Pfizer

Patient turned pale, felt foggy head, couldn't hear for a while. After laying down and drinking some water he felt better and gained back color.

Patient appear to have a mild seizure (faint, stiffness on the arm that got the vaccine injection, eye rolled) about less than 5 seconds. Patient became fully awake as being put to laying down on the floor. Patient was able to answer to all questions was asked. Patient stated that he was nervous and scared of getting the vaccine. Patient's mother stated that he had fainting history of seeing cut or bleeding. The event occur 30 seconds after received that vaccine.

12 yo male presenting with bilateral lower extremity paresthesias and confusion. Admitted to the hospital. Pending discharge to rehab facility. ED Note 5/19/21 Patient is a 12-year-old male with hypogammaglobulinemia, asthma, IBS who presents with weakness in his lower extremities. 6 days ago, patient had seafood and later that night vomited once, nonbloody, nonbilious. 4 days ago, he received the first dose of the Pfizer SARS-CoV2 vaccination. That day, he also felt some burning over the anterior parts of his bilateral ankles. Over the past 3 days, he has been sleeping a lot and had a headache. He has not had a fever or other muscle aches, no subsequent N/V, abdominal pain. Last night, he reported ankle pain to his mom. Today at school, he was playing kickball when he had the sensation that his ankles were not working/gave out and he fell to the ground. He had difficulty getting up and required a wheelchair. He did not lose consciousness, denied CP, palpitations, SOB, headache, vision change during or before that episode. He was not incontinent of urine/stool and had no abnormal movements noted at the time. Since then he has noted twitching in his thighs, calves and toes. He reports weakness throughout both lower extremities and has difficulty with intentional movements at the toes/ankles/knees, weakness in hips. He reports a burning sensation over the anterior ankles/dorsum of foot b/l. Denies fevers, chills, cough, SOB, CP, palpitations, abdominal pain, N/V/C. He endorses diarrhea 3x daily which is his baseline. He has panic attacks 3x daily w palpitations/SOB that self resolve. He has been on keflex for an ingrown toe nail for the last week. MRI performed with normal brain and spine. However, on repeat exam patient has diminished sensation in the bilateral feet and diminished ability to dorsiflex or plantarflex both ankles with very limited toe range of motion. Still with preserved reflexes in the patella and Achilles. Discussed at length with neurology and the family. Differential diagnosis at this point of functional neurological disorder versus Guillaine Barré syndrome. Neurology note 5/21/21 Patient is a 12yo M with hypogammaglobinemia, IBS, and poorly controlled anxiety, presenting with 4 days of lower extremity paresthesias and 1 day of hyperacute onset of lower extremity weakness and perhaps some mild confusion. History notable for covid vaccine three days prior to presentation and anixety surrounding covid and return to school. His general examination is notable for anxious affect with difficult to localize neurologic exam. Exam shows possible bilateral lower extremity weakness of TA and hamstring>quad/IP that is very challenging to grade due to poor effort and giveway, and decreased sensation in a bilateral stocking/glove distribution to all sensory modalities. MRI w/wo contrast brain and spinal cord normal on admission. LP perfromed in ED also normal. Given negative workup and history of anxiety with recent psychosocial stressors, most likely sudden onset weakness is secondary to a functional neurologic disorder. Plan for discharge to rehab pending PT evaluation.

Patient received IM vaccine, was under observation when felt dizzy and lost consciousness. Spontaneously awoke a few minutes later and was confused, and wasn't able to feel his legs. Confusion resolved after about 5 min but leg numbness/weakness remained. Was taken via EMS to the hospital, with clinical assessment showing no neurological deficit, withdrawing to pain, and patient demonstrated ability to ambulate independently about 12 hours after symptom onset. CBC, CMP, Urinalysis, UDS unremarkable.

PT was sitting with guardian and started to have seizure like activity for him which consists of audible and visual auras and Right arm twitching. This lasted about 1 min. Once we got him into a dark room he started having slurred speech and Left sided weakness that lasted about a min. He was A&OX1. Pt had a right sided slant in his eyes. His pupils were dilated to a 9 and were equal and non reactive. he became sluggish and kept starring off to the right side. This lasted about 2 mins and 45 sec. His pupils returned to 6 and were equal and reactive and he became less lethargic. He started to complain of a head ache. At 1302 he stated that he stated tapping his face and trying to speak. He began to have a right sided glance again and his pupils dilated to an 9 again and we equal and non reactive. he did not respond to his name. This lasted for almost 2 mins. He then stated he was foggy and his pupils returned back to a 6 and were equal and reactive. He was struggling to find sounds in the room. His Vital signs were initial B/p 138/98 resp 22 HR-78. at 1320 his B/P was 128/68 Resp 20 HR 80. Pt was transported by EMS for medical evaluation by his neurologist.

My son developed a fever, brain fog, and his legs felt like they were burning. More worrisome was the heart pain he woke up with in the middle of the night and throughout the day on 5/20. He complained of a sharp stabbing pain on left side of his chest and said it was hard to take a deep breath. I gave him ibuprofen and he rested. I called his doctor and they said not to worry, these side effects were normal. I?m a bit nervous for him to get the second vaccine since he had the chest pain side effects as to why I?m reporting this. I?m surprised they give the same dose to a 80lb child, they do to a 200 lb grown man.

Patient nauseous, vomited and anxious. Patient vitals-BP(120/70), HR(81), Resp 16. Vitals are stable and patient will be transferred via ambulance to hospital with mom.

Next day and every day thereafter he started getting more symptoms of feeling sick. The arm pain began the next day after injection. Followed by runny nose, sore throat, croup sounding cough, shortness of breath, gasping, chest pains, vomiting, back of the skull pain. He described the head pain as a square from the base of the back of his skull to the crown of his head and back down. Felt more like a pressure in the bones of his skull and less like a standard headache. The chest pains are sharp and come on sporadically. At first they were accompanied by hacking cough but then progressed to sharp chest pains at random times especially when lying down. He has difficulty sleeping and staying asleep. Also, lower abdominal pain but no vowel issues.

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.

Nightmare on 6/4, persistent chest pain since 6/5. Pain is 4 on the scale of 10 as indicated by the child on 6/7. Going to see doctor on 6/8. Looks fine though.

Complaining of chest pain/sharp pain, needle pain in his chest/ the patient reported sharp stabbing chest pain more in the right side; Sweating; Felt sick; Diarrhea; Dehydrated; Headaches; Chills; Fatigue/extreme fatigue; A fast heartbeat; The patient reported sharp stabbing chest pain more in the right side, the first time it was more like the sternum.; Vomiting; Nausea; Slept on and off for about 4 days.; His blood sugar spiked up.; Pericarditis; This is spontaneous report received from a contactable consumer (patient mother). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown and Expire Date: unknown) on 22May2021 via unspecified route of administration as 1st dose, single dose for covid-19 immunisation. As medical history it was reported that, he had allergies and allergic to a lot of things, mold, feather dust and everything and dyspepsia. He had been taking Claritin for allergies (but not when he got the vaccine). She stated her son did not have any allergies to medications. Concomitant mediations were not reported. On 26May2021, 4 days after that he was complaining of chest pain. Caller wants to know if her son should get the 2nd dose of the vaccine. Caller stated, "He had other symptoms. On Tuesday the chest pain went away then complained again on Thursday. His doctor gave him an EKG and his heart rate was fine. Caller did not take him to the ER at the time because did not want a medical bill. His blood sugar spiked up. He had sweating, vomiting, diarrhea. He said he had "sharp pain in my chest and never felt that before" His blood sugar spiked up. He was dehydrated. He had ketones from it. Caller gave him extra insulin. He had chest pain from the vaccine. It was on Tuesday and happened again on Thursday but had not come back since then. It subsided. EKG was ok." No one was informed (doctors). I took him to the regular doctor. She did not know. She was not aware of the symptoms. They are not specialized in the medications they are giving. It was hard to give them any kind of referral. Both of us had vomiting, headaches and chills. He had never had chest pains from any vaccines. He had fatigue, these are symptoms form the covid shot. It was 4 days and then 6 days after the vaccine. A fast heartbeat. HCP are not going to help. If they are dosing the covid shots but they are not given the vaccines they did not want to do anything. There was no accountability. Caller having a hard time. No one can give me an answer, no one. Not from the experts, no one was telling me. The vaccine administration should have been through the doctors, they will not take your data without understanding the vaccines. All the kids 12 and up and all male and like my son and probably a lot more but they are not saying it. Caller scared. My son did not have a heart defect. Caller did not know. Heart inflammation; they need to know if it was safe or not. It was scary to know no one knows what was going on or not. Caller asked about myocarditis. The patient had heart burn before but said the chest pain was not that. With the symptoms the caller saw online, she thinks the patient had pericarditis. The patient's next dose was on 12Jun2021.The caller was reading online that people reported chest pain and ended up in the emergency room and the caller did not want that. All the events occurred on an unspecified date in May2021. The patient underwent lab tests and procedures which included blood glucose increased: spiked up on May2021, electrocardiogram: fine on 25May2021 EKG and his heart rate was fine, heart rate increased: fast on 25May2021. The outcome of event chest pain was recovered on an unspecified date in May2021. Therapeutic measures were taken as a result of dehydrated. The outcome of blood sugar spiked up, sweating, vomiting, chills, diarrhea, felt sick, extreme fatigue, and slept on and off for about 4 days, dehydration, fast heartbeat and pericarditis was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Patient was at immunization clinic for second pfizer immunization with his mother and older brother. His brother had his immunization and patient had his second immunization given reassurance and diversion for immunization offered to lay down for immunization but refused. Giving home instructions to family and patient stated felt funny, color pale, unresponsive for approximately 5 sec, lowered to floor turned on side, patient became nauseated and vomited x 1 small amount of brown emesis, Skin moist and warm to touch pale. EMS here to assist and taken back to observation area via wheelchair. Report given to EMS. Patient awake.

Patient fainted after receiving first pfizer covid vaccination. Fainting occurred approximately 1/2 hour after administration at the front registers of store. I did not witness the event. Patient was alert and seemed okay, although confused, when I arrived at the front of store.

Had 2nd Pfizer vaccine at 5:15pm Thursday June 3. Felt fine that evening, just complained arm was starting to hurt when he went to bed around 11pm. Threw up twice on Friday June 4 at 9:30am & 1:30 pm. Very uncomfortable, bad headache, no energy. Mostly slept from 6pm Friday June 4 to 5am Saturday June 5. Immediately threw up when he woke up Friday. Threw up again about 30 min. later and 4 more times during the day. Still having bad head pain. Started to become confused and say things that didn't make sense. Went to ER around 4:30pm Saturday June 5. Blood work showed his sodium level was dangerously low. He was immediately given sodium and transported to Hospital ICU. Had brain MRI, lumbar puncture and lots of blood work done. Brain MRI showed signs of encephalitis. Also had myocarditis. Was in hospital until Thur. June 10. Encephalitis and myocarditis seemed to resolve quickly and he was just treated with rest and fluids along with antibiotics in case there was any viral/infectious cause of symptoms. All such tests have been negative to date

Patient complained of nausea and dizziness after vaccine. Patient was sat down and BP was taken. Pt allowed to sit for 20 min in the flu shot room until recovered. Reaction was non-allergenic and attributed to anxiety.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient received 2nd vaccination, did not sit and wait around 15 minutes as directed and fainted in the store. patient was very nervous before getting shot and stated later that he was sick last week and had not eaten anything all day (shot administered at 1230p). pt felt dizzy and lightheaded before fainting. paramedics were called and pt vitals were checked and all normal. pt went home with dad to be monitored closely for rest of day.

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.

Child developed a massive PANDAS OCD Flare and possibly cytokine storm. He ended up in the hospital asking to die because OCD thoughts became over whelming. Child has had PANDAS for 6 years and never had an incident like this.

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.

ongoing, prolonged headache migraine started within 24 hours of vaccine, to date 19 days of headaches out of 20, same spot on forehead between eyes above, requires multiple doses of pain medication to subside the pain and has required migraine ( headache) cocktail of Benadryl/ ibuprofen/ Compazine on occasion to relieve pressure and pain of headaches, than it returns. Extenuating headaches after Pfizer vaccine, seems the vaccine has triggered a prolonged immune response we have yet been able to stop. Constant daily headache same area requiring more medication and lasting longer, some days after first does of tylenol he will need a 2nd dose of ibuprofen 4/5 hours later as the headache with first does of pain meds did not remove the headache. , achy pressure pain same with each headache, not sever pain but moderate and affects daily movements and activities as to not escalate the pain further, drinking multiple bottles of water and trying to stay hydrated along with medications trying to remedy the prolonged headache from the vaccine . Drs have very limited information on how to treat or handle prolonged headaches from vaccination, information on these events or recommended treatments not easily found.

Adverse event: It was reported that patient received first dose Pfizer vaccine at 08:37. He had emesis in post-observation at 08:40. Treatment: Assessed by post-observation RN. EMT called and assessed. Patient taken by EMT to private observation area with parent. His father stated he (the patient) did not eat before vaccination. Given juice. Patient also stated he was very anxious about being vaccinated. Outcome: Patient asymptomatic. Vital signs stable (per EMT). BP 104/70, HR 82, Resp 16, Temp. 96,4 F, O2 Sat 98%). EMT discharged patient with parent to home.

Patient received his pfizer vaccine and two weeks later after traveling on his way home he became confused, was not making sense on the airplane. There were no seizure like activities, and patient was interactie. These symptoms started on 6/25/21 on the flight home where mom states he had 6-7 episodes of talking, being agitated and not making any sense. He was seen in the ER and evaluated with normal MRI, normal electrolytes and drug screening. Symptoms improved after a night of rest. Possibly due to dehydration/fatigue, but due to close proximity to covid-19 vaccine would like to report event.

within about 30seconds to 1min after administering Pfizer covid vaccine, 12 year old patient passed out....went from talking, laughing to sagging off his chair, I grabbed him and slowly lowered him to the floor....he was having difficulty breathing, focusing , etc.....talked to him, focus him on breathing, gave him water to drink, wet cloth to forehead, face and neck...he came out of it and said he felt ok....he got up and walked to the waiting area with his mom...appeared to be fine, was talking and laughing again, when all of a sudden he was just sitting there, eyes wide open, but not aware. Another customer was there and she noticed him and immediately got him to focus, breathe, popped an ammonia inhalant, applied instant ice pack to his back and neck which brought him out of it.....asked mom and we called 911, EMT's responded and transported Patient to the hospital to be checked.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild

high fevers 104 very swollen tonsils and sore throat extreme tiredness/sleeping constantly Dr. assumed Strep throat and started on Amoxil July 6th. Finished the 10 day course of treatment. Condition worsened and Dr. started on Keflex July19th. No improvement and was seen in urgent care July 21st. Fever of 99.6 at urgent care and heartrate of 132 and very lathargic and weak.. It is determined that he has mono. He has had mono before but it is explained that possibly the vaccine triggered it to be reactivated in his system. He is on steroid as of July 21st to try to decrease the inflammation.

Intern administered dose 1 of vaccine in patient's left arm. at 6:45pm. Within 2 minutes patient's eyes started rolling in the back of his head,his face turned pale, started clenching his teeth and making guttural noises. Mother supported patient's head and neck and RPh was called to the immunization room. Patient was placed in supine position. At this time patient had come to but was still looking pale and confused. Offer to call 911 was declined at 6:50pm. Patient's blood pressure was checked-94/58 at 6:50pm. A cold compress was applied to patient and water was offered. Blood pressure was retaken and was 97/68 6:55pm. EpiPen and offer to call 911 was again denied by mother. The color started returning to his face, atient was monitored and blood pressure was taken again-100/68 at 7:08pm. At this time he was able to sit up in a chair. He was then able to walk to our waiting room with assistance and was offered snacks. At 7:20pm blood pressure was rechecked 100/68 and patient and mother were escorted out of our pharmacy.

Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium

Patient had convulsive seizure, became unresponsive and was cyanotic, sternal rub, patient opened eyes. Heart rate was thready. Patient felt nauseous. Patient was disoriented for 1min and quickly regained orientation. Patient was given water, patient laid on the floor. Discharged to ER Past Medical Hx Hx of seizure at age 4

At 1:03 pm, patient went over to father shortly after being vaccinated and stated "I do not feel well." He sat down and briefly for <1 second became unresponsive. Upon arousing, he was pale in color and clammy to touch. RN (school nurse was at pt. side). Dad and pt. stated he was worked up and nervous before vaccine. Dr. also at pt. side. 1:15pm: Pt. drank 2 juice boxes and color improved to pink, and conversing without problem. Dr. suggested to pt. and father to have pt. lie down when he returns for his 2nd dose in 3 weeks.

Approximately 5 minutes after receiving first dose of Pfizer, patient became disoriented, eyes began rolling back in the head, loss of skin color, hands tingling, and altered hearing. We administered 25 mg of benadryl and patient began to feel better within 5 minutes. Patient stayed an additional 30 minutes and continued to improve to normal per parents.

Patient became nauseous 15 minutes after receiving vaccine,then vomited,then fainted. We lowered him to floor with legs raised. He regained consciousness after a few seconds,but was still not clear-headed. He was very anxious and shaking and pale. 911 was called . He was taken to ER.,but was clear headed,with heartrate slightly elevated.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild

Patient was given the shot at 9:36 am and was asked to sit down for 15 minutes to watch how he reacts with the vaccine. He had been very nervous and anxious before getting the shot because he never had a shot before and was afraid of needle. After around 5 minutes, his dad notified me that his son had upset stomach. I asked the patient if he ate or drank anything in the morning. His dad and he confirmed that he didn't eat or drink anything (because dad thought that he should not eat anything before getting the shot like getting blood drawn). He confirmed that he breathed okay and didn't have swelling of lip and throat. His father told me that his son did feel a little bit dizzy and sweating. Since the clinic is full of patients and humidy, I told him and his dad to sit in a room in clinic without patients and bring a fan to the room. After 15 minutes (around 9:51am), after drinking water and eating a banana, all the side effects were gone. He felt better, and he could watch videos/games and have full focus. At 10:24 am (which was more than 30 min resting in clinic), his father and he confirmed that he was feeling better and didn't have any side effects and decided to leave the clinic and go home.

5/15 vaccination 5/25 He got up and go dressed, ate breakfast, was ready to do work out in yard. Went to walk across the room to his brother, turned to look out the window, and all of a sudden fell straight back. Came to 10 seconds later, didn't know where he was, felt like he had had a bunch of dreams, 'everything turned white', doesn't remember much, didn't know where he was (thought he was in bed). He had hit his head on the wood floor, back of head (standing to smacking head). We live on an island, had to take ferry to town. Possible concussion. We went to Hospital in town. We worked with Dr. They gave us the verbal instructions if HA gets worse, anti nausea meds, rest, ibuprofen; concussion.

Was fine the night before. Woke up and his eyelids were swollen and his lips were swollen. Immediately, my wife called Telehealth and described the situation. They said to get him some Benadryl and we gave him that. He also had a headache - we might have give him a Tylenol. With Benadryl - he took four or five doses according to the protocol on the Benadryl. He did not go to school. The next day, he was swollen but not as bad. My wife bought him Claritin and he didn't do anything because he didn't know which to take (Benadryl or Claritin). His swelling went away quite a bit that day without taking anything and he went back on Wednesday -there was still a little bit of swelling but not much. He wasn't feeling great though that whole week. He was still tired and was a bit headachy until Friday or so. Somewhere on the weekend he felt back to himself. He is due for second vaccine this weekend and we aren't going to have him take it then. We're concerned and have decided to hold - the physician said he shouldn't have had a COVID vaccine two weeks before this Pfizer one (he received the Varicella) on the 29th of April- -Dr said it should have been a month or so of waiting still before he had this vaccine after that.

VS 121/64, HR 73, OxSat 98%. Vaccine received and pt. States he blacked out. No loss of consciousness, but foggy. Alert x 3. VS obtained when pt. Placed on cot and monitored by Fire fighter.

Client received the 2nd COVID vaccine of Pfizer (Lot# EW0182, expiration 06/28/2021). At 1729, Client reports nausea and wants to vomit. RN, RN, RN, RN, and RN respond to this event. The registered nurses placed Client in an anti-gravity chair and provided an emesis bag. RN responded to this event at 1730. Client appears pale, diaphoretic, states being nausea, wants to vomit, and dizzy. At 1730, vital signs are heart rate 89, oxygen saturation 99%. At 1733, vital signs are blood pressure 110/82, heart rate 62, oxygen saturation 99%. Client is offered supplemental nutrition and fluids. Client accepted both. At 1735, heart rate is 61 and oxygen saturation is 99%. At 1735, PHN responds and speaks to mother to educate her about ED precautions and common adverse effects. Client's mother reports Client has a history of ADHD, takes medications as needed, no known allergies, had a long day, as not ate much today, and was nervous prior to vaccination. At 1736, vital signs are blood pressure 110/78, heart rate 66, oxygen saturation 99%. Client reports no chest pain, no blurred vision, no headache, no shortness of breath, nausea is improving, and skin tone is returning to appropriate coloration of ethnicity. At 1742, vital signs are blood pressure 117/82, heart rate 82, oxygen saturation 99%. Client reports no new symptoms and improvement of nauseousness. At 1753 vital signs are blood pressure 112/68, heart rate 86, oxygen saturation 99%. Client reports all symptoms has resolved and is now hungry. Client stood up with no complaints at 1754. At 1754, Client walked out of facility with a steady gait accompanied by his mother.

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

Body aches, nausea, lethargy, decreased appetite, possible fever, sleeping difficulties approx. 24 hours

Pt c/o dizziness immediately after receiving 2nd dose of Pfizer. Pt had one episode of syncope. Father was present and assisted pt to the ground. No falls. Pt reports feeling nervous. A&Ox3. pt speaks in full complete sentences. No facial/mandible/tongue swelling. No stridor. Pt ambulatory to med bay, refusing to sit in w/c, w/ steady gait. Pt refusing pulse oximeter. Resp regular/deep. BP stable 149/50, HR 88, RR 16. Pt tol PO. Pt stable and released from the vaccination site. Recommended that the patient follow up w/ their healthcare provider.

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

Auditory and visual hallucinations, confusion, headache. Symptoms waxed and waned for approximately 15 hours and were preceded by chills, mild fever, myalgias, malaise and anorexia.

Mother told me he sometimes passes out with shots - gave vaccine and after about five seconds patients head shook like a seizure with lasted less than 5 seconds then he went unconscious - the mother and I laid him on the floor and he become conscious after 15 to 20 seconds but was confused and didn't remember what happened - we helped him back to chair and he said felt a little shaky and warm - we had him sit for 5 to 10 minutes - he felt better so we moved him to a chair outside counseling room - They waited an additional 15 minutes and said felt fine - mother said had never had the seizure symptom before - advised her to call Dr and make him aware and to ask Dr about second dose - she said would get his second dose with the Dr present.

Felt 'funny', slightly dizzy Initial Treatment: Arrived at clinic alone and riding bike. Gave water, juice, and snacks prior to vaccine. 4:20 Vitals: BP 110/80 HR 102 O2Sat 98 Skin Signs: Warm and dry Follow up Treatment: Water, snacks, laying down Doing well on discharge. Dad's friend came to get son (cleared upon phone call with Dad). Stable and no symptoms on discharge.

Patient presents to the ED with myocarditis s/p dose #2 of Pfizer COVID-19 vaccine. From note: Patient is 13 yo M who was in his usual state of health prior to getting his Pzifer COVID-19 vaccine #2 on Saturday morning (6/5). Saturday night he began to feel fatigued with fevers as high as 102.8 F. These symptoms continued through the night and into Sunday morning when he had episodes of NBNB emesis. Sunday night he was actually feeling somewhat better and was able to sleep through the night. He stayed home from school on Monday due to fatigue. At 3 am this morning (6/8), he woke up with aching parasternal non-radiating chest pain that he describes as an 8/10 and worse while lying down. Denies SOB and heart palpitations. His parents took him to a hospital where he was found to have an elevated troponin (reported 5.84 - unknown scale) and Hct 28.8. There was also question of an abnormal EKG (?p wave inversion). He got a bedside echo which showed no pericardial effusion. Additional labs included: WBC nml, plt nml, MBCK 16. In the ED, his vital signs have been stable. EKG was normal sinus. Trop elevated to 0.43 and echo was normal. Reassuringly his echo was normal, he has had no arrhythmias (after nearly 24hrs of continuous monitoring), his chest pain has largely resolved and his troponin has remained stable.

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

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

13 yo M with a history of autoimmune hepatitis who presents with 1 day of fever, headache, altered mental status, and vomiting. He received his 2nd Pfizer Covid vaccine on 6/12 and began having symptoms the next night. He began taking ibuprofen for headache and fever. His symptoms worsened through the day until he had vomiting. He was saying strange things and behaving oddly. He became very hot and agitated at home, prompting mom to bring him into an outside hospital ED. There, rectal temperature was 106F and he was noted to be combative. A CMP was obtained, which was mostly normal. CT of his head was obtained, during which he had an episode of left upper extremity shaking concerning for seizure. He was reportedly alert throughout. Patient is a 13 yo M with a history of autoimmune hepatitis who presents with 1 day of fever, headache, altered mental status, vomiting, found to have cerebral edema and elevated CRP. There is no acidosis, elevated lactate, or metabolic derangement, and utox is neg. The etiology could be related to the vaccine. Ingestions are also possible given the high fever and altered mental status - particularly serotonin syndrome. Infectious etiologies are also possible given the fever. Treatments: hypertonic saline given x1 EEG started Tox screen negative Ceftriaxone and vanc given

started experiencing a foggy mind right after the 1st vaccine. We waited an extra week beyond the time when he qualified for the second dose. After the 2nd dose, the fog got stronger. It has been 3 days and there is very little sign of improvement.

feeling horrible; Since the first dose he woke up with what mother states is herpes zoster on his lips; Arm hurt; headache; Tonsils hurt; didn't feel well; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EW0167, expiry date: Aug2021), dose 1 via an unspecified route of administration, administered in left arm on 13May2021 at 12:15, as 1st dose, single for COVID-19 immunization. The patient's medical history and other allergies compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity were none. The patient's concomitant medications were not reported. The patient had no family medical history relevant to AE. The patient received no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines administered on same date of the Pfizer Suspect. On 13Jan2021 at 20:00, 8 hours after getting the shot, the patient experienced tonsils started hurting. He didn't feel well and had headaches. On 14Jan2021, he had some pretty bad symptoms on Saturday morning, he woke up with herpes zoster on his lips and his mother called to pediatrician and he was very dismissive about it and said that if the body was under stress it can come out, but he never had anything like this before. It looks like little pustules around his mouth and looks like when my mom had shingles. He did mention his arm hurt a little but went to soccer practice. Clarifies the herpes zoster didn't show up until Saturday evening/night and it was starting to go away. She took son to get Covid PCR testing on 14Jan2021 and it was negative and was told that the herpes zoster was probably a reaction to the vaccine. The patient received treatment with Abreva. The outcome of the events Since the first dose he woke up with what mother states is herpes zoster on his lips was not recovered, and the other event feeling horrible was unknown, and all other events was recovering. PSCC Communication: PC Filed Product Complaint: Yes, Description of Product Complaint: Description of complaint: Asks if this could be a bad one since he was so sick and took him to get Covid PCR testing and it was negative. Thought was weird since she and her husband both had the Pfizer Covid shot and did not have any reactions. This was son's first Covid vaccine, Lot number: EW0167, expiry.

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.

run a fever of 107F; He also had aches all over; He just feels horrible; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 17:30 (at the age of 13 years old) (Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history included had gotten Covid twice this year; He had allergies to food, dog dander, and fish; Asthma. He had them for years. He had an asthma medication, Qvar. He was an allergy kid and had an epi pen. Concomitant medications included epinephrine (EPIPEN 2-PAK); beclometasone dipropionate (QVAR) ongoing for asthma (They just changed his medication about a year ago. She (mother) didn't know where it was to give a dosage). No vaccines administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Family Medical History Relevant to AE(s). The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 02Jun2021. Today (03Jun2021) he started to run a fever of 107F and was given Tylenol and went down to 100.3F. He also had aches all over. Caller was asking how high was the normal fever, what can she give to her son and how long would the AE last. He was running a fever and had aches all over. This was his first dose of the Covid vaccine. She asked if that was normal and how high his temperature should go. Aches all over was reported as worsened. The mother called and said he was running a fever. Her daughter just gave him Tylenol and he still had a fever of 100.3. It was a little bit higher. It was like 100.7 and came down to 100.3 (03Jun2021). He just feels horrible. It was Extra Strength Tylenol, lot: SMC200, expiration date: Jun2022. The aches started this morning. The events did not require a visit to Emergency Room and Physician Office. The outcome of the events was not recovered.

Few minutes after getting the shot, Mom knocked on the Pharmacy door. The child was on the floor and the Dad's hand was supporting his head. Patient was totally alert and spoke perfectly fine. He demonstrated and said that he has some tingling in his hand and something in his stomach. Child slightly diaphoretic. We called 911- vitals normal and "everything checking up good" paramedics left. When leaving patient said he is feeling anxious, nothing else.

PATIENT'S MOTHER DESCRIBES THAT THE PATIENT DEVELOPED A FEVER WITH HIS 2ND PFIZER DOSE WITHIN 24 HOURS OF RECEIVING. WITHIN 24 HOURS, HE ALSO DEVELOPED CHEST PAINS SPECIFICALLY WHEN BREATHING (INHALING). THE CHEST PAIN HAS GRADUALLY GOTTEN A LITTLE BETTER BUT THE PATIENT STILL DESCRIBES HIS BREATHING AS 'UNUSUAL' AND 'DOESN'T FEEL LIKE IT USUALLY DOSE'. PATIENT'S MOTHER TOOK HIS PULSE AND REPORTS A PULSE RATE OF 60 WHICH IS LOW FOR THE PATIENT. TODAY IS DAY 4 AFTER VACCINATION AND PATIENT STILL REPORTS NOT FEELING EXACTLY RIGHT.

not talking right; sweaty; appeared disoriented; This is a spontaneous report from a non-contactable consumer. A 13-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Jun2021 11:00 (Batch/Lot Number: EW0171) as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Unknown if Covid prior vaccination. The patient experienced not talking right, sweaty, appeared disoriented on 09Jun2021 11:30, was transferred to a clinic/hospital resulted in Emergency room visit. Treatment received first aid, vitals. The outcome of event unknown. Patient has not been tested for COVID-19 Since the vaccination. No follow-up attempts are Possible. No further information is expected.

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.

Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: The patient felt dizzy about 3 minutes after receiving vaccine (after walking and sitting in observation area). Pharmacist ran out and caught patient as he lost consciousness and the patient was not injured. Patient regained consciousness after ~10 seconds. Pharmacist and Technician helped patient to lay on the floor and elevated feet. Vitals taken every 5 minutes. Lowest BP reading was 98/60. Patient offered water and drank some. Patient laid down for ~25 minutes, BP came up to 116/84.

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.

1707- Patient in observation area and vomited on floor. Emesis white. Mask removed. Patient's lips appeared pale. Communicare team called for assistance. BP 128/88, HR 111, O2 sat 97%. Patient denies headache or dizziness. Denies further nausea. Reports feeling 'anxious'. Patient offered juice. 1711- HR 104,O2 sat 99%, RR 18. denies nausea, continues to report anxiety, patient sipping juice. 1718- Lips and skin pink and dry, denies further nausea. BP 118/82 HR 100, O2 sat 98%. Patient reports feeling better. 1720- HR 100, O2 sat 99%. Denies dizziness. Communicare provider discussed with family that reaction likely from being nervous and that he would 'do fine with his next shot". 1728- HR 100, ambulated to private vehicle with parent and this provider. HR after ambulation 104, no dizziness, O2 sat 99%. ER precautions reviewed via interpreter. Father stated understanding.

Patient stated he felt light headed and dizzy with the first Pfizer vaccine and requested to lay down to have the Vaccine administered. The nurse took the patient to a private area, with the mother and brother. The nurse vaccinated the patient at 1423, patient then had a seizure at 1425, I was called to assisted. Patient at the time was crying and felt sick. I asked for the nurse to place the patient on his left side while I obtained the necessary equipment for vital signs. Patient then became no verbal, I Immediatley asked for the staff to call 911. Patient was cool, diaphoresis, not responding. I sternal rubbed the patient as he was not responding. He was breathing, O2 saturation was 98%, HR 59. Vital signs 100/60 RR 16. Patient remained non-verbal. I asked the mother if the patient had any medical conditions and she stateed no. I asked about seizures and then the brother stated the patient had seizure when he was child about 3 years ago and the patient currently is not on any seizure medication. EMS was called at 1427 and are in route. Vital signs again, 110/78, HR 78, resp 18. I continued to ask the patients questions and the patient remained no-verbal. The patient followed directions, but remained non verbal. EMS arrived 1435 and took over. Patient did awake a little more and stated he didnt want to go to the hospital. EMS took the patient to the nearest Hospital

Escitalopram began to stop working for dark/depressive thoughts during the evening, no treatment was given.

APPROX 8-10 hours after receiving 2nd dose patient started to become noticeably disengaged in social activity The following days a major loss of apatite and further withdrawal in even the most intimate and immediate family social functions Complaints of delusions. voices giving him" bad" thoughts and" bad" visions. voices come as either "monsters" or "a little boy" We have noticed when he seems to be battling with these thoughts his eyes tend to go absent and twitches his mouth as if wanting to speak but at the same time not.

Following Covid vaccine on 6/30, Patient has significant fatigue. This has continued for the last month and continues today. Pt has some days that are better with less fatigue, however notable fatigue with falling asleep for extended periods of time is noted. Pt at one point slept 21/24 hours in the day. Pt is pale with no other symptoms or findings.

PATIENT EXPLAINED THAT HE HAS SLIGHT DIZZINESS DUE TO BEING NERVOUS ABOUT THE SHOT. THE PATIENT WAS SEATED AND EXPLAINED THAT HE FELT MUCH BETTER. THE PATIENTS PARENTS EXPLAINED THAT THEY WOULD TAKE PATIENT HOME AND MONITOR.

Patient is a 14 YO male with no previous medical history that received the Pfizer vaccine administered into his left Deltoid at 1406. He was sent to the observation area where the nurse noted him looking pale at 1410. His mother was present during this whole event. He was taken over to the medical tent for privacy and further evaluation. He was complaining of being light headed. He was given apple juice and crackers as he had stated that he had not eaten or drank anything all day. At 1430 his VS read BP 132/80, HR 145, O2 99%. At this time he was lying down and feet elevated, shaking, pale, and cold. Lung sounds clear. Nausea but not needing to throw up he was covered up to try and keep him warm. At 1440 his blood pressure was 130/82, HR 130, 02 98% At this time he was lying flat with feet elevated, shaking, pale, and cold. His lung sounds clear. Nausea, but not needing to throw up. At 1450 BP 138/74, HR 120-135, 02 98%. Symptoms had not changed at this point except he mentioned his ears felt cold, although they were warm to touch. He was laid on his left side at this point to try and lower his HR, which did come down to 115-125 when on his L side. We did not take a BP at this point as we wanted him to be on his back when taking them. At 1515 he was laid back on his back to see how his HR would do and how his BP was. BP 138/60, HR 135, 02 98%. Again symptoms were the same except he was complaining of colors being more ?dull?, and his teeth being numb. At this point his pupils were noted to be +8, equal and reactive. 1521 VS read 138/50, HR 135, 02 98%. Vision still dull and pupils unchanged from 1515. He was laid on his R side to see if this would lower his HR. It was brought down to 120-130 on his R side. We gave him a cookie to snack on to see if that would help with any of the paleness, shakiness, and light headiness. He was able to take a few small bites. Hands pale and washed, with +1 bilateral radial pulses. 1529 he was sat up slowly to try to get him to hydrate, as it was apparent he needed fluids onboard. His BP read 142/80, HR 124, 02 98%. He was still complaining of lightheadedness. After sitting up and drinking half a bottle of water and some cookie, he stated that colors were becoming more vibrant. He noticed my eyes were very blue, which previously he had stated they were grey. He stated his lightheadedness had improved and that he was feeling better. We had him sit up for a while and his color started to come back, although his L arm was still pale, of note this was the Vaccinated arm. At 1546 his VS read 150/82, HR 117, O2 99% while sitting. His only complaint was feeling like the air he was breathing ?was cold?. At 1607 he was stood up and when doing so his HR went to 140. After standing for about 4 minutes his BP read 120/82, HR 114, O2 98%. His pupils +6 , equal, round, and reactive. He was feeling way better and his color in his L hand was back equal to his right. He was slowly walked around a chair just to see how he would do with activity. His HR was anywhere from 94-120 when walking around the chair, he complained of no dizziness, or other symptoms. At this point he had finished 2 apple juices, crackers, a cookie, and a bottle of water for a total of 1.5 L of fluid. He was sat back down in the chair to rest and see how things went for a while. His HR was anywhere from 109-120 when in the chair, although he did appear very anxious through this whole process. When he was given a task it appeared that his HR was a few points lower. His final HR was 109, BP 130/82, O2 98%. Of note he did complain of his feet and fingers feeling tingly a few times during this process. Sometimes his feet would be tingly when elevated and then when the garbage can holding them up was readjusted it resolved. These were intermittent complaints. At this point it is 1630. He has responded to fluids and is stable to go home with his mom. It was recommended for him to increase his fluids tonight, and to eat something. He was sent with a bottle of water. It was also recommended to get a pulse ox machine from a pharmacy so that his HR could be monitored and if it does not come down under 100 by tomorrow to make an appointment with his MD to follow up. If any of these symptoms were to come back or if his mom had any concern at all it was recommended to take him to the ED for observation. It was also recommended to follow up with his primary even though he left stable. Throughout this process, I considered administering Epinephrine. The problem was his BP was not low and we could not get his HR to come down. I did not want to increase his HR any more than it already was unless I was absolutely necessary. Given that he responded to fluids, it was decided not to administer it. Given that it took him 2.5 hours to recover from this vaccine, I strongly recommend that he does not get his second dose. I consider this to be an adverse reaction, and his mom was in agreement.

HX ANXIOUS/NEEDLEPHOBIA, FAINT WITH SIGHT OF BLOOD. DURING OBSERVATION, PT STARTED TO WOBBLE AND COLLAPSED ON THE FLOOR, WOKE UP RIGHT AFTER, PROVIDED GATORADE, VSS, NO TRANSPORT

Patient passed out immediately following administration of the vaccine to the left deltoid. His head fell backwards and limp. The Rph administering the vaccine moved in front of the patient and gently moved his head into an upright position. The patient had mild muscle spasms and twitches while passed out but when he regained consciousness he immediately began talking saying he was ok. Father came into the consultation room at that point and Rph explained what had occurred. Patient looked a little pale and eyes were having a hard time staying open so with the help of his dad Rph helped him down to the ground in the corner of the room so he could have back and head support from the wall. Patient was given a glucose tablet and water, and later orange juice. Patient stayed in the consultation room for about 20 minutes before leaving on his own and saying he was feeling much almost back to normal.

Patient received the 1st COVID vaccine (Pfizer Lot #EW0185 expiration 05/22/2021) at 1426. Patient alerted EMT at 1503 that his palms were feeling sweaty, and he was feeling a discomfort in the right side of his chest on inspiration. PHN responded. Patient?s skin was appropriate to skin tone, and warm to the touch. Patient was alert and oriented and was breathing and speaking with an even tone. Vital signs were taken at 1505 (oxygen 99% heart rate 73 blood pressure 156/102). Patient stated that he was feeling anxious about the vaccine prior to receiving it. Vital signs taken at 1510 (Oxygen 98% heartrate 67 blood pressure 138/78). Patient stated that his palms were not sweaty anymore. At 1514 patient stated that the discomfort was a ?little better.? Blood pressure taken at 1516 (136/78). Patient offered water. At 1523 patient stated that he took a sip of the water and the discomfort came back more intense and was a ?burning? feeling traveling up his right lung. Patient pointed to his right collar bone area when asked to point to where the pain was coming from. At no time did the patient complain of difficulty breathing or shortness of breath. Vital signs taken at 1526 (oxygen 97% heartrate 68 blood pressure 150/90). Patient stated that the feeling would come and go. His stepsister who was accompanying him went to grab his mother from outside at 1530. EMS was called at 1537 by PHN. EMS arrived at 1539. Patient and mother refused transport to hospital and signed AMA at 1551. Patient and mother advised to follow up with primary care provider. Mother stated that they were taking him to the hospital as soon as they left. Patient and mother advised that if life threatening symptoms accrue on the way to the hospital to call emergency services. At 1553 the patient stated that the pain was ?gone for now.? Patient left at 1553 with mother and stepsister unassisted with a steady gait. Patient has no medical conditions, is not taking and medications and does not have any allergies.

Pt receive the vaccination at 1147, immediately after administration pt has syncopal episode where patient was able to regain consciousness within 30 seconds. Pt able to answer questions appropriately. Vital signs were taken - WNL, STAT RN was called, ice pack applied behind neck, apple juice and granola bar given to pt. Pt assessed and was a&0x4. Pt states he was very anxious about vaccine. Pt transferred to gurney and taken to treatment room for further observation due to pt sweating perfusely a few minutes after syncopal episode. Report given to RN in treatment room at 1210. Pt's mother at bedside and even at all times:

Pt screened to wait for 15 mins and when asked if he was feeling okay to leave, reported fatigue and tightness in throat. Father reported hx of asthma. I evaluated him and determined reaction to be anxiety-induced. HEENT and Pulm exams normal. I encouraged hydration, and calmed pt down with casual conversation and held for 40 mins

Pt received shot and after shot pt complain of feeling flushed and "nervous". Pt was given water with gatorade packet. No acute distress noted. Pt given extra 15 minutes for wait time. A/Ox3. Pt tolerated well.

Pfizer vaccine given 5/20/2021 Per mom/ pt the shot was given at 11:02 around 11:07 he leaned forward and became unresponsive. He was slightly drooling from the mouth. Mom says that his body was tight and that he was shaking a little. His eyes were closed and did not appear to be rolling back in his head. This episode lasted for less than 1 minute. He did not remember what happened and thought he wet himself after; which he did not. About 1-2 min after that episode mom states that he appeared to " passed out" for less than a minute. The ambulance was called and he was taken to hospital. He was evaluated and appeared well at that time. No fever. EKG was done and per pt it was normal. No EEG was done. He was discharged without admit That evening he has multiple episodes of vomiting > 10 times. No diarrhea or fever. Seen today at medical office for follow up. Vaccine not given at our clinic

As per father the pt had 3 convulsions, became very disoriented. Upon my arrival he was extremely pale and somewhat disoriented. His heart rate was 47 as per the pulse ox and he had no palpable radial pulse. His initial blood pressure was 101/60. During our interaction his pulse increased to 60 and became palpable at the radial. His pulse was irregular. His color improved as did his mentation. Pt was transported to hospital

Pt received first shot of Pfizer vaccine on 5/14 - 12:30 PM EST. On 05/17 around 7:45 AM, Pt passed out/fainted. He woke up few minutes prior to the event and this event started after he passed urine. As soon as he finished Urination, he felt nauseated, dizzy and then lost consciousness thereafter. He fell backwards as a result and hurt his back as well as back side of the head. During his unconsciousness his body was completely stiff and his eyes were rolled back. For few seconds then he became completely still (it felt he was not breathing). I gave him physical stimulus (slight slaps on the face) post which he started reviving. During this time we called 911. I gave him few sips of water forcibly and he started reviving thereafter. on 5/15 and 5/16 (post vaccination on 5/14) he was feeling tired and seemed bit dull. This was unusual as Pt is a competitive soccer player and highly active.

Patient (14 years old) fainted in the observation area receiving the first dose of the Pfizer vaccine. Patient fell from chair and had some scratches to right temporal region. Patient was accompanied by his mother. Patient was assisted to chair and appeared very pale and disoriented to time and place. EMS was called at 1138. Patient also stated his vision was blurred, reported nausea (emesis x1), and reported feeling very weak and ?really weird?. Patient also reported he was very sleepy and wanted to go to sleep. Patient was kept awake. Mother stated patient had history of ADHD and anxiety but no other past medical history. Paramedics arrived at 1145 and assessed patient. Blood glucose and VS were normal. Patient continued to report feeling unwell and wanted to go to the hospital but also wanted to ?stop for food?. Patient?s mother reported that patient was starting to sound like his normal self and that his color was returning. Patient?s mother agreed for the paramedics to transfer patient to ED for further evaluation. Patient left in ambulance at 1157.

Patient is a 14 yo male c/o intermittent upper left chest pain for >20 min after Pfzier vaccine. Reported pain 3/10, described as sharp and non-radiating. Denied previous episode w/ similar symptoms. Reported feeling some anxiety but denied being diagnosed or treated with anxiety. Upon assessment no acute distress noted. Alert and orientedx4, verbal and able to make needs known. Respiration even and unlabored. Skin pink, warm, dry and intact. No sx of allergic reaction. Chest non-tender, heart rate WNL, noted irregular rhythm, no murmur or extra sounds noted. No loss or altered level of consciousness noted. Mother present with patient and reports having HX of elevated BP which physician recommended increased activity and weight loss, denied medication treatment. No HX of allergies per mother. Past medical HX obtained from patient and physical assessment completed simultaneously. Pt assessed while sitting in chair. VS 160/81, HR 62, O2 97% RR 20, sponataneous resolution on symptoms after 2-3 minutes, patient observed additional 30 minutes, no acute distress noted, pt denied pain or symptoms. Advised mother to have patient evaluated by PCP for irregular heart rhythm ASAP. Advised mother to take patient immediately to ER if symptoms return or develop new symptoms. Advised mother to call 911 if patient develops chest pain, SOB, altered or loss of consciousness. Mother verbalized understanding of all advice and education. Patient went home with mother

He feels uncomfortable and worried. Always says that he feels like head ache. Also he is abnormal and afraid that he has covid-19.

1-2 days after administration of vaccine, the patient had a week-long episode of moodiness and irritability. This culminated in a suicide attempt by hanging in his bedroom that was interrupted by his father. There is no prior history of suicide attempts and no other clear, identifiable triggers to this incident. After 7 days, the patient returned to his previous baseline of mood.

Pt with presyncope event. Pt complained of sudden onset of nausea and feeling ?weird.? Clinician immediately at chair side. Initial vitals 102/58, HR 49, RR 18, O2 sat 98%. Pt assisted with receptacle for emesis-none. EMS medic 153 on scene and present. 4:25p BP 102/64, HR 62. 428p transferred to avail cot to lay supine. Aox3 and verbal entire time. Ice pack to neck. Water to drink without difficulty. Orthostatic vitals assessed ,WNL. Parent present throughout event. Mom refused transport. 446p EMS called verbal report to hospital MD as part of release for transport refusal. Permission granted to refuse transport . Pt up, walking around. States he now feels fine at 452p

patient fainted after 10 minutes of receiving the Pfizer vaccine. He revived really quickly. Did not require paramedic help. Patient was confused for a very short period. Bumped his right knee but no head injury.

PT STARTED TO FEEL NERVOUS. PT SAID HE FELT HE NEEDED SOME AIR SO HE WALKED OUTSIDE. MOTHER WITNESSED HIS FALL. PT FELL ON HIS ELBOWS, HANDS SHOOK FOR 2 TO 3 SECONDS. PT DID NOT RECALL FAINTING. REPORTED HAVING A HEADACHE IMMEDIATELY AFTER.

Ten minutes after receiving vaccine patient had syncopal event. He was unconscious approximately 5-10 seconds. After event patient was extremely diaphoretic, pale and slightly confused for <5 minutes. He complained of feeling very tired. Patients systolic bp unable to be detected, HR 57, O2 97%. Patient was laid in modified Trendelenburg position. BP rechecked after 5 minutes and was in the 90s systolic. Mother said he had a history of a heart murmur that nothing needed to be done about until he was an adult. Advised to go to ER for EKG d/t unknown cardiac condition.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadedness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Mild, Additional Details: Patient received the shot in the left arm. After he passed out his left wrist bent and twisted.

Patient received 2nd dose of vaccine. right after the recommended 15 minutes wait, as patient was about to leave, he stood up and fell over. I responded by checking his pulse. He recovered while on the floor and said he felt dizzy and blanked out. Patient also said that he did not have breakfast before coming for the vaccine. I made the patient to wait for another 30 minutes to observe him. He left feeling better.

Flu-like symptoms consisting of myalgias and malaise started on 6/4/21 at 1300. Overnight into 6/6 around 0230, he began having chest pain that felt like severe heart burn and shortness of breath. Tried to sleep through it but was unable and sought care. Found to have elevated troponin level and transferred to our facility pediatric ICU for higher level of care. Currently hospitalized in Pediatric ICU.

Within 5-10 minutes following vaccination patient nearly lost consciousness and felt nauseous. Parent states he has a history of vaso-vagal reaction following blood draws but never following vaccination. Patient was alert and oriented x3. Patient brought to cot to lay down. Vital signs taken x3 and were stable. Patient drank water and felt improved. Patient sent home with parent.

Patient in lobby for covid flu observation Father present Called by staff to child Patient observed altered consciousness Diaphoretic Near syncope episode Vitals: 06/08/21 1450 06/08/21 1452 06/08/21 1503 06/08/21 1509 BP: (!) 80/27 96/41 109/54 107/54 BP Patient Position: SITTING LYING LYING SITTING BP Location: RA-RIGHT ARM RA-RIGHT ARM RA-RIGHT ARM RA-RIGHT ARM Cuff Size: Standard Adult Standard Adult Standard Adult Standard Adult Pulse: (!) 44 (!) 40 (!) 48 (!) 49 Resp: 32 SpO2: 99% 100% 100% Assisted child to wheelchair, 2 person assist Initial blood pressure while sitting And then layed patient on gurney Legs elevated Past Medical History reviewed, Rechecked vitals Continuously monitored patient Patient at 1503 alert, no longer diaphoretic Denies nausea or shortness of breath Heart rate remains brady cardia reivew of previous vitals 1/12/20 105/65Hr 60 Lung sounds clear no wheezing Per father he has not needed his inhaler for asthma recently He does play basketball and baseball Call to urgent care to discuss patient status Verbal order for 911 related to bradycardia 911 called at 1521 Father agreed to plan of action for son to be assessed by physician Paramedics on scene, verbal report provided 114/54 hr 47 upon arrival

Patient developed sudden onset of chest pain which was diagnosed as myocarditis. Feeling a little bad on 6/2/2021 with some mild chest pain on that date. Took ibuprofen. Woke up suddenly on 6/3/2021 with severe chest pain. Called pediatrician and was going to wait for them to open; however, it was so severe that they took him to the Emergency Department.

On the 4th - woke up weak; light headed; and a lot of discomfort - his arm really hurt. General body achiness. After a little while, he got up and was able to take some Tylenol and attend his video school day with frequent breaks. In afternoon, he started to feel worse. 102. 6 fever - we called Tele-doc appt. His throat was sore and he had some chest pain. The doctor recommended that we go to ER to have him fully evaluated. Pain and fever got better with the Tylenol. He took another couple of dose. Next morning, he had a lot better but continued to have a low fever 100.2 - on and off that day. His lymph nodes under his left arm were quite swollen and painful. The fever did not continue yesterday but the swelling has and the pain has. He was very light-headed and brain fogged on Sunday and Monday. Seems to be better today - the lymph nodes have gone down a lot but are still swollen today. He is in process of recovering.

Pt received Covid #1 at out of office vaccine clinic on 5/27/21. Seen at ER 5/30/21 for behavior change (decreased level of responsiveness, staring off into space, vomiting & nausea, hyperventilation, anxiety Please see enclosed ER note. Spoke with Mom on 6/1/21 is improved History of Present Illness HPI Narrative: 14-year-old boy with history of autism presents with behavior changes, nausea, vomiting. Patient and his mother provide the history. He was in his usual state of health last night, had a normal dinner. Did not answer his door this morning. Parents found him staring off into space with decreased level of responsiveness. He was able to drink fluids. Patient reported having a few episodes of vomiting and abdominal pain earlier. They were concerned that he could be having a reaction to his COVID-19 vaccine which was given 4 days ago. Mom gave 25 mg of Benadryl at home. They were driving to Hospital for evaluation when the patient started looking worse. He has been hyperventilating but also has now clenching of hands and reports that his feet feel funny. Mom reports that he is not at his behavioral baseline currently. No prior abdominal surgeries or additional issues. Not currently take any medications. Patient denies taking any Illicit medications/substances.

Patient reported chest tightness about 13 minutes after vaccination. No breathing issues, no shortness of breath. EMS was called vitals were normal mom elected to have him taken to hospital just to make sure. Was later reported by a family member to us that patient was released and doctors believed it to be a panic attack.

Fatigue - began about 14 hours after, lasted 12 hours Sleeplessness - began about 14 hours after, lasted 12 hours Headache - began about 14 hours after, lasted around 12 hours

Headaches aches fatigue since shot, headaches more severe at night, can?t sleep Severe allergic reaction with trip to ER following excederin 6/5 Headaches continue trying Tylenol and imitrex

About 3-5 min after vaccination patient felt unwell, hot, dizzy, feeling of passing out, had his head down between hands. Pharmacist and patients mom got patient down on the ground flat with legs elevated on chair, a cold pack and water. Pharmacist did not witness loss of conscientious. Patient was nervous about getting vaccine. We called 911, emergency services came, did a work up. It appeared to be a vagal response, possibly from fear of needles. When emergency services got patient up he seemed a little nauseous. They took him to hospital.

5 minutes after injection: reported feeling hot + dizzy, then passed out momentarily. Recovered to normal within seconds. Approx 90 minutes after injection: rapid onset of extreme headache (outward pressure), difficulty breathing, chills, shaking, extreme fatigue, feeling of racing heart, mildly impaired vision, mildly impaired thought. These symptoms continued in waves over the subsequent 2-3 hours. Between waves, reported feeling fine.

Around 3 am he woke me up saying he couldn?t feel his legs and had a stomach ache. He got up in the morning to use the bathroom and almost passed out. Headache stomach ache , slight nauseous feeling lasted until about 12/1 pm. Very tired slept all day until around 6 pm. Very tired into the next day. Around noonish the following day he seemed to be back to normal.

He received the second dose of his covid vaccine on 6/7, began to experience sharp chest pain with exertion on 6/11. Pain is central, to the right of the sternum, without radiation. The pain then became more dull, aching, and has been interfering with his sleep. It does seem to be worse when he is thinking about it, better when he is distracted. He went to basketball tryouts 6/15 and the pain has been more frequent since that episode of strenuous exercise. He has not taken anything for the pain. He also notes more frequent fatigue. He denies any prior covid infection. No recent illness or sick contacts. Denies cough, fever, GI upset, diarrhea. He is going to school in-person, they all wear masks.

14-year-old male presents to the emergency department 4 days after his second Covid vaccine. Initially after the vaccine he had some generalized fatigue and nausea but yesterday started experiencing some chest tightness lasting up to 4 minutes. He also feels an irregular heart rate or like his heart is bounding. He also had some generalized bilateral neck stiffness. This is all resolved currently. He did vomit 1 to 2 hours ago. No fevers or chills. No cough or cold symptoms. ECG shows normal sinus rhythm with ST 1 box upsloping elevation V3 through V6. Initial troponin is elevated at 2.6. Attempted to consult cardiologist and they recommended pediatric cardiology consultation. Spoke with Dr. . She recommended admission with trending troponins and Motrin. She says they typically do echocardiogram and if normal then cardiac MRI. Spoke with Dr. in the ER and they graciously accept patient in transfer.

My son experienced hallucinations several hours after 2nd dose. He also experienced really bad headaches that required more than one dosage of Tylenol. Slept for 10hrs after last dose.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Severe, Systemic: Weakness-Mild

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

14 y/ male, admitted from the ED for further evaluation and management of chest pain, acute onset. Patient was well until 6/21/21 at ~ 6 AM when patient was woken up by sharp pain in his chest, he describes as intense for about 30 minutes. He was brought to the ED where chest pain was more bearable "heaviness". By 10 AM patient states that the pain is gone. EKG showed ST segment changes. Troponin 3.87 ng/mL. Due to concerns for myocarditis, patient was admitted to the ICU. Cardiology consulted. Echocardiogram obtained 6/21/21 was normal. LR started for maintenance fluids to ensure adequate hydration. Patient had no further episodes of chest pain. No pain medications administered in ED or PICU. Repeat EKG on 6/22 with Normal Sinus Rhythm with sinus arrhythmia. Pt discharged on 6/22/21 AM.

Client 5 minutes after receiving Pfizer 1 st dose vaccine client felt lightheaded. Client laid down to floor supine and was awake and alert. Client face was flushed and client appeared anxious--HR 80bpm. Client's extremities cool and client reported tongue was swelling and bilateral arms were tingling. Epi pen 0.3 mg IM administered in left thigh and 911 called. Client remained alert until paramedics arrived--breathing labored and hands clenched down. Mother at side

The patient received the vaccine and 4-5 minutes later he fell out of his chair, facedown. He appeared to be convulsing. He was pale, diaphoretic, and disoriented. His blood pressure was 76/36 and his pulse was 84. Radial pulse was 2+. EMT was called. His EKG appeared to have a slight elevation in his inferior leads. He and his guardian deny any significant history. Upon discharge with EMT, the patient was alert and tolerating liquids well. The patient's guardian states that he has had a similar reaction prior when he was the age of 6. She states that he also felt slightly lightheaded from the first Pfizer vaccination.

Patient received the vaccine. He stated he felt fine-not dizzy/etc He stood up and I walked him to the vaccination waiting area. Myself as well as 2 of my technicians checked in on him for a total of 3 checks. He was waiting for another person to get their vaccination. Upon checking in on the other person (he was still sitting in the waiting area) I asked him how he was feeling. Approximately 25 min had elapsed. He said his throat felt weird like closing. I had him remove his mask immediately. I assisted him to the immunization booth. He was able to walk on his own. I observed him. He said it felt the same maybe a little worse. No other signs of allergic reaction. Technician called 911. He said he was not dizzy and his color was normal. His blood pressure was slightly elevated. He said he had to keep yawning and felt tired and his throat seemed to be getting worse. I administered an epipen and immediately afterwards the paramedics were there. He walked to the stretcher and they took him to the hospital for further evaluation.

Patient c/o dry mouth, difficulty swallowing, chest felt heavy and fogginess. Spoke to Mother of pt she stated pt is fine, she gave him claritan and the symtoms resolved. I advised he shoud wait 30 minutes when recieving dose #2

My son experience after the vaccine around 03:40pm, he felt dizzy, started to black out and passed out. I gave him fluids and called his PCP. I made him eat since he did not eat earlier that day. He states he felt off, I gave him some Tylenol medication. He also had a headaches and started with diarrhea. The next day he stayed in bed, continued with flushed bright red cheeks, diarrhea and the headaches. The day after that he started to feel bit better, I think his symptoms lasted between 36-48 hours. His glucose level was 90.

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.

Hallucinating at about hour 9; He had a high temperature; This is a spontaneous report from a non-contactable consumer. A 14-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration in Arm Right on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration in Arm Right on 21Jun2021 12:00 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies and other medical history. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 15Jun2021 04:30, the patient experienced hallucinating at about hour 9, he had a high temperature. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. No treatment was received for events. The outcome of events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient reports onset of chest pain three days after his second Pfizer COVID vaccine. In the following three days after his vaccine, he had headache, decreased appetite, and mild nausea. However was still taking in fluids, decreased solid food intake. He also experienced insomnia and generalized malaise. At midnight on 07/02 he began to experience 9/10 substernal chest pain that was sharp, burning in sensation and located in the middle of the chest, non-radiating, pleuritic which lasted for several hours. Patient has had no fevers, vomiting, diarrhea, congestion, sore throat or cough. Denies any SOB, dizziness, syncope, palpitations, edema, orthopnea. There has been no trauma to the chest. No recent URIs. He was seen at a hospital where he was found to have a trop of 1251 ng/L (converting to ~1.5 in our system) then one hour later up to 1500mg/L. His EKG at the hospital demonstrated lateral ST elevations. Had a normal CXR. He was given Maalox which was not helpful. He was transferred to another medical facility after 3 hours at the hospital. Upon presentation to the emergency department, his vitals were stable. He had elevated CRP to 7.69, troponin was 1.0. CBC and Chem were normal. BNP normal at 15. Bedside ultrasound showed no pericardial effusion. Cardiology was consulted and ECHO showed mild left ventricular dysfunction with EF 47%. Repeat EKG here showed ongoing ST elevations in lateral leads, though mild. His pain has since improved to a 2/10. He has not required any medication for his pain. He is COVID/flu/RSV negative. On arrival to the floor, his chest pain had completely resolved. Patient reports the pain was pleuritic, worse with exertion and improving on rest. PMH: idiopathic urticaria Allergies: NKDA Family history: none reported, no cardiac disease or sudden cardiac death Hospital Course: Patient was admitted to the cardiology floor for continued monitoring of his troponin levels and EKG. He was then treated with IVIG 2g/kg and started on methylprednisolone IV x 2 doses. He initially had some very mild chest discomfort that improved by day 2 of admission. An echocardiogram was performed which showed improvement in his EF to 54%. Given his dysfunction, he was started on Enalapril 2.5mg twice daily. He was transitioned over to PO steroids which he tolerated well. On day of discharge, his troponin levels were trending down, and EKG was WNL. Cardiac MRI was performed and showed late gadolinium enhancement in the left ventricle. He had occasional PVCs but no arrhythmias. Viral myocarditis studies were sent and all negative. By time of discharge, patient was well-appearing, vitals stable, demonstrating good PO intake. Prescriptions sent to preferred pharmacy. Follow up with cardiology in place. Discharge instructions and return precautions reviewed with patient and parent, who expressed good understanding and agreement with plan. Patient will follow up in cardiology clinic next week with a repeat MRI 3-6 months.

~10 mins post vaccine became diaphoretic, described a buzzing in his ears, and was not aware of where he was, talking throughout, no LOC, BP stable 100's/60's, sats 98-99%, no respiratory distress, vomited a moderate amount and immediately felt better. Seen by PCP on site immediately following episode.

Patient received the vaccination at approximately 7pm 07/08/2021. He had a prolonged blood glucose from 6am-9:18am and consumed 75 grams of Carbohydrates and had a bg reading of 64 and steady on his continuous glucose monitor. Patient lost consciousness and had a seizure at approximately 9:20 am 07/09/2021. The seizure lasted approximately 3 minutes. Glugagon was administered due to the thought that it was Diabetic hypoglycemic. He was taken to medical facility and released. He was taken to another medical facility on Sunday July 11 to be evaluated for neurological issues. He is continuing to have symptoms of fatigue and overall lethargy, body aches and runny nose and his ability to focus is impaired.

after vaccine was administered, patient was told to wait in the store for 15 minutes. Within 2 minutes, patient told their mom, he felt "woozy". Patient dropped to his knees. Pharmacist was alerted by immunizing technician. Pharmacist went to the lobby to assist. Patient was alert but stated he did not feel good. Pharmacist helped patient to a chair. within another minute, patient stiffened and would not answer to his name. 911 was called. ambulance arrived within 5 minutes. Patient was alert, but pale, said felt sweaty, and dizzy. paramedics took blood pressure and place the patient on the gurney. blood pressure was normal. paramedics stated they would run a few tests in the ambulance, and mom agreed to going to hospital after. patient left the store with paramedics.

After 12 hours of the vaccine on 7/23 he started exp chest discomfort, heavy breathing and felt feverish. The next day on 7/24 he had aches and pain took Melatonin to sleep. As of today he is feeling better a little anxiety.

Patient was alert but disoriented, difficulty breathing, speaking in between breathes, chest tightness, dizziness, and nausea 5 minutes after receiving the Pfizer Covid 19 Vaccine. 911 was called & paramedics arrived at the scene about 10 minutes from onset of patients symptoms. Patient was taken into Paramedics care and transported to the hospital.

Very heavy nose bleed; Got another very heavy nose bleed; Very tired; Not feeling well; This is a spontaneous report from a contactable consumer or other non-health care professional (parent- mother). A 14-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration (at the age of 14-years), on 09Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration on 18Jun2021 as dose 1, single for COVID-19 immunization. On 12Jul2021, the patient experienced very heavy nose bleed, got another very heavy nose bleed. On Jul2021, experienced very tired and not feeling well. Reporter stated that I am calling about my son, he was 14 years old and he had his second vaccine this past Friday and two nights in a row, he has had very heavy nose bleed but he does not get these bloody noses ever but it started last night and then he just got another very heavy nose bleed. I just do not know if we need to watch for this or worry about this just because as I said he just had his second and he has never ever had nose bleeds. She stated that her 14 year old son received his second dose of the Pfizer COIVD-19 vaccine on 09July2021 and the past two nights has been having nose bleeds and is looking for any information on this, has this been reported, what to look for? She stated that her sons first and second doses were the same LOT number, EW0182, and they did not provide NDC/EXP for either dose on the vaccine card. She clarified that it was after he had the second dose, now he is having bloody noses and she would like to know if she should worry or is this normal and others have reported experiencing this. Is there a product complaint to report?-Yes, Description of complaint: This is a follow up report. Report Reference: Unknown, caller says this was not provided during the call she made yesterday. Pfizer COVID-19 vaccine: Caller says that her son's first and second doses were the same LOT number, EW0182, and they did not provide NDC/EXP for either dose on the vaccine card. Product strength and count size dispensed: not provided, second dose. Additional lot numbers: N/A. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided. Is there a medical information request?-Yes. Please describe the medical information request she would like to know if she should worry or is this normal and others have reported experiencing bloody noses after second dose of Pfizer COVID-19 vaccine? Information on the lot/batch number has been requested.

Approximately 20 minutes after the vaccine the patient was the passenger in his mother's car when he started feeling confused, experienced blurred vision and reportedly lost consciousness. Upon regaining consciousness, the patient vomited.

Patient was anxious and scared "worked up" prior to vaccine per mom. The patient received Pfizer vaccine at 3pm and at the vaccine table he was verbalizing he was scared,nervous and his hands were cold and clammy, he felt dizzy. He sat at the vaccinator table and we gave him water and crackers, VS 2:57 BP 129/70, HR 78, O2sat 1005. VS 2:58pm 129/80, HR 78, O2sat 98%. VS 3:01pm BP 125/69, HR 70, O2sat 100%.Patient taken to observation area,stated feeling better, walked without feeling dizzy and continued monitoring VS 3:03pm. BP 123/64, HR 68, O2sat 100%. 3:06pm eating cookie VS BP 122/69, HR 64, O2sat 100%. 3:12pm VS BP122/64, HR 60 and sat 100%. Patient stating feeling better, not lightheaded or dizzy. VS 3:16pm BP 124/62, HR 58 and O2sat 100%. Patient left at 3:20 with mom "feeling good".

AFTER RETURNING TO WAITING AREA, PATIENT BEGAN TO FAINT. IMMEDIATELY REGAINED CONSCIOUSNESS AND STAYED IN AREA. PATIENT WAS VERY PALE AND HAD BRIEF NAUSEA. BOTH HAD SUBSIDED WITHIN ABOUT 5 MINUTS. PATIENT CONTINUED TO STAY IN THE AREA FOR 20-25 ADDITIONAL MINUTES AND SINCE HAS ONLY A SORE ARM. PATIENT WAS VERY NERVOUS AND ARM WAS VERY TENSE UPON ADMINISTRATION.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: sweating profusely, EMS called and came to pharmacy, checked on pt and all clear for him to leave, parents had no problem and said they didnt need anything before they leave

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient started experiencing numbness, tingling, and hand cramps minutes after receiving his pfizer vaccine. We sat him down in the chair and had him relax. I called EMS shortly after and they arrived quickly. They worked him up and concluded that he was having a panic attack related to being give the vaccine. Patient states that he wasnt anxious about it previous to administration nor did he seem anxious as well. He was calmed down by the EMS personnel and then was able to walk out of the store

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

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: possibly seizure related. patient fainted and hit head on wall upon fall. came to and went in and out a couple times. stable until EMS arrival

Sunday afternoon(5/16) got Pzifer COVID vaccine Dad says on Monday am early they woke him for school and he was asking where was he and why they were waking him up- kinda like in a dream like state and confused looking; they told him to just get up- he was able to get out of bed but seemed out of it -this lasted a few hours- he went back to sleep and when he woke back up he was not confused anymore but very tired; he also had some nausea and vomited; No fever; no cough; no body aches; L arm is a little sore- not as much today; each day a little better has had a little headache- but not much of one; Last night had better appetite so ate a lot of food then vomited again; has not really have an appetite before last night ; this am able to eat and kept food down today; Sleeping more but was restless sleep until last night as well Back in school for the past month; No school work this week- tried some math this am but trouble focusing so just stopped doing work

PT REPORTED FEELING ANXIUS AND DIZZY, ALSO REPORTS BLURRY VISOIN PT REPORTS FEELING BETTER AFTER ABOUT 5 MIN, HR 80, 96% O2, PT REPORTS SMILAR REACTION TO PREVIOUS VACCIN DID NOT TASKE ANY MEDICATION TODAY PT WAS ENCOURAGE TO LIE FLAT AND TO HYDRATE PT LEFT SITE WITH PARENT AFTER 15 MIN WAS RESOLVED SYMPTOMS

After injection, patient stood up and we noticed he was falling. We caught him, laid him on the floor and called 911. His blood pressure was 75/33 and heart rate was 57. Emergency crew took him to the hospital. I called his mom in he evening and she said he was fine, he got nervous during vaccination

slurred speech, difficulty putting thoughts into words, difficulty completing a whole sentence when talking occurred almost immediately after receiving the vaccine (within 15 minutes or so) lasted for about 8 hours

Pt reported to briefly lose consciousness and stated that his vision changed. Pt did not fall completely from chair. Pt was gently lowered to the ground. Pt was alert and oriented x 3 and vision restored while lying on the ground. Patient was given water but then when he sat up, he soon became unconscious again and again was gently lowered to the floor. Regurgitated/ spit out the water. After initial confusion, was alert and oriented again.

At approximately 6 PM on 05/23/2021, family was sitting down for dinner when all of a sudden she noticed that he was turning his head to the left and appeared to be falling out of his chair. Mom states that eyes were darting back and forth at this time. He was not responding to her shouting his name and his left arm was curled in towards his body with the rest of his body remaining stiff. This lasted approximately 1 minute, followed by a time of confusion and drowsiness. Approximately 1 minute later mom states that patient's eyes rolled back to his head and he had full body movement consistent with tonic-clonic seizures. Family were able to lay him onto the ground during this time. Mom denies any color change, apnea, or loss of bowel or bladder. States he did have one episode of emesis following the event, and 2 episodes of emesis in the ambulance on the way to ED. Patient has no previous history of seizures or seizure-like activity. No new ingestions. Has not been sick recently and denies any new sick contacts. There has been no head trauma. Per Mom, patient's dad has a history of "partial seizures" but never required any medication for them. At arrival to the ED he continued to be drowsy and not at his normal baseline. Continue to hold his left wrist up toward his body in a contracted manner and tended to have repetitive speech. Briefly, ER course significant for a CT head and evaluation by pediatric neurology. CT head was unremarkable for acute intracranial process. A CBC, CMP, and coags were also obtained due to patient's continued contracture positioning and the possibility of a stroke. CMP was unremarkable with a sodium of 139, potassium of 3.7, chloride of 107, bicarb 25, BUN of 12 and creatinine of 0.64. CBC was also unremarkable with WBC of 10.72, hemoglobin of 14.8, hematocrit of 44.4 and platelets of 370. There was 81.77% neutrophils after evaluation by neurology it was felt that the patient remained postictal and recommended that he be admitted on continuous EEG and possible MRI in the a.m.

Approximately 8 days after first shot I started to feel strange feelings in chest after spending multiple hours outdoors. It was a pressure like feeling. Occasionally when I swallow it will feel uncomfortable, but not every time.

Client received the 1st dose of Pfizer COVID vaccine lot #EW0185 and expiration date 6/24/21 at 5:52PM. Per vaccinator, reports that client was saying, "Wow that was aniclimactic" after getting vaccine. Per vaccinator, she notices within 1-2 minutes client got quiet and then reported "I am not feeling well." Client received vaccine in left deltoid. RN requested PHN 1 to get gravity chair. PHN grabbed gravity chair and asked RN to get BP cuff and pulse ox. PHN arrive to assess client and found client alert and oriented x 4 in chair at 5:53PM. Client was already drinking water given by vaccinator when PHN arrived. Client reports he was experiencing "dizziness and slight shortness of breath." PHN ask client if he thought he was steady enough to switch to gravity chair. Client stood up slowly and sat in the gravity chair. RN 1 asked client if his throat felt tight-client responds-"No" and coached client to take deep, slow breaths. At 5:55PM vitals are: blood pressure: 130/90, pulse: 55 and oxygen: 98%. At 5:57pm client reports no longer feeling shortness of breath. Client is speaking in full sentences and able to answer all PHN questions about chest pain and headache and client reports having neither. At 6pm vitals: blood pressure:125/90, pulse:75, and oxygen:100%. PHN instruct RN to get Lead PHN or Co-Lead. Client reports he has slight dizziness and feels lightheaded and reports that earlier he had blurred vision but now is seeing clearly. At 6:03PM vitals are: blood pressure:160/100, client appears pale and heart rate:140, and oxygen: 100%. Lead PHN arrives to take over assessment and PHN starts calling 9-1-1 at 6:04PM as blood pressure is repeated by co-lead :180/90, oxygen100% and pulse 129 and upon auscultation hears clear lungs and heart palpitations. Client is then reports shortness of breath and dizziness, no headache and no blurred vision. Parent reports that client has a history of asthma but rarely needs inhaler so she does not have it on her and that client recently had been on antibiotics for Gastrointestinal history and a bad cough (not COVID)-all symptoms had been resolved before receiving vaccine. At 6:07pm Vitals: blood pressure: 170/90, pulse:100%; no change in symptoms. At 6:08pm vitals: blood pressure:170/90, pulse: 94, and oxygen: 100%, client reports experiencing tightness in chest and unable to complete breath. Client reports no chest pain. Vitals taken again by RN due to new symptom, blood pressure: 122/70, pulse:93 and oxygen: 100%. RN auscultate again and hears palpitations have slowed and lungs clear. At 6:10PM, vitals are blood pressure:124/74 and pulse: 96. Client reports feeling "shaky, tightness on chest" and could not take full breaths. Paramedics assumed care at 6:12pm. Client and parent left on stretcher with paramedics to be transported to Hospital. Tell security that mother is leaving blue pathfinder in parking lot. Security assures he will not tow vehicle.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PATIENT RECIEVED VACCINE AT 2P. Sat in waiting area for about 10 minutes. Our observer noticed that the patient was sliding in his seat and looked dizzy. Patient starting to flutter his eyes and lost consciousness for about 5 secs. He complained about blurry vision, feeling hot, sweating, but with chills. Patient was given water. After he drank the bottle of water patient felt fine. The ambulance was called and arrived, patient reported he felt fine. Patient did not eat/nor drink water today.

Weak and tired. He felt like he was numb. Like he couldn't really move. He slept - didn't have any fever. Was really hot though. He had a really bad headache and his dad gave him Tylenol. He felt still tired the next day but felt better. The headache was gone. Doctor exam - physical and labs

On 5/23 two days after vaccine he was irritable, tired, fatigued, not sleeping well. He could not complete his track meet . He had abdominal pain, felt bloated, and he felt this nausea & discomfort. He thought he might be constipated, so he took MiraLAX and then he had diarrhea all day yesterday. on 5/26 he had a temperature of 99.2, he had acute chest pain retrosternal and feeling of compression on the chest, head fullness as if he is going to explode. He had nausea, insomnia. Ibuprofen was given to him by his mother and this helped a lot But he woke up on morning of 5/27 , but the chest pain returned with increased pressure, very nauseous, agitated, unable to be comfortable. No fever,, the pain was a sharp pressure. He had no syncope or chest shortness of breath He was seen at Hospital ER where a chest x-ray was normal. Echocardiogram was done, ,noted to have EKG changes. Troponin was elevated. He had a cardiac catheterization done emergently at hospital through the right radial artery and was noted to have normal coronaries. He also had a chest x-ray done which was negative for pulmonary lesions, and his abdominal pain he says was relieved after the MiraLAX and the diarrhea. His twin sister who received the vaccine 15 minutes after him is completely asymptomatic.

15-year-old patient received their first dose of the COVID-19 vaccination. Was in Post Vac 20 mins and then he stated he was feeling "weird". Nurse brought patient over to stretcher to lie down. Patient denied any symptoms of allergic reaction. No signs of allergic reaction noted. Took vitals and they were all within normal limits and a neuro check that was within normal limits as well. Patient was given juice and water. Captain notified of patient condition. He stated he was feeling better within 15 mins of lying down. Nurse raised the head of the stretcher and he began to feel "weak and shaky." Nurse lowered the head of the stretcher and continued to monitor him. Vital signs and neuro check all remained within normal limits. He felt better again lying flat, but when the head of the stretcher was lifted again, he began to feel "weak and shaky". Nurse alerted the captain and mom wanted to be taken to the hospital. 911 was called for transport to facility. Mom and sister drove to the hospital and patient was taken to facility ER via ambulance in no acute distress.

Shortly after vaccine my son had extreme pain in his chest and heart area. It expanded to his shoulder and part of his neck and could not stand up. We took him to the local hospital and after examination they said the blood work and ekg was fine so they released him. We are at home now and he feels the pain still if he pauses his breath, and he just showed me you can hear a very strange sound coming from his heart as it beats. I can hear it sitting near him a loud pumping or squirting sound in there as his heart pumps! Never heard anything like that before coming from someone?s chest!

DOSES GIVEN TOO EARLY TOGETHER PER RECOMMENDATION DATES 1ST DOSE MAY 18,2021 2ND DOSE MAY29,2021 SON MESSENGER ME MOTHER THIS MORNING MAY30,2021 WHILE BIO AT CHURCH SYMPTOMS :'I'M SICK ,RLLY SICK, BARELY SLEPT LAST NIGHT BECAUSE WHOLE BODY HURT. " "DIZZINESS WEAKNESS CAN'T STAND STRAIGHT LACK OF PERCEPTION ACHES AND SORENESS HEADACHE" PER MESSENGER FACEBOOK TO ME MOM 30,2021 9;48 AM CONVERSATION REQUESTED MEDICAL CARE AMBULANCE FOR HIM TO CALL HE SAYS JUST RESTING BIO AT CHURCH 'PLEASE GET TO DR CAN THEY TAKE YOU" mom me "they are at church"

Three days after receiving the firts dose, my 15 years old soon started to felling bad, with fever (between 99 to 102 f grades, muscle pain, headache, general discomfort and not energy at all. Syntomps lats for almost 3 days, My main concern is why the symphtoms showed up three days after the vaccination day, and not before.

patient has stuffy nose; scratchy throat; not able to go to school; runny nose; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 21May2021 15:00 (Batch/Lot Number: EW0191) as 1st dose, single dose for covid-19 immunisation. Patient's relevant medical history included none. The patient's concomitant medications were not reported. The patient experienced stuffy nose, scratchy throat, not able to go to school and runny nose on 24May2021 06:00. Patient was asking she was expecting that Pfizer can give recommendations if her son needs to have COVID testing due to his symptoms after receiving the vaccine. The Caller was calling about the Pfizer Covid-19 Vaccine. Her son got his vaccine on Friday, he was 15 and the next day he experienced nothing. He did not feel anything but he was having a stuffy nose and then he had some scratchy throat. Caller wants to know if a stuffy nose and scratchy throat are a side effect or if she should get her son checked for Covid. Caller adds that really all side effects will happen in 24 hours, but this is more than 24 hours, it is like, 48 or 50 hours later. Caller wants to know if the stuffy nose and scratchy throat are side effects. The caller clarifies that she means will he test positive for Covid -19 after getting the vaccine. The caller states she did not want to provide name or date of birth information and Pfizer can call her instead if they want. Stuffy maybe a little bit runny nose, scratchy throat, both of these occurred today morning around 6 o'clock. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received. The outcome for the event not able to go to school was unknown while rest of all was not recovered. Follow-up attempts are needed; Additional information has been requested.

This information was reported to this writer. Immediately after receiving the second dose of the Pfizer vaccine, the patient reported a "weird sensation" in his chest. The patient became pale, and reported nausea and lightheadedness. According to the vaccinator it seemed as though the patient went into a syncopal episode. A nurse attempted to do a sternal rub to wake the patient up but was unsuccessful. The patient was then laid onto the ground and woke up; attempted to sit patient up and then went into another syncopal like episode. EMTs were notified and were on their way to attend to the patient. Patient's feet were elevated. No history of vaccine reaction. Patient had eaten and had fluids 2 hours prior to the vaccine. Patient was sat up again with assistance but immediately felt lightheaded and had another syncopal like episode. He was again placed in a supine position with feet elevated. Immediately reported improvement of symptoms. Patient had several sips of juice and was placed on a stretcher and taken to a back room. Patient had mom and sister at his side. As the patient remained in supine position, he denied nausea and lightheadedness; no chest pain, no dizziness. Patient was alert and oriented. Remained pale in color according to his father who just arrived. Per the advice of the EMTs, patient was transferred to hospital per ambulance.

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.

Patient felt like a lump in his throat. No difficulty breathing or swallowing. VS 110/70 P. 56 Patient drank water and felt a little better. He went outside and felt better after removing mask. He felt it was starting to go away but was still there on one side. Both parents were with him and he went to the ER with them in their vehicle. This was dose 2 of Pfizer and he had no difficulty with the first dose.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted once, then almost again. Called 911 to have evaluated before leaving. Was feeling ok upon departure

Patient has severe anxiety when getting vaccines per Dad. Patient did eat before vaccine at around 10am. He stayed conscious the entire time, but had trouble standing and said he felt like he could not breathe.

My 15-year-old son received dose #2 of Pfizer?s Covid-19 vaccine at 10:30am on 6/6/21. At 1:00am on 6/8/21 he was struggling to breathe due to pain in the center of his chest upon inhalation. Nothing like this has ever happened to him before. His chest pain was worse lying down and he could not lie down or sleep and wanted to stay standing on his feet. He felt pain in both forearms too. He was crying from the pain and the difficulty of breathing, and was very tired but unable to recline in order to sleep. I called the advice nurse, who checked with the doctor on call at his pediatrician?s office, and she told us to go to the ER due to concern it may be myocarditis or pericarditis.

Pt was given his 2nd dose of Pfizer vaccine at pharmacy on 6/3/21 at 1:20pm. Minutes after the vaccine pt developed headache, stiffness of neck, dizziness, fatigue and SOB. Epipen was brought out but never administered, pt was there for about 45 min. Was sent home and took Advil 400mg. Was playing badminton with lots of running 30-45 min prior to vaccine. No other vaccines given in the past year. Since the vaccine, pt has had fever up to 102. Continued headache, neck stiffness. 1st night 6/3/21- bad headache, throbbing headache all around head but worse back right side and then "spikes" on left side (like someone was hitting him with an axe) and fell asleep d/t sever pain, trouble breathing in the next few days 2nd night 6/4/21- neck pain and stiffness was really bad, he looked pale and almost disoriented. Had fever. Slow to respond. Would get rush of bad headache if he moved his neck too fast. Afraid he would fall down if he moved too fast. 3rd night 6/5/21 - (called 911) chest pain, difficulty breathing, vomited stomach acid, pain radiated down chest to the left, pain only when breathing in and went away the next AM 6/7/21 Chest still feels sore on Left side. Biggest issue right now is headache.

IMMEDIATELY AFTER PATIENT RECEIVED HIS VACCINE, HE FELT NAUSEOUS. PATIENT SAT DOWN AND SOON AFTER SITTING, STARTED SEIZING (HIS FATHER REPORTS ARMS CONTRACTING AND SHAKING). PATIENT DOES NOT REMEMBER THE EVENT. UPON REGAINING CONSCIOUSNESS, THE PATIENT SAID HIS FACE FELT FUNNY BUT THERE WAS NO THROAT SWELLING OR SIGNS OF ALLERGIC REACTION. PATIENT LAID DOWN WITH HIS FEET UP FOR ABOUT 15 MINUTES AND REPORTED FEELING MUCH BETTER. NO OTHER SIGNIFICANT EVENTS OCCURRED DURING THE OBSERVATION PERIOD. PATIENT DENIES A HISTORY OF PREVIOUS ALLERGIC REACTIONS OR REACTIONS TO VACCINES.

Pt was a little nervous before receiving the vaccine, but did fine. He was sitting with his brother for the 15 minute wait period when his brother called for help. I told my staff to call 911. Pt had his head back and his legs outstretched in front of him. He was unresponsive at first and pale. Then he sat upright and said he thought he had just hallucinated. He was distraught and did not understand what had just happened to him. I asked the brother if an adult was with them. He called for his mom and she suggested we lay patient down on the floor. She sat with him until EMS arrived. A paramedic took his blood pressure and EKG. He drank some soda and was able to sit up, his color returned, and he was able to stand.

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.

Patient became dizzy and clammy but did not lose consciousness. He began throwing up. No sign of anaphylaxis. Remained pale, dizzy, for about 5-10 minutes. EMT called to scene but was doing a lot better by the time they arrived. Treated patient with cold compress face/neck. Dad stated he has anxiety and that this same thing happened previously after having blood drawn. He was able to walk out on his own with his father approximately 30 minutes later.

Developed fever, chills, nausea by about 9pm that night (6/12/21). Administered alternating tylenol/advil. Symptoms lasted approx 36 hours. Too weak and fevered to attend school the day following 2nd vax (6/13/21). Still fevered on the morning of the 14th, but given last dose of Tylenol and was then fine for school.

Patient came in for 2nd dose and was already anxious about getting the vaccine as he had the same fainting episode after the first dose. Rph and intern giving vaccine where both in the immunization room along with the dad. Rph counseled patient on what to do if feeling light headed and to help prevent fainting . Intern gave vaccine and within a few seconds he said it was getting dark and so immediately as the patient was sitting down I grabbed him gently from the front and his dad came and held him from behind. We both supported him as he was sitting down and within 10 seconds he came back and was fine. We then moved him to the floor lifted his legs and supported his head and he remained there for about 20 minutes. He then sat up slowly and we monitored him sitting for another10 minutes. He we doing well. My intern then proceeded to help his dad walk them out to the car. The dad did NOT want us to call paramedics as this was a known issues with his son fainting after getting immunizations. Made a follow up phone call with patient after about an hour and half and dad said he was doing great.

healthy kid with no health issues or ever illnesses. woke up in middle of night day after 2nd vaccination with sever chest pain. he had shortness of breathe. checked blood pressure and pulse, and both were very high. gasped for air often kept him upright all night. As of 6/14 he is still slightly gasping for deep breathes and it is hard for him to concentrate. has pressure in chest. seeking pediatric cardiologist.

Patient was administered 2nd dose of Pfizer Vaccine at 3:30 PM. At exactly 3:37 PM, patient was seated in waiting area and was exhibiting symptoms, specifically circumoralcyanosis, turning blue around the mouth. Patient was also perspiring all over the body, (arms, face, etc) Patient was also warm and clammy. Patient was disoriented and unable to respond typically. 911 was called. Patient was given a sprite and could not hold the sprite independently. Directly after, blood pressure Pulse and oxygen levels were checked and were below normal. (Blood pressure - 54/47) (Pulse - 87 BPM). Patient then became more responsive and was able to say name and specified location upon asking. Within 5 minutes of 911 call, ambulance arrived and emergency response took over care. Patient was then transported to local hospital.

My son developed neck soreness and and an enlarged lymph node that weekend. On Monday following the vaccination a severe headache started which lasted 4 days, even with tylenol and ibuprofen. On Tuesday, he started complaining about not remembering what he did the day before when he woke up in the morning..memory started coming back around noon. The memory issues lasted one week and began to dissipate thankfully. After a few weeks got a call to schedule his second shot. Called the pediatrician and the pediatrician told us not to administer the second vaccine due to adverse reaction to the first. We are monitoring his memory issues..he is almost a straight A student in school last year and on an Advanced Learning Plan in high school due to high IQ. We will know if this is long lasting after attending school and monitoring his grades and headaches in the fall.

Starting from the night of the second day (i.e., June 10th), the patient feels chest pain. The pain also extends to neck and left shoulder. Deep breath aggravates the pain. The patient could not fall asleep. He had a light fever at the night of vaccination day but the fever was gone before the chest pain. Single lead ECG with Watch has been measured and sent to a friend of the parents' who is a physian, and no abnormal sign was shown from ECG. 400 mg Advil (ibuprofen) was given in the coming morning around 7 AM and the patient was able to fall asleep and symptons were gradually relieved. Another two doses of 200 mg Advil were given with six hours apart on the same day. The pain was gone by the following morning (i.e., June 11th) and no ibuprofen has been given afterwards. We suspect that this is related to myocarditis or pericarditis. This was the second dose of Pfizer COVID-19 vaccine. There was no symptons for adverse effect after the first dose.

Chest pain started 1 day after each vaccine dose, continued for 2-3 days after onset. Heavy squeezing pain felt mostly on the left side, sometimes on right, with no radiation down the arm. Pain prevented falling asleep. No exercise intolerance. Pain resolved and absent since 3 days post second dose. Heart rate 77 bpm, O2 sat 98% (6/18/21)

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

Patient felt like he was having an asthma attack on the night of the 21st when playing outside with friends (running and climbing). He has never had asthma, but said his chest was tight and it was hard to breathe. He said when he stopped and sat for a while it seemed to get better. He went to sleep at about 2am and woke me up at 5:20am crying. His chest hurt really bad and the pain was traveling down his arm. When we took his blood pressure at home it was 205/125 and his heart rate was 112. We went to the emergency room at hospital immediately. Once there they did an EKG. The doctor said there was not reason to be alarmed, but the EKG showed signs of possible pericarditis. They then took blood work, a urine sample, an xray and did an echocardiogram. The doctor told us that the blood work did not show any signs of an actual heart attack or any damage done to the heart. She said the echocardiogram showed some fluid build up in the pericardia sac surrounding his heart. She said this is considered pericardia. She mentioned that some young men are having this happen after being vaccinated. She said we seem to have caught it early. They gave him Tordal through his IV when we were there and that took his pain away. We were told to follow up with a cardiologist within 24-48 hours. We have an appointment at Hospital tomorrow at 10:45am.

days of left arm and 1 day of acute left side chest pain following 2nd administration of COVID-19 vaccine. Patient reports that 3 days ago, he received the 2nd COVID-19 vaccination (Pfizer ) in his left anterior deltoid area. Following this he developed diffuse body aches and headaches. On day prior to admission, patient developed fever at home with T-max 101.8° F. after going to sleep, he was awoken with nausea. Patient experienced episodes of vomiting, which he reported mostly consist of water, and also reported left arm and left chest pain at this time. He reports the pain felt like pressure and was a severity of 9/10. Patient also experienced numbness and tingling in his left hand. He attempted to take Tums and Motrin at home with mild relief of symptoms. Mother then brought patient in to Emergency Room. Patient denies syncope, no palpitations, pain does not worsen with deep breathing, pain unchanged by position.. emergency department course: Presented with temperature 99.7° F, heart rate 92, blood pressure 138/90, saturating 98% on room air. Laboratory work revealed elevated troponin, elevated CK-MB, and elevated creatine kinase. Chest x-ray was performed which was normal. EKG revealed normal sinus rhythm. Patient was transferred to our emergency room and subsequently admitted to the floor. Hospital Course: He was evaluated in Hospital Emergency Room and admitted to the floor for more close monitoring. His repeat labs showed elevated troponin and an echocardiogram was unremarkable. In view of the elevated troponin was case was discussed with the cardiologist who recommended a cardiac MRI which was performed which did reveal myocarditis, pericarditis. In view of this ICU service is consulted for admission closer monitoring further evaluation management.

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was given vaccine and walked to observation area, with mom. He sat down and few minutes later he started shaking, seemed to faint/was unresponsive. He slipped/was lowered to ground where he came to, but started vomiting. He vomited several times and was confused. 911 was called and the paramedics arrived. Water was offered by pharmacy staff, but was not taken. Paramedic stated to pharmacist that patient did not show signs of being post-seizure. Patient was put on strecther by paramedics

And is experiencing a fever of 102.5/temp is 102; Doesn't feel good; This is a spontaneous report from a contactable consumer (Caregiver). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0178), dose 2 via an unspecified route of administration, administered in right arm on 17Jun2021 as 2nd dose, single (at the age of 15-years-old); and previously received BNT162B2 (Lot/batch number: ER8733), dose 1 via an unspecified route of administration in right arm on 27May2021(at the age of 15-years-old) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included MELATONIN 10 mg, gummy, one at night. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no family medical history relevant to adverse event (AE). On 18Jun2021 12:00 (Today, around noon), patient doesn't feel good and experienced fever of 102/102.5. It was reported patient received Tylenol last about 15 minutes after temperature measurement. Patient had laboratory test included Vitamin D and some kind of hormone: Vitamin D is within normal limit on unknown date; and body temperature on 18Jun2021: 102/102.5. Therapeutic measures were taken as a result of events with Tylenol. The outcome of events was recovered on an unspecified date in Jun2021. Information on the lot/batch was available, Additional information has been requested.

Bloody noses/ Nose bleeds; Runny nose; headache; Little bit of Asthma; Her grandson is nervous about this; Pretty upset; This is a spontaneous report from a contactable consumer or other non hcp (the patient's grandmother). A 15-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 13Jun2021 as single dose for covid-19 immunization. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date in May2021 as single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On 14Jun202, the patient had a headache and a runny nose and then the following day the patient had 4 bloody noses during the day and one at night. The patient is continuing to have bloody noses. On an unknown date in Jun2021, the reporter also stated that the patient might have a little bit of asthma. The reporter mentioned that the patient was pretty upset, nervous and he had the nose bleeds they are a lot, not just a little drip. The patient was treated with Advil for headache. The outcome of the events nose bleeds was reported as not recovered; runny nose was reported as recovering while other events were reported as unknown at the time of report. Information on the lot/batch number has been requested.

He received his 2nd dose of COVID vaccine (Pfizer) on 6/19. He developed a fever on 6/20 which lasted for a day. He then felt better on 6/21. Then, on 6/22 at 1am, he woke from sleep due to chest pain. It was sharp and did not radiate anywhere, and not reproducible. He took 400 mg ibuprofen which improved his pain somewhat. Denies any other fever, rhinorrhea, cough, SOB, difficulty breathing, n/v/d, dysuria or difficulty with urination. Admitted 6/22 due to elevated troponin and abnormal EKG. Troponin leak and MRI with findings consistent with myocarditis. Had NSVT x 4 beats on 6/22. He was treated with 5 days of Motrin 600 mg ATC.

Pupils dilated and he couldn't see.; Pupils dilated and he couldn't see.; shaky; rigid; and was very hot to touch; This is a spontaneous report from a non-contactable consumer (patient). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0202), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jun2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. No medical history was reported. Patient had no known allergy. Other medical history was none. No concomitant medication was reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced pupils dilated and could not see, shaky, rigid, and was very hot to touch on 05Jun2021. This was within a few minutes of receiving the vaccine and lasted about 20-30 minutes. Seriousness criteria was reported as no. As AE treatment, Pharmacist used cold compresses and gave him juice. The outcome of the events were recovered on 2021. No follow-up attempts are possible. No further information is expected.

7/7-7-8 high fever, 7/8 midnight woke sweating couldn't sleep stated felt like someone was shaking his head so hard that his brain was bouncing in his skull. Following day 7/9 , brain shaking incidents occurred off and on all day for a minute or so in duration, 7/10 had 3 incidents less duration less severe, 7/11, 1 incident less severe than previous day. Extremely fatigued as well. Seeing pedetrcian 7/12.

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

Patient had a vagal response caused by an anxiety attack due to fear of needles. Technician, gave the vaccine and then immediately called me in. The mother and son were worried about the needle disappearing due to the retraction mechanism. The son was loosing color in his face and becoming dizzy. I had him sit upright, talked with him for a few minutes, gave him Benadryl as a precaution, and checked his blood pressure. He was having no difficulty breathing and blood pressure was WNL. His mother said that he has passed out with needles before and that he had not eaten today. Eventually the patient claimed to lose his sight, and within 30s passed out. He was still sitting in the chair, bent over, vomited, and then immediately came back to consciousness. The patient then said that he felt fine and wanted to leave. I talked with him and his mother for around 20 minutes, had him eat a banana, and drink a full bottle of water. After the time, he felt fine and him and his mother left.

Seizure. I found my son on the sofa, twisting his body, pale, sweaty, weak, confused, and staring into space. I had to call 911.

covid_test_name_post_vaccination=PCR covid_test_result=Positive; Condition worsen; pericardial effusion; develop GI; Heavier Insomia; dierrea; vomiting; fever; Headache; Hypotensive; Dehydrated; Developed into MISC; Patient said he had 4 vaccines; PCR resulted as positive on 17Jun2021 Nasal Swab; This is a spontaneous report received from a contactable other-HCP (father) reported for old son (patient). A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173 F) via an unspecified route of administration in left arm on 07Jun2021 as dose 2, single for COVID-19 immunization. Medical history included ongoing known allergy in mosquito bite (sketter syndrome) an allergic reaction to mosquito bites, as his son has grown up it has become less and less relevant. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Dose:01 Lot number: EW0171 Anatomical Location: Arm left) on 17May2021 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations dates of birth or immunizations are not available. It was reported that my son traveled on 16May2021. Covid test prior traveling negative. On Jun2021, 4 days after vaccination develop GI, heavier insomia, dierrea, vomiting, fever, hypotensive, dehydraeted. On 11Jun2021 experienced pericardial effusion. On an unknown date Jun2021, developed into MISC and was intubated. The patient was hospitalized from 14 Jun 2021 to 6 Jul 2021. Treatment was received. On 15Jun2021, admission at (withheld), (Hidratation IV and IVIGs). On 16Jun2021 condition worsen and Intubated in (withheld). On 17Jun2021, transfer to (withheld) (7 days at PICU, another 7 at pediatrics). On Jun2021, developed a strong insomnia and headache. Events resulted in emergency room/department or urgent care. Treatment received for the adverse event was MISC protocol IVIGsAnakinra, esteroids and others. On an unknown date, Patient said he had 4 vaccines. His son spent 7 days in the ICU and 7 days in the pediatric unit was discharged from the hospital yesterday. Reported that other researchers studying MIS-C in children have seen how the epithelium cells in the intestine become loose, then the protein goes through the blood stream and can start a cytokine storm and asked if we have studies regarding how much S protein is being produced by different age groups; can it be checked how much S protein is going into the bloodstream to see adverse effects of the vaccine and stated he needs more data to see if his son was possibly infected with Covid during his vaccination period or what he previously infected and absolutely asymptomatic. Most MIS-C occurs 4-6 weeks after having Covid. States that for his son to travel he had to have antigen testing, which was negative. His son did well until 3-4 days after the second shot. States at that time his son became ill with vomiting, diarrhea, headache, and insomnia. She took her son to the hospital and they found him to be hypotensive and dehydrated. They started intravenous fluids and their protocols; the hospital did not have all the required medications for their son and recommended he be transferred to (withheld) Hospital. He was very tired and they decided to put him on ventilation for the ambulance drive. States that when they arrived in (withheld), his son was placed in ICU where he was on the ventilator for 5 days, the recuperating for 2 more days. His son was then moved throughout the hospital system until his discharge yesterday. His son's insomnia may have started before he left for the (withheld). States that it was worsened after the vaccine, his son mentioned after his hospitalization that he was actually given 4 shots the day he got his vaccines, assumed it to be some kind of delirium from his son being in the ICU for so long, stated he told his son that was not possible that he got 4 vaccines at once because of the paperwork you have to fill out to get the vaccine, the lady at the vaccination site told him to sit down and then gave shothim four shots. The patient underwent lab tests and procedures which included IgG and IgM resulted as positive on 15Jun2021, PCR resulted as negative on 15Jun2021 Nasal Swab, PCR resulted as positive on 17Jun2021 Nasal Swab. The clinical outcome of the event developed MIS-C and was intubated, vomiting, dierrea, headache, insomnia, hypotensive, dehydrated on an unknown date 2021 was resolved and the event pericardial effusion, develop GI, fever was resolving, the event condition worsen, Vaccination failure, patient said he had 4 vaccines and PCR resulted as positive on 17Jun2021 Nasal Swab was unknown; Sender's Comments: Based on the limited information currently available, the causal association between the event Insomnia, Diarrhea, vomiting, fever, Drug ineffective, COVID-19, Headache, overdose and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Multisystem inflammatory syndrome in children, Pericardial effusion, Gastrointestinal inflammation, Condition worsened, Hypotensive, Dehydration and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

Received 1st dose of Pfizer Covid Vaccine and started becoming increasingly manic within about an hour. Complained of stomach discomfort. Became increasingly anxious and manic and was only able to sleep for two hours (received at 4pm, slept from 12am to 2am). Awake and manic the day following. Complained of stomach pain. Eating normally with no other symptoms. Started complaining of being cold and chills. Applied rotating heated blankets until he feel asleep about 10pm. Woke up at 2am. Manic and anxious. Stomach started swelling more and becoming rigid. Gave him Miralax. No change in swelling. Increased stomach pain. Gave him a suppository. Immediate small bowel movement. After two more hours and no change in swelling, gave a second suppository. Immediate small bowel movement. Stomach becoming distended and complaining of increased pain. Took him to the ER. Pain amplified on the way. Admitted to PICU after EKG in ER. Quickly declined and went into respiratory failure. Right lung had no air exchange and left lung collapsed. Myocarditis, pleural effusion, kidney damage and new onset Type I diabetes. Unexplained pneumonia. No growth from fluid in lung.

Patient lost consciousness two times, one on 06/28 and the second one on 07/15. First time patient felt dizzy/nauseous, blurred vision (loss of color), loss of hearing, and then loss of consciousness. The patient woke up 5 minutes after. Patient felt slight confusion with no adverse effects after. Second time patient almost lost consciousness three times before finally losing consciousness. First time patient loses consciousness for less than 3 seconds before waking up. 3 minutes later patient felt dizzy before losing consciousness for less than 3 seconds. 6 minutes later patient felt dizzy before losing consciousness for less than 3 seconds. Less than 1 minute later patient felt dizzy and nauseous before losing consciousness for 1 minute. After waking up patient felt slight confusion with no adverse effects.

I don't know if any of his adverse events are related I wanted the CDC to be aware. He started feeling uneasy, unwell, vomiting, itchy ears (both), upper chest pain, upper back pain and difficulty breathing. We went to the ER at 17:00 - 22:00 on 7/18 was discharged couldn't figure out what was happening was given medication for migraine, Benadryl, Loratadine.

neither she nor her husband could wake up their son for school; Her son was not coherent this morning; This is a spontaneous report from a contactable consumer (parent) or other non hcp. A 15-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0171, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21May2021 16:00 (at the age of 15-Years-old) as dose 1 single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. AE not resulted in visit to emergency room or physician office. No AE following prior vaccinations. No family history relevant to AE provided. The patient experienced neither she nor her husband could wake up their son for school and her son was not coherent this morning on 25May2021. Caller stated her 15-year-old son received the first dose of Pfizer's COVID vaccine on Friday, 21May2021 with no symptoms, fever, or discoloration. Caller stated, my son has been sleeping for the last 13 hours (he slept at midnight). This morning we could not wake him up for school for 3 hours. patient mother said her son had no symptoms after receiving his first COVID-19 Vaccine, but on 25May2021, neither she nor her husband could wake up their son for school. She said her son was just getting up now after 1:00PM. She said both she and her husband tried to wake their son up over a couple hours, and it was impossible to wake up their son. she wanted to know if what her son experienced was related to the COVID-19 Vaccine, and if there were any other symptoms she should watch for. she said she and her husband tried waking their son by taking down their son's blankets and shaking him. She said her son was not coherent this morning. She said neither she nor her husband were that concerned that their son was in danger because their son was breathing fine and had no fever. Caller was advised she would be transferred for further assistance. Reported her son had some diagnostic testing coming up on Thursday (27May2021) for ADHD, or anything else with that. she felt that her son's ADHD testing was more adolescent related. No further details provided. Reported her son woke up after 1:00PM and came out of his room to ask to use his phone, and then he went back into his room. No relevant tests were reported. The outcome of the reported events were recovered. Follow-up (26Jul2021) No follow-up attempts are possible. No further information is expected

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt's dad noted he was well when recieving vaccine however when they were in line in the coffee shop area of the store pt leaned against dad with light headedness as if to faint. Store staff called 911 and I rushed over and took pts vitals which were normal with bp 115/72. Pt sipped some water and when I asked if he had eaten today he responded no (215 pm) his dad also reported he had just woken up and doesnt follow a sleep schedule. I was able to offer him some juice which improved his weakness

pt had shot and went to sit for observation period. when period was almost over mom noticed pt looked asleep and just not right. she tried shaking him and he seemed groggy and unoriented. called for nurse and we checked him then took him to ER. symptoms seemed most consistent with vagal syncope so epinephrine was not administered.