Reporte zur Charge FL 8094

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COVID + 10/24/22 . Vaccination status - Pfizer x2 BRIEF OVERVIEW: Discharge Provider: MD Primary Care Physician at Discharge: MD Admission Date: 10/24/2022 Discharge Date: 10/27/2022 Active Hospital Problems Diagnosis Date Noted POA ? Influenza A 10/25/2022 Yes ? COVID 10/25/2022 Yes ? Autism 08/16/2016 DETAILS OF HOSPITAL STAY: Dehydration Viral pneumonia Hypoxia HOSPITAL COURSE: Patient is a 9 y.o. male with PMHx autism spectrum disorder and HIE who was admitted on 10/24/2022 for acute hypoxic respiratory failure and moderate dehydration secondary to Covid-19 and Influenza A coinfection. The patient presented on 10/24/2022 to hospital after 6 days of lethargy, fever, cough, and headache. He was tachypenic and hypoxic on arrival requiring 2L NC. He was also given two NS boluses for dehydration after failing a PO challenge. Film array was positive for both Influenza A and Covid-19. CXR revealed peribronchial thickening consistent with his viral illness. He was admitted to the hospitalist team for further care. Patient was treated with Tamiflu and Decadron. After consultation with Infectious Disease, Remdesivir was also begun in the setting of Covid-19 positivity and hypoxia. The patient was supported with supplemental oxygen and maintenance IVF. He was successfully able to be weaned from supplemental oxygen approximately 24hrs prior to discharge. At the time of discharge, the patient was hemodynamically stable and on room air. His PO intake was increasing. He was discharged with a two day course of Tamiflu to complete a total of 5 days of treatment. All parental questions and concerns were addressed prior to discharge. CONSULTS/RECOMMENDATIONS: Infectious Disease - Use Remdesivir for the duration of admission

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Chief Complaint Neurologic problem (Complaint of) Arrival Date/Time: 01/21/2022 13:05:00 History of Present Illness 5 yo M with hx of autism (non-verbal) presenting with unresponsive episode. Pt was in usual state of health last night when he received his 2nd COVID-19 vaccine. He awoke today with fatigue and malaise that seemed to improve so pt went to school where he was sent home for malaise and fever (temp unknown). After arriving home, father went to change his pull up and while laying down pt was unresponsive and drooling and did not appear to be breathing. His eyes were open and rolled backwards. He appeared limp. No rhythmic jerking but family did say he seemed shaky earlier today. He turned blue during the episode so family called EMS and when police showed up, cyanosis resolved and pt had rapid, shallow breathing. He was sleepy afterwards but slowly improving. POC glucose 185 en route. PIV placed. No meds or interventions performed. Tachy en route 140-150's. He was given tylenol earlier today. PMHx: Autism (non-verbal) Home meds: None. NKDA FMHx: NO hx of seizure or febrile seizure. Social Hx: Lives with family. Attends school. Review of Systems General: +fever, +decerased appetite today Neuro: no headache or focal weakness. Skin: no rashes, bruising. HEENT: no vision changes, nasal congestion, sore throat. Cardiac: no chest pain. Respiratory: no cough, difficulty breathing, shortness of breath. GI: no recent nausea, vomiting, diarrhea. GU: no dysuria, hematuria. MSK: no joint pain or swelling. 10 ROS reviewed and otherwise negative Physical Exam Vitals & Measurements T HR RR BP Sp02 First Set 37.4 DegC (01/21/22 13:15:25) 140 bpm (01/21/22 13:25:13) 28 br/min (01/21/22 13:25:13) 121/63 mmHg (01/21/22 13:25:13) 100 % (01/21/22 13:25:13) VS as above. GEN: sleepy, non-verbal, intermittently follows commands. No acute distress. HEENT: PERRL, clear conjunctiva, oropharynx clear, moist mucous membranes. NECK: supple, full neck ROM. No LAD. CV: RRR, no murmurs. RESP: CTAB. ABD: soft, nontender, non-distended. EXT: warm, well perfused. NEURO: Moves all extremities equally. He is unable to cooperate with strength exam but full strength in lower extremities noted when touching his feet. Normal gait but slow. Normal balance. No tremors. Medical Decision Making 5 yo M with autism (non-verbal) presenting with unresponsive episode with cyanosis in the setting of malaise and fever post-COVID vaccine last night. DDx: febrile seizure, epileptic seizure, syncope, arrhythmia, myocarditis (post-vaccine), acute COVID-19 infection. Plan: chemistry, troponin, EKG, ibuprofen, COVID PCR, observe Reexamination/Reevaluation 15:45 - Pt is still sleeping. Feels warm to touch. HR downtrending. Labs significant for mild hyponatremia (Na 134), neg trop, neg rapid COVID/FLU/RSV PCRs. EKG normal. Will continue to observe to re-assess after waking. 16:57 - Pt is awake, alert and at baseline. Eating a banana. Care instructions and return precautions given to family. Family will follow-up with his primary Neurologist. Given this was a simple febrile seizure, he does not require Neuro consultation in ED or urgent EEG/imaging. Final Diagnosis 1. Febrile seizure Additional information for Item 19: Problem List/Past Medical History Ongoing Autism Global developmental delay Low muscle tone Relative macrocephaly Historical No qualifying data Procedure/Surgical History No Procedure History Family/Social History Basic Social History Living Arrangement Parent(s)/Guardian. Legal Guardian: Parent. Lives With: Mother, Father, Sister. Language Spoken at Home. Medications Prescribed This Visit Prescription No prescriptions for this encounter Allergies No known allergies Most Recent Results Current Encounter Lab Results - Current Encounter Sodium: 134 mmol/L Low (01/21/22 14:32:00) Potassium: 4.38 mmol/L (01/21/22 14:32:00) Chloride: 102 mmol/L (01/21/22 14:32:00) CO2: 20 mmol/L Low (01/21/22 14:32:00) Anion Gap: 12 mmol/L (01/21/22 14:32:00) Glucose Level: 99 mg/dL (01/21/22 14:32:00) BUN: 11 mg/dL (01/21/22 14:32:00) Creatinine: 0.35 mg/dL (01/21/22 14:32:00) Calcium: 9.4 mg/dL (01/21/22 14:32:00) Phosphorus: 4 mg/dL (01/21/22 14:32:00) Magnesium: 2 mg/dL (01/21/22 14:32:00) Troponin T: <0.01 (01/21/22 14:32:00) SARS-CoV-2 POCT: BINEG (01/21/22 14:32:00) Influenza A POCT: BINEG (01/21/22 14:32:00) Influenza B POCT: BINEG (01/21/22 14:32:00) RSV POCT: BINEG (01/21/22 14:32:00) Diagnostic Results EKG: sinus tachycardia, normal intervals, normal axis. rsR' in V1 which is likely normal variant. No pre-excitation, WPW, Brugada, or prolonged QTc.

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COVID-19 vaccine (Pfizer 5-11 years old; Lot # FL8094) administered to client at 3:00pm. While this 8 year old client is waiting for the end of the 15 minute observation period, at 3:10 pm, client stood up from her mother's lap and told her that she "couldn't see", and stumbled sideways, hitting her head on a wooden panel in the hallway. Mother stated she guided child slowly to lay her down on the floor, client stating "I don't want to die, I want to stay with you mom." Mother reported to the nurse that she saw her child hit the back side of her head on the wooden panel after she stumbled. Child was immediately assessed by the nurse, child is observed to be pale, however conscious and has her eyes open. Child was crying and seemed scared with this occurrence. Nurse checked the child's head for any injury or swelling, none noted at this time. Assisted child to the wheelchair and brought into the exam room, assisted the child to transfer to the exam table and laid her down for further observation. Vital signs checked at 3:16pm - Blood Pressure 135/90 mmHg; Pulse 110 bpm; Respirations 20, Oxygen Saturation via pulse oximeter 97%. Patient is alert and oriented to name and place, in no respiratory distress, denies any dizziness, and reported slight pain where she hit her head. Nurse re-assessed patient's head for any injury or swelling, none noted at this time. Ice pack placed on the client's back side of the head to provide comfort. Physician on site was notified immediately for further assessment. MD further evaluated the client, per MD no visual or palpable injuries noted on the patient's head or any other parts of her body noted at this time. Client is noted to be pale. Client reported that her last meal was breakfast time at school. MD recommended to observe client for 30 minutes more in the clinic. Mother reported that prior to today's vaccination, child was feeling anxious about COVID-19 disease and vaccination due to what is heard and seen in the news/media. Mother stated that this is the first time that the client had this kind of reaction after a vaccination, and feels that this occurrence is related to child's anxiety to current events. Vital signs re-checked at 3:28 pm Blood Pressure 125/69 mmHg; Pulse 116 bpm; Respirations 16; Oxygen Saturation via pulse oximeter 99%. After 30 minutes, client is observed to regain her normal color, talking more and is alert and oriented to name, time, and place, denies any headache, nausea, or dizziness. Nurse re-assessed client's head, no visual or palpable injuries noted at this time. On-site physician advised mother to follow-up with child's PMD as soon as possible, and to continue to observe the child for any headache, nausea, altered mental status, or sleepiness, if any of these occur to call the emergency number or take the child to the nearest Emergency Room as soon as possible. Client is ambulatory with a steady gait, discharged to home, accompanied by mother and sister.

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Per Mom, immediately after vaccine he began experiencing headache. On Monday he began experiencing right sided facial drooping that has progressed over last 2 days to abnormal/ drooping smile, inability to close right eyelid. Pt denies any pain. Speech and vision WNL. Pt states he is numb in certain spots on face. Denies fever/chills, URI symptoms, N/V/D, abdominal pain, rash, decreased urination, paralysis of upper/lower extremities. This has never happened to pt before. No known sick contacts. No known tick bites.

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About 5 minutes following administration of the vaccine, patient was walking and fainted. Quickly came to after lying down, taking soda and crackers.

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Patient presented to office for her second covid vaccine. Pt received covid vaccine and was waiting in the check out area with her Father. Pt's father was talking to one of the Providers when patient passed out. Pt was lowered to the floor by the provider and did not hit her head. Provider was able to be arouse patient after about 20 seconds. 911 was immediately called by clerical staff at the front desk. Pt was taken by ambulance to Med Center to be evaluated. VS-99.0-100-22-97/67. Blood sugar was 84.

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This patient came into the vaccine clinic for her SARS-COV-2 (COVID-19) - PFIZER (5 years through 11 years) booster. She received it at 9:05 per documentation. She left the clinic ambulating. While her mom was driving away through the parking lot, she noted her daughter shaking, and let out a couple of gasps then loss consciousness in back seat of care, mom denies patient hitting her head. She awoke as mother was carrying her back into the vaccine clinic. The patient arrived being carried by her mother. Placed in the observation area of the vaccine clinic in a reclined chair, reclined as far back as patient would permit. Patient was pale, cool, and clammy to the touch, but alert and conversing. 0915 vital signs: B/P 117/83 Pulse, 101 regular rate and rhythm, R.18 regular rate and rhythm, O2 sat 99%, 0945:T 36.6. Taking sips of Apple juice 5 minutes after arriving, stomach feeling uncomfortable, declined graham crackers. Discussed with mom about initiating EMS, she declined does no think it was a seizure as she had at first. No loss of bowel and bladder. Patient has had two fainting episodes after vaccines, the last episode was 2 years ago, mom was not present for those fainting spells or the recovery after the fainting 0945- feeling dizzy if closes her eyes. Leaving eyes open, remains pale evidenced per moms observation of her daughter having darker circles under eyes (patient is very light skinned as well), not cold or clammy at this time. Elevated feet more with pillow under legs, sitting calmly with mom conversing. 0952- Accepted graham crackers, taking bites, and sipping apple juice. 1015- moms stated patient is feeling like herself, patient demeanor has changed, conversing more, smiling, feet curled up under her self while sitting in chair. Stood up no complaints of dizziness or imbalance. O2 Sat 100% P. 92. 1022- Mom and patient feel ready to leave. Patient ambulated on down the hall and out the clinic door her own, mom and nurse walking beside her, no loss of balance. Signed: Show: Clear all. Written Templated Copied. Added by: assisting R.N.. Hover for details added by assisting R.N. at 7/29/2022 9:34 AM. This patient came into the vaccine clinic for her SARS-COV-2 (COVID-19) - PFIZER (5 years through 11 years) booster. She received it at 9:05 per documentation. She left the clinic ambulating. While her mom was driving away through the parking lot, she noted her daughter shaking, and let out a couple of gasps then loss consciousness in back seat of care, mom denies patient hitting her head. She awoke as mother was carrying her back into the vaccine clinic. The patient arrived being carried by her mother. Placed in the observation area of the vaccine clinic in a reclined chair, reclined as far back as patient would permit Patient was pale, cool, and clammy to the touch, but alert and conversing. 0915 vital signs: B/P 117/83 Pulse, 101 regular rate and rhythm, R.18 regular rate and rhythm, O2 sat 99%, 0945:T 36.6. Taking sips of Apple juice 5 minutes after arriving, stomach feeling uncomfortable, declined graham crackers. Discussed with mom about initiating EMS, she declined does not think it was a seizure as she had at first. No loss of bowel and bladder. Patient has had two fainting episodes after vaccines, the last episode was 2 years ago, mom was not present for those fainting spells or the recovery after the fainting. 0945- feeling dizzy if closes her eyes. Leaving eyes open, remains pale evidenced per moms observation of her daughter having darker circles under eyes (patient is very light skinned as well), not cold or clammy at this time. Elevated feet more with pillow under legs, sitting calmly with mom conversing. 0952- Accepted graham crackers, taking bites, and sipping apple juice. 1015- moms stated patient is feeling like herself, patient demeanor has changed, conversing more, smiling, feet curled up under her self while sitting in chair. Stood up no complaints of dizziness or imbalance. O2 Sat 100% P. 92. 1022- Mom and patient feel ready to leave. Patient ambulated on down the hall and out the clinic door her own, mom and nurse walking beside her, no loss of balance.

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Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Caregiver went limp following the vaccine and fainted, for report 10 seconds. Patient was clenching hand and looked to be having a mild seizure. No history of seizure or adverse effects of to any vaccines Patient did not fall or hit head. Patient states felt disease and began to black out. After 10mins patinet reported felt shaky and had a small headache

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The father informed that his daughter was diagnosed with bel Palsy on 07/13/2022

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lost consciousness; went pale; chest pain; vomited; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 9-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 at 13:00 as dose 3 (booster), single (Lot number: FL8094) at the age of 9 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Single, Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Dec2021, when the patient was 9-year-old, for Covid-19 immunization; BNT162b2 (Dose 1, Single, Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 10Nov2021, when the patient was 8-year-old, for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown"; LOSS OF CONSCIOUSNESS (medically significant) with onset 24Jun2022 at 13:00, outcome "recovered" (24Jun2022), described as "lost consciousness"; VOMITING (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown", described as "vomited"; PALLOR (non-serious) with onset 24Jun2022 at 13:00, outcome "unknown", described as "went pale". The events "lost consciousness", "went pale", "chest pain" and "vomited" required emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram: (Jun2022) Unknown results, notes: given an EKG. Therapeutic measures were not taken as a result of loss of consciousness, pallor, chest pain, vomiting. Clinical course: It was reported that, the other vaccine in four weeks and other medications in 2 weeks was None. Adverse event: Moments after receiving the shot, he went pale, had chest pain then lost consciousness. Paramedics were called. He was unconscious for a minute of two and when he woke, he vomited. Upon sitting up, he vomited again. Under paramedic advice, he was taken to the ER where he was observed, given an EKG and sent home. Covid prior vaccination and Covid tested post vaccination was None. No Known allergies reported and other medical history was None.

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Patient received 2nd dose of Pfizer Ped. After the injection, patient sat down and after about a minute fainted. The father of the patient picked him up and the patient had a spasm upon waking up. The patient was seated again and 9-1-1 was called. The patient said he felt a little dizzy and had a headache. The EMT's came and evaluated the patient and the blood pressure was low. After sitting for about 30 minutes patient felt better and the parents took the patient home. They will follow up with the patient's pediatrician.

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Patient fainted shortly after receiving vaccine (roughly 4-5 min)

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During post observation period after administration of the first dose of Pediatric Pfizer 0.2ml, pt seem to have fainted. Mother moved pt to the floor, and mother believed son had some sort of convulsions before pharmacist was able to attend. By the timepharmacist ran to the scene with the immunization cart, patient had already came out of syncope. 911 was called, and pharmacist administered 10ml (25mg) of oral diphenhydramine. Approximately 5 minutes after event occurred and was witnessed by sibling who also received their 1st dose of Pediatric Pfizer, sibling also stated she felt dizzy and sick, and maybe a little swelling around lining of mouth. Once ambulance arrived, the patient and pt sibling were checked out by paramedic staff. Blood pressure waswithin normal parameters. Patient was taken in ambulance to hospital for further observation. Will follow up with pt mother via phone.

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Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe

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Syncope

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, Additional Details: Patient passed out while RPh was signing his brother's immunization card. He fell on the chair but RPh got hold of him before he was on the ground. Patient remained conscious the whole time, immediately responsive, complained of dizziness and tiredness. Paramedics were called. All vitals were normal. Mother chose not to go to the ER as all seems well after about 5-10 mins. Patient was given some cold water by mother. He then regained full strength about 30 mins after the incident.

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collapse and drop in BP

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Pt fainted after getting up from seat and taking a step after receiving the covid vaccine

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Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium.

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Patient developed symptoms of MISC on 1/9/22; fevers began on 1/10/22 with a Tmax of 40.8 degrees Celsius. Over the course of illness, symptoms and complications included fevers, shock, sinus tachycardia, hypotension, cough, abdominal pain, rash, mucocutaneous lesions, headache, neck pain, and cervical lymphadenopathy. Abnormal labs included elevated transaminases, thrombocytopenia, elevated NT-ProBNP, elevated CRP, elevated ferritin, and elevated D-dimer. ECHO studies showed trivial mitral regurgitation. Patient was admitted to the hospital on 1/12/22 and treated with IVIG, infliximab, norepinephrine, and high flow nasal cannula. She was admitted to the ICU from 1/12/22 to 1/14/22. She was discharged on 1/16/22.

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Client was observing her sibling receive a vaccine. Client then had a vasolvagal response about 5 minutes after her COVID-19 vaccine. She fell to the ground and hit her head. The client become oriented seconds after the event occurred. No visible trauma was observed. Both parents were in the room at time of the event.

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Myocarditis - treated with hospital confinement, monitoring, Motrin. Overnight stay in the hospital.

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Vasovagal Syncope. Patient lost consciousness briefly and fell off chair but recovered instantly.

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Patient passed out about 5 minutes after vaccine administration. He was caught by his dad, came to pretty quick, and was no longer dizzy. Called EMS just incase.

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patient came in with her family to receive her second dose covid pfizer pediatric vaccine. Patient received her vaccine around 12:10 pm. She stood up and moved towards wall to stand with mom and sister, so her dad could sit to get his pfizer booster vaccine. around 12:15, there was a bang/thud and patient slumped to the floor. The mom picked her up and put her on dad's lap, and found she had passed out and hit the back of her head against the wall. The patient came to on her own and started crying. She was scared, complained back of her head hurt and that her tongue was numb. She was given an ice pack for her head and a bottle of water. Patient was able to take sips of water. we offered to call ambulance, family declined. Patient stayed in our immunization room for observation for 30 minutes. Patient had no issues breathing/swallowing. we suggested that she be seen by a medical professional, the mom said they would watch her. We then suggested at least contacting family doctor. The family then went to the food court to get some food. Checked on the patient, she was no longer crying, she was sitting on her own and eating. Again had no complaints of breathing or swallowing issues. Called mom around 5:50 pm, no answer, left a message checking up on patient. It is unknown as of today if patient seeked medical care.

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Per the patient's mother, the patient became dizzy and must have blacked out, fell off the bench and hit the right side of her head on the ground. A loud "thump" was heard. The mother immediately picked up her child and witnesses stated the patient started to seize in her mother's arms. This occurred about 8 minutes after being vaccinated. As soon as I ran out, the patient had appeared to have stopped seizing. We laid her on the bench in a supine position. Patient stated her head was sore. No bleeding or inflammation of the area was present at the time. The vaccine was given around 12:32pm. A cold compress was applied to the right side of her head around 12:42pm. At this point, patient stated her head wasn't sore anymore so the compress was removed. Around 5 minutes later, patient stated her right eye was sore and it appeared to be turning red with a little inflammation forming so the cold compress was placed on her right eye. Patient stated the cold compress made it feel better. Management and EMS were alerted when the event had occurred. EMS had arrived approximately around 12:50pm and transported the patient to the hospital. Spoke with the mother an hour later and she stated patient is doing okay and is waiting to get released from the hospital.

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While monitoring patient post COVID19 vaccine, approximately at 5:10pm patient started to have rapid eye movement. According to personal RN that accompanied patient gave prn ativan after 3 minutes of sz activity. Patient coloration or breathing did not change. Patient is globally delayed at baseline. He also has a known history of at least 1-2 seizures per day. Mother states that he did not have this activity with his last dose fo the COVID19 vaccine. Private Duty RN states that he is tired, and has had a hard day with 4 appointments and little food. Reviewed stress triggers for epileptic patients. Mom and private duty RN stated understanding. As a precautionary measure and concern for possible reaction to COVID19 vaccine, on call provider notified of patient condition change. Dr. visually assessed patient and reviewed care. VS 98/53 HR 65 02100% on 2LNC temperature 97.8F at 5:20pm. 5:22pm patient WNL for health condition. Last set of VS taken prior to leaving observation area post covid vaccination were: HR 65, 100% sp02 on 2LNC, BP to L Up Extremity was 103/61. Temperature 97.7 axillary, No signs of visual distress. Reviewed education for EMS and ED warning signs related to increased seizure activity and possible COVID19 reaction concern. This included facial, lip swelling, upper airway noises, increased seizure activity unresolved with seizure regimen and abnormal to patients baseline seizure activity, coloration changes, swelling or widespread rash, difficulty breathing, shallow breathing, and increased oxygen needs or other concerning signs that warrant urgent care. Mom and private duty nurse stated understanding and left at 5:35 pm.

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Immediately after receiving vaccine, patient slumped over. Dad said she never lost consciousness. She started shaking/convulsing for about 5 seconds. At that point I requested we call 911. A technician was able to speak with EMS and direct them to the store. While waiting, patient began speaking with dad. She was able to answer his questions. She began to develop a rash on her arms. At that point EMS was arriving. All over the course of about 10 minutes.

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near fainting pale lips dizziness

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Vasovagal syncope following administration of the vaccine. Within 1-2 minutes of getting the vaccine the patient said she felt dizzy, fell to the ground and then quickly (less than 10 seconds) regained consciousness once laying down. She remained for extra post-vaccination observation but had no other signs or symptoms.

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Patient fainted shortly after his brother but he clenched up and told his mom and she was able to catch him so he did not hit his head on the floor. His parents were able to lay him on the floor where we used an ice pack and wet towels to cool him down since he felt very hot. He drank a bottle of water and his brother got him a sprite. He was not interested in crackers. Shortly after he got up from the floor to the chair, he stared straight ahead and started to have a seizure briefly with his parents holding on to him. He was finally able to speak a few seconds later and we laid him on the floor on his side in case a second seizure happened to prevent any aspiration. EMS was contacted and they arrived to assess his vitals and he began feeling nauseas. He was taken by stretcher to the hospital to be assessed there.

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Patient passed out and fell to the floor hitting the back of his head before anyone could catch him. He said his vision got black and fuzzy and he fainted. We gave him a bottle of water, family got him a soda, and he ate a few crackers. After he sat up in the chair we iced the bump on the back of his head and took a wet paper towel to put on the back of his neck and face. He felt really hot initially and pale throughout the time sitting there for about an hour. He was able to walk out without any other issues than the bump on the back of his head.

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Right Bells Palsy, mild

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A few minutes ( 5 -10 minutes) after the vaccine was given, the patient was in the waiting area getting her coat on. Her grandfather was assisting her when she felt dizzy and her vision turned black. She then fell to the ground, but did not lose consciousness. The patient was pale and was seated in a chair. She waited another 30 minutes in our waiting room and then felt good enough to go home.

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Client experienced syncopal episode immediately following vaccination of 2nd dose of (PEDS) pediatric 0.2cc IM Pfizer vaccine; client was sitting upright talking with vaccinating nurse and mother when became lightheaded, fell from chair onto floor; never lost consciousness; parent with client, moved to wheel chair and moved to EMS tent. Monitored for 30 minutes. Provided popsicle and water. Symptoms resolved and left with parent.

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date of 2nd vaccine was 1/12/22. That night the patient awoke in the middle of the night crying around 2am. Between 4-5 am patient became dizzy, belly hurt, headache. Febrile up to 104.9. Given Tylenol at 0545. Unwitnessed seizure lasting 2 mins at home followed by witnessed post-ictal state. Brough to ED. Vomited once. Second seizure in ED while being evaluted. Less than one minute duration. No abortive medications given.

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Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted and hit her head on immunization chair and floor.

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The patient received the vaccine and I directed her and her mother to be seated for 15 minutes for observation. Shortly after that the mother approached me and asked if it was normal for a child to be dizzy and weak after the vaccine. She also said that her daughter passed out. I checked her BP and it was 74/53. Ten minutes later I checked it again and it was 84/56. Ten minutes after that it was 81/63. I recommended that we call 911 to be sure she was ok and the mother agreed. I called 911 and the fire department and then the ambulance came and took over.

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seizure 3 days later

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Patient was administered his first dose of the pfizer covid vaccine on 1/5/22 at around 5:20pm. About a minute or two after receiving the vaccine, patient's mom was about to receive her pfizer booster vaccine and patient was standing outside our booth and suddenly fainted and hit his head on the floor. Patient's mom and technician immediately went to the patient's aid. Tech notified myself and another technician and we got management to pharmacy who immediately called 911. Patient was awake by then, but was still out of it and mom held his head in her lap. He responding with yes and no to mom and I didn't want to move him to check his blood pressure, but mom said he felt warm so I provided an ice pack to place behind his head on the injury. Right before the paramedics arrived around 5:30pm, patient was much more alert and having a conversation with his mom. Paramedics arrived around 5:34pm and took his blood pressure and told the mom either she can take him to the ER or they can. Management told me that the patient eventually walked outside with the assistance of the paramedics/his mom. Mom was called 1/6/22 to see how he was doing. She said he felt fine. She ended up not taking him to the ER. She called primary prescriber who told her to monitor him and he has been fine thus far

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The patient's mom stated the patient felt severe chest tightness and pain for about 8 hours after the vaccine then came back 2 days later and still having signs and symptoms.

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The shot was administered and as she stood up she immediately fainted. Patient's mom admitted patient was anxious about the shot and had had little to eat in the previous part of the day. Patient did return to consciousness after about 30-40 seconds and was able to go home after the event.

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On 02/09 had to take him to doctor for sinus drainage and chronic cough. Was instructed to give him OTC antihistamine and OTC cough meds. On 02/11 took him to walkin clinic and was prescribed an antibiotic and prescription cough suppressant. Symptoms persisted for 4 days and then he was able to return to school. Chronic sinus drainage persisted for another 2 days. 03/13 had stomach virus and missed 4 days of school. 06/01 had kindergarten exam and everything was good August he ran slight fever a few different days. 09/14 developed diarrhea and he was taken to PCP on 09/22 and 09/28. Flu shot was given 10/10/2022 09/25 went to Hospital and was diagnosed with Flu B and pneumonia. Was prescribed antibiotics and to alternate Tylenol an motrin. 12/04 tested positive for Flu A. Lethargic, no appetite, and poor color.

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She tested positive for COVID-19 on 12/8/22. She had Influenza A, COVID-19, and Strep all at the same time, so it is hard for me to determine which symptoms were COVID-19. She had fever of 103, congestion, a light cough. Her symptoms lasted for about 3 days. On 12/23/22, we had to take her to the ER because she was having chest pains. She was prescribed Xofluza and Amoxicillin, but nothing or COVID-19. She is doing better, but she was just diagnosed with another strain of Influenza A.

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Patient with onset of dizzy spells, headaches, body pain post vaccine, worsened after 2nd. Diagnosed with POTS Saw PEDI Neuro

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6y.o. male with no significant PMH presented with progressive worsening of fever, chills, vomiting, myalgias, chest pain, abdominal pain, dizziness, weakness since Saturday. Initial symptoms were cough and congestion. Wet cough not in bouts present throughout the day. Since Monday, started having worsening fatigue, chest pain and vomiting. Vomiting was NBNB, projectile, 3-4 episodes following feeds. Chest pain is intermittent, diffuse, non radiating. Fever started since tuesday, last Tmax was yesterday morning 102.8 F relieved after giving Tylenol. Patient tested positive for COVID-19 on Sunday. Patient was given ampicillin. He admitted to the floors for definitive management. Initial physical examination on the

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Large bruising extending to L upper chest; lasting for 3 days following immunization. Patient report of chest pain

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Right chest pain, he was transported to another hospital. Spent the night in hospital and released home on July 20 with a follow up with his pediatrician and a heart doctor.

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He did not feel pain to the injection site. On the following day he went to school, he began vomiting with non stop. I gave him medication for the vomiting. I took him to the ER on 08/27/2022. He had trouble breathing and like an asthma attack. He had no temperature and began with cough spasms, mucus, nasal sputum. His symptoms worsened and they did diagnostic tests and when they did lung tests they noticed he had shortness of breath and cough. They gave him therapy with the oxygen and the right lung had some problems with his breathing. They gave him Albuterol and Ondasentron which helped him control his symptoms. Today he is doing alot better and is taking Pedialytie and Pediasure. Before the vaccine he had no problems with asthma or trouble breathing.

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dizziness, vomiting, sob, hypoxia,

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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Tachycardia-Mild, Additional Details: Symptoms felt 3 hrs after administration. Went to Emergency Room however on the same day patient is stable

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Started with headaches about a week after the second vaccine. Headaches continued for about 5 months after the second vaccine before resolving. Two of the headaches escalated to migraines that required two emergency room visits.

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Tight cough, chest pain 5 days after vaccination. Treated with albuterol inhaler, improving

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-Patient got vaccine wed 5.25.22 -Patient had fever 101 with Tylenol and Ibuprofen Thursday & Friday, chills, body aches, and cried with pain -Patient had right arm pain and swelling of lymph node in his right arm pit and his arm was tender to the tough and he held it against his body and would not movie with with out crying out in pain -Patient was taken to the doctor Friday due to the pain and inability to straighten or significantly move his arm (doctor was unsure if it was swelling from the shot or possible irritation of a nerve ) -Patient's pain and swelling improved Saturday and Sunday and he still was limited in arm movement -Patient was taken back to the doctor Monday 5/30/22 due to still not moving his arm past 90 degrees without crying in pain (doc recommended passive movement/ arm sling/ physicals therapy) -On Monday night after wearing the sling for a few hours after a hot shower he extended his arm, but it was painful -On Tuesday 5/31 Patient worse his sling in school and his arm "felt better" he could extend it, but it was hard to bend without increased pain. Patient's movement was limited, but can bend and straighten his arm with pain

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Today I brought my child to the pharmacy to get her COVID booster. The pharmacist checked her temperature before giving the vaccine. She said it was 100.0 so she could not give the vaccine. She said my child must be dehydrated and needed to drink some water and return. I told the pharmacist that 100 is not a fever and asked if that was pharmacy policy. She said no that was just her policy. I told her that I would like her to give the vaccine. She did give it but I am very concerned that she is turning away people for the vaccine based on her own made up policies and made up medical advice. This needs to be stopped immediately.

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Left armpit swollen painful lymph node and pin on left chest

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Pt complained of nausea, dizziness, chills, headache abdominal pain with severe generalized abdominal pain to palpation as well as substernal chest pain. This occurred one hour after vaccination. He was sent to ER.

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Patient began experiencing chest pain, shortness of breath, dizziness, and nausea hours after vaccines were administered. Mom took patient to emergency room around 11:30pm on date of vaccine administration. At the Emergency Room patient was given ondansetron and ibuprofen for symptom management. Patient was discharged home around 1:40am on 4/14/22.

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intense fatigue/malaise, nausea, vomiting, child could not keep food or any fluid (including water) down for almost 48 hours, zofran prescribed by pediatrician to reduce nausea. child did not leave bed for almost 24 hours. onset of symptoms occured 4 hours after injection. Child appeared healthy prior and immediately following injection.

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hands started shaking and her teeth were chattered together and she had shaking in the legs; hands started shaking and her teeth were chattered together and she had shaking in the legs; hands started shaking and her teeth were chattered together and she had shaking in the legs; got sick after the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 11-year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2022 (Lot number: FL8094) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "dairy and milk allergy" (unspecified if ongoing), notes: Verbatim: dairy and milk allergy; "colitis" (unspecified if ongoing), notes: Patient had colitis. There were no concomitant medications. Vaccination history included: Dtap vaccine (it was the DTap vaccine. it made her allergy to milk worse.), for Immunization, reaction(s): "allergy to milk worse". The following information was reported: CHILLS (non-serious), TREMOR (non-serious), LIMB DISCOMFORT (non-serious) all with onset 01Mar2022 10:00, outcome "recovering" and all described as "hands started shaking and her teeth were chattered together and she had shaking in the legs"; ILLNESS (non-serious) with onset Feb2022, outcome "unknown", described as "got sick after the vaccine". The events "hands started shaking and her teeth were chattered together and she had shaking in the legs", "got sick after the vaccine", "hands started shaking and her teeth were chattered together and she had shaking in the legs" and "hands started shaking and her teeth were chattered together and she had shaking in the legs" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness. Additional Information: The reporting mother stated that her children who received the 1st 5 to 11 formulation, orange cap pediatric dose on 11Feb2022 and were supposed to go back for the second dose on Saturday. Reports shaking in both her daughters hands and teeth chattering. Daughter is 11 years old. Mother confirmed above information and adds her daughter's had school and her hands started shaking and her teeth were chattering together and she had shaking in the legs and she stayed at school. Her leg would shake when she would lift it up. She did not know about this till later of course. It all started this past Tuesday. It has continued and her daughter says it has improved. She confirms it started 01Mar2022. The teeth were still chattering, but the hands and leg shaking has definitely improved. The teeth chattering is not as hard. Her daughter also got sick after their first dose after the vaccine and was placed on antibiotics, a Z-pack. She started that on 17Feb2022 and was on that for five days. She was unable to provide NDC, lot or expiry, she has discharge papers and on the box there is a pharmacy label, that is the only thing she has left from the box came which came in a bag and there isn't anything on the bag. Her daughter has a dairy allergy and milk allergy other than that she is healthy. She brought her daughter to the doctors yesterday and they did a Covid and Flu test and that was negative. The also did some blood work and another swab she is unsure what it was for but those results are not back yet. The doctor also ordered a CT scan but that has not been scheduled yet. That is done at the local hospital and she needs an appointment to for it, confirms it has not been scheduled yet. The doctor also did a neurological exam and had her follow the doctors finger and that was fine. Her daughter said it happened sometime before lunch about 10:00am. They got sick after they got the vaccine and started antibiotics for 6 days, even though it was probably viral. She was asking if because they got sick after getting the vaccine, could it have stormed into something. It was reported that the patient had colitis after receiving some shots, never confirmed officially but that is when she develop a milk allergy. mother states she believes it was the DTap vaccine. it made her allergy to milk worse. Her daughter was 3.5 years old. Relevant Tests: Covid test: Negative, Flu test: Negative, another swab unable to confirm the type: pending, blood work unable to confirm which type of labs: pending, and a CT scan: not scheduled yet. Prior Vaccinations (within 4 weeks): no. Other conditions (unspecified), diagnosed when she was about three and a half years old, so either in Jan2014 or Feb2015. No follow-up attempts are possible. No further information is expected.

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Vaccine administration error. There was an error discovered that the Pediatric Covid vaccine was mistakenly not diluted prior to administration of vaccine to child resulting in higher than authorized dose (0.2 mL of undiluted vaccine administered). Upon discovery of error, management consulted Health Department pharmacist, Medical Director, Administration, and Pfizer. Parent was notified on 03/22/22 of error and given guidance based on CDC and manufacturer's recommendation to not repeat dose and inform recipient of the potential for local and systemic adverse events. Mother states the patient woke up in the night coughing and complained that her chest was hurting and mom gave her Tylenol. Mom states she also gave Tylenol again before school, and at that time said her arm was sore. The mom reports that she has been giving both children allergy medications. Both children have been at school all day (call took place at 1:30) and the mother has not been contacted with any issues. The mother states that she will call their Pediatrician for an appointment if the daughter has chest pain when she gets out of school. Questions answered. Informed mother to contact the health department and the child's pediatrician and/or seek medical care if the child has any concerning side effects. Health Department to follow-up with family over the next days and week.

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My child developed MISC after receiving her first does of the Pfizer Covid vaccine. She was hospitalized for a week with severe symptoms. She received IVIG and steroid treatment at the hospital and is on daily aspirin for risk of blood clotting. Many of her organs were impacted and we have a long road to recovery. Patient was admitted on 3/1/2022 with a high fever and abdominal inflammation evidenced by ultrasound and CT scans of her abdomen. She had tachycardia for days, had bloodshot eyes and a full body rash. She had severe back and neck pain and was unable to walk. She was weak in her extremities from joint and tendon inflammation. She was in a lot of pain as her body was trying to regulate the reaction to the Covid vaccine.

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*Note I do not know if this was related to vaccine or if son had another illness. VSAFE encouraged me to report on 3/4 ~6pm complained of mouth pain (unknown etiology) , had shakes, eye pain and developed >103 fever later that evening (~10pm). Rapid test Covid - neg. Next morning (3/5) mentioned "could feel his heart beat" (3/5) went to pediatrician - strep test and Rapid PCR Flu/COVID - negative. Was told could return to school if fever resolved. Fever stayed ~102 for 24 hrs (although resolved with 6 hr dosing of motrin and then would return). Headache and tired and intermittent oral pain on 3/5-3/6. Temp elevated but not fever on 3/6. Seemed normal on 3/7 although tired rest of week. 3/11-3/12 hoarse no other symptoms

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Reaction to Pfizer vaccine close to the 15-minute mark. Dizzy and hard to breathe through mouth. patient stated he felt like he had a lump in his throat, and it was hard breath. a rapid response was called and I (G.Thiebaut RN) administered Benadryl 25 mg per MD verbal order. The order was repeated back and acknowledged by MD, that 25mg of Benadryl was the correct dose. The rapid response team administered kids EPI auto injector. 911 was called, and EMS transported the patient to a higher level of care in stable condition.

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patient was given an undiluted dose; patient was given an undiluted dose; patient was given an undiluted dose; She is having the chest pain; fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 20Jan2022, outcome "unknown" and all described as "patient was given an undiluted dose"; CHEST PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "She is having the chest pain"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "fever". Additional information: Patient was given an undiluted dose of the Pfizer-Biontech Covid19 vaccine for pediatrics (orange cap). Caller stated that patient has been experiencing fever since then. No follow-up attempts are possible. No further information is expected.

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It makes him nervous; shaking and can''t stop, hands and everything; got sick after the vaccine, sore throat and everything; got sick after the vaccine, sore throat and everything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 11Feb2022 (Lot number: FL8094) at the age of 6 years as dose 1 (tris), single for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 26Feb2022 10:30, outcome "not recovered", described as "shaking and can't stop, hands and everything"; ILLNESS (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset Feb2022, outcome "unknown" and all described as "got sick after the vaccine, sore throat and everything"; NERVOUSNESS (non-serious), outcome "unknown", described as "It makes him nervous". The events "shaking and can't stop, hands and everything", "got sick after the vaccine, sore throat and everything", "got sick after the vaccine, sore throat and everything" and "it makes him nervous" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor, illness, oropharyngeal pain, nervousness. Additional Information: He took the vaccine on 11Feb2022 and is due back this Friday for the second dose. On Saturday, her son told the caller he was shaking and can't stop, hands and everything. The caller's son was going to the ball field for signup and the caller thought it was just nerves and it would pass and then he never said anything else. He was fine. Then today 03Mar2022 we went out to play catch and he started shaking like he did before. He is perfectly healthy. Caller said that her son's shaking was mainly in his hands and legs and it is like a whole-body shiver. It makes him nervous. Her son also got sick six days later after getting the vaccine. He had a sore throat and everything. They tested him for everything and that was negative. They gave him antibiotic but that didn't really help, she thinks it was viral. She thinks it was cefdinir, she threw the bottle away and is unable to confirm or provide NDC, lot, or expiry. He started it six days after getting the vaccine and took it for 7 days. The patient does not went to Emergency Room. The patient has not had prior Vaccinations (within 4 weeks). The patient had a vaccine at this 4-month-old appointment and he had colitis and blood in his diaper, they have not said what it was for sure but the caller suspected it was from the vaccine. Caller cannot provide which vaccine this was, and states he received a few, it was the normal vaccines you get between the ages of 2 months old and 4 months old. The patients have no medical history, her son has never had anything like this no problems, he is healthy as a horse. The patient has no family Medical History. No relevant rests were done on him. The antibiotic didn't really help, thinks it was Cefdinir, unable to confirm with caller. As they no longer have the product. Unable to obtain NDC, lot or expiry. No follow-up attempts are possible. No further information is expected.

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As per the mother, 5 hours after the vaccination, he developed chest pain and difficulty in breathing; she massaged his chest and gave him tylenol . Within 30 to 45 minutes he fully recovered. All of this occured at home.

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Hitting himself, bending fingers and toes; Exacerbating autistic syptoms; Exacerbating autistic syptoms; Crying; Screaming; Pressing face, looking for pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). A 9 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Dec2021 (Lot number: FL8094) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing). Patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The following information was reported: on 29Dec2021, the patient experienced crying, screaming, hitting himself, bending fingers and toes, pressing face, looking for pressure every 15 minutes for about 5 days exacerbating autistic syptoms. Events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 28Jan2022, patient received dose 2 (tris), lot number: FL0007, intramuscular administered in arm left.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine to the reported events can not be excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

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Constant Sharp chest pain that lasted several minutes. 5 minutes or more. Very painful.

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Patient report feeling "hot" in the evening, mother took temperature reported no fever. Next day patient report a severe pain in area of administration.

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Patient report feeling "hot" in the evening, mother took temperature reported no fever. Next day patient report a severe pain in area of administration.

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He started having diarrhea the same day as his vaccination. At first, he was going two to four times per day. He hasn't had a fever and has been acting normal. We tried the BRAT diet. I contacted his doctor when I noticed it had been going on for a while. They collected a stool sample. She prescribed fiber gummies for two weeks. There was no improvement. She referred us to a gastroenterologist. We had an appointment a little over two months later. They did blood work and took a different stool culture. They set him up for an endoscopy and a colonoscopy that took place about two months later. Before that appointment, he experienced extreme diarrhea. He was crying and complaining of extreme pain in his stomach. He was also talking non-stop from the time he woke up until almost midnight. He was also prescribed Omeprazole 40mg. They scheduled an appointment for an MRE of his small intestine a little less than two months later. He was diagnosed with Crohn's Disease. He is still experiencing diarrhea, but he goes once or twice a day now.

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He developed a high fever of 104F, acute onset body chills, fatigue while he was in the bath on a Friday evening. He said he felt very cold in a warm bath and had some congestion. I decided to check his temperature; when we noticed how high his fever was, we gave him ibuprofen. The next morning, his fever was still pretty high so we decided to take him to the urgent care shortly after on 01/07/2023. They tested him for strep and viral infection panel including COVID-19, pneumonia, RSV and others. no change in treatment; they prescribed him MOTRIN and told us to keep him hydrated and allow him to rest. Three weeks prior, he had been treated with a steroid and antibiotic for congestion and early signs of pneumonia. They prescribed him prednisone at that time. He slowly got better, but my wife and I thought it was a second infection that could be developing which triggered this current one. Right now, he's doing much better and feeling fine.

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He tested positive for the flu on 11/26/22. He was sick for about a week with a fever, cough, congestion, and body aches. He was not prescribed medications, but he was taking over-the-counter MOTRIN and TYLENOL. He is feeling better, but still has a lingering cough and stuffy nose.

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On Sunday November 13 he began sneezing a lot. He began complaining about feeling bad and hot, I checked his head and he was burning up. His fever was 103. Monday he developed cough and congestion and still had the fever. Tuesday was about the same. Wednesday he seemed better so I sent him to school. He called about 11 in the morning unable to stop coughing and burning up. I got him into the doctor on Thursday. He tested positive for COVID-19 and Flu-A. We treated his symptoms with OTC meds. His fever was better by the weekend. His congestion cleared up around November 24 and his cough finally cleared up around November 27.

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Participant had a breakthrough case of Covid had fever, chills and nausea.

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3 children were given booster doses of the orange cap that were not diluted; 3 children were given booster doses of the orange cap that were not diluted/ vaccine was not appropriately diluted.; Fever; Achiness; More robust immune response; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician) from medical information team. A 7-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2022 at 15:30 as dose 3 (orange cap; booster) 0.2ml, single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 7 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Pertinent details: Mild/ related to illness; "Food allergies" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma; ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral taken for hypersensitivity. Vaccination history included: BNT162b2 (DOSE: 1, SINGLE, Time: 04:34 PM, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot: FK5127), administration date: 09Nov2021, when the patient was 6-year-old, for COVID-19 Immunization; BNT162b2 (DOSE: 2, SINGLE, Time: 03:19 PM, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Lot: FK5127), administration date: 03Dec2021, when the patient was 6-year-old, for COVID-19 Immunization. The following information was reported: IMMUNISATION REACTION (non-serious) with onset 2022, outcome "unknown", described as "More robust immune response"; PAIN (non-serious) with onset 26Aug2022, outcome "recovered" (2022), described as "Achiness"; PYREXIA (non-serious) with onset 26Aug2022, outcome "recovered" (2022), described as "Fever"; OVERDOSE (non-serious) with onset 26Aug2022 at 15:30, outcome "unknown", described as "3 children were given booster doses of the orange cap that were not diluted"; PRODUCT PREPARATION ERROR (non-serious) with onset 26Aug2022 at 15:30, outcome "unknown", described as "3 children were given booster doses of the orange cap that were not diluted/ vaccine was not appropriately diluted.". Therapeutic measures were not taken as a result of pyrexia, pain. Therapeutic measures were taken as a result of immunisation reaction. Another reporter (Health Care professional) considered "3 children were given booster doses of the orange cap that were not diluted" and "3 children were given booster doses of the orange cap that were not diluted/ vaccine was not appropriately diluted." as related to BNT162b2. Additional information: Booster dose (Other). Prior vaccination (within 4 weeks): None. Relevant tests: None. Specific relevant test for thromboembolic events with thrombocytopenia: None. AE term: Fever Achiness, Onset time: within 1-2 hrs of vaccine, Seriousness criteria: not-serious. Please clarify the type of medication error: the medication/vaccine was not appropriately diluted. Please provide the stage of medication error (e.g., prescribing, dispensing, preparation, and administration): Preparation error. Please provide contributing factors to the medication error: Busy day, no staff available for help, other vaccines being used are pre-diluted. Please clarify if the medication error affected the patient or consumer with clinical consequences: Yes- lead to more robust immune response. Please provide the details of hospitalization: N/A. Please provide the details of treatment received as well as any clinical evolution: Treated at home with OTC medications. Follow-up (06Sep2022): Follow-up attempts are completed. No further information is expected. Follow-up (17Oct2022): This is a spontaneous follow up report from a contactable Physician. This Physician reported for the patient in response to HCP letter [sent to physician] via follow-up letter which included that: Updated information included: Reporter details (alternate phone number, suffix, department, health care professional selected as yes and PC, CC check-box unchecked to make as true reporter), historical vaccines details (time, route , anatomical site and lot added in notes), new relevant medical history (asthma, food allergy, seasonal allergy), suspect details (dose start and stop time, vaccination facility name and phone number), new concomitant medications, new events (Fever, Ache, Immunisation reaction), event details (onset time of events Overdose and Product concentrate, event causality and clinical information.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201099703 Same drug/event, different patient.;US-PFIZER INC-202201099704 Same drug/event, different patient.;

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3 children were given booster doses of the orange cap that were not diluted; 3 children were given booster doses of the orange cap that were not appropriately diluted; Fever; Achiness; More robust immune response; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician) from medical information team. A 5-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2022 at 15:03 as dose 3 (orange cap; booster), 0.2 ml single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 5 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 14Sep2019 (ongoing), notes: Albuterol prn; "Wheezing", start date: 14Sep2019 (ongoing), notes: Albuterol prn. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time of administration: 16:08, Lot number: FK5618, Anatomical site of injection: Left Arm, Route of administration: Intramuscular), administration date: 14Dec2021, when the patient was 5-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Time of administration: 16:20, Lot number: FK5618, Anatomical site of injection: Left Arm, Route of administration: Intramuscular), administration date: 04Jan2022, when the patient was 5-year-old, for COVID-19 immunization. The following information was reported: IMMUNISATION REACTION (non-serious) with onset 2022, outcome "unknown", described as "More robust immune response"; PAIN (non-serious) with onset 26Aug2022, outcome "recovered", described as "Achiness"; PYREXIA (non-serious) with onset 26Aug2022, outcome "recovered", described as "Fever"; PRODUCT PREPARATION ERROR (non-serious) with onset 26Aug2022 at 15:03, outcome "unknown", described as "3 children were given booster doses of the orange cap that were not appropriately diluted"; OVERDOSE (non-serious) with onset 26Aug2022 at 15:03, outcome "unknown", described as "3 children were given booster doses of the orange cap that were not diluted". Therapeutic measures were not taken as a result of product preparation error, overdose. Therapeutic measures were taken as a result of pyrexia, pain, immunisation reaction. Additional information: The patient did not receive any prior vaccination within 4 weeks. The patient did not receive any concomitant drugs. No staff available for help, other vaccines being used were pre-diluted. It led to more robust immune response. The events fever and achiness started in 1-2 hrs. The patient did not have any relevant tests or tests for thromboembolic events with thrombocytopenia. The event did not require the initiation of new medication/other treatment/ procedure. The patient was treated at home with over the counter (OTC) medications. The adverse event outcome was also reported as recovered with sequelae. The patient provided information regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event. This report is not serious. Follow-Up (06Sep2022): Follow-up attempts are completed. No further information is expected. Follow-up (17Oct2022): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP letter sent to physician via follow-up letter. Updated information included: Reporter details updated, historical vaccines (time, route, anatomical site and lot number updated), relevant medical history added, suspect drug (start and stop time updated), new events added, event details (onset time updated for product preparation error and overdose). Additional information updated. Sender's Comments: Linked Report(s): PFIZER INC-202201099254 Same drug/event, different patient.

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Additional vaccines administered on same date of the Pfizer suspect: flu shot; Additional vaccines administered on same date of the Pfizer suspect: flu shot; Received 2 ml instead of 0.2ml; Sore arm; Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team. A 9-year-old female patient received BNT162b2 (BNT162B2), on 15Sep2022 at 14:00 as dose 1 (orange cap), 2 ml single (Lot number: FL8094, Expiration Date: 31Dec2022) at the age of 9 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), on 15Sep2022 as dose 2, single (Lot number: UJ878AA) intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Streptococcal infection", start date: 01May2022, stop date: 11May2022, notes: Strep. There were no concomitant medications. Vaccination history included: Fluzone (Dose 1, Manufacturer: Sanofi). The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Sore arm"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 15Sep2022 at 14:00, outcome "unknown" and all described as "Additional vaccines administered on same date of the Pfizer suspect: flu shot"; OVERDOSE (non-serious) with onset 15Sep2022 at 14:00, outcome "unknown", described as "Received 2 ml instead of 0.2ml". Therapeutic measures were not taken as a result of off label use, product use issue, overdose. Therapeutic measures were taken as a result of pain in extremity, fatigue. Additional information: Medical assistant calling in about the Pfizer Covid 19 Orange cap formulation (NDC number: 59267-1055-1). The vaccine was administered to a 9 year old female patient. She received 2 ml instead of 0.2ml. This was her first dose. Caller wants guidance on what to do next. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event did not require a visit to emergency room or physician Office; No medical treatment required. The type of medication error was Administration/dosing. The stage of medication error (e.g., prescribing, dispensing, preparation, and administration) was Administration (10X the correct dose). Contributing factors to the medication error was Training. The medication error affected the patient with clinical consequences of Sore arm, fatigue. Treatment received was just Tylenol and Supportive care. The physician did not consider the Pfizer product had a causal effect to the adverse event. The information on the batch/lot number for BNT162b2, has been requested and will be submitted if and when received. Follow-up (16Sep2022 and 20Sep2022): This is a spontaneous follow-up report from a contactable Other HCP. Updated information included: suspect product information (date and time of vaccination, lot number, expiry date, NDC number, administration route, anatomical location), concomitant medication (flu shot), medical history (none), event details (no medical treatment required, no visit to emergency room or physician office), new event "Additional vaccines administered on same date of the Pfizer suspect: flu shot". Follow-up attempts are completed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Dose number updated as '1' and LRN was updated. Follow-up (04Oct2022): This is a spontaneous follow-up report from a contactable physician. Updated information includes: Reporter #02 was updated as true reporter. New reporter was added, patient date of birth was added. Historical vaccine added for dose 1 of Fluzone, Medical History added, Vaccine start time was updated, information of Co-suspect vaccine Fluzone. Event onset time was updated. New events sore arm and fatigue were added.

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Received 0.3mL undiluted dose; The patient received 0.3mL undiluted for his dose; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. A 12-year-old male patient received BNT162b2 (BNT162B2), on 26Jul2022 as dose 3 (booster), 0.3ml single (Lot number: FL8094, Expiration Date: 05Aug2022) at the age of 12 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 (Primary immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious) with onset 26Jul2022, outcome "unknown", described as "Received 0.3mL undiluted dose"; OVERDOSE (non-serious) with onset 26Jul2022, outcome "unknown", described as "The patient received 0.3mL undiluted for his dose"; FATIGUE (non-serious), outcome "recovered", described as "severe fatigue". Additional information: The patient did not administer any additional vaccines on Same Date of the Pfizer Suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's relevant tests were none. The Pfizer product had a causal effect to the adverse event. Vaccination Facility Type was a Pharmacy or Drug store. No prior vaccinations (within 4 weeks). No tests for thromboembolic events with thrombocytopenia. Patient was administered 0.3ml of undiluted Pfizer vac covid-19 5-11 y injection. The Pfizer vac covid-19 5-11 y injection vial was used to draw the vaccination dose. The error was discovered where vials were inspected after the vaccination. The patient's mother was called to report of the doses discrepancy. Patient's other reported the patient was laying on the couch. On 01Sep2022, its parent were called to question any issue after the immunization father reported that the patient experienced covid vaccine syndrome. Patient experienced severe fatigue for 48hours. After 48 hours period, was back to normal without showing side effects. Follow-Up (22Aug2022): Follow-up attempts are completed. No further information is expected. Follow-up (13Sep2022): This is a spontaneous follow-up report received from a contactable Pharmacist . This Pharmacist reported in response to HCP letter sent which included that: Updated information included: new event Fatigue was captured. Vaccination anatomical Location (left arm) was captured.

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Patient became ill at school on 8/8/22 complaining of tiredness and stomach pain and registering a low fever, and vomited twice. He tested positive for COVID on an antigen home test on 8/9/22, fever continued, no more vomiting, runny nose. Isolated at home for 5 days with no more fever or stomach symptoms, but runny nose continued. Positive antigen home test on 8/13/22. Negative antigen home test on 8/14/22. Runny nose initially abated, then returned after negative test. He returned to school on 8/15/22.

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mild headache + fatigue; mild headache + fatigue; 4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap; 4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap; Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022; Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID: (159558). A 4-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2022 as dose 1 (orange cap), single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 4 years intramuscular, in left arm for covid-19 immunisation; measles vaccine live (enderS-edmonston), mumps vaccine live, rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (PROQUAD), on 01Aug2022 as dose number unknown, single (Lot number: W004028) subcutaneous, in left arm for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), on 01Aug2022 as dose number unknown, single (Lot number: H9917) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "COVID", start date: 17Jul2022, stop date: 17Jul2022, notes: Brief illness-totally resolved prior to visit. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 01Aug2022, outcome "unknown" and all described as "4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 01Aug2022, outcome "unknown" and all described as "Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022"; HEADACHE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "mild headache + fatigue". Additional information: It was reported that the patient had mild headache and fatigue for 1-2 days after administration. Follow-Up (23Aug2022): Follow-up attempts are completed. No further information is expected. Follow up (06Sep2022): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP follow-up letter sent that included: Updated Information Included: Reporter Information, facility information, dosage regimen, RMH and New adverse events.

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sore deltoid muscle; she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient; she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient; "she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient"; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (orange cap; booster), 0.3 ml single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 81 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious) with onset 20Jul2022, outcome "unknown", described as ""she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient""; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious) all with onset 20Jul2022, outcome "unknown" and all described as "she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient"; MYALGIA (non-serious), outcome "recovered", described as "sore deltoid muscle". Therapeutic measures were not taken as a result of product administered to patient of inappropriate age, underdose, product preparation error. Additional information: It was reported that, incorrect formulation of the Pfizer COVID 19 Vaccine that was administered to two 81-year-old patients, one male and one female. The two patients were administered an undiluted 0.3mL dose of the Pediatric Formulation of the COVID 19 Vaccine. It was stated that this results in the patients having received 30mcg, so it actually added up to the appropriate amount of the vaccine for the patients. Transferring agent provides the NDC number for the administered vaccines as: 5926710554. Given undiluted dose of the pediatric formulation of the vaccine on the day of reporting. When prompted for specific seriousness criteria it was stated as no. Both of the patients waited for a half of an hour after vaccine administration for monitoring. The patient did not receive any other medication. The patient had no lab tests.Wrong vial was choosen from the vaccine refrigerator. Both patients that received the vaccine had a sore deltoid muscle for a couple days no other reaction conveyed. Follow-up (29Aug2022): This is a follow up spontaneous report from a contactable Nurse. This Nurse reported in response to HCP letter sent: Updated information included: Reporter details, Dosage regimen, Vaccination Facility details, Event details (new event sore deltoid muscle.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200991553 Same reporter/ drug/ event for different patient;

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she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient; she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient; she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient; sore deltoid muscle for a couple days; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. An 81-year-old male patient received BNT162b2 (BNT162B2), on 20Jul2022 as dose 4 (orange cap; booster), 0.3 ml single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 81 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3, (BOOSTER) SINGLE), for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "sore deltoid muscle for a couple days"; PRODUCT PREPARATION ERROR (non-serious), UNDERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 20Jul2022, outcome "unknown" and all described as "she inadvertently administered 0.3mL of undiluted Pfizer-BioNTech Covid-19 Vaccine (orange cap) to an 81 year old male and an 81 year old female patient". Therapeutic measures were not taken as a result of product preparation error, underdose, product administered to patient of inappropriate age. Additional information: It was reported that, incorrect formulation of the Pfizer COVID 19 Vaccine that was administered to two 81-year-old patients, one male and one female. The two patients were administered an undiluted 0.3mL dose of the Pediatric Formulation of the COVID 19 Vaccine. It was stated that this results in the patients having received 30mcg, so it actually added up to the appropriate amount of the vaccine for the patients. Given undiluted dose of the pediatric formulation of the vaccine on the day of reporting. When prompted for specific seriousness criteria it was stated as no. Both of the patients waited for a half of an hour after vaccine administration for monitoring. The patient did not received any other medication. The patient had no lab tests. wrong vial was choosen from the vaccine refrigerator. Both patients that received the vaccine had a sore deltoid muscle for a couple days no other reaction conveyed. Follow-Up (15Aug2022): Follow-up attempts are completed. No further information is expected. Follow-up (29Aug2022): This is a follow up spontaneous report from a contactable Nurse. This Nurse reported in response to HCP letter sent which included that: Updated information included: Reporter information, suspect product information (vaccination facility phone number, anatomical location), reaction information (event added) and additional information.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200992412 Same reporter/ drug/ event for different patient;

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He tested positive for COVID-19 on 8/22/2022. He had a fever, cough, stuffy nose, stomach pain, and vomiting. I had to take him back to the doctor yesterday 8/29/22, because he was vomiting again and he had a terrible headache. He is about to be looked at by his doctor to see if he has migraines. When he was diagnosed with COVID-19 the just had him taking TYLENOL, MOTRIN, and MUCINEX. Then, when we went to the doctor on 8/29/22, he was prescribed amoxicillin, MOTRIN, and a compound of PHENERGAN.

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WITHIN 2 MINUTES OF RECEIVING VACCINE FACE WAS BRIGHT RED & SWOLLEN. BENADRYL 7CC WAS GIVEN PULSE OX 98% PULSE 111 R15 NO RESP DISTRESS, MILD PURITIS AT SITE OF POLIO VACCINE

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Patient was received undiluted vaccine, which made the dose to be close to adult dose. Patient experienced side effects extreme tiredness type of side effects. Unable to have an appetite.

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Patient developed a rash on multiple locations of his body. It developed most on his face, predominantly his left, and swelled one eye completely shut and the other partially shut. The rash started developing on Monday Aug 8th and by Wednesday his left eye was swollen shut and by Thursday his right eye was partially swollen shut. After evaluation by his doctor, who thought it might be contact dermatitis, we put him on a prednisolone course of treatment, and about 24 hours after starting that, the symptoms slowly abated. Today, Aug 18th, he still has a few skin irritations left but is mostly recovered. This was Patient's 2nd reaction to a Covid shot. In December, he also developed a rash on his body, again largely on the left side of his face. This developed 3 weeks after his shot. This current reaction came more quickly and was more severe.

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Received the first dose of COVID-19 immunization on 8.15.22 - four hours after receiving dose - minor developed hives all over her trunk and both upper and lower extremities. Minor strongly denies any respiratory distress. Minor states that she felt itchiness all over her body. Minor took Diphenhydramine 25 mg and after one hour of taking it symptoms completely subsided.

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She suffered and severe rash that spread over her entire body and up to her hair lines and turned her skin red.

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Headache and vomiting after Covid vaccine

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Vaccine administration was above and posterior to the vastus lateralis, and therefore caused bruising and increased pain.

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This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. A 5-year-old male patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose 2 (orange cap), single (Lot number: FL8094, Expiration Date: 15Aug2022) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history included: "Hemophilia" (ongoing), notes: Bruises Easily. There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer Covid 19 Vaccine for 5-11 year olds Orange Cap; First Dose; Lot: FL8095; Expiration Date: 31Aug2022; 59267105504), administration date: 06Jul2022, when the patient was 5-year-old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 04Aug2022, outcome "not recovered", described as "Fever"; SOMNOLENCE (non-serious) with onset 04Aug2022, outcome "not recovered", described as "Sleeping all day"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Aug2022, outcome "unknown" and all described as "received 1 undiluted dose of the Pfizer BioNTech covid-19 vaccine orange cap". Therapeutic measures were not taken as a result of product preparation error, overdose, somnolence, pyrexia. Additional information: Nurse called to request revaccination guidance for Pfizer BioNTech covid-19 vaccine (orange top) administered undiluted. Nurse stated that a 5 year old male patient received 1 undiluted dose of the Pfizer BioNTech covid-19 vaccine orange cap as the first dose. Had an incident today where the Pfizer 5 to 11 years old was administered without dilution. Concerned, reporter stated, "I am calling because I work for (Institution name (State name) and I am calling because we had an incident today where the Pfizer 5 to 11 years old was administered without dilution and they were wondering if there is a procedure or protocol or what is the apology regarding the administration of Pfizer (COVID-19 Vaccine) without dilution." QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default (as reported). Upon recent follow-up, they had an incident yesterday and she called yesterday and reported it and spoke to someone in Medical, but she was informed by a colleague at (Facility name Withheld) that it was the patient's first vaccine, when it was actually his second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (04Aug2022 and 05Aug2022): This is a spontaneous follow-up report from same contactable Nurse. Updated information included: patient information (height, weight); medical history; historical vaccine; concomitant medication; suspect drug details (lot number and expiration date); event details (new events: Sleeping all day and Fever); and additional information. Additional information has been requested.

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Patient received Pfizer COVID vaccine at clinic. About 15 minutes afterward developed swelling of right eye and whole body itchiness. Was given benadryl about 30-45 min after vaccine dose for these symptoms. She was then observed at the clinic. Epi given at about 1753 and patient was subsequently brought to Emergency department for further management. No breathing issues. No swelling of lips, tongue, mouth. No rash noted on body. No vomiting. Patient is otherwise healthy. Takes no medications. No food allergies or other known allergies. No recent fevers, rhinorrhea, cough, abdominal pain, dysuria, diarrhea. Patient received lidocaine under arm prior to vaccine injection. Family wondering if she could have touched the lidocaine and then touched her thigh. Had eye redness and itchiness with swelling initially.

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Anatomical Location: Leg Left; started itching behind both of her knees/thought it was general eczema; started itching behind both of her knees/thought it was general eczema; hives on the back of her knees and extended beyond the back of her knees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 9-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Aug2022 at 09:45 as dose 1 (orange cap), single (Lot number: FL8094) at the age of 9 years, in left leg for covid-19 immunisation. The patient's relevant medical history included: "Food allergies" (unspecified if ongoing), notes: has a history of life threatening food allergies, allergy to pets and seasonal allergies; "Allergy to pets/ Known allergies: pets" (unspecified if ongoing), notes: has a history of life threatening food allergies, allergy to pets and seasonal allergies; "Seasonal allergies/ Known allergies: seasonal" (unspecified if ongoing), notes: has a history of life threatening food allergies, allergy to pets and seasonal allergies; "Known allergies: all major allergens (proteins)" (unspecified if ongoing), notes: Known allergies: all major allergens (proteins). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 03Aug2022, outcome "recovering", described as "hives on the back of her knees and extended beyond the back of her knees"; PRURITUS (non-serious), ECZEMA (non-serious) all with onset 03Aug2022, outcome "recovering" and all described as "started itching behind both of her knees/thought it was general eczema"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 03Aug2022 at 09:45, outcome "unknown", described as "Anatomical Location: Leg Left". The events "started itching behind both of her knees/thought it was general eczema" and "hives on the back of her knees and extended beyond the back of her knees" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, eczema, urticaria. Additional information: It was reported as started itching behind both of her knees after about 5 minutes after receiving the vaccination. (Patient name withheld) mom applied hydrocortisone as she thought it was general eczema and notified the nurse in the meanwhile. By the time (within the next minute) the nurse got in to check on, (Patient name withheld) developed hives on the back of her knees and extended beyond the back of her knees. (Patient name withheld) was administered Benadryl and supervised for the next hour and half or so, while continuing to keep a check on her vitals and oxygen saturation. At Doctor's office/urgent care facility most recent COVID-19 vaccine was administered. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not received any other medications within two weeks prior to the vaccination. No follow-up attempts are possible. No further information is expected.

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PATIENT VACCINATED AT 1130; MOM RETURNED AT 1345 C/O HIVES AND COUGH. MOM STATED SHE GAVE BENADRYL RIGHT BEFORE RETURNING TO CLINIC. SPO2: 95% DR. SPOKE W/ PARENTS AND OBSERVED PT, LISTENED TO LUNGS AND HEART. PT STATED HE'S NO LONGER COUGHING AND DOES NOT HAVE ANY SOB OR DIFFICULTY BREATHING. WILL CONTINUE TO MONITOR.

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Approximately 30 minutes after receiving the COVID booster shot patient began to display a red rash across both cheeks. The rash continued to spread across the cheeks, covering both cheeks from under the eyes to jawline. Rash also spread to splotches across the forehead. One splotch on each side of the neck. Splotches and rash were warm to touch. Child appeared tired, but remained fully responsive and conscious. Denied any evidence of respiratory concerns. Did not show any evidence of mouth swelling. Several places on the cheeks and above the eyebrow appeared slightly puffy, but unable to tell if this was actually puffiness/swelling or normal skin. Symptoms remained for several hours and then began to slowly dissipate. After the first hour they did not increase in intensity or severity. The administering facility was contacted and a message left for a return call. A RN returned the call and recommended monitoring and cool compress, and to seek emergency medical attention if symptoms worsen or trouble breathing or facial swelling. Also recommended to follow up with MD if symptoms do not dissipate. In hindsight, the previous 2 covid vaccine administrations also resulted in splotchy and red cheeks, however mild on the first dose, and moderate on the second and were attributed at the time to chapped skin from the cold wind and/or flushed due to warmth from jacket and scarf.

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High fever up to 104 degrees lasting 24 hours and improved down to 100 degree x 2 more days then resolved

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The wrong vaccine was inadvertently administered. The patient is 4 years old and the 6 month-4 years vaccine was ordered (3 mcg dose). The patient was instead given the 5-11 year dose of 10 mcg. The patient has had some vaccine injection site soreness but otherwise no other side effects from the inadvertent dosing error.

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Pt is here for 2nd dose of covid vaccine. Mother states pt developed rash on B arms and neck 5 days after initial dose on 07/08/22. Mother spoke to Dr after days of onset. Advised by Dr not to administer vaccine due to reaction. No difficulty breathing or trouble swallowing.

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chills; mild nausea; pallor; fatigue; LGT (100.5); This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. A 10-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jul2022 as dose 3 (booster), single (Lot number: FL8094) at the age of 10 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=1), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE , prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=2), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022), described as "LGT (100.5)"; CHILLS (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022); FATIGUE (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022); NAUSEA (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022), described as "mild nausea"; PALLOR (non-serious) with onset 23Jul2022, outcome "recovered" (Jul2022). Therapeutic measures were taken as a result of chills, nausea, pallor, fatigue, pyrexia. Additional information: 20h after injection: chills, mild nausea, pallor, fatigue and LGT (100.5). Sx lasted 5h and resolved c rest and 300mg of ibuprofen. Patient did not receive any other vaccines in four weeks prior covid-19 immunisation. It was unknown if patient tested covid-19 post vaccination.

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Woke up on July 26th with a mild headache and mild sore throat. Ate and felt a bit better but hours later the sore throat got worse. Gave him a rapid test and it was negative. Woke up next morning still woke up with same sore throat. Gave him another rapid test and was negative. Called pediatrician office to make sure he didn't have strep. They ran a respiratory panel. My son by this point started to get congestion, was sneezing, headache was back, and as the evening the progressed he got stuffier and the sneezing continuing. He took MOTRIN and felt fine and the sore throat went away and did not come back. But the congestion is really bad, he can't breathe through the nose. He used inhaler and slept well. Had no temperature but woke up the next day with a slight cough, runny nose with mucus and a temperature of 100.4. The doctor office called back this morning and said that he was positive for rhino virus but negative for everything else. His temperature as of right now is really mild and his symptoms are mild except for the mucus.

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