COVID19 shot on 06/05/2021. On 06/07/2021 we dropped patient off at Soccer Camp. At 10am he started basic soccer ball control drills, which did not include rigorous exercise. At 10:30am we received a call from him, asking for us to pick him up as he had almost blacked out a few times. We arrived at the sports field at 10:40am. I found patient to be red faced, sweaty, but cohesive. He described the following symptoms occurred during mild exercise: difficulty breathing, thirsty, fast heartbeat, "black things" over eyes, preventing clear vision, difficulty focusing, difficulty hearing, feeling faint He took a water break and used his pro-air inhaler, as he thought he might have been having his 1st asthma attack (he's only ever presented with slight wheezing or night time cough). After a short break, his symptoms subsided, so he re-joined the group. After one more soccer drill, the symptoms came back again, but this time he experienced very hard palpitations and the feeling that his shoes were squeezing his feet. At that point he asked for permission to call to us and have us collect him. We took him home and monitored him for a while. He seemed calm and symptom free. I had him shower and he was fine for the rest of the day. The following day I had him jog on our treadmill for a period. He was symptom free. I increased inclination on the treadmill and he handled it ok without any of the previous symptoms. However, now realizing that he was within the 3 day window of his COVID shot, I decided not take him back to the soccer camp. As of 06/13/2021 he has not complained of any symptoms returning. That said, he also has not performed any significant outdoor exercise since then either, besides walking.

two hives to right upper arm with itching and 2 hives on left upper arm with itching, pt given 25mg IM pt waited extra 30 minutes, hives resolved, VSS =88HR, RR=20,BP=108/74, sats=98%

injection site pain, headache, daytime sleepiness, sleep excessive, sore throat, swallowing difficult (because of throat pain), difficulty talking because of pain, lethargy, nasal stuffiness, nasal drip, swollen cervical glands, cough lasted 5 days, left cheek swelling

Site: Pain at Injection Site-Mild, Additional Details: Patient described that the vaccine "hit in weird spot of the arm, it hurt."

13 year old previously healthy male presenting on 6/13/2021 with petechiae and ecchymosis. Found to have thrombocytopenia (platelet count 2). Diagnosed with ITP. Currently admitted and receiving IVIG. No adverse sequelae of ITP thus far.

blistering rash started 24 hrs after vaccination on hands- hands then swelled and an erythematous rash appeared on body Rash persisted for 2.5 weeks; hands swelled so much he could not use pencils

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain - started 1hr after shot, lasted for 2 days Tiredness - started 4 hr after shot, lasted for 2days Headache - started 1.5 hours after shot, lasted until next day morning Fever - started morning of the day after shot, lasted until same day evening

During the night that he got the vaccine my son woke up with hives and I gave him some Benadryl. I gave him his rescue inhaler in the afternoon. He has not used his inhaler for over a year. The next day he had hives were much worse and his fever was going up. The hives were worse on his left arm and his arm was red around the vaccination site. He also had swelling in his face and he was having a little trouble breathing. I gave him Benadryl and Zyrtec which helped as well as Pepcid. The breathing difficulty subsided after that. He got a different rash on his back that was different from the original hives. We continued the medications and he was still Febrile until the sixth day. The sore throat is still present after nine days but the fever and hives are gone.

Immediately had an pain at injection site, then 16 hours later had moderate to severe pain requiring ibuprofen, repeated ibuprofen 6 hours later and then again 6 hours later for arm pain. Generalized fatigue and headache throughout starting 16 hours out from vaccine.

On the night of the vaccine, patient developed fever (Tmax 104), chills, and myalgias. He had an outbreak of herpes on his shoulder. Continued to feel very fatigued. Three days after the vaccine, he started having chest pain and shortness of breath with exertion. He continued to be fatigued. Chest pain was intermittent. Saw pediatric cardiologist at outpatient appointment on 6/15/21 where he had a normal EKG and ECHO. High sensitivity troponin on 6/15/21 was 0.08. He had a Holter monitor placed. He was asked to do activity while wearing Holter monitor and self-limit based on symptoms. He played basketball that night and had to press the Holter button 8 times while playing when he was experiencing chest pain. When he got home from practice, he felt weak and dizzy with associated chest pain. Mom notes his nails were blue/purple, and he was "lethargic" . Symptoms improved with ibuprofen. Patient did not want to do usual activity, mom called cardiology who recommended going to ED. Patient has not had chest pain since coming home from practice on 6/15/21. He was admitted to hospital on 6/16/21. Repeat high sensitivity troponin was 0.82 on 6/16/21 and repeated on 6/17/21 was 0.41. Cardiology consulted. Cardiac MRI performed with normal results. He was dizzy on 6/17/21 when he got up to use the restroom, self-resolved. Cardiology evaluated him and cleared him for discharge with outpatient follow-up and self-limitation with activity.

This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient's mother) reported that a 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not available), via an unspecified route of administration on 16May2021 at 12:30 PM (at the age of 13 years old) as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site, vomiting and feeling tired on 16May2021. The reporter said that her son's second dose was scheduled on June 6, 2021. The outcome of events was unknown. Information on the lot/batch number has been requested.

Developed the first symptoms of pityriasis rosea less than one week after dose one of the vaccine. Was diagnosed with pityriasis rosea by his pediatrician 12 days after receiving his second dose of the vaccine.

Raised rash on chest. Numerous red pimple like bumps. Confined to chest area, not at site of injection.

Hives all over torso/back, arms/under arms, legs/behind the knees, neck and chin. NO wheezing or shortness of breath.; itching; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04Jun2021 at 08:00 (Batch/Lot number was not reported) (at the age of 13-year-old) as single dose for COVID-19 immunisation. The patient medical history included COVID-19 from an unknown date to an unknown date. No known allergies. Since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. On 04Jun2021 at 10:00, the patient experienced hives all over torso/back, arms/under arms, legs/behind the knees, neck and chin with itching. No wheezing or shortness of breath. The events were serious, medically significant. The events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was recovering. Information about lot/batch number has been requested.

Many itchy skin hives on back, front, neck found in the evening of 06/18 and hives were gone in the morning 06/18

PATIENT RECEIVED PFIZER COVID 19 VACCINE ON WEDNESDAY 06/16/2021 AND EXPERIENCED RASH. MOM REPORTED THE ADVERSE EVENT TO PHARMACY STAFF ON SUNDAY, 06/20/2021. THE PATIENT WAS GIVEN BENADRYL TABLET BY THE PATIENT'S MOM AND WENT HOME.

Patient had hives appear about 4-5 hours after his second Pfizer Covid vaccine was administered on 6/6/21. He had hives on his arms, legs, stomach, torso, and groin. He said they were very itchy. No signs of any other issues, so we gave him Benadryl and monitor him. He continued to have hives for about 36 hours. We continue the same course of care and gave him Benadryl during that 36 hour period. The hives eventually went away and he has not had any other issues as of today 06/21/2021.

Patient developed tactile fever and shingles rash near the L arm, below the L axilla and the L upper back about 2 days after receiving the vaccine. Rash appears like vesicles in clusters. Patient describes rash as itching and has burning sensation at the site of the rash. Of note, patient had chickenpox infection around 1 year of age. Denies any recent illnesses.

Pain at injection site and entire leg, Nausea, severe exhaustion, chills, general feeling of sickness

Headache (for the past 2 weeks), and Rash (neck) Bell's Palsy-Patient presents with mild worsening weakness of the right side of the face.

Patient is a 13 year old male who presents to the office for pain of right axillae x 3 days, swelling of right axillae x 1 day. Pain began 24 hours after receiving first covid19 vaccination in right arm. He received pfizer vaccine. Clinical exam is notable for tenderness and swelling in right axialle, diffuse erythematous flat macular rash on right chest wall. Swelling of chest wall likely is adenitis possibly due to covid19 vaccination.

Approx. 15 minutes after vaccination to rt deltoid muscle, pt began breaking out on both arms with small, raised bumps. Gave 10ml Benadryl 12,5/5 solution. Approx. 10 minutes later pt indicated he was having "a little" difficulty breathing. Dad said he has Ehlers Danlos Syndrome and that his breathing was likely due to stress reaction. pt was ok a short time later and dad said if reaction continued, or his breathing worsened that he would take him to the ER. I followed up with dad an hour later and dad said the bumps were still there, but son's breathing was fine.

Tightness of chest; Severe headaches; Rashes on skin; Feverish ness; This is a spontaneous report from contactable consumer (patient). A 13-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route on 04Jun2021 (at the age of 13-years) as dose number unknown, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had known allergic to Aspirin and Ibuprofen. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jun2021 at 13:15, the patient experienced tightness of chest for about 15 minutes. Happened again on 06Jun2021 for 5mins and on 07Jun2021 for about 3 minutes. Also experienced severe headaches, rashes on skin and feverish ness. The patient did not received treatment for events. The events was assessed as serious Life threatening illness. The outcome of the events was recovering. Information on the lot/batch was available, further information has been requested.

Patient experienced fatigue and soreness at the site that improved. This morning developed uticaria - all over .

My son experienced after 2nd vaccine and on Wednesday late afternoon he started getting a rash on his hands and then his eyes started to get puffy. The next morning, his face were more swollen and rash in hands were very itchy. We gave him some Benadryl. On Friday his eye was shut closed. I took him to the urgent care and they gave him a steroid shot and prescribed steroids and Pepcid for the itchiness. They gave him a Kenalog injection, Medrol 4mg therapy pack and 5 tablets of Pepcid at the urgent care. As of today, he still has some rash to his hands but his face is not swollen.

blood pressure 127/90; heart rate of 111; Felt weird; headache; his arm had swelling and redness/Right arm, swelling, redness, rash, bump, at injection site, after second vaccine; his arm had swelling and redness/Right arm, swelling, redness, rash, bump, at injection site, after second vaccine; his arm had swelling and redness/Right arm, swelling, redness, rash, bump, at injection site, after second vaccine; This is a spontaneous report received from a contactable consumer (patient's mother). A 13-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 09Jun2021 around 18:00 hours as dose 2, single (at the age of 13-years-old) for covid-19 immunisation. Medical history included ongoing attention deficit disorder (was in fourth grade, around 4 years ago) and patient's sister also has autism spectrum and attention deficit hyperactivity disorder (ADHD) and patient had seasonal allergy from an unknown date and unknown if ongoing. Patient had no prior vaccinations (within 4 weeks). Patient received no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication(s) included atomoxetine hydrochloride (HCl) (was in fourth grade, around 4 years ago) taken for attention deficit disorder from an unspecified start date and ongoing; guanfacine HCl extended release (was around 3 years ago) taken for an unknown indication, from an unspecified start date and ongoing; montelukast (about 4 and a half years ago) taken for preventing seasonal allergies, from an unspecified start date and ongoing. The patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 18May2021 (in the afternoon) as dose 1, single (at the age of 13-years-old) for covid-19 immunisation and was good after that. Mother stated that doctor, did not want patient to get the Covid vaccine. On 09Jun2021around 18:00 hours, patient had the second dose, and he was good for a few hours, but around 21:30 or 22:00 hours, patient started having a headache that night and headache was on and off. On 10Jun2021 (the next day), when patient woke up, he felt alright, but in the middle of the day around 15:00 hours, his blood pressure was 127/90 and his heart rate was 111 and he was feeling weird and needed to lay down and on the same day around 23:00 hours, events resolved completely. On Jun2021 (5 days after the vaccine), patient had local redness, where the vaccine was injected and also had a little bump/right arm, swelling, redness, rash, bump, at injection site and after he went out in the sun and went outside, the redness was circling his arm. Mother stated that patient did not tell her and then by Friday (11Jun2021), patient had a red rash, and she gave him antihistamine pills and pills helped a somewhat. Mother was not sure if the rash was from the heat or the sun. On 14Jun2021 in the morning, around 10:00 or 11:00 hours, patient had a big red circle, on his arm and it was persisting. Patient had no emergency room and physician office visit. No relevant tests were performed. The patient had not recovered from his arm had swelling and redness/Right arm, swelling, redness, rash, bump, at injection site, after second vaccine and recovered from other events. Information on Lot/Batch number has been requested.

Rash on legs and tops of feet that ended up in broken blood vessels (on tops of feet) . Thought it might be related to sun exposure, but went to specialty doctor who recommended blood work done. When that came back as normal, doctor said it may be due to reaction from vaccine. Took antihistamine for several days and the rash and itching has gotten better. The doctor thought it could possibly be a reaction to the second dose of vaccine and urged us to report it.

Fever, vomiting, rash, hepatitis with direct hyperbilirubinemia, acute kidney injury (resolving) Amoxicillin for strep throat, IVIG for possible Kawasaki disease,

Severe headache, 10 days after vaccination he started having a rash at the injection site. Soreness in the arm, chills, fever, fatigue.Took tylenol.

I took the first dose of the vaccine( lot numberEW0196 ) on 06/16/2021, and the second dose (lot number FA6780) on 07/07/2021, The injection site started to swell and be very painful and the lymph nodes under the armpit were very swollen and painful, I also had tiredness and a headache, and I don't really get headaches. The whole left arm was also very painful. This lasted for two and a half days.

Three days after the 1st COVID shot, the patient developed a rash on the inner side of elbow on the left arm. The rash developed into blisters, serum/clear liquid bumps, and formed scars after bursting. The rash gradually increased in surface area as it progressed, and would itch after exercise. The patient took prednisone and amoxicillin, and as of today the affected area covers most of the upper arm, although it itches less than before.

36hr after first Covid vaccine, developed urticaria multiforme; diffuse head to toe pruritic rash with welt, wheals, hives, some swelling around hands and feet. Also with cough and headache, no fever.

Hives present within a few hours on stomach, chest and back Were still present 3 days later but did not irritate.

He woke up with chest pain in the upper right quadrant at midnight and then it intensified when he was breathing deep breaths. They woke him up when he was sleeping and did not go away. Then, it continued through the next day and we asked our doctor if we needed to keep an eye on him because of all the reporting and stuff about the heart problems. They did a triage consult visit to see if it could be an adverse event from the vaccine. The course of action was to take 2 ibuprofen every 4 hours and use ice and heat to see if the pain improved to rule out musculoskeletal situations because that was what they thought it was. We did that for 2 days and then the pain moved to his back upper right quadrant and we noticed a rash all over his abdomen and we were not sure where he got that. Based on the fact that the pain moved the doctor was more confident that it was not an adverse event.

Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: swollen, red and warm to the touch

truncal and upper thigh rash - appears c/w pityriasis rosea; small focus, slightly itchy at first after first dose, resolved/improved and then spread rapidly after second dose

2 weeks after the 2nd shot (6-24-21) rash on torso and extremities. treated with oral antihistamine and oral steroids per the pedatric doctor. After 2 days of the oral medication it got worse. went back to pediatric doctor and was referred to dermatologist who prescribed a topical steroid and 10 mg of zyrtec and after a week and a half the rash is not better. This is still ongoing and very frustrating. Called my local health department and was advised to contact an allergist-immology doctor and report to CDC. will be calling today. It has now been over a month since this started.

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: Chills-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Additional Details: Patient fainted shortly after receiving dose one of Pfizer vaccine. Parmedics came, and monitored vitals. They felt his faining was the result of a Vagal nerve response. His mom later explained he often is nervous about needles, receiving shots. I spoke with mom and dad, and let them know I'd be reaching out later in day to check on Patient and submitting the VARES,

Patient showed red rash on the injected arm. The rash was warm and a little raised. Patient said he feels fine but his arm just feels really warm. We administered 10 mL of children's Benadryl and applied a cold pack to the site of the rash.

Heaviness and discomfort left arm. Little bit of pain in the vaccinated area. July 27 2021 he said he was cold and axillary temperature was taken it was 37.66 Panadol was given and cream was applied on vaccinated area for discomfort. Since it is the first reaction and is early morning and is not a complication at the moment he will continue under my observation and then I will call his doctor.

Pt.'s states that after receiving the 2nd dose of Phizer 07/23/2021, starting to develop a rash on the right side of the neck presenting 07/26/2021. Pharmacy recommended use of Benadryl.

At 0950, client requested assistance from emergency medical technician (EMT). EMT?s responded and brought gravity-chair. Client reported feeling dizzy, nauseous, blurry vision, and hard of hearing. Client was assisted into gravity chair. EMT obtained vital signs at 0954: blood pressure 110/78, heart rate 67, oxygen saturation 97%, respiratory rate 18, alert & oriented x4, skin was warm and dry to touch. Registered Nurse (RN) was alerted and assessed client. Client?s father accompanied client and reported client had no allergies or chronic conditions. Client is not taking any medications. Client reported eating cereal for breakfast. RN provided vaccination education and was encouraged to follow-up with primary care provider to report the reaction and to complete the survey on VSAFE. Vital signs at 1002: blood pressure 108/78, heart rate 71, oxygen saturation 99%, respiratory rate 20. Client reported symptoms decreased to a ?3/10? from a ?10/10?. Vital signs at 1007: blood pressure 112/68, heart rate 80, oxygen saturation 99%, respiratory rate 16. Client reported symptoms mostly resolved. Vital signs at 1014: blood pressure 108/70, heart rate 81, oxygen saturation 97%, respiratory rate 18. Vital signs at 1024: blood pressure 102/66, heart rate 65, oxygen saturation 99%, respiratory rate 18. At 1030, client stood up from gravity chair unassisted and walked out of vaccine site unassisted with steady gait.

Pt developed white spots on left arm below the immunization site. Pt felt a little itchy. 25 mg of Benadryl given with no change in spots. Pt reported being a little less itchy. No trouble breathing or swallowing. No obvious swelling.

59kg 14 yo M with NKDA and PMH of headaches had a syncopal episode after receiving first Covid19 vaccination in left deltoid at 1458 5/14/21 (lot # EW0179) . Patient described feeling light headed and does not recall losing consciousness. Fell face side down and had trauma of right knee and nose and above the left eye. Bruising on his nose. Reportedly hit the metal base of the curtain that separated the vaccination area from the observation area. EMS called for concern of facial fractures. BG 98/48 and HR 75 with O2 sats 99% post event. EKG negative. BG within normal limits. Patient did have sustained loss of consciousness. Followup BP 101/69 with HR 77. Event attributed to vasovagal reaction.

Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: 3 "injection marks" at sight-Mild, Additional Details: took off bandaid and saw 3 injection marks, as if pharmacist had tried to give shot 3 times? pharmacist made comment of "wow you have tough skin, you bent my needle" which worried father and led him to checking.

He noted his skin was sensitive/tingly in his trunk/abdomen and that he felt a little achey when he woke up yesterday morning (5/17/2021) but nothing severe, I just assumed is was post injection soreness, he also had some left arm soreness about 18-24 hours post injection. Around 5pm yesterday (5/17/2021) he has sudden onset of fever (103 degrees) and he had just been checked for volleyball practice at 2:30pm and was afebrile. Fever continued through the night between 102 and 104 with Tylenel every 4 hours and one episode of Ibprofen. Fever down to 99 degrees by 7am this moring (5/18/2021). Did rapid COVID test from drug store and was negative. Pediatricians office said to monitor through day, call back if high fever returned and to notify VAERS.

Time to onset: 6 hours. Patient developed full body hives, severe congestion, lip, tongue, throat, and eye swelling. Wheezing. Difficulty swallowing. Treated with Claritin 20 mg po, Benadryl 25 mg po, albuterol inhaler 2 puffs, prednisone 50 mg po, and Asmanex 2 puffs. Within 1 hour hives and lip swelling began to resolve. 1 hr after taking prednisone, tongue and eye swelling resolving. As of 740 am on 5/19/21, hives resolved. Only continuing sx was mild throat swelling sensation.

Patient developed maculopapular uticarial rash day of vaccine that started on his lower extremities and progressed over a few days to include part of his trunk and his proximal upper extremities. Parents gave benadryl at home. It began to self resolve 5 days after vaccine, with complete resolution on day 6 after vaccine. Additionally, on day 5 following vaccine, the patient had one, isolated, episode of chest pain and SOB that lasted 2-3 minutes. Patient believed he was having a panic attack. Patient's mother took BP during event which was 190/95. Patient subsequently brought to ED where all his vitals were diffusely within normal limits including BP. No persistent chest pain and physical exam unremarkable. Troponin was obtained in ED and found to be elevated at 1951. Patient was admitted, troponins were trended, and patient remained in stable condition without further adverse events, and was subsequently discharge home with diagnosis of suspected myocarditis.

05/17/21; Patient attended school, orthodontist, baseball training and practice. Mother picked patient up from baseball practice at approximately 07:30pm and both of patients legs were a pale pink color and developed into a deep red over the next hour. Patient started developing hives that were itchy, red, and uncomfortable, "all over body" per Mother. Mother states hives were mostly on his trunk, both legs down to calf/shin area, thighs, both arms (notably more irritated on the same arm where patient received injection). Mother took patient to the Emergency Room between 9:30-10pm. Patient was seen by ER Physician, who stated rash did not appear to be poison ivy, mother denied any recent changes in laundry detergent, soap, lotion, etc. ER Physician informed mother and patient that he thought the reaction was to the COVID-19 vaccine and advised against receiving the 2nd dose. Patient was prescribed 40mg Prednisone for 8 days, and mother is giving patient Benadryl as needed.

Patients mom stated her son got the vaccine on Tuesday 5/18/21 and about 4 days later he ate seafood and then started to get an allergic reaction about 2 hours later. Patient started to feel that his lips swelled up along with a rash all around chin, neck and around mouth, on forehead between eyes. He took Benadryl which helped symptoms subside. He also complained of a little chest pain that lasted less than an hour but no shortness of breath. As of Monday 5/24/21 he feels fine no other symptoms. No c/o fever, fatigue, nor headache, body aches. Pain at injection site from vaccine was also reported but that subsided.

NECK, BACK, CHEST AND NECK HIVES + ITCHING WITHIN FEW HOURS OF RECEIVIING PFIZER COVID-19 VACCINE. SYMPTOMS PERSIST AS OF 5/26/21 WITH MINIMAL IMPROVEMENT. PREDNISONE TREATMENT STARTED 5/26/21.

Patient developed fever, starting low and increasing to 102.1, as well as feelings of hypersensitivity in his skin, chills and extreme fatigue about 20 hours after his first dose of Pfizer. Symptoms resolved by the following morning - lasted about 18 hours.

The day after his first Covid-19 shot, patient complaint of itchy face. No swelling, no rashes, no difficulty breathing. Mild and lasted 2 days. On 3rd day after the vaccine, symptoms resolved.

Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium

6/2, complained of feeling hot and sick, no fever. Joint aches and leg weakness 6/3 had a strange bruise like spot on the back of his neck. Continues leg aches and weakness 6/4 had a strange bruise like spot near corner of mouth. Neck was better though. Never pain at the bruise like spot sites Spot on face is fading, but still present on the face as of today. All other symptoms resolved besides the spot on his face

Pain at injection site, painful/swollen lymph nodes under arm (injection arm). Complaints 2.5 days later of acute stomach pain, and swollen lymph nodes persists. Complaints of severe headaches since 6 hours after second injection and fatigue.

2nd dose was on Saturday at 10a. Felt body aches and headache that evening and the next day. Arm was sore at the injection site. Treated with ibuprofen (400 mg). Was able to go to school on Monday. Tuesday morning at 3a woke up not feeling well with chest pain and headache. Treated with ibuprofen. Still felt a little unwell in the morning, but by afternoon was feeling normal.

2 days post vaccination patient developed hives--parent treated with Benadryl, 3 days post vaccination--patient's finger began swelling, worsening symptoms over following 4 days included increased difficulty walking (started with a limp), diarrhea, extreme pain with inability to walk Patient went to ER--admitted and given IV Toradol

-Large red blotch on neck immediately after injection; resolved within 20 minutes, no shortness of breath or other signs of allergic reaction - Extreme fatigue next day (slept 15 hours) - diarrhea (moderate, x4 day on Day 2 and Day 3 after injection ) - stomach/abdominal cramps - feeling unwell day of injection, and on Day 2 and Day 3 after injection - headache - feeling hot (but no fever) - severe arm pain (injection site) - no appetite Note: it is now the end of Day 3 after the vaccine, and my son feels well.

He started taking Giferan gel - for acne - it dried out his skin - he started using this a week before the vaccine; on the 31st - rash around his mouth - it was getting red and crusty and looking abnormal - called the Intertrigo- bacterial infection. Put him on antibiotic cream - Mupirocin 2 % ointment. Five day treatment It's resolved now. Dermatologist: dermatology is where we went and he saw a PA.

Chest pain started on the day of the 2nd dose along with chills, myalgias and 'tactile temp'. The other symptoms resolved but the chest pain persisted. Worse with exertion, and also worse with leaning forward and also lying flat. Went to PCP who drew troponin, which was elevated, sent the pt to the ER. Troponin was elevated in the ER, ECG was normal, echo also normal. Admitted for trending of labs, work up for infectious causes of myocarditis sent. cMRI showed LGE in small area of the inferolateral wall of the LV. Symptoms resolved with Tylenol prior to arrival at the ER, discharged after ~24 hours observation on ibuprofen RTC with close follow-up planned. Restricted from strenuous activity.

According to the patient's parent, he received Pfizer dose 2 on Sunday afternoon 6/6/21 around 12-12:30pm and woke up Monday morning 6/7/21 w/ redness, hives, facial swelling, hand swelling, and then the patient became pale and fainted. No vomiting or diarrhea. He was taken by ambulance to the Emergency room where he received epinephrine x1 and Benadryl PO after which he improved.

Intense pain at injection site. Site is red and swollen on 2nd day. Extreme tiredness and feeling of being sick

rash on face and body that began the day after the 2nd shot. Treated with hydrocortisone and Sudafed. Pediatrician then ordered rx cream and 5 mg of Zyrtec 2 x's a day

Patient received vaccine at 11:14 and had an episode of syncope of at approximately 11:20. Patient received a laceration on his chin approximately 2 cm in length. He was rolled on his back and left supine, direct pressure was placed on the laceration until EMT arrived. Patient's mother denied EMT transport and did transport the patient to the Emergency Department for assessment.

shortness of breath; hives on nouth; throat swelling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 (Batch/Lot Number: ew0177) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Concomitant medication included fluticasone propionate (FLOVENT); montelukast sodium (SINGULAIR); and cetirizine hydrochloride (ZYRTEC) and METHYLPHINATE. The patient previously took peanut, tree nut, coconut. The patient experienced shortness of breath, hives on mouth, throat swelling, and dizziness all on 19May2021 14:00 with outcome of recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment antihistamine was received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.

3 days after the vaccine patient developed urticaria on groin, legs worse next day the spread all over body treated with claritin and benadryl and topical steroid then all over him for 4-6 hours then resolved

1258 Called to lobby. Pt pale, diaphoretic, and having tremors of extremities. Per mom he does this with vaccines. She did not say anything thinking it was psychological and if she did not mention it he would be OK. C/O dizzy. Transferred by parents to wheelchair then to treatment room. Two person standby assist to treatment table and lying in supine position. Verbalizes had not eaten and feels better lying down. 1300 VS 117-67 HR 76, Resp 14, O2 sat 97% room air. 1314 Skin color improving. Skin dry. Assisted to sitting position. 1315 VS 116/71 HR 71 R 14 O2 sat 98% room air. Dad assisted with ambulating to lobby waiting area. Instructed to sit for 20 min and will reassess. If dizziness returns to not stand up and let parent know. Verbalizes understanding

About 36 hours after vaccine was administered, the area around the site became reddish and painful, like a bruise (not like a rash).

Noticed rash 6/9, getting progressively worse. Took to urgent care 6/10. Neck swollen and bright red 6/11.

COVID vaccine (Pfizer) given 5/13/21 and 2nd vaccine given 6/3/21. Both given in L-upper arm. No urticaria after 1st vaccine. Initially after 2nd vaccine he developed symptoms of tired, fever Tm 101.1 F, upset stomach, headache, body aches, chills and sensation that arms and legs were "numb" about 12 h after vaccine. The "numb" sensation lasted 30 min and no longer present. Denies enlarged lymph nodes, extremity edema. No hx/o COVID in the past. Went to Urgent care on 6/7/21 due to full body hives, so given benadryl and topical steroid triamcinolone. It continued to worsen during the day so taken to ER later that day and given Pepcid, steroid IM and benadryl. Discharged home on PO prednisone 20mg x 5 days. No Epi was given. Given benadryl every 6 hours and by the 4 hour mark it would come back. Given zyrtec twice daily 10mg/dose on 6/8/21 evening, 6/9/21 BID. Overnight didn't wake him for benadryl (last dose 8pm). On 6/10/21 given steroid, pepcid and zyrtec and seen by PCP in clinic for ER follow-up. No hives present on exam on 6/10/21 (present the night before). Hives would fade and then come back and were migratory. Hives were pruritic. Also used calamine. Once his lips were swollen, but denies any tongue swelling, itchy throat, cough, wheeze. Denies N/V/D. Mother cooked with a new crock pot seasoning at Farmer's market used at dinner the night before the hives developed. Also had strawberry short cake for dessert the night before. The day he had hives he also had strawberries and complained of stomach pain after eating them. No hx/o strawberry allergies or food allergies in the past. No knew meds, detergents, lotions, soaps prior to hives. No recent illness.

Approximately 48 hours after shot hives appeared on arms. The next day they were larger and are on neck, arms, torso, and legs.; This is a spontaneous report received from a contactable consumer (patient). A 14-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COIVD-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in arm left on 27May2021 at 13:15 (at the age of 14-year-old) as single dose for COVID-19 immunisation. Medical history included Wolf Parkinson White syndrome, ADHD, ODD, mold allergy, pollen allergy and pet dander allergy. Concomitant medications included atomoxetine hydrochloride (STRATTERA), fluoxetine, montelukast and hydroxyzine. Patient was not diagnosed with COVID prior to vaccination and was not tested for COVID since the vaccination. On 29May2021, approximately 48 hours after shot hives appeared on arms, the next day they were larger and are on neck, arms, torso, and legs. Patient did not receive any treatment for the adverse event. The outcome of the event was resolving.

He had soreness at the site, he is extremely tired and fainted upon standing. He additionally has a headache and is clammy/sweaty.

Extreme hives aAll over body extremely painful feels like getting bit by a whole bunch of fire ants really bad red v hives

Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe

2 days following vaccine, noted petechiae so platelets drawn and 2,000. Received 5 day course of Prednisone x2, then developed a nosebleed unresponsive to a third round of steroids requiring admission for IVIG. There is a possibility that he has some prolonged mucosal bleeding 2 days prior to the dose when he lost a tooth.

itchy rash resembling pityriasis rosea and diagnosed as such by me, sudden onset itching at 36 hours after vaccine with progression of rash from buttocks to all over the trunk and extended to neck and extremities after 1 week

Patient started with facial flushing at about 5pm which progressed to swelling of the face and right lower eyelid and left ear, flushing of chest, patient began scratching. NO RESP symptoms, patient was happy, laughing.

My son experienced severe bruising about one week later after receiving his Pfizer vaccine. My son right arm was very sore as well. He also had little bumps, petichae all over his body. He still has the bruising and he had a sore, scab where he fell down before the vaccine and he could not stop the bleeding at the site. I took him to ER, performed a complete blood work and platelet count. On 06-22-2021, his platelet count had dropped to 15,000. The ER did not admit him and we had to go back to the ER last Thursday 06-24-2021 and his platelet count 13,000.

Pt developed rash within a few hours of receiving the vaccine; it has spread over his body and persists after 20 days; it is pruritic but not painful, it is blanchable and no systemic symptoms

Patient received vaccine together with his family (he was 3rd out of 4). He said the shot hurt. After all were vaccinated, he said he felt weird. I had him sit for monitoring with his family. His parent told me he still felt weird, and that they walked around the store, but now he has a bad headache and feels a little winded. I had him sit in the immunization room with mask off for further monitoring. After a few more minutes, he said it felt like he was suffocating. I administered 1 Epi-Pen at 10:08PM in his left thigh and called an ambulance. Soon after, he was shaking/shivering, but said it was getting easier to breathe. EMT arrived shortly after, noted the hives on his back, and took him to the hospital.

Developed mildly itchy, raised red plaque around 3 - 4 cm in diameter, treated with cetirizine and topical diphenydramine and seems to be resolving over 1 week

Broke out into rash (red, bumpy and itchy) on right arm that was moving towards injection site - on the 23rd. We saw the doctor and they gave him Triamcinolone cream - 0.1% cream - twice a day and the rash is almost completely gone now. He started that on the 25th - the rash had moved over to left arm on the 25th.

The patient presented on 6/22/2021 with bruising to the lower extremities and longer than usual bleeding from a cut he had on his right leg. The patient had a CBC done and showed he had thrombocytopenia with a platelet count of 15,000. He was evaluated by hematology and the CBC repeated and showed platelet count was indeed very low at 13,000. He was diagnosed with immune thrombocytopenic purpura. No treatment was given, observation only. Patient had Covid antibodies performed and on 7/1/2021 he had a positive IgM antibody to COVID-19 and a negative IgG antibody to COVID-19. He was ANA negative. His platelet antibodies were positive confirming the diagnosis of autoimmune thrombocytopenia.

Patients eyes rolled back, turned very red, and his arms became rigid for about 30 seconds, then he passed out. He came to about 30 seconds later. We called 911 - paramedics assessed the patient and concluded that he was feeling ok.

Patient received 1st Pfizer vaccine on 6/18/21 then 5 days later developed freckles/dark spots on both hands and arms that have not gone away as of today 7/9/21 when he comes in to get 2nd Pfizer dose. He and his sister both developed these spots at about the same time and in same areas of arms and hands. Concerned 2nd dose will make it worse and if and when it will go away.

Patient stated he started to feel itchy about 7 minutes after shot was administered. Stated his neck and upper arms felt itchy. Patient was given 25 mg oral Benadryl, observed for 23 additional minutes, and left the pharmacy feeling well. No visible redness was observed by responding RPh

My son was given the Pfizer Vaccine on 6-24-2021 and a few days later his back being having involuntary movements (spams) and than he told me a day or so later his left arm where he had the shot started to have involuntary movements as well. On Sunday July 11th I noticed his arm jumping and I asked him why is he jerking his arm he said it?s doing it on it?s own. I scheduled an appointment for him to be seen by his doctor. He was seen on July 13th, they saw him and gave us these forms to fill out and asked us a series of questions. He was scheduled to take the second dose of the Pfizer Vaccine on July 15th but I will not take him until I?m sure this is not a side effect of the Vaccine. Any information would be very helpful.

After about 15 hours, my son was experiencing injection site pain, was feeling tired, had a mild headache, muscle pain (mostly in his legs), some mild chills, some joint pain, arm pain, feeling "unwell", and was running a fever of approximately 100 degrees. After 24 hours of rest, drinking water and Gatorade, and three doses of over the counter Acetaminophen (one full adult dose followed by two half-doses) he awoke the next morning feeling much better. He continues to do well as I am writing this, which is now 50 hours since the injection.

Client reported "burning" in his arm around the vaccination site immediately after receiving the COVID vaccine. The client reported "numbness" around the deltoid where he received the COVID vaccine. No noted redness or swelling around the site. At 1:35PM the client reported a headache, stomachache, and left arm pain from his elbow to shoulder. The client described the arm pain similar to sore muscle pain. The client denied any s/s of anaphylaxis. The client stated "I feel the food in my stomach." Vitals obtained at 1:38 PM were as follows BP 141/84, HR 95, and O2 98%. The client stated he went to bed at 2:00AM last night and did drink water this morning. At 1:40PM the client requested, was provided, and began consuming a snack and juice. At 1:48PM the client said, "I feel good." Vitals obtained at 1:49PM were as follows: automatic BP 172/73, HR 95, and O2 98%. Noted the automatic BP cuff was placed incorrectly. Repeat automatic BP obtained at 1:532PM was 151/82. At 2:03 the client reported that his arm was still sore but his headache was improving. The client denied any dizziness, nausea, or chest pressure. Vitals obtained at 2:03PM were as follows: automatic BP 162/83, HR 90, O2 97%. At 2:07PM education was provided to client and his mother regarding elevated BP, s/s of anaphylaxis, when to seek EMS. The client and his mother voiced understanding of this. The client stated that he felt nervous. Recommended the client and his mother follow up with PCP regarding elevated BP. Client's mother voiced understanding of this education. Assessed upper extremity strength, which was equal bilaterally. Assessed facial nerve function which was equal bilaterally. The client denied any shortness of breath, dizziness, or itching. Examined the vaccination site, and noted no redness or swelling. Manual BP obtained at 2:09PM was 150/86. Vitals obtained at 2:24PM were as follows: manual BP: 150/78, HR 86, and O2 96%. Offered to call EMS to evaluate the client. The client's mother declined EMS at 2:29PM.

Dizzy; Heart palpitations; Difficulty breathing/ he couldn't breathe/his throat started closing up; Allergic reaction; Swollen throat and tongue/ his throat was swollen; Swollen throat and tongue/ his tongue was swollen; Hives all over his body; This is a spontaneous report from a contactable consumer (parent). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187), via an unspecified route of administration on 29Jun2021 at 09:40 (at the age of 14-year- old), as dose 1, single in left arm for COVID-19 immunisation at pharmacy. The patient's medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccine on the same date of the Pfizer vaccine and no other vaccines were taken within 4 weeks of COVID vaccine. On 29Jun2021 at 09:40, right after the first dose of vaccine, the patient experienced allergic reaction and had swollen throat and tongue/his throat was swollen, difficulty breathing/he couldn't breathe/his throat started closing up, hives all over his body, and heart palpitations; all for a duration of 1 day 14 hours and 20 minutes. On 30Jun2021, 14 hours and 20 minutes after the administration of first dose of vaccine, the patient was dizzy, for a duration of 2 days. Later, the patient felt better. Treatment received included Epi Pen. Reporter stated that the pharmacist called the ambulance and took him to the Emergency Room for Pediatrics where he received Benadryl and something else for his breathing. Adverse event resulted in visit to emergency room on 29Jun2021 and physician office for allergic reaction. The clinical outcome of the event dizzy was resolved on 02Jul2021 and clinical outcome of all other events was resolved on 01Jul2021. Follow-up attempts are completed. No further information is expected.

Patient received his second dose of Pfizer Vaccine, Lot number, EW0179 at about 10:05. At approximately 1030 the patient developed a small hive on his left upper arm without any congruent signs or symptoms. Patient brought back to the observation unit. VS stable, 10:33 BP= 125/85 O2= 100% 97.9F R= 12 Temp= 98.9 F Lung sounds clear, no stridor indicated. Dr. Notified. Verbal order for 25 mg of Benadryl obtained and administered at 1040. 10:55 VS remain stable 110/67 100% on RA 95= pulse 99.3 F Resp=14 Patient denies any further symptoms Hives are dissipating. Lung sounds remain clear. 11:10 BP= 108/63 HR=97 O2=99% Resp=14 Temp= 99F Dr. updated. Requests for patient to be observed another 30 minutes. 11:40 Follow up VS stable BP 101/70 O2= 99% P=90 Temp = 99.1F Followed up with Dr. who cleared the patient to go home. Advised the parents to bring the patient to the ER if the patient develops any further allergic or anaphylactic symptoms. They verbalized understanding.

The patient broke out with hives on 7/ 22/2021 associated with itching. No breathing difficulty or wheezing. No fever, no body ache

Shingles outbreak on right side of head above right eye with pain; pain; Headache; Fever; This is a spontaneous report from a contactable consumer or other non-health care professional, the patient himself. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182) via an unspecified route of administration on 27May2021 (age at vaccination: 14-years-old) as dose 1, single for covid-19 immunization, at Pharmacy or Drug Store. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies were reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included as the patient received medications within 2 weeks of vaccination reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021, patient experienced shingles outbreak on right side of head above right eye with pain, headache and fever. The events were reported as non-serious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient received treatment for the adverse events which included Valacyclovir, Prednisone, Ibuprofen and Tylenol. Patient underwent lab tests with nasal swab for Sars-Cov2 results negative on 02Jun2021. The outcome of the events was not recovered at the time of report. Follow-up attempts are completed. No further information is expected.

Concern for a possible post-vaccine MIS-C-like inflammatory reaction Symptoms at presentation included intermittent fever and hives-like rash x 5 days, conjunctivitis x 1 day, and lip erythema x 1 day.

Eczema, worst breakout ever. Big red patches of blisters and pus. Took several days to clear with topical medications.

Developed a rash on the face; Rash has now spread on the face, behind the ears, neck and on the stomach, rash did not itch; He has no itching its just bumps; This is a spontaneous report from a contactable consumer (patient's mother).A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization.The patient's medical history and concomitant medications were not reported.On an unknown date, after 10-15 minutes of vaccine administration, the patient began having a rash on his face. It was reported that the rash had now spread to most of his face, behind his ears, down his neck, on his stomach and sides. The rash was not itchy, it was just bumps and was not bothering him, he felt fine. He was doing everything like normal and eating junk food, everything that a age boy would normally do. She asked if it was safe for him to receive the second dose of the vaccine since he had this side effect. The outcome of event was unknown. information about lot/batch number has been requested.

low grade temp 4/28, tylenol x 2 doses, shingles rash on rt forehead, onset 4/30/2021 seen by me 5/3/2021, rx valtrex

Patient feel dizzy, light headedness, vision changes, observe peel, muscles relax. Did not loose consciousness during brief event, was alert and oriented there after. Escorted by nurse and family member to observation area. observed for 30mins.

First day 20 min after injection: big hive at injection site Day 2: big rash on both forearms + face Day 3: Rash on forearms (gave benadryl) Thinking no 2nd shot based on these daily reactions

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt hypotensive after vaccination bp 52/36 hr 57-Medium, Systemic: Hypotension-Medium, Additional Details: blood pressure normal upon departure 103/77

Patient is a 15-year-old, male. Alert, oriented X4, clear speech, able to answer to questions. No known medical history. History of anaphylaxis twice in past, requiring the use of epinephrine. History of allergies to peanuts, animal hair, and grass. At 11:43 am, the patient received his first dose of Pfizer (lot number EW0185, expires on 08/2021) on left deltoid. Patient walked with a steady, balanced gait to EMT observation area. At 12:00 pm, patient's mother notified EMT that patient had blotchy redness in left hand. Lead RN responded immediately and assessed the patient. Upon observation, the patient had localized redness at the injection site, with erythema on the entirety of his back and hands. Patient was assisted patient to anti-gravity chair. Patient states he feels "tingling" at injection site. Patient denied SOB, itching, and dizziness. Patient remained A&Ox4 and talking to EMT. RN requested vitals Q5 minutes for 30 minutes while she drew up 1.0 mL of IM Benadryl. At 12:02 pm: BP of 108/70, HR 78, SPO2 98%. At 12:08 pm, the redness and rash on patient's arm and back had completely subsided. Patient denies feeling tingling sensation at injection site. At 12:10 pm: BP of 110/67, HR 75, SPO2 99%. Patient's mother declined use of IM Benadryl. Lead RN education patient and mother on signs and symptoms of anaphylaxis, and requested the patient stay for an additional 20 minutes for monitoring. RN disposed of 1.0 mL dose of Benadryl. At 12:18 pm: BP of 110/70, HR 79, SPO2 99%. At 12:26 pm: BP of 108/70, HR 82, SPO2 99%. At 12:37 pm: BP of 106/70, HR 85, SPO2 97%. Lead RN provided patient's mother with education concerning when to call 9-1-1, including worsening of symptoms and trouble breathing. Patient was instructed to follow up with PCP and allergist. At 12:40 pm, patient stood up from chair, denied lightheadedness and dizziness. Patient walked to car with steady, balanced gait. Patient's mother drove patient home.

Many small red hives on the upper lip inside the mouth. Pain when making movements in the area of the condition.

Pt received vaccine in R arm at approx. 3:45 PM and was advised to wait in observation area for 30 minutes due to patient history of having multiple allergies. At approx. 4:15 PM pt alerted observation RN of a single isolated raised bump on R arm located approximately 4 inches away from vaccination site. Raised bump is noted to be 0.5 square inches large with surrounding redness. Pt denies any itchy, irritation, to the bump and otherwise reports no symptoms. Pt advised to stay in observation for an additional 15 minutes. 3 RN skin check of his chest, back, and abdomen revealed no other bumps or redness of any kind. Pt discharged at 4:35 in his mother's care. Pt and pt's mother advised to go to urgent care/emergency room in the event that any further reactions occur while at home.

pt c/o itchy throat and pain at injection site(left arm) PS 4/10 with throbbing pain noted. Advised pt. to keep moving arm. 5:32 pt. given benadryl 25mg 1 tab for itchy throat and sips of water given v/s monitored 5:20pm vitals 134/70 bp 18 RR P-70 99% o2 SAT pt. verbalized feeling anxious.Advised to do breathing relaxation. 5:35pm vitals 126/70 P-68 RR-18 o2 99%RA pt reported with no relief from symptoms still noted with itchy throat , no SOB pt alert and verbally responsive. patient was advised to go to urgetnt care/hospital for further eval. 6:10pm pt guardian mother will accompany the patient to hospital /urgent care

Scattered 5-10 mm urticaria which came in clusters of 10-15 lesions. The entire crop covered an area of perhaps 10x20 cm. The first crop started around injection site and resolved after one day. Each subsequent day, a similar crops developed and resolved. These happened on the contralateral forearm, and face. No new crops developing as of follow up call on 5/20/21. OTC Benadryl PRN itching.

Developed itching of scalp 2 hours post injection, spread to arms the next day. 3 days later developed hives over her wrist and knees. On day 4 hives worsened, and experienced brief (~1hr) period of chest heaviness that self resolved. Treated with Zyrtec which helped itch for a day. Benadryl not helpful. Day 5 woke with morbilliform rash over trunk and fever to 101.9, lasted a few hours, all symptoms resolved over the course of day 5.

At time of injection, patient seemed tense and told his dad he was dizzy. Vaccinator noticed "clenching of the muscle" and thought they saw a hematoma bump when the muscle clenched. Gave patient apple juice and let patient rest with father and observed for 15 minutes. Patient and family (father and sibling) left pharmacy by walking on their own with no issues

it looked like the blood vessels or veins in the bend of elbow, inside of the elbow that looked like possibly a blood vessels that burst there.; feels sick; his body didn't feel right and he felt that way again yesterday when he felt so bad.; numbness and tingling right arm; tingling/numbness and tingling right arm; rash on the right arm; he has pain and a rash on his right arm; feeling like passing out; dizziness/lightheadedness; nausea; chest tightness/ chest was so tight and pulling.; pain in the arm at the injection site; headache; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 11:15 (Batch/Lot Number: EW0173; Expiration Date: Aug2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 15 years). Medical history included asthma, allergy, acne, pain, Gastroparesis, eczema, red blotches /bright red dots on his whole body and anaphylaxis. Concomitant medications included cetirizine (CETIRIZINE) taken for allergy; beclometasone dipropionate (QVAR) taken for asthma; mometasone furoate (MOMETASONE FUROATE) taken for allergy; isotretinoin (ZENATANE) taken for acne; paracetamol (TYLENOL) taken for pain; sodium chloride (AYR SALINE, both nasal spray and nasal gel) taken for allergy; herbal extract nos, homeopathics nos (SIMILASAN) taken for allergy, all are ongoing. The patient previously took advil [ibuprofen] and experienced anaphylactic reaction (when he was about 4 years old in about 2009 or 2010.). The reporter who is mother of patient calling regarding the Pfizer Covid 19 vaccine. States she wanted to call and report some side effects from the vaccine for her son. Reports he received the first dose of the Pfizer Covid 19 vaccine 14May2021 at 11 15 AM in the upper left arm. He stayed extra minutes after the shot because he had anaphylaxis before and had red blotches before in the past. Reports after receiving the first dose of the Pfizer Covid 19 vaccine, when they got to the car he said his chest was so tight and pulling. That lasted 1 to 2 minutes only on that day (on 14May2021, 12:00). Since then and even on the very first day he has had dizziness; lightheadedness; and felt like passing out (on 14May2021, 12:00). Adds he has been having to go to the nurse's office for headaches for the last two days (occurred on 14May2021). The reporter states her son has been very disappointed and mad at her for making him have the vaccine. Nausea - she adds her son also had some nausea (on 14May2021, 12:00). Right arm - he has pain and a rash on his right arm, the opposite arm from the shot, with numbness and tingling right arm (occurred on 17May2021); tingling. When he went to the nurse someone in that office mentioned that it looked like the blood vessels or veins in the bend of elbow, inside of the elbow that looked like possibly a blood vessels that burst there on an unspecified date. Pain in the arm at the injection site (occurred on 14May2021, 12:00) from the first day that is improved. The patient's body didn't feel right - when they started walking to the car his body didn't feel right and he felt that way again yesterday when he felt so bad. The first day and yesterday he felt his body didn't feel right (occurred on 17May2021, 11:45). Dizziness - is mostly when standing up and is lasting a lesser amount of time and getting better. Feels the sensation of like passing out with the dizziness on standing. Headaches - he has every day but yesterday was terribly bad and today were the worst. The reporter mentions that the patient stated the he feels sick on an unspecified date. Outcome of the events loss of consciousness, dizziness and vaccination site pain was recovering. Outcome of the event chest tightness was recovered on 14May2021 while outcome of the events numbness and tingling right arm was recovered on 18May2021. Outcome of the events pain in arm, vascular injury and malaise was unknown. Outcome of the remaining events was not recovered.

Extremely swollen lymph nodes in the arm pit of the injected arm. Red, hot and swollen. Sore and painful. Last almost 5 days.

Patient's father reported that patient received the second dose of COVID-19 vaccine at a vaccine clinic on Monday 6/7 and noticed a silver-dollar sized area of redness and swelling at the injection site today, 6/9. Denies any other symptoms.

Pt had 101 fever Sunday evening. We gave him 400mg of IBU at 6pm and 500mg of Tylenol at 10pm. His fever was gone in the morning. Monday morning, lymph nodes under his arm were swollen to the size of quarters. Pt upper arm was swollen and red around the injection site the size of a softball. The redness and swelling of the lymph nodes have been slowly diminishing.

PT had his first dose of Pfizer vaccine at 5pm on 21st. He looked low energy at night. We felt his forehead and he was warmer than usual. However, thermometer did not show he had a fever. He looked much better in the morning on 22nd. We thought that was it. Only after a week did PT tell us he had more reaction. However, because he was well then, we did not pay too much attention. When we learned of the link between Covid 19 vaccine and Myocarditis, we asked him in detail again. Here are his responses. He started feeling his throat hurt when he had dinner that around 7pm. It lasted only that night. He started feeling chest pain around dinner time too. It only hurt when he moved. That chest pain lasted longer and disappeared on the 23rd. He started feeling there were air bubbles under his skin on the flat part of his left shoulder (above the injection site and below his neck) on the 22nd. He did not see them. He just felt them. When he pressed them with fingers, he felt them popping. This feeling lasted for a total of three days. He could feel the amount of air bubbles become less over the three days. We have not seen any side effect in the news like his. We are not sure that he should get his second dose. Please someone could advise us, please send us an email. Much appreciated.

This is a 15 year old male without PMHx who presents with chest pain for one day after having Pfizer COVID vaccine 2-3 days prior. As per father patient had first dose without any sx except mild soreness on the site of injection. On 6/9/21 he received the second shot of Pfizer vaccine. That day he only fell mild pain on site of infection only. Next day he suffered from chills, HA, and fever. He took Tylenol for it. The day prior admission he had a mild headache and pain on the middle of the chest, dull, not radiating, and on/off. There was one episode of emesis after dinner and after taking TUMS he went to sleep. The parents check on him through the night and upon waking up he complaint still with chest pain, now increased and radiating to left side of the chest. The parents decided to bring him to ED for evaluation where he was found to have elevated troponins and he was admitted for myocarditis likely secondary to the Pfizer vaccine. His troponins were monitored q8hrs and he was started on Toradol q6hrs. See EKG and Echo results below. Due to increasing troponins 6/13, he was given IVIG with resulting improvement. At this time, we are still monitoring his troponin inpatient with plan for potential cardiac MRI. He will be discharged home on Ibuprofen 600mg TID and follow up with cardiology with exercise restriction likely for a few months, tbd by outpatient cardiology follow up.

Got second dose of vaccine 6/2. Same day had chills, myalgia, fatigue and soreness at injection site. 6/3 developed substernal chest pain and dyspnea. Admitted to hospital for suspected myocarditis given elevated troponin and mildly elevated inflammatory markers 6/4. No treatments given. Symptoms resolved and troponins improved prior to discharge 6/8. He remains well today 6/14.

Mom reports that nurse/vaccine administrator injected son/patient at a higher than usual site on the shoulder and the needle did not go in all the way, in fact of the needle was outside his skin. The skin around the needle puncture "bubbled" up and it caused him pain (more than the 1st dose when he received it). No leakage of vaccine fluid was observed. He had some soreness in the arm. The next day he did develop some nausea, body aches, and slight fever. He is feeling a bit better today (6/14) and only has some nausea remaining. Mom will take him to PCP to evaluate his Left shoulder since it is still achy.

Fifteen hours after the vaccine my son woke up and his respiratory rate was high. It was over 140. I woke him up and he had chills and diarrhea. Because of his Cortisol Deficiency I called his doctor. I was advised to give him 30mg Hydrocortisone and lots of water. His Respiratory and heart rate were high. He was feeling a little short of breath and he had heart palpitations. We went to the ER and they did lots of testing. He had a fever and Sepsis testing. All results were normal and they gave him a Liter of fluids. He was discharged after two hours and his pulse was still high at 105-110. We monitored him and his heart rate was slowing and he started to feel better. His Endocrinologist had him take a double dose of Hydrocortisone the next day. His improvement progressed and by the fourth day the symptoms were gone. He was able to do his normal activities but tired and worn out from the ordeal. One week later he had a slightly elevated heart rate but it resolved quickly. He had had a local reaction in his arm with swelling and a rash after the first vaccine.

On May 24th, 6 hours after receiving first dose of Pfizer COVID-19 shot, patient noted red, itchy hives-rash from neck down to upper legs, covering trunk. No hives noted on the arms. Benadryl administered at full dose (50mg) every 4 hours, requiring 3 doses (12 hrs) before hives subsided fully. No further adverse reactions following that.

With no prior injury toe on right foot became swollen and red, similar to chilblains. Showing signs of improvent as of June 16th.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: patient has history of passing out because he gets nervous according to mom

24 hours after vaccine developed malaise, fatigue, flu-like symptoms including fever to 101.5F. Rash on lower extremities - serpiginous and lacey most consistent with serum sickness like reaction. Rash very classic for this, but unclear if flu-like symptoms and fever were typical immunogenic effects of vaccine vs SSLR. Rash was not itchy and improved overnight prior to clinic presentation on 6/16 (vaccine on 6/14). Took benadryl x 2. Patient well in clinic with no residual fever and improved overall. No treatment given in clinic and no medicine prescribed for home.

6/7 - patient received 2nd dose of Pfizer vaccine. 6/8 - patient developed tactile fevers (for 2-3 days), diarrhea (4-5 days of non-bloody diarrhea) 6/9 - developed chest pain and tightness and mild cough 6/12 - few episodes of NBNB emesis, cough with blood tinged sputum 6/13 - presented to urgent care, referred to hospital and admitted to floor. Patient found to have tachycardia and hypertension. CXR with pleural effusion, renal US with medical renal disease. Worsening renal function and concern for hyper coagulable state with worsening D-Dimer and possible pulmonary embolus but unable to obtain contrast images due to renal failure. 6/15 - transferred to ICU for heparin drip for worsening D-dimer. Nephrology, rheumatology and infectious disease consulted. Continued chest pain, cough with hemoptysis. Remains afebrile and otherwise hemodynamically stable. Started on ceftriaxone empirically. Concern for MIS-C, vaccine related adverse event vs autoimmune vasculitis.

6/12/2021: Nausea, slight fever, dizziness, black outs, fatigue, muscle aches By night time, rashes started appearing all over his body including arms and legs and all over his face. The rashes looks like big blotches/ map looking red marks all over his whole body. His face was all covered with the blotches of rashes including his scalp. He had no fever though. He was breathing normally but the rashes were very itchy. gave him double dose of Benadryl. Then switched to adult Benadryl but still taking double the dose. This went on for 2 days and no sign of improvement despite taking Benadryl every 6 hours. Patient was sleeping most of the days due to the medication. 6/15/2021: reached to Family doctor and explained the situation. doctor recommended to go to ER after seeing pictures of the rashes. Patient adamantly refuses to go. Doctor suggested take Allegra on top of Benadryl. Patient took Allegra 24D. Patient mostly sleeping. 6/16/2021: saw some slight improvements. Back and chest cleared of the rashes but still heavy on the arms, most especially the thigh area and legs. still taking Benadryl but only the normal dosage. 6/17/2021: All rashes are gone and cleared/

broke out into hives; throat began to swell; breathing became difficult; anaphylaxis; patient age: 15; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), dose 2 via an unspecified route of administration, administered in left arm on 03Jun2021 14:30 (at 15-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included low growth hormone production, and known allergies: many foods. Concomitant medications included somatropin (NORDITROPIN); anastrozole (ANASTRAZOLE DENK); olopatadine; levocetirizine dihydrochloride (XYZAL); diclofenac sodium, heparin sodium (ALLE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173), via an unspecified route of administration, administered in left arm on 13May2021 17:30 (at 15-year-old) as 1st dose, single dose for COVID-19 immunization. On 03Jun2021 at 17:30, the patient experienced 3-4 hours after dose, broke out into hives. He took benadryl. Throat began to swell and breathing became difficult. He used epi-pen to stop anaphylaxis. The seriousness criteria of the events was reported as life threatening. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events hives, throat began to swell, breathing became difficult, anaphylaxis was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Adverse allergic reaction after approx 24 hours. Entire body erupted with hives that did not subside with 5ml of Benadryl. Visited Urgent Care and was administered Steroid shot. The hives went after 12 hours but another minor allergic reaction occurred after 48 hours but got controlled with another 5ml of Benadryl

Redness and swelling of arm; Redness and swelling of arm; Headache; Chills; This is a spontaneous report from a contactable nurse (patient's mother) reported for son. A 15-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left upper arm on 13May2021 07:20 (Batch/Lot Number: EW0167) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Patient received dose 2 via an unspecified route of administration, administered in right arm on 03Jun2021 07:20 (Batch/Lot Number: ER8736) as 2nd dose, single. Medical history included patient is immunocompromised and oral steroid dependent due to asthma and adrenal insufficiency, ongoing Hypothyroidism Diagnosed about 10 years ago, ongoing Acid reflux Diagnosed since birth, ongoing Adrenal insufficiency Diagnosed about 2 years ago, Asthma Diagnosed since birth, ongoing allergies Diagnosed since birth/infancy, ongoing Pseudotumor cerebri since 2015. Concomitant medications include acetazolamide sodium (DIAMOX) taken for Pseudotumor cerebri from 2015 and ongoing, fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma about 8 years and ondoing, Fluticasone taken for asthma about 4 years and ongoing, Budesonide for Sinus rinse from sinus surgery care about eight years and ondoing, Hydrocortisone for adrenal insufficiency since 16May2021 and ongoing, lansoprazole (PREVACID) taken for acid reflux since 2006 and ongoing, levothyroxine sodium (SYNTHROID) taken for Autoimmune hypothyroidism hashimotos and ongoing. Patient experienced pretty big redness and swelling of arm on 14May2021, and got worse about 2 weeks later, which was odd, like a delayed response. Had headache on 13May2021 around 14:00, lunch and took two regular strength Tylenol and drank water. Classifies as medically significant since patient had to miss two days of school. Other symptoms went away after 24 hours like the chills and normal vaccine symptoms, headache. His blood pressure and all vitals were all normal. The outcome of redness and swelling of arm was recovering but still has faint bruising color, other events outcome was recovered on 14May2021. Information on the lot/batch number has been requested. Follow-up (03Jun2021): New information reported from a contactable nurse (mother) includes: removed event "15 years old patient received t vaccine", add events "headache", "chill", "redness and swelling of arm". Case upgrade to serious.

Patient is a 15 y.o. male presenting for 5 days of symptoms following his second dose of Pfizer SARS CoV 2 vaccine culminating in an urticarial rash which prompted him to present to emergency department. Patient received the second dose of the Pfizer vaccine on June 8 (first dose was administered on may 17 without symptoms). The next day (June 9) he complained of nausea and subjective fever. On June 10 he complained of chest "weakness" and shortness of breath intermittently. He had also mild light headedness but no syncope or palpitations. All those symptoms resolved by June 11. However, he had a diffuse rash on extremities, pruritic, and non-exudative.

Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital, initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen. Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course. Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.

2.5 weeks after second dose. Hives all over body. High tropinin T High sensitivity test. Confusion, dizziness, lightheaded, chills, hot flashes.

Rash on his neck and his face and is raised up; This is a spontaneous report from a contactable consumer (grandparent) reported for a 15-year-old male patient (grandson). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/lot number was not reported) via an unspecified route of administration in the arm left on 16Jun2021 04:15 as unknown, single for COVID-19 immunisation. The patient medical history included allergies and sinuses. Concomitant medications included loratadine (LORATADINE) taken for hypersensitivity, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported and consumer stated it as a mood stabilizer; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported. Consumer stated, he was taking a SSRI. (Later clarified as Lexapro) and asked, whether lot number is, is it EW01. On 16Jun2021 at around 4:15, yesterday, Wednesday, his grandson had the Pfizer COVID shot (Pfizer COVID-19 Vaccine). On 18Jun2021, a day after vaccine administration he experienced a rash on his neck and his face and is raised up and stated, this is probably a reaction not a side effect. It started to appear at around 11 AM clock right when I woke up in the morning and it remained the same still tonight. There is a difference in reaction and the reaction is worse. And asked is this normal to have a rash around the neck and face. No treatment was received. The clinical outcome of the event was not resolved. Information regarding the lot/batch number has been requested.

Body/Joint ache, Red hives, very itchy arms, legs, ankles, swollen face, hands, feet. Injection site stung after shot.

Hives and Chest Pains about 8 hours after vaccine. Went to ER given benadryl, corticosteroids, pepcid. Given a prescription for 4 days of 20mg Prednisone and instructed to take OTC Pepcid if needed. Symptoms resolved after about 3 days

About 25 minutes after vaccine was administered, the patient developed erythematous patches bilateral deltoid muscles, bilateral forearms, upper back, and bilateral shins/ankles. He denied itching. He did not experience any additional symptoms. His vital signs were stable and he was breathing comfortably and speaking in full sentences. He received 25 mg capsule of Benadryl with some improvement seen in rash on arms and shins. He was discharged to home after being monitored in the health center for about 90 minutes after vaccination. Vital signs remained normal. He was accompanied by his mother who was going to be able to watch him closely and with a prescription for Benadryl to take prn every 6 hours. Mom was instructed to call 911 for any worsening including difficulty breathing.

We don't know when the rash actually started on his chest and back but we noticed it around 8pm that same day. We gave him an allergy pill but that didn't really help. We saw an Allergist (6/30) and he mentioned, it wasn't hives but that he would need to research if he could get another shot based on the reaction. After this weekend, Patient said his back would sting when he would get hot so I called back the doctor. On Wednesday, he prescribed Triamcinolone Acetonide Cream. We have used it once so far and Patient's back does look a little better but the rash is still there.

After receiving the Pfizer vaccine at 11:30am patient showed reaction of erythematous on the bilateral deltoid and forearms, bilateral shins and and ankles and upper back. No itching, vitals were normal, no difficulty breathing, and no distress noted. Patient received 25mg of diphenhydramine capsules PO and showed improvement within 45min of additional observation by the provider. Patient was sent home with close observation by his mom educated of signs to report and call 911 on, patient was also prescription Benadryl to take PRN.

The patient was given the first dose of the Pfizer covid vaccine, subsequently he was standing waiting with his mother for his younger sibling to receive his vaccine and after I had administered that, I turned around and saw that he was starting to lean over and his mother and I went to grab him as he went down and he fainted momentarily. We slowed his descent, but he had a small abrasion on his head (I think from the carpet). He said he felt dizzy and nauseous. I'm not sure if he was also watching while I was giving his sibling the shot and that exacerbated the situation. We had him checked out by EMT and he was fine after the initial fainting.

Site: Swelling at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadedness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium

Swollen lip and rash around mouth that developed on the evening that 2nd dose of Covid vaccine was given (i.e on evening of 07/01/2021). Rash and swelling of lips and mouth initially seemed to improve, then worsened again by 07/06/21, at which time medical provider (this writer) was contacted. Rash was itchy. Other symptoms included chills, body ache, headache, and soreness at the injection site. Treated with oral Cetirizine with full resolution of symptoms. These symptoms were reported by parent via online messaging system to patient's pediatrician (this writer).

Patient developed Kawasaki disease like symptoms with fever, rash and large coronary aneurysms. He received IVIG and infliximab treatment. Aneurysms remain large 2 weeks out from treatment.

After vaccination 18 days, I found rashes on his face and back. I am not sure whether it was caused by vaccination .And I am worried whether he can accept the second dose. I tookMy son to see his doctor . His doctor said he can still vaccinate. Before the second dose, no medicine will be taken. So 21stdayafter first, my son got Sencond dose. Rashes more.

Pt was discharged stable after covid-19 vaccine. Pt went home and came back complaining of Rt arm rash and SOB: Dr and RN for triage the patient.

Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt exhibited rash on both arms, that he noticed after 15 min wait, observed pt, rash itch worsened, 50 mg benadryl chewed, within minutes pt complained of facial and mouth numbness/tingling, then a couple minutes later difficulty swallowing. 911 called, 1 dose epipen administered in right thigh. mother did not wait on 911, took son to ER. mother Chambree called to say pt was fine.

The patient had COVID-19 in July 2020. In August 2020, he developed a whole body pustular rash. He was then admitted for an "asthma exacerbation" and found to have hilar lymphadenopathy. He was treated with several courses of prednisone for his asthma during the next few months. Within few days of his first dose of the COVID19 vaccine he developed fever and severe exacerbation of his rash (which thought to be acne at that time) that resulted in hospitalization on 6/7/2021. Interestingly, he received his second dose of the meningococcal vaccine (MCV4P, Menactra, lot # U6877BA) on 6/7/2021. The patient has been treated with antimicrobials (both antibiotics and antivirals, completed course) and high-dose corticosteroids (both oral and IV) and is slowly improving. He has severe skin scarring.

Within 10 minutes, the patient developed one hive with itching on left lower leg. Within 2 minutes, he developed pruritus on arms. No other associated symptoms.