Pfizer

Nervous system symptom reports

Male, 12 - 15 years

Age Reported Symptoms Notes
12 2021-05-14 slurring Tiredness, slurring of words, vomiting,
12 2021-05-14 pain in extremity Fever of 102.2 began 27 hours after the shot. Extremely sore arm, hurts to move it. Headache. Dry... Read more
Fever of 102.2 began 27 hours after the shot. Extremely sore arm, hurts to move it. Headache. Dry eyes. Fatigue - extremely tired, took a 3 hour nap. Cold - not chills, just cold in general. Gave motrin, but fever is still at 102.0 nearly 3 hours later.
12 2021-05-14 tingling Patient hands felt tingly, head felt tingly, got light headedness. patient was put into a wheelchair... Read more
Patient hands felt tingly, head felt tingly, got light headedness. patient was put into a wheelchair and taken to observation room by nurse. Patient was alert and oriented. Patient feels better after drinking some water.
12 2021-05-16 seizure Patient received the vaccination. Approximately 20 seconds after receiving the dose patient said "I... Read more
Patient received the vaccination. Approximately 20 seconds after receiving the dose patient said "I'm going to faint'. Patient appeared to faint but also appeared to be having a seizure. The patients legs appeared to go rigid and he make movements with his arms. He appeared very pale. The patient "came to" within approximately a minute? Patients mother and I were able to lay Patient down on the floor. I asked his mother if she would like us to call 911 and she said yes. Prior to the incident, I discussed Patients past history of seizures with his mother. She sail he had seizures when he was younger and had been on medication, but he was no longer on any medication and had been seizure free for approximately 5 years.
12 2021-05-16 tremor From ED Note: 12 year old male with PMH of asthma on flovent, food allergies with epi-pen (has not r... Read more
From ED Note: 12 year old male with PMH of asthma on flovent, food allergies with epi-pen (has not required this) and pre-syncope/syncope who presents with concern for loss of consciousness and possible seizure-like activity following a COVID vaccine. Mom notes that he was in his usual state of health when he presented to COVID clinic to get his first vaccine. He got the Pfizer vaccine, seconds after getting in his left arm, mom noted that he looked very "wide eyed" and distraught. She notes that he slumped forward and had lost consciousness for approximately 5 seconds. She noticed shaking movements in his right arm and bilateral lower legs. She notes that his left arm was against her and therefore cannot comment on it. She notes that his eyes were closed. No tongue biting and no incontinence. No secondary trauma. She notes that when these 5 seconds were over he then had a period for about 30 minutes where he looked pale and was breathing heavy but was alert and answering questions. She notes that he has had presyncopal episodes and episodes of feeling faint when getting flu shots in the past. However, this time she noted that he had shaking which made her nervous for possible seizure activity. Patient denies any chest pain or headache prior to the symptoms. She came via ambulance for further evaluation. On arrival, he reports that he feels 90% back to his baseline. He notes that he does not feel quite ready to run around yet however denies any pains or discomforts, headache, weakness, numbness, or tingling. He had eaten a full breakfast prior to getting the shot. He had a normal night sleep and a normal day yesterday per mom. Medical History: as above Surgical history: none Family History: Reviewed and no pertinent related family hx pertaining to this visit Social History: Lives with family Allergies: food allergies Medications: flovent, epi-pen Immunizations: Up to date Medical Decision Making 12 year old male with PMH of asthma on flovent, food allergies with epi-pen (has not required this) and pre-syncope/syncope who presents with concern for loss of consciousness and possible seizure-like activity following a COVID vaccine. On arrival, he was alert, well-appearing, in no acute distress. His vital signs were normal for age on room air. His physical exam was very reassuring as above with a normal neurologic and cardiac evaluation. Differential includes vasovagal/syncope in the setting of a known stressful trigger vs seizure given report of shaking in his extremities. We feel the latter is significantly less likely given the timeline of the events. Has no known seizure activity nor any triggers per history (fever, trauma, etc.). He also has a normal neurologic assessment. At this time we will defer neurology consults given low concern for seizure. It is possible that this represents a side effect of the vaccine however we also feel that this is less likely given the fact that his symptoms have been seconds after receiving the vaccine. Nonetheless we reported the symptoms to the pharmacist who recorded it in the database. We attained an EKG showing a known incomplete right bundle branch block (unchanged from 2013) and a slightly prolonged QTC of 477 (previously 451). I encourage patient to stay well-hydrated, well rested in the setting of his suspected syncopal episode this morning. I also suggested that for further vaccinations, that he lay down on the table and drink/eat well prior. We provided strict return to ED criteria in the setting of worsening symptoms. All questions were answered at the time of discharge. Mom verbalized her understanding and agreement of the plan. He was discharged in a stable condition with mom at side. **After patient was discharged, cardiology called the follow-up team due to the prolonged QTC to ensure that we were aware. I contacted the patient's PCP to do a follow-up EKG in 1 month's time.
12 2021-05-17 seizure Patient appear to have a mild seizure (faint, stiffness on the arm that got the vaccine injection, e... Read more
Patient appear to have a mild seizure (faint, stiffness on the arm that got the vaccine injection, eye rolled) about less than 5 seconds. Patient became fully awake as being put to laying down on the floor. Patient was able to answer to all questions was asked. Patient stated that he was nervous and scared of getting the vaccine. Patient's mother stated that he had fainting history of seeing cut or bleeding. The event occur 30 seconds after received that vaccine.
12 2021-05-18 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Medium
12 2021-05-19 weakness Pt had vasovagal reaction and emesis immediately post vaccine admin. NO ALLERGY to vaccine. Okay to ... Read more
Pt had vasovagal reaction and emesis immediately post vaccine admin. NO ALLERGY to vaccine. Okay to receive 2nd dose. At 1:37PM, 6 min post receiving vaccine, patient told mom that he felt lightheaded and was having pain at injection site left arm. Rn assessed immediately and pt reported feeling "sick". He drank few sips of water. MD called to bedside. I assessed pt at 1:39PM, pt sitting chair, elevated his legs onto the footrests of wheelchair sitting in front of pt. +Facial and lip pallor, and complaining of nausea followed by 1 episode NBNB emesis consisting of what he ate for lunch 1 hour prior. Pt immediately reported feeling better post emesis. Lips appeared pink. Pt brought to triage area, lay supine on stretcher with legs elevated. Nausea and "lightheaded" sensation resolved prior to lying down. BP improved post emesis from 75/39 to 84/46 at 1:48 PM. Stayed lying down for 5 minutes after which time pt wanted to sit up. Upon sitting BP and HR increased 96/64 and 69, stable with no nausea or lightheadedness, only remaining sx "slightly weak". drank 12 oz apple juice and ate 2 graham crackers without any further emesis or symptoms. Observed for 15 more minutes and was ambulating without return of symptoms, discharged home with mom and brother with instructions to seek medical care if symptoms return.
12 2021-05-19 cold sweat Redness on arms after injection, light-headed Vital Signs: BP 120/84 HR 107 Resp 16 O2Sat 97% Skin... Read more
Redness on arms after injection, light-headed Vital Signs: BP 120/84 HR 107 Resp 16 O2Sat 97% Skin Signs: Cool and dry, clammy, diaphoretic Circulation: Cap refill <2sec 1sec Respiratory: Breath sound clear bilaterally Initial Treatment: Vitals taken. Patient felt better after given juice and sitting down. 4:09 PM Vital Signs: BP 110/80 HR 107 O2Sat 99% Notes: Patient heart rate was still over 100 bpm. Other vitals were in good range. Cheeks still rosy with potential rash. Follow up with provider recommended. Parent provided CDC link with information regarding hx of GBS and safety of receiving COVID19 vaccine. Patient discharged home with parent.
12 2021-05-19 feeling hot, unresponsive to stimuli After vaccine was administered, patient was asked to wait for 15 minutes, at which time Parent noti... Read more
After vaccine was administered, patient was asked to wait for 15 minutes, at which time Parent notices that child had passed out, looked pale and unresponsive to name calling. I (pharmacist) was alerted to the event and I and couple technicians went out to assist patient. I elevated child's feet, supported head, took blood pressure and pulse. Child regained consciousness and was able to respond to name in less than two minutes. Child stated that he was hot and agreed to drinking cold water. I also applied cold compress to child's forehead and wrists. Child took sips of water and BP was continuously monitored. Parents stated that child looked much better and had regained color to his face. Child was monitored to 30 mins by the pharmacy team with no event before parents took child home.
12 2021-05-19 flushing, unresponsive to stimuli, weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Weakness-Medium
12 2021-05-19 seizure 30 hours after vaccine had a generalized siezure
12 2021-05-19 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium
12 2021-05-20 muscle twitching, tingling, burning sensation, sensory loss 12 yo male presenting with bilateral lower extremity paresthesias and confusion. Admitted to the ho... Read more
12 yo male presenting with bilateral lower extremity paresthesias and confusion. Admitted to the hospital. Pending discharge to rehab facility. ED Note 5/19/21 Patient is a 12-year-old male with hypogammaglobulinemia, asthma, IBS who presents with weakness in his lower extremities. 6 days ago, patient had seafood and later that night vomited once, nonbloody, nonbilious. 4 days ago, he received the first dose of the Pfizer SARS-CoV2 vaccination. That day, he also felt some burning over the anterior parts of his bilateral ankles. Over the past 3 days, he has been sleeping a lot and had a headache. He has not had a fever or other muscle aches, no subsequent N/V, abdominal pain. Last night, he reported ankle pain to his mom. Today at school, he was playing kickball when he had the sensation that his ankles were not working/gave out and he fell to the ground. He had difficulty getting up and required a wheelchair. He did not lose consciousness, denied CP, palpitations, SOB, headache, vision change during or before that episode. He was not incontinent of urine/stool and had no abnormal movements noted at the time. Since then he has noted twitching in his thighs, calves and toes. He reports weakness throughout both lower extremities and has difficulty with intentional movements at the toes/ankles/knees, weakness in hips. He reports a burning sensation over the anterior ankles/dorsum of foot b/l. Denies fevers, chills, cough, SOB, CP, palpitations, abdominal pain, N/V/C. He endorses diarrhea 3x daily which is his baseline. He has panic attacks 3x daily w palpitations/SOB that self resolve. He has been on keflex for an ingrown toe nail for the last week. MRI performed with normal brain and spine. However, on repeat exam patient has diminished sensation in the bilateral feet and diminished ability to dorsiflex or plantarflex both ankles with very limited toe range of motion. Still with preserved reflexes in the patella and Achilles. Discussed at length with neurology and the family. Differential diagnosis at this point of functional neurological disorder versus Guillaine Barré syndrome. Neurology note 5/21/21 Patient is a 12yo M with hypogammaglobinemia, IBS, and poorly controlled anxiety, presenting with 4 days of lower extremity paresthesias and 1 day of hyperacute onset of lower extremity weakness and perhaps some mild confusion. History notable for covid vaccine three days prior to presentation and anixety surrounding covid and return to school. His general examination is notable for anxious affect with difficult to localize neurologic exam. Exam shows possible bilateral lower extremity weakness of TA and hamstring>quad/IP that is very challenging to grade due to poor effort and giveway, and decreased sensation in a bilateral stocking/glove distribution to all sensory modalities. MRI w/wo contrast brain and spinal cord normal on admission. LP perfromed in ED also normal. Given negative workup and history of anxiety with recent psychosocial stressors, most likely sudden onset weakness is secondary to a functional neurologic disorder. Plan for discharge to rehab pending PT evaluation.
12 2021-05-20 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt has history of passing out after shots. passed out brief;y after adminstration. did not fall or hit head. was given water and ice pack while mom attended to him. EMTs were called and took blood pressure did not bring to hospital
12 2021-05-21 weakness Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium... Read more
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
12 2021-05-21 numbness, weakness Patient received IM vaccine, was under observation when felt dizzy and lost consciousness. Spontaneo... Read more
Patient received IM vaccine, was under observation when felt dizzy and lost consciousness. Spontaneously awoke a few minutes later and was confused, and wasn't able to feel his legs. Confusion resolved after about 5 min but leg numbness/weakness remained. Was taken via EMS to the hospital, with clinical assessment showing no neurological deficit, withdrawing to pain, and patient demonstrated ability to ambulate independently about 12 hours after symptom onset. CBC, CMP, Urinalysis, UDS unremarkable.
12 2021-05-23 tingling Thurs 5/20 4pm 1st COVID vaccine given Friday: tingly all day; 6pm developed diffuse erethema, scc a... Read more
Thurs 5/20 4pm 1st COVID vaccine given Friday: tingly all day; 6pm developed diffuse erethema, scc alp brigh tred Sat 5/22: redness, hives worse, facial swelling started. Seen at Danbury ED. Given all supplental anaphalsix stuff, then epi. Discharged home Sunday: 5/23: Facial swelling returns, mom gives IM Epi, returns to hospital. Found to have ST abnormalities on EKG, sent to hospital for prolonged allergic reaction and eval of possible pericarditis. 5/24: continues to have urticaria, now with new petechiae/purpuric breakouts in areas where hives were, but most prominently in bilateral ankles.
12 2021-05-24 weakness, tingling headache, weakness, tactile fever 1 day after the 1st dose of vaccine. On day 5 (today) developed le... Read more
headache, weakness, tactile fever 1 day after the 1st dose of vaccine. On day 5 (today) developed left arm tingling and chest pain, so seen at ED. Symptoms subsided on ED arrival.
12 2021-05-25 pain in extremity current_age: 12; Sore arm; This is a spontaneous report from a contactable 12-year-old male consumer... Read more
current_age: 12; Sore arm; This is a spontaneous report from a contactable 12-year-old male consumer reported for himself that he received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EWO0182), via an unspecified route of administration in the right arm on 17-MAY-2021 15:45 as 1 ST DOSE SINGLE for covid-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested positive for covid-19. The patient's medical history and concomitant medications were not reported. On 17May2021 at 04:00pm, the patient experienced sore arm. Since the patient was 12-Year-old Off label use in unapproved age group was added as an additional event. The outcome of the event was recovered.
12 2021-05-25 seizure Seizure for 20 seconds and then post ictal for 10-15 minutes, by time got to the ED back at baseline
12 2021-05-26 cold sweat sees black, dizzy, blurriness, clammy skin, diaphoretic 84,16, 82/42 86/58, 99, 16, 98% given jui... Read more
sees black, dizzy, blurriness, clammy skin, diaphoretic 84,16, 82/42 86/58, 99, 16, 98% given juice, icepack-- felt better no meds, no previous fainting episode
12 2021-05-26 cold sweat sees black, was dizzy, blurriness, clammy skin, diaphoretic. Apple juice, Grahm crackers, icepack,... Read more
sees black, was dizzy, blurriness, clammy skin, diaphoretic. Apple juice, Grahm crackers, icepack, fan air-- felt better, having whole conversation, no complaints 18: 50 --84,16, 82/42, 18: 58-- 86/58, 99, 16, 98% monitored for 30 minutes, walked out of clinic with parent in stable condition give juice, icepack-- better no meds, no previous fainting episode
12 2021-05-26 seizure like phenomena, unresponsive to stimuli, slurring, mild one side paralysis PT was sitting with guardian and started to have seizure like activity for him which consists of aud... Read more
PT was sitting with guardian and started to have seizure like activity for him which consists of audible and visual auras and Right arm twitching. This lasted about 1 min. Once we got him into a dark room he started having slurred speech and Left sided weakness that lasted about a min. He was A&OX1. Pt had a right sided slant in his eyes. His pupils were dilated to a 9 and were equal and non reactive. he became sluggish and kept starring off to the right side. This lasted about 2 mins and 45 sec. His pupils returned to 6 and were equal and reactive and he became less lethargic. He started to complain of a head ache. At 1302 he stated that he stated tapping his face and trying to speak. He began to have a right sided glance again and his pupils dilated to an 9 again and we equal and non reactive. he did not respond to his name. This lasted for almost 2 mins. He then stated he was foggy and his pupils returned back to a 6 and were equal and reactive. He was struggling to find sounds in the room. His Vital signs were initial B/p 138/98 resp 22 HR-78. at 1320 his B/P was 128/68 Resp 20 HR 80. Pt was transported by EMS for medical evaluation by his neurologist.
12 2021-05-27 burning sensation My son developed a fever, brain fog, and his legs felt like they were burning. More worrisome was... Read more
My son developed a fever, brain fog, and his legs felt like they were burning. More worrisome was the heart pain he woke up with in the middle of the night and throughout the day on 5/20. He complained of a sharp stabbing pain on left side of his chest and said it was hard to take a deep breath. I gave him ibuprofen and he rested. I called his doctor and they said not to worry, these side effects were normal. I?m a bit nervous for him to get the second vaccine since he had the chest pain side effects as to why I?m reporting this. I?m surprised they give the same dose to a 80lb child, they do to a 200 lb grown man.
12 2021-05-27 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium
12 2021-05-27 pain in extremity Dizziness, sore arm,
12 2021-05-30 pain in extremity, night sweats Inflammation of arm where injected. A lot of arm pain day after vaccine. Little nausea. Very tired. ... Read more
Inflammation of arm where injected. A lot of arm pain day after vaccine. Little nausea. Very tired. Night sweats.
12 2021-06-01 burning sensation After half an hour after i had left the pharmacy after the first dose of Covid Pfizer vaccine, Hamza... Read more
After half an hour after i had left the pharmacy after the first dose of Covid Pfizer vaccine, Hamza(12 yrs) started clutching his neck saying its on fire, tears were coming from his eyes and he started choking and coughing. He barely managed to say that his throat felt like something burning hot was pouring down. I immediately gave him cold water to drink. He drank and continued to drink in small sips for the next hour and was feeling normal in an hour. He had not eaten or drank anything after his vaccine. He had also had lunch at 3 pm, a full 2 hours before the vaccine.
12 2021-06-01 pain in extremity Next day and every day thereafter he started getting more symptoms of feeling sick. The arm pain beg... Read more
Next day and every day thereafter he started getting more symptoms of feeling sick. The arm pain began the next day after injection. Followed by runny nose, sore throat, croup sounding cough, shortness of breath, gasping, chest pains, vomiting, back of the skull pain. He described the head pain as a square from the base of the back of his skull to the crown of his head and back down. Felt more like a pressure in the bones of his skull and less like a standard headache. The chest pains are sharp and come on sporadically. At first they were accompanied by hacking cough but then progressed to sharp chest pains at random times especially when lying down. He has difficulty sleeping and staying asleep. Also, lower abdominal pain but no vowel issues.
12 2021-06-01 seizure seizure; This is a spontaneous report from a contactable physician. A 12-year-old male patient recei... Read more
seizure; This is a spontaneous report from a contactable physician. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced seizure in May2021 with outcome of recovered. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
12 2021-06-01 tenderness He got a superficial blood clot in left arm ?He's got the shot May 21 and I noticed he had two hard ... Read more
He got a superficial blood clot in left arm ?He's got the shot May 21 and I noticed he had two hard knots on left arm and there was probably about a half inch between them and as hard as a rock on that following Monday may 24,2021 , he said it was sore some more when you touched it we was told to keep an ion it make sure it didn't get any worse, turn red, swell, feel hot to the touch, and then to put a warm compresses on it ??
12 2021-06-02 muscle twitching Had headache & mild fever (100 on forehead) evening of vaccine but woke up on 3rd day with chest pai... Read more
Had headache & mild fever (100 on forehead) evening of vaccine but woke up on 3rd day with chest pains. Complained of pain when taking a deep breath and would flinch in pain. By the time got to ER in the afternoon, pain had subsided. Not sure if vaccine related but never had chest pains before & considering report of myocarditis after 2nd shot for younger males. Wanted this documented in case there is a pattern.
12 2021-06-02 pain in extremity, feeling hot The next morning he woke up with arm hurting him (he couldn't lift it). He felt a little warm - had... Read more
The next morning he woke up with arm hurting him (he couldn't lift it). He felt a little warm - had a low grade fever -99.something. He had a headache all day. He was very sluggish, tired. He did online school that day. He took a nap and laid down on the couch in between classes. He was really tired. I was giving him Tylenol every four hours. The first time he felt a little better, The second time, it didn't work. I called the doctor for advice and he told me to give him Children's Motrin. That seemed to do better. I gave that to him once that day. The next morning, he felt better. I gave him a Motrin anyway because he had a light headache. He did say he felt some heart racing. And he was a little tired. He called me from school around 11:30 am and he said that his heart has been racing through the whole morning - he was gym and said he couldn't run or anything but his heart was racing. I told him to go to t he school nurse - he had a pulse of 120. I met him there and I called the pediatrician and he saw him at 03:00. His pulse was high but not as high as before. He had rested in between. My son did see a cardiologist in June 2020- they put him on a heart monitor and she couldn't find anything at that time. At the regular doctor on the 19th, the doctor checked breathing and heart but did not have the materials at that location to do an EKG but said with the lowered heart rate just to watch and if it goes up again to go to Cardiologist we saw in June 2020. He rested some more and it went away on it's own. After that he was fine and no other issues. In fact, the next day he felt better and was running around and had energy and felt great.
12 2021-06-06 bell's palsy Bells Palsy Diagnosis
12 2021-06-06 feeling hot Sore arm at the injection site; whole body and muscle aches; fever of 101 degrees; whole body feels ... Read more
Sore arm at the injection site; whole body and muscle aches; fever of 101 degrees; whole body feels warm; nausea; fatigue and sleeping more than usual. Symptoms started at 4 AM the following morning, gave him some Tylenol to bring down the fever, and have him drinking lots of ice water. He has no appetite because he feels nauseous but he was able to eat a piece of bread which seemed to settle his stomach somewhat.
12 2021-06-06 pain in extremity Very sore arm, shoulder and armpit immediately after dosage, continuing 48 hours after dosage. Chil... Read more
Very sore arm, shoulder and armpit immediately after dosage, continuing 48 hours after dosage. Chills and headache 12 hour after dosage, lasting 4 hours.
12 2021-06-06 seizure My son had a fever, seizure and vomiting. We administered valtoco (diazepam nasal spray) for seizure... Read more
My son had a fever, seizure and vomiting. We administered valtoco (diazepam nasal spray) for seizure.
12 2021-06-07 pain in extremity Fever, tiredness, sore arm, giant red circle around injection site hot to touch appeared has a red b... Read more
Fever, tiredness, sore arm, giant red circle around injection site hot to touch appeared has a red border kinda middle is swollen.
12 2021-06-07 seizure Patient collapsed to the floor and sustained a seizure <1min. patient states LOC. parent of the pati... Read more
Patient collapsed to the floor and sustained a seizure <1min. patient states LOC. parent of the patient states no prior hx of seizure.
12 2021-06-08 flushing Systemic: vomited x 2-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild
12 2021-06-10 unresponsive to stimuli Patient was at immunization clinic for second pfizer immunization with his mother and older brother.... Read more
Patient was at immunization clinic for second pfizer immunization with his mother and older brother. His brother had his immunization and patient had his second immunization given reassurance and diversion for immunization offered to lay down for immunization but refused. Giving home instructions to family and patient stated felt funny, color pale, unresponsive for approximately 5 sec, lowered to floor turned on side, patient became nauseated and vomited x 1 small amount of brown emesis, Skin moist and warm to touch pale. EMS here to assist and taken back to observation area via wheelchair. Report given to EMS. Patient awake.
12 2021-06-13 feeling cold, tremor Grandmother (guardian) said at around 3:30am 6/12/21 patient woke up and came to her bedroom, was sh... Read more
Grandmother (guardian) said at around 3:30am 6/12/21 patient woke up and came to her bedroom, was shaking uncontrollably, felt cold to the touch, this lasted for about 45 minutes. Patient did not have a fever but continued with the shaking, she said it reminded her of a seizure but patient was able to talk and walk around. Patient was able to go back to sleep after that and only had a fever of 101 during the day of 6/12/21.
12 2021-06-13 pain in extremity, discomfort, weakness Had 2nd Pfizer vaccine at 5:15pm Thursday June 3. Felt fine that evening, just complained arm was st... Read more
Had 2nd Pfizer vaccine at 5:15pm Thursday June 3. Felt fine that evening, just complained arm was starting to hurt when he went to bed around 11pm. Threw up twice on Friday June 4 at 9:30am & 1:30 pm. Very uncomfortable, bad headache, no energy. Mostly slept from 6pm Friday June 4 to 5am Saturday June 5. Immediately threw up when he woke up Friday. Threw up again about 30 min. later and 4 more times during the day. Still having bad head pain. Started to become confused and say things that didn't make sense. Went to ER around 4:30pm Saturday June 5. Blood work showed his sodium level was dangerously low. He was immediately given sodium and transported to Hospital ICU. Had brain MRI, lumbar puncture and lots of blood work done. Brain MRI showed signs of encephalitis. Also had myocarditis. Was in hospital until Thur. June 10. Encephalitis and myocarditis seemed to resolve quickly and he was just treated with rest and fluids along with antibiotics in case there was any viral/infectious cause of symptoms. All such tests have been negative to date
12 2021-06-13 pain in extremity Fatigue, pain at injection site and soreness under left arm starting around 11pm on 11Jun2021; fatig... Read more
Fatigue, pain at injection site and soreness under left arm starting around 11pm on 11Jun2021; fatigue and underarm soreness and still continuing today (14Jun2021); dizziness starting around 6am on 12Jun2021 and still continuing today (14Jun2021); fever and chills starting around 8am on 12Jun2021 and subsiding by around 9am on 13Jun2021; raised, red/irritated skin around injection site, in shape of band-aid that was applied after injection, observed 13Jun2021 and still persisting as of 14Jun2021; increased dizziness and racing heart beat starting morning of 14Jun2021 and still continuing.
12 2021-06-13 pain in extremity Sore arm on 5/16 , shortness of breath - mild - on 5/17 ,- child complained , but never in distress ... Read more
Sore arm on 5/16 , shortness of breath - mild - on 5/17 ,- child complained , but never in distress , no fever that day . SoB mild on 5/18 . Then resolved . 5/18 through 5/20 had fever / chest pain ( with tenderness to palpation on the right costochondral junction ) . Started on Motrin on 5/17 - one dose 5/18 - added on Tylenol along with Motrin , continued through 5/20. Child was better by 5/21-5/22 . Never had any hives / wheezing . Was tachycardia in 110 range on 5/18-5/20 , but was also febrile .
12 2021-06-13 pain in extremity Sore arm, headache, fever (103.5).
12 2021-06-13 seizure Patient received vaccine and within 1 min of administration fainted. Patient also convulsed upon fai... Read more
Patient received vaccine and within 1 min of administration fainted. Patient also convulsed upon fainting due to quick drop in blood pressure. Patient was taken to hospital and received IV hydration only. He was able to return home after.
12 2021-06-13 seizure 1st time seizure
12 2021-06-14 weakness, feeling cold Patient received the 2nd dose of vaccine and he fainted 3 - 4 minutes after. His blood pressure was ... Read more
Patient received the 2nd dose of vaccine and he fainted 3 - 4 minutes after. His blood pressure was after 3 measurements over 15 min at an average of 98/58 with a pulse of 70. He also experienced a little dizziness, EMTs came at 2:20 pm and repeated the BP/pulse monitoring for about 20 min. Patient said that at one point felt cold and week but he was able to walk to the car with paramedics. No other symptoms mentioned during observation. Mom was counseled to monitor the patient and call MD if any new symptoms.
12 2021-06-14 feeling hot Felt faint and nauseous five minutes after injection. Skin felt hot and sweaty. Said his stomach hur... Read more
Felt faint and nauseous five minutes after injection. Skin felt hot and sweaty. Said his stomach hurt and he felt like he was going to faint. Removed his jacket, sat him down, fed him crackers and water and he recovered after about five minutes.
12 2021-06-14 pain in extremity Mother of PT states this survey report is for her her son. Mother of PT states her son received the... Read more
Mother of PT states this survey report is for her her son. Mother of PT states her son received the Pfizer vaccine NOT the Moderna as stated on this survey. Mother of PT states her son received the second dose Pfizer vaccine on 06-10-2021and her son experienced fever, chills, fatigue and more soreness to his left arm with also lump under his left armpit. Mother of PT states she gave her son on the night of the second vaccine, Tylenol for relief of pain. Mother of PT states her son states that as of this morning her son does not have the lump under his left armpit nor any pain. Also Mother of PT states that for her son's first dose, was on 05-20-2021 and that he experienced soreness to his left arm, tiredness, pain and a lump under his left arm pit. Mother of PT states she did not take his son to see a doctor.
12 2021-06-15 pain in extremity Patient received 2nd dose of Pfizer vaccine on 6/10/2021. Initially had typical symptoms of fatigue ... Read more
Patient received 2nd dose of Pfizer vaccine on 6/10/2021. Initially had typical symptoms of fatigue and arm pain. On 6/13/2021, woke up with central chest pain and "fluttering" of his heart. Mother read the Agency website concerning possible myocarditis after Covid vaccinations so then took him to the ED. The chest pain lasted about an hour (resolved in triage in the ED). There he had a normal ECG and chest x-ray. He was referred to see me in clinic on 6/15/2021. He had a normal echocardiogram. Due to the parental concern for possible myocarditis, I recommended a troponin which would show if his chest pain were possibly related to that. It returned mildly elevated at 0.21 ng/mL, prompting me to enter this as a possible mild case of myocarditis after vaccination.
12 2021-06-15 seizure This 12-year old's first dose of the Pfizer was deemed invalid due to storage error and repeated 13 ... Read more
This 12-year old's first dose of the Pfizer was deemed invalid due to storage error and repeated 13 days later. About 14 hours after revax he had a seizure in the middle of the night, which he reported to his mother the next morning. He also had fever that next day lasting about 24 hours. His mother reasoned his seizure was due to fever since his last seizure was 150 days ago and he had been well-controlled on 2 meds. She presented today for 2nd vaccination, (technically 3rd dose of Pfizer) expressing concerns about another seizure. She was advised to consult his neurologist, for guidance and was advised vaccine will be available if/when she and the doctor deem it safe to give.
12 2021-06-15 tremor Nausea, fatigue, chest pain, hand tremoring started last night and this morning suddenly 3 occupanci... Read more
Nausea, fatigue, chest pain, hand tremoring started last night and this morning suddenly 3 occupancies of chest pain followed by feeling ok Was strong pain
12 2021-06-15 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient received 2nd vaccination, did not sit and wait around 15 minutes as directed and fainted in the store. patient was very nervous before getting shot and stated later that he was sick last week and had not eaten anything all day (shot administered at 1230p). pt felt dizzy and lightheaded before fainting. paramedics were called and pt vitals were checked and all normal. pt went home with dad to be monitored closely for rest of day.
12 2021-06-16 burning sensation Patient was experiencing burning sensation in calves 4 hours after vaccination but has resolved. The... Read more
Patient was experiencing burning sensation in calves 4 hours after vaccination but has resolved. The following morning, patient was taken to urgent care for back pain between the shoulder blades (writhing in pain and crying)
12 2021-06-16 pain in extremity 24-36 hours after injection - fatigue and slept for an extended time. Pain in arm of injection. 3 da... Read more
24-36 hours after injection - fatigue and slept for an extended time. Pain in arm of injection. 3 days after 2nd injection, hives on arms, legs, back, shoulders, tops of hands and feet. Raised and looked like target hives. Very itchy.
12 2021-06-16 tremor, pain in extremity Blister-like hives appeared on tops of ears, then upper back and back of hand; Sore arm; Nausea; Fat... Read more
Blister-like hives appeared on tops of ears, then upper back and back of hand; Sore arm; Nausea; Fatigue; Tremors; Headache; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 09:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously had the known allergies included hives developed after 1 dose of amoxicillin and Azithromycin, hives present after several doses of m (as reported). The patient did not have the COVID prior vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received Multivitamin and Probiotic in two weeks. On 14May2021 at 01:00 PM, after the 4 hours of dose the patient experienced blister-like hives appeared on tops of ears, then upper back and back of hand. Then, sore arm, nausea, fatigue, tremors, headache through night. Following day continued with hives, headache, fatigue, sore arm, plus vomiting. Felt much better by the second day post shot. Just hives and arm soreness continued. The patient did not receive treatment for the events. On an unspecified date, the events nausea, fatigue, vomiting, tremors and headache were resolved. The outcome of blister-like hives appeared on tops of ears, then upper back and back of hand and sore arm were not resolved. Information on lot/batch number has been requested.
12 2021-06-21 unresponsive to stimuli, brain damage 12 y.o. male patient with history of developmental delay, seizure disorder who presented to the emer... Read more
12 y.o. male patient with history of developmental delay, seizure disorder who presented to the emergency department today with acute encephalopathy, unresponsive with bradycardia, V-tach requiring defibrillation, and acute respiratory failure requiring intubation. The family had been traveling and vacationing with extended family members and recently returned Saturday night. No sick contacts during the trip and he recently received his second COVID-19 vaccine on June 5th. On Sunday, June 20th, he had cold symptoms with stuffy nose, sneezing and minimal oral intake. Mother gave him 10ml of a multi-symptom OTC cold medication that evening. Unsure what is in the medication or if it contains Benadryl. This morning, he had an 11am swim lesion and then came back and slept on the couch. Still minimal oral intake and was resting all day long but awake most of the time. This evening at 5:43pm per mother, he received another 10ml of the multi-symptom cold medication. He was given his Vimpat and Valproic Acid medications around 7:30pm. Around 8:20/8:25pm, he was asleep and had an emesis and was not responding In the ED, he was unresponsive and poor respiratory effort with episodes of apnea and was incontient of stool during the exam. He was brought to the resuscitation room, PIV placed x2. Placed on oxygen initially. Ativan given once for possible seizure. Epinephrine given for bradycardia. Noted V-tach on rhythm. Second Epi given, started Epinephrine infusion and Shock given 2J/kg. Cardiology at bedside. Rocuronium and Etomidate given for intubation. He was intubated on the second attempt with 6.0c ETT.
12 2021-06-22 migraine ongoing, prolonged headache migraine started within 24 hours of vaccine, to date 19 days of headache... Read more
ongoing, prolonged headache migraine started within 24 hours of vaccine, to date 19 days of headaches out of 20, same spot on forehead between eyes above, requires multiple doses of pain medication to subside the pain and has required migraine ( headache) cocktail of Benadryl/ ibuprofen/ Compazine on occasion to relieve pressure and pain of headaches, than it returns. Extenuating headaches after Pfizer vaccine, seems the vaccine has triggered a prolonged immune response we have yet been able to stop. Constant daily headache same area requiring more medication and lasting longer, some days after first does of tylenol he will need a 2nd dose of ibuprofen 4/5 hours later as the headache with first does of pain meds did not remove the headache. , achy pressure pain same with each headache, not sever pain but moderate and affects daily movements and activities as to not escalate the pain further, drinking multiple bottles of water and trying to stay hydrated along with medications trying to remedy the prolonged headache from the vaccine . Drs have very limited information on how to treat or handle prolonged headaches from vaccination, information on these events or recommended treatments not easily found.
12 2021-06-23 feeling of body temperature change Had the vaccine on Saturday and on Tuesday afternoon, felt very dizzy, became very pale, had chest p... Read more
Had the vaccine on Saturday and on Tuesday afternoon, felt very dizzy, became very pale, had chest pain, pressure in chest and couldn't take a deep breath, vision kept moving in and out, had to sit down, felt very hot and cold at the same time and was actually sweating and feeling chills. Took it easy for the next 4-5 days and just stayed home and in bed. When it got really bad, took a dose of ibuprofen. The symptoms slowly got better and disappeared. Took about three doses of ibuprofen total over a few days. Talked to our pediatrician a week later who said we should report this.
12 2021-06-24 numbness He says he woke up and couldn?t smell anything or feel textured with his fingers. He then threw up a... Read more
He says he woke up and couldn?t smell anything or feel textured with his fingers. He then threw up and got a headache and has a fever of 103.2.
12 2021-06-24 pain in extremity Headache; fatigue; aches in large limbs; fever; injection site pain-all mild to moderate; This is a ... Read more
Headache; fatigue; aches in large limbs; fever; injection site pain-all mild to moderate; This is a spontaneous report from a contactable consumer or other non health care professional. A 12-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number was not reported), via an intramuscular route of administration, administered in left arm on 16Jun2021 at 09:45 (at the age of 12-year-old) as a single dose for covid-19 immunization at clinic. The patient medical history included ongoing seasonal allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for seasonal allergy (received within 2 weeks of vaccination). Since the vaccination, the patient has not been tested for COVID-19. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number was not reported), via an intramuscular route of administration, administered in left arm on an unspecified date in May2021 as a single dose for covid-19 immunization and did not experienced any reaction. On 16Jun2021 at 23:00, the patient experienced headache, fatigue, aches in large limbs, fever, and injection site pain- all mild to moderate. Patient did not receive any treatment for the events. Events did not result in hospitalization. The outcome of the events was recovered on an unspecified date in Jun2021. Information about batch/lot number has been requested.
12 2021-06-24 seizure Extremely high fever that led to a seizure; Extremely high fever that led to a seizure; This is a sp... Read more
Extremely high fever that led to a seizure; Extremely high fever that led to a seizure; This is a spontaneous report from a contactable consumer (patient's parent) received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Jun2021 at the age of 12 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at the age of 12 years old, dose 1 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jun2021 at 20:00, the patient experienced extremely high fever that led to a seizure. The adverse event did result in an emergency room/department or urgent care. Therapeutic measures were taken as a result of extremely high fever that led to a seizure, which included emergency medical services (EMS) support, paracetamol (TYLENOL), and ice bath. The patient recovered from the events on an unspecified date. Information on the batch/lot number has been requested.
12 2021-06-25 pain in extremity, weakness Sore arm, headache, weakness, upset stomach, fatigue
12 2021-06-27 feeling hot ED Physician documentation from 6/7/21 Fever, chest pain and palpitations. Patient states he had hi... Read more
ED Physician documentation from 6/7/21 Fever, chest pain and palpitations. Patient states he had his second Covid vaccine yesterday. Tactile fever. Treated with Tylenol at 10:30 PM. Chest pain began yesterday during the afternoon but got more intense at 11 PM.. Left-sided, constant, sharp, 6/10, worse with movement. Patient also with palpitations of the same duration. Temperature measured was 38.6 C.
12 2021-06-28 grand mal seizure yelled out loudly when he received the vaccine but was fine immediately after. He was sitting for ab... Read more
yelled out loudly when he received the vaccine but was fine immediately after. He was sitting for about 5 minutes before his mother said that he was feeling dizzy. The doctor was going to grab an ice pop for him when he fainted. was there as he was sliding off of the chair and had him in her arms. He then began to have a tonic-clonic seizure that lasted approximately 1 minute. The mother called 911. He woke up and asked what happened. The ambulance arrived and suggested that he go the hospital. The mother was on the phone with his father and he said he did not think an ER visit was necessary. The ambulance left and after waiting another 30 minutes, mom took home.
12 2021-06-28 tingling At 2:45 pm I was informed that a 12-year-old who had just been given the vaccine was dizzy. I went t... Read more
At 2:45 pm I was informed that a 12-year-old who had just been given the vaccine was dizzy. I went to get a cotton ball with alcohol and immediately went out to assist him. After a few minutes he indicated that he felt better. The nursing graduate came out to check it again and was dizzy again. His arms were raised, ice was placed on him, then we put him on several chairs with his legs raised by pillows and 911 was called at 3:01 pm. The patient presented a complaint of tingling in the face and arms. The pressure was taken (126/76) Pulse 84. The father requests a stethoscope because he feels the young man's heart agitated and an oximeter since it also indicates some difficulty in breathing. Oxygen is placed and oximeter reflects a saturation of 99%. BP: 124/65. 911 is called back at 3:20 pm. They arrived at 3:26 pm. Paramedic indicated to give him liquid Benadryl. He was given 10ml. They proceeded to take the young man to the Hospital.
12 2021-06-29 flushing, unresponsive to stimuli, weakness, tremor Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
12 2021-07-01 feeling hot Dizziness overheated Oxygen 99 Heartrate 73 BP 110/62
12 2021-07-02 cold sweat After receiving the injection, within about 5 to 10 minutes patient felt dizzy and fell in his fathe... Read more
After receiving the injection, within about 5 to 10 minutes patient felt dizzy and fell in his fathers arms. Patient did not pass out but was dizzy, clammy, sweaty and pain in his left arm at injection site. I called 911. 911 came within a few minutes since they are stationed across the street from us. The EMT took his vitals. Vitals initially low at 88/55 then climbed back up to 102/68. No fever. Patient started to feel better. EMT stated patient is ok and may have
12 2021-07-05 pain in extremity approximately 2 inch long x 1.5 inch swelling under left armpit identified 2 days after vaccine adm... Read more
approximately 2 inch long x 1.5 inch swelling under left armpit identified 2 days after vaccine administration. no redness or pain. Complained of general pain in the arm and "deep inside" his left shoulder. Has good range of motion.
12 2021-07-05 seizure Systemic: Dizziness / Lightheadness-Mild, Systemic: seizure for 30 sec on next day-Mild
12 2021-07-06 feeling cold, cold sweat Pt began experiencing a short burst of nausea shortly after injection. Pt began dry heaving. Pt's sk... Read more
Pt began experiencing a short burst of nausea shortly after injection. Pt began dry heaving. Pt's skin became cool and clammy. Pt was evaluated during this time by a Physician's Assistant, as well as a Registered Nurse, and vital signs were all within normal range. Pt began feeling much better shortly after, and was able to leave the clinic after their observation period without any other medical attention.
12 2021-07-06 muscle spasms Chest tightness in the morning after with shortness of breath. Mild cough and neck spasms. Patient r... Read more
Chest tightness in the morning after with shortness of breath. Mild cough and neck spasms. Patient received prednisolone
12 2021-07-07 bell's palsy Next day, developed high fever (104-105) for 2 days. 2 weeks later, developed Bell's Palsy (right-si... Read more
Next day, developed high fever (104-105) for 2 days. 2 weeks later, developed Bell's Palsy (right-side).
12 2021-07-07 pain in extremity lymph node noticeably swollen and in pain on left side under arm.
12 2021-07-07 pain in extremity His reaction he felt like he had pneumonia, legs and arms hurting, stomach hurts and fever.
12 2021-07-11 migraine 4 days following 1st COVID vaccine, pt developed erythema migrans vs cellulitis vs insect bite to le... Read more
4 days following 1st COVID vaccine, pt developed erythema migrans vs cellulitis vs insect bite to left lower back. ? Lyme disease, treated with doxycycline, began resolving in 3 days after start of doxycycline. No other systemic signs and symptoms at that time.
12 2021-07-12 impaired body coordination Patient came in for second dose of vaccine. Patient and mother read and consented to the vaccination... Read more
Patient came in for second dose of vaccine. Patient and mother read and consented to the vaccination and read the prevaccination checklist. patient advised of potential side effects and recommendations of care for next few days (stay hydrated, possible soreness, take Advil or Tylenol for possible low grade fever or headache). Patient asked about hydration and meal prior to visit. Patient presented with nervousness/ anxiety and mother/ patient still consented to vaccination. vaccination was given, patient was taken to waiting area with crackers and juice given. while waiting the patient became diaphoretic. As patient walked to the back with mother to use restroom, patient showed signs of ataxia. patient was assisted into recovery position and never lost consciousness. Vital signs taken at 11:15 am BP: 99/45 (left leg), HR: 77, SPO2: 99%. Patient was fanned to cool off and decreased in diaphoresis. vital signs taken again at 5 min intervals. Patient monitored for 30 minutes, encouraged fluids with total intake of 700mL fluid. Last set of vitals taken while standing at 11:45 am were BP: 118/60, HR: 102, SPO2: 99%). Patient was given more fluids and monitored for 15 more minutes and then discharged from the clinic with parents.
12 2021-07-12 migraine Patient reports a Migraine daily from the time of the vaccination.
12 2021-07-12 numbness and pain in extremities, grand mal seizure full generalized tonic clonic seizure; fever; troponins checked and they were elevated; 70-80 systol... Read more
full generalized tonic clonic seizure; fever; troponins checked and they were elevated; 70-80 systolic on 06Jun2021; heart rate 160s on; This is a spontaneous report from a non-contactable consumer (patient). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 05Jun2021 12:00 as dose 2, single for covid-19 immunisation. Medical history included history of autism, controlled seizures. The patient's concomitant medications were not reported. patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 15May2021 as dose 1, single for covid-19 immunisation. The patient underwent lab tests and procedures which included blood pressure measurement: 70-80 systolic on 06Jun2021, cardiac monitoring: unknown results on 06Jun2021, echocardiogram: unknown results on 06Jun2021, heart rate: 160s on 06Jun2021, neuropathy peripheral: unknown results on 06Jun2021, body temperature: 103.6 on 06Jun2021, troponin: elevated on 06Jun2021. On 06Jun2021 08:00. After shot done at 12 PM, next morning at 8 AM patient had full generalized tonic clonic seizure lasting 20-25 minutes, fever of 103.6. EMS was called, went to ER, fever eventually went down and got IV fluids due to HR in 160s and BP 70-80 systolic. After 2 hours, troponins checked, and they were elevated. Transferred to hospital for overnight observation and monitoring of troponins (peaked at midnight, then trended down). Echo was okay. Will follow up with neurology and cardiology. The outcome of the events was resolved on unknow date in 2021. No follow-up attempts are possible. No further information is expected.
12 2021-07-12 tremor, flushing, seizure Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-M... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient began feeling light-headed and dizzy about 1-2 minutes after receiving vaccine while sitting in obs. area. Was given water which helped for a little and then shortly after that patient began lightly shaking- looked almost like a seizure and his eyes rolled back for 3 seconds. Came back to consciousness after 5 seconds- stayed on chair whole time never hurt himself just a vagal reaction to vaccine. Paramedics were called to examine him and brought him to hospital for monitoring with mom.
12 2021-07-12 unresponsive to stimuli within about 30seconds to 1min after administering Pfizer covid vaccine, 12 year old patient passed ... Read more
within about 30seconds to 1min after administering Pfizer covid vaccine, 12 year old patient passed out....went from talking, laughing to sagging off his chair, I grabbed him and slowly lowered him to the floor....he was having difficulty breathing, focusing , etc.....talked to him, focus him on breathing, gave him water to drink, wet cloth to forehead, face and neck...he came out of it and said he felt ok....he got up and walked to the waiting area with his mom...appeared to be fine, was talking and laughing again, when all of a sudden he was just sitting there, eyes wide open, but not aware. Another customer was there and she noticed him and immediately got him to focus, breathe, popped an ammonia inhalant, applied instant ice pack to his back and neck which brought him out of it.....asked mom and we called 911, EMT's responded and transported Patient to the hospital to be checked.
12 2021-07-14 pain in extremity Pt returned to office at 4:30 today after starting to break out in a rash around 1440. Rash started ... Read more
Pt returned to office at 4:30 today after starting to break out in a rash around 1440. Rash started on his left forearm initially and then spread to right forearm, both knees, and right flank. Rash is itchy. Pt denies any fevers, no shortness of breath, no sore or tickly throat. He does complain of right upper arm pain (HPV vaccine) and pain in both legs. He is ambulating without issue. No limp. Since leaving the office this AM he has eaten a steak quesadilla and SODA. He also took his zyrtec, singulair, flonase and flovent.Per mom he hasn't been playing outside over the past few days. Rash looked more red prior to entering the office (though they had walked from mom's workplace at and outside temps today are in mid to upper 80's Physical Exam- Areas of rash consist of erythematous, flat lacy appearance and are over the inner aspect of the right and left forearm, right flank, and above the left and right knees. No raised areas noted.. Lesions: no petechiae or rash. Pt given script of 25mg benadryl to take at night and 2.5% hydrocortisone ointment to apply to rash areas 2-3 times a day as needed. Mom to return to office tomorrow if rash is worse, spreading. Will also do allergist referral to ensure that second doses of HPV and COVID can be given per schedule
12 2021-07-15 weakness, tremor, flushing Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / S... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient became lightheaded about 10 minutes after immunization. He presented as pale, shaky, and almost ready to faint. Patient was given pedialyte, ice, and chocolate after vomiting one time. EMS was contacted, they arrived and assessed the patient. He was cognizant and able to stand on his own. Mother refused transport to the hospital and the family left about 45 min after immunization was given.
12 2021-07-17 burning sensation, weakness tiredness; weakness; head is burning; fatigue; drooling; hives; itching; redness; gained weight sinc... Read more
tiredness; weakness; head is burning; fatigue; drooling; hives; itching; redness; gained weight since the vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729; Expiration Date: 31Jul2021) via an unspecified route of administration, in left arm on 27May2021 (at the age of 12-years-old) as dose 1, single for covid-19 immunisation. Medical history included patient had an allergic reaction to penicillin before. The patient's concomitant medications were not reported. The patient had a meningitis vaccine a month before the covid vaccine. Patient's mother was calling on behalf of her 12 year old son. She stated her son received the first dose of the Pfizer COVID vaccine on 27May2021. On 27May2021,6 hours after receiving the vaccine the patient said he was very itchy and had hives on the left side of his chest. At first she thought the patient had poison ivy because it was like 3-4 inches across. The next day the patient said he was itchy when he sat up and it went up onto his neck and cheeks and that's when she realized it was hives. She called the doctor, applied cold compresses to the patient and gave him Benadryl. The hives resolved very quickly, the patient has never had hives or an allergic reaction before. By 2:30 the patient had the Benadryl and you couldn't see the red anymore. The patient could sit up but kept saying it itched and that went on for about 48 hours. You would have to look pretty closely to see the bumps. One week after the patient received the vaccine he was really weak and tired (on 03Jun2021). She stated her son also keeps having episodes of tiredness and weakness. It felt like the patient had been exercising and his legs were tired and his head felt like it was burning (on 03Jun2021). The patient's temperature was 97.7. The patient laid down and he slept pretty hard, and was drooling, for a couple of hours. When the patient woke up he didn't know where he was, the time or date and within a couple of hours the patient was fine. She didn't think anything of it the first time it happened. This event happened again 2 weeks after the vaccine. The doctor said they symptoms sound like mono but the patient's lymph nodes aren't swollen and he doesn't have a sore throat. The doctor thought the patient was having a delayed immune response to the vaccine because of the timing of it. The doctor said that by 3 weeks this should have resolved. The patient has had 2 mild episodes of this since, but he didn't go to sleep he just laid down. The doctor said to wait to get the second dose, so now it is 4 weeks since the first vaccine. The patient was at the 30th percentile for his height and average for his weight. The patient had gained weight since the vaccine but his mother didn't know if that was related to the vaccine. She was afraid of the patient having myocarditis with the second dose. The patient went to sleep after taking the Benadryl last time and she was afraid that the patient won't be able to tell her if he was having chest pain or problems breathing. She stated if his reaction was just hives she would give him Benadryl but with the risk of myocarditis after being given Benadryl he wouldn't be alert enough to tell her if something was going on with his heart due to him having fatigue as well already. The redness went away within 24 hours and the itching was gone in 48-72 hours. The redness was gone the evening of the 28th. The patient could still see and feel the bumps, the bumps were just white. The patient's head was burning happened the first 2 times he had these events. The patient's temperature was 97.7 and 98.1 fahrenheit when this happened. The other two times the patient said his head burned between his eyes and not like a headache. The doctor said that if the fatigue symptom continued he would recommend doing some blood work but since it has gotten better his mother may take him to an allergist. She thinks that the patient may be allergic to something in the vaccine. she was thinking of taking him to an allergist to see if he was allergic to one of the ingredients in the vaccine. She stated from the list of the ingredients the only ingredient she found that could be linked to the vaccine that could cause an allergic reaction would be PEG. She stated her son never had any allergies to medications or vaccines in the past. She stated she was not sure what advice should be given regarding her son receiving the second dose of the vaccine due to him having an allergic reaction to the first dose and tiredness and weakness. She stated she was not sure of the risks of vaccine versus him not being vaccinated. She would like to know if he should receive the second dose after experiencing side effects with the first dose. Reporter seriousness events was unspecified. Outcome of the events hives and itching recovered on May 2021, redness recovered on 28May2021, event tiredness and weakness was recovering and for other events was unknown.
12 2021-07-18 feeling cold ? At approximately 6:50PM vaccine was administered. ? Within 10 minutes of the dose being administe... Read more
? At approximately 6:50PM vaccine was administered. ? Within 10 minutes of the dose being administered, patient began vomiting. ? At approximately 7:03PM, RN attempted to assess patients pulse. RN determined pulse to be approximately 100 BPM but was difficult to be confident as the pulse was indistinct. Another RN also attempted to collect a pulse and was not confident in a reading. Oxygenation and heart rate was attempted to be collected using a pulse oximeter. A reading could not be determined. Additionally, a temperature could not be collected using an infrared thermometer. Upon observation, the patient appeared pale and diaphoretic. He did not present or report difficulty breathing at any time. Patients skin was cool to the touch. Patient reported to his parents that he felt nauseous and cold. ? At approximately 7:08PM patient was offered juice. ? At approximately 7:10PM RN observed that nail bed began to become discolored, slightly blue. RN requested call 911. ? EMS onsite by 7:15PM. EMS vitals included, o BP 131/88 o HR 103 o Resp. 24 o O2 Sat 98% o Temp 98.4 ? Family declined glucose screen and transport to emergency department as patietn began to report feeling better. Patients color improved. ? EMS, family, and staff left scene at approximately 7:50PM. ? RN connected with patients father on 7/16/21. Father reported that patient was doing much better, slept through the night with no issues. Patient was still sleep when father left for work that morning, however, father looked in on him. Per fathher, his color appeared good and he was sleeping well. Father wondered what gauge needle was used for the procedure. He stated he thought is was long and perhaps a 1 ½ ? size. RN assured it was a 1? needle as the type of set-up used was a complete set-up with a standard 1? needle.
12 2021-07-18 numbness Patient received vaccine 7/16/21 and complained of numbness is the arm. Patient's mother called tod... Read more
Patient received vaccine 7/16/21 and complained of numbness is the arm. Patient's mother called today, 7/19/21, to inform us of the reaction. She stated the patient was experiencing numbness from the shoulder down to the hand. He can move his arm, but cannot feel. Mother was advised to call patient's PCP.
12 2021-07-19 flushing patient was sitting on bench in front of pharmacy and fell out of the seat onto the floor. Patient b... Read more
patient was sitting on bench in front of pharmacy and fell out of the seat onto the floor. Patient became very dizzy, flushed, and vomited. This happened about 10 minutes after vaccine given and lasted for about 10 more minutes. After throwing up, patient drank plenty of water and rested in which they started feeling good enough to walk away with their parent.
12 2021-07-19 tremor, unresponsive to stimuli, flushing Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild
12 2021-07-20 tremor Pt stated shaking and stomach pain and his parent wants to call 911
12 2021-07-21 weakness high fevers 104 very swollen tonsils and sore throat extreme tiredness/sleeping constantly Dr. assu... Read more
high fevers 104 very swollen tonsils and sore throat extreme tiredness/sleeping constantly Dr. assumed Strep throat and started on Amoxil July 6th. Finished the 10 day course of treatment. Condition worsened and Dr. started on Keflex July19th. No improvement and was seen in urgent care July 21st. Fever of 99.6 at urgent care and heartrate of 132 and very lathargic and weak.. It is determined that he has mono. He has had mono before but it is explained that possibly the vaccine triggered it to be reactivated in his system. He is on steroid as of July 21st to try to decrease the inflammation.
12 2021-07-21 tremor Developed fever, fatigue, shaking, and tachycardia. Required admission to the hospital for observat... Read more
Developed fever, fatigue, shaking, and tachycardia. Required admission to the hospital for observation due to persistent tachycardia and concern of myopericarditis. He did not develop myopericarditis or end organ dysfunction of (Privacy). He was discharge in approximately 48 hours and is continuing to improve.
12 2021-07-22 feeling hot Broke out in a full body rash; Red, warm to touch, itchy, it was not too raised, just slightly swoll... Read more
Broke out in a full body rash; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; Red, warm to touch, itchy, it was not too raised, just slightly swollen; This is a spontaneous report from a contactable consumer reported (reporter's son). A 12-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 08Jun2021 09:00 (Batch/Lot number was not reported) as dose 2, single (at age of 12-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. No known allergies. Concomitant medications included ascorbic acid (VITAMIN C); vitamin d nos (VITAMIN D). Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18May2021 09:00 administered in left arm (at age of 12-years-old) for COVID-19 immunisation. The patient broke out in a full body rash starting 2 days after the 2nd shot on 10Jun2021. Started on top of his feet and spots on his leg and by the 3rd day, was covering most of his body up to his neck. Red, warm to touch, itchy, it was not too raised, just slightly swollen on 10Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Used Zyrtec and Benadryl per advise of doctor. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No Hospitalization Prolonged. Outcome of the events was recovered/resolved. Information on the lot/batch number has been requested.
12 2021-07-22 pain in extremity Patient was in his usual state of health until 3 weeks after the covid vaccine, when he played baske... Read more
Patient was in his usual state of health until 3 weeks after the covid vaccine, when he played basketball for 3 hours on 6/22. He had been inactive prior to 6/22 and it was hot day. He developed leg pain that evening and was diagnosed with rhabdomyolysis with a CK of 21,980. Patient was hospitalized for IV fluids and since then his CK has been down trending and his leg pain has now resolved.
12 2021-07-22 pain in extremity Pt presented to the ER 7/11/21 with joint pain in bilateral arms, left hip, and posterior knees, and... Read more
Pt presented to the ER 7/11/21 with joint pain in bilateral arms, left hip, and posterior knees, and 1 episode of SOB for over a week. 3 weeks prior he reported having a fever and headache but that resolved. Pt at this time was Diagnosed with Rhabdomyolysis
12 2021-07-25 involuntary muscle movements, unresponsive to stimuli Patient pre-screened and reported cough but stated it could be caused from seasonal allergies becaus... Read more
Patient pre-screened and reported cough but stated it could be caused from seasonal allergies because otherwise feels well. 1st dose of Pfizer vaccine administered and well tolerated. Patient transferred independently to post vaccination waiting area with mother. Almost immediately upon sitting, mom called for help. Upon arrival of documenting RN patient noted to be unresponsive to deep stimuli. Patient noted to have rapid, involuntary fluttering of bilateral eyes, and involuntary jerking of head, neck, and shoulders. This RN requested for clerk to call 911 and lowered patient to floor in supine position with assist from the mother. Mother instructed to keep feet elevated. 2nd RN, arrived and assisted with placement of blood pressure cuff and SpO2 monitor. Immediately after being placed supine with feet elevated all involuntary movements ceased and patient began responding to verbal stimuli. Patient answering question appropriately indicating orientation to person, place, time. Vitals as follows: HR68-72, Bp110/70, SpO2 96-100%. Patient without generalize redness, rash, hives or other signs or symptoms of allergic reaction. Breath sounds clear bilaterally. Pulse strong but irregular initially, but became regular as patient stopped crying stated to calm. Mother denies history of anxiety or inappropriate hydration patterns. Mother updated/informed that we are unable to diagnose, but to be on the safe side we would recommend being evaluated at the Emergency Room. EMS arrived at this time and report given by documenting RN. EMS verbalized/suggested ER evaluation and mom agreed with POC. Patient transported to the ER via EMS with moms approval.
12 2021-07-25 flushing Systemic: Dizziness / Lightheadedness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension... Read more
Systemic: Dizziness / Lightheadedness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Pt felt lighted & turned pale shortly after administration. Clinic had pt lay flat for a while & he recovered thereafter.
12 2021-07-25 pain in extremity Headache, Nausea, Vomiting, Low Grade Fever, Soreness in the arm, tired
12 2021-07-25 pain in extremity First dosage: sore arm Second dosage: Headaches, chills, nauseated, lump under left arm pit, and s... Read more
First dosage: sore arm Second dosage: Headaches, chills, nauseated, lump under left arm pit, and sore arm
12 2021-07-25 pain in extremity Headache, soreness in arm, tired, nausea
12 2021-07-25 tremor Patient was vaccinated with first dose of Pfizer vaccine within the pharmacy lobby of clinic then fa... Read more
Patient was vaccinated with first dose of Pfizer vaccine within the pharmacy lobby of clinic then fainted seconds later. He was caught by staff member and transferred to a chair with the assistance of father and staff member; the patient was noted to have involuntary shaking of extremities. Rapid response was alerted. Patient regained consciousness within a minute and informed staff that he started feeling lightheaded immediately after receiving shot. Episode was witnessed by father and two pharmacy staff members. Patient was transfered to clinic, then discharged with an appointment set up with a cardiovascular doctor at the hospital to follow up on previously known heart murmur.
12 2021-07-26 flushing Swallowing of lips and rush in the face aftee second dosis of Pfizee vaccine
12 2021-07-29 weakness Tiredness; Loss of appetite; lack of energy; Chills; Fever; Soreness at the injection site; Warmness... Read more
Tiredness; Loss of appetite; lack of energy; Chills; Fever; Soreness at the injection site; Warmness at injection site; difficult to lift his arm; This is a spontaneous report from a contactable consumer (parent). A 12-year-old male patient received (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EV00191) via an unspecified route of administration in left arm on 22May2021 at 11:00 (age at vaccination 12-year-old) as dose number unknown, single for Covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were none. The patient previously took Flu vaccine, 2 years before, onset Age was about 10 years and experienced flu symptoms. Patient was healthy, no allergies and no medical history. Not even regular vitamins. Patient did not receive any other vaccines on same date of the pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Patient's mother was a bit concerned. He was doing great and then on 23May2021, Sunday onwards he had chills. Then he had a temperature of 100 and she gave him plain acetaminophen and Sunday onward 6 or 7 hours onward he kept getting chills. On 23May 2021, for six to seven hours, he had chills. There have been temperatures of 90 and she has to give him a blanket or heater. It was more or less the same today 26May2021 Attempted to clarify that the caller stated the intensity was a little less. Caller confirmed. She thought it was a normal reaction and waited patiently for 3 days. She was not allowing the temperature to go up as soon as he gets chilled and breaks into fever, she checked his temperature and it was always less than 100 like 99.9 or 99.7 Fahrenheit, axillary. Then he broke into a sweat and feels a little better. He also had tiredness and loss of appetite on 24May2021. She also reported that on 22May2021, his arm was sore and difficult to lift and then it disappeared in one or two days. He took the vaccine on 22May2021 in the morning and then by Monday symptoms were gone, the soreness, and warmness at injection site. Patient experienced tiredness on Monday 24May2021 in the morning after fever, the lack of energy and tiredness started. On 24May2021 patient experienced loss of appetite. His breakfast, lunch or dinner reduced to one fourth. On 22May2021 in the morning started in the evening, around 6 or 7 o'clock, patient experienced soreness at the injection site. On 22May2021 in evening, patient experienced warmness at injection site. The time range for adverse events was 3 to 5 days. 3 days of fever no one gives her answers. Pediatrician says wait and after 4 or 5 days they look into it. Adverse events did not result into emergency room visit and physician office visit. Treatment received for chills was gave acetaminophen every 6 to 7 hours. Treatment received for fever was Tylenol every 6 to 7 hours. Treatment received for tiredness and lack of energy was keeping him hydrated and his appetite was quite less and she was giving him lemon juice keeping fluids. Treatment received for event warmness and soreness at injection site was gave him ice and it helped a lot localized. Patient did not receive any treatment for event loss of appetite. The patient underwent lab tests and procedures which included fever was 99.9 and 99.7 Fahrenheit on 23May2021. The outcome of event chills was unknown. the outcome of event pyrexia, tiredness, loss of appetite and lack of energy was not recovered. the outcome of event soreness and warmness at the injection site and difficult to lift his arm was recovered on 24May2021. No follow-up attempts are possible. No further information is expected.
13 2021-05-12 muscle spasms, feeling cold I administered the Pfizer COVID vaccine to the patient at about 2pm. I completed the vaccine, put th... Read more
I administered the Pfizer COVID vaccine to the patient at about 2pm. I completed the vaccine, put the used syringe into the sharps container, grabbed the bandage, and turned back toward the patient. As I did this, he started slumping over in the chair, and his eyes rolled back into his head. I immediately put my arms around him so he wouldn't fall out of the chair. The patient's father was in the room as well and knelt down in from of him. The patient's body spasmed for a few seconds, then he came to but was breathing heavily and starting to sweat. I called to technician in the pharmacy and asked him to call 911 at 2:03pm. I brought the patient a cool cloth and asked a technician to bring some water. The patient's breathing started to slow, but he was nauseous and dizzy. He dry-heaved once, and I put the garbage can in front of him. He slumped over the garbage can for a few minutes. Then he asked to lie on the floor. He seemed to do better lying on the floor. When the EMTs arrived, they attempted to have him sit in the chair again, but his dizziness returned, and he complained of being cold. The EMTs moved the patient to the gurney and transported him to the Hospital for further medical attention.
13 2021-05-12 tremor he had his vaccination at 2:18, sat down in observation and after one minute, he lost consciousness,... Read more
he had his vaccination at 2:18, sat down in observation and after one minute, he lost consciousness, caught by father, and began having tremors. Woke up after 30 seconds - 1 minute. Helped to wheelchair. Skin was pale, but pt. was alert and oriented x 3, he reported blurry vision prior to incident. Observed on cot for 30 minutes. Given water, vital signs checked, wnl. Pt. left with father, escorted in wheelchair.
13 2021-05-13 concussion, grand mal seizure Patient received the vaccine and was completely fine immediately following. We walked around the sto... Read more
Patient received the vaccine and was completely fine immediately following. We walked around the store, conversed, and 10-12 minutes after injection he had syncope and generalized tonic clonic seizure for minutes. We were transported 911 to Hospital ED where he had normal labs, normal brain MRI, and consultation with Peds Neuro. He was post-ictal for 30+ minutes to follow the incident. He has secondary trauma to his R temporal and occipital bones and likely a mild concussion resulting from the fall.
13 2021-05-13 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: PATIENT PASSED OUT, HAD SYNCOPE, EMT WAS CALLED AND CAME TO EVALUATE. BP DROPPED BUT CAME BACK. MOM WAS WORRIED.
13 2021-05-14 weakness Weakness. Seen by EMS on site. Discharged home with father at 12:50 p.m.
13 2021-05-14 pain in extremity Very swollen armpit Fever 100.5 Sore arm
13 2021-05-15 seizure Syncope, seizure lasting less than 5 min, vomiting
13 2021-05-15 seizure Systemic: Seizure-Mild, Additional Details: Mother stated that he had the same reacaction after gett... Read more
Systemic: Seizure-Mild, Additional Details: Mother stated that he had the same reacaction after getting the flu shot but did not tell us prior to injection. Called 911 (parents called MD) pt was assessed by the fire department and EMS and was cleared to leave. parents did not want the patient transported to the hospital, they plan to follow up with the MD
13 2021-05-16 difficulty speaking Intern administered dose 1 of vaccine in patient's left arm. at 6:45pm. Within 2 minutes patient's ... Read more
Intern administered dose 1 of vaccine in patient's left arm. at 6:45pm. Within 2 minutes patient's eyes started rolling in the back of his head,his face turned pale, started clenching his teeth and making guttural noises. Mother supported patient's head and neck and RPh was called to the immunization room. Patient was placed in supine position. At this time patient had come to but was still looking pale and confused. Offer to call 911 was declined at 6:50pm. Patient's blood pressure was checked-94/58 at 6:50pm. A cold compress was applied to patient and water was offered. Blood pressure was retaken and was 97/68 6:55pm. EpiPen and offer to call 911 was again denied by mother. The color started returning to his face, atient was monitored and blood pressure was taken again-100/68 at 7:08pm. At this time he was able to sit up in a chair. He was then able to walk to our waiting room with assistance and was offered snacks. At 7:20pm blood pressure was rechecked 100/68 and patient and mother were escorted out of our pharmacy.
13 2021-05-16 cold extremities Pt felt cold L arm, sitting next to large fan. Moved pt away from fan, cold hand resolved <3 min af... Read more
Pt felt cold L arm, sitting next to large fan. Moved pt away from fan, cold hand resolved <3 min after relocating. ROS neg. Bilateral hands warm to touch w/good movement. Stress management & emotional support given. D/C home in stable condition w/father
13 2021-05-17 cold sweat Received Vaccine, immediately became pale, clammy, diaphoretic, had near syncope episode, brought t... Read more
Received Vaccine, immediately became pale, clammy, diaphoretic, had near syncope episode, brought to mat to lie down, elevated feet on chair, AAO, no loc, no sob, ice pack to neck, front, back, and stomach, MD assessed surmised vaso vagal reaction occurred, patient came from a baseball game, Patients mom at the side, Vitals: 110/80, HR-60, regular and strong, respirations 12, regular nonlabored, 02 Sat 98%, After 10 minutes sat up and had water for hydration and snack for nourishment. Monitored for 30 minutes, provided reassurance, okay to exit with Mom after 30 minutes, provided education to mother regarding reaction
13 2021-05-17 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium
13 2021-05-17 flushing Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Med... Read more
Systemic: Confusion-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium
13 2021-05-17 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Additional Details: administered vaccine at 2:56 pm. within 5 minutes patient had loss of color, sweating and felt dizzy. Patient laid on the bench and was responsive the entire time. Called EMS at mother's request. Patient walked out of the store with mom and EMS and seemed fine. Spoke with father about 20 minutes after patient left and he said he was ok. He said he will follow up with us if anything changes.
13 2021-05-18 cold sweat, unresponsive to stimuli At 1:03 pm, patient went over to father shortly after being vaccinated and stated "I do not feel wel... Read more
At 1:03 pm, patient went over to father shortly after being vaccinated and stated "I do not feel well." He sat down and briefly for <1 second became unresponsive. Upon arousing, he was pale in color and clammy to touch. RN (school nurse was at pt. side). Dad and pt. stated he was worked up and nervous before vaccine. Dr. also at pt. side. 1:15pm: Pt. drank 2 juice boxes and color improved to pink, and conversing without problem. Dr. suggested to pt. and father to have pt. lie down when he returns for his 2nd dose in 3 weeks.
13 2021-05-18 seizure, unresponsive to stimuli Patient had convulsive seizure, became unresponsive and was cyanotic, sternal rub, patient opened ey... Read more
Patient had convulsive seizure, became unresponsive and was cyanotic, sternal rub, patient opened eyes. Heart rate was thready. Patient felt nauseous. Patient was disoriented for 1min and quickly regained orientation. Patient was given water, patient laid on the floor. Discharged to ER Past Medical Hx Hx of seizure at age 4
13 2021-05-18 unresponsive to stimuli, cold sweat Patient had a syncopal reaction: skin became hot and clammy, patient was dizzy, upon asking him to r... Read more
Patient had a syncopal reaction: skin became hot and clammy, patient was dizzy, upon asking him to repeat a command or do a simple action (like wiggling fingers, lifting arm) he was not responding and his eyes were rolling to the back of his head and would not vocalize (when asked if ok, or what his symptoms were, or if he was having trouble breathing) at which time we called 911 since he was not responding verbally or physically. Had him sit, take off his mask, gave him water to sip, took BP (102/60), within 5 minutes he started to come back around, was able to follow command (wiggle fingers) vocalize that he could breathe fine, and felt that there was water behind his ears. His temperature to touch seemed to start to go back down, and once paramedics arrived they evaluated him and released him as "ok" within 10 minutes.
13 2021-05-19 weakness Roughly 7-10 mins after the patient received the vaccine he complains of black out and cant see anyt... Read more
Roughly 7-10 mins after the patient received the vaccine he complains of black out and cant see anything for a couple minutes and feeling weak and nausea. I measured the patient blood pressure and it seems lower than normal. After the patient rest for a while I reassess the patient blood pressure and he seemed to feel a lot better. I asked the family to stay for additional 15 mins or 20 mins to observe him but they insist on leaving . I instructed the parents to observe him and if he gets worst get medical help. I have a staff member at the facility to call the family after 30 mins later and the parents stated he is moving around and feel a lot better. The parents also called back a few hours later and stated he is doing good.
13 2021-05-20 weakness, unresponsive to stimuli, tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: The pt felt lightheaded and passed out for a few seconds. His father was with him and caught him and laid him on the ground. I contacted my nurses who stayed with the pt and monitored him for more than 30 mins. The pt was awake but felt light headed, had low blood pressure and blood sugar. The pt was given water and crackers. My DM was also here and called the paramedics who took him to the hospital.
13 2021-05-20 numbness Patient reports right arm, right leg, and right face numbness that resolved over the course of 24 ho... Read more
Patient reports right arm, right leg, and right face numbness that resolved over the course of 24 hours without treatment. No loss of function, no muscle weakness, normal neurologic exam.
13 2021-05-20 unresponsive to stimuli Patient was administered vaccine at 3:20pm, symptoms started in approximately 10 minutes. (911 call... Read more
Patient was administered vaccine at 3:20pm, symptoms started in approximately 10 minutes. (911 called and stayed on phone until paramedics arrived). difficulty breathing, shortness of breath, became less responsive, eyes closed, stopped speaking. Patient lying down with legs elevated. epinephrine 1.25mg injected into left thigh via auto-injector at about 3;25 continued to monitor patient with the help of parents. Patient started arousing in a couple minutes. paramedics arrived. paramedics transported.
13 2021-05-20 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
13 2021-05-21 involuntary muscle movements Post vaccination patient lost consciousness, had involuntary muscle movements. mother was worried sa... Read more
Post vaccination patient lost consciousness, had involuntary muscle movements. mother was worried same reaction patient had during anaphylactic reaction to tree nut allergy and insisted to use the epipen patient had on hands and rph administered epipen and contacted paramedics
13 2021-05-21 tremor after administering vaccine patient started to vomit and drop in his pulse, dizzy and bit shakier. ... Read more
after administering vaccine patient started to vomit and drop in his pulse, dizzy and bit shakier. after observation called 911 and paramedic came and after checking everything falls within normal limits and patient went home.
13 2021-05-23 weakness, cold extremities sycope, pt started experiencing fainting symptoms such as sweating, paleness, hearing disturbances, ... Read more
sycope, pt started experiencing fainting symptoms such as sweating, paleness, hearing disturbances, weakness, dizziness, coldness of extremities after about 3 minutes of the vaccine, symptoms resolves in about 20 minutes.
13 2021-05-23 flushing Pt c/o lightheadedness, dizziness, flushing/sweating, nausea. Pt vomited 200mL digested food. Pt g... Read more
Pt c/o lightheadedness, dizziness, flushing/sweating, nausea. Pt vomited 200mL digested food. Pt given PO fluids. BP 93/42, HR 66, RR 20 -- > 105/57, 59, 18 -- > 108/60, 65, 16 -- > 109/68, 68, 16. Pt was COVID positive Jan 2021 (s/sx body ach). No h/o fainting with vaccines or blood draws. Pt's symptoms resolved after drinking water and laying down with knees bent. Advised taking 2nd dose supine.
13 2021-05-23 pain in extremity At first patient was fine just sore arm. Approx 2pm the next day we were at Aunt's house & he becam... Read more
At first patient was fine just sore arm. Approx 2pm the next day we were at Aunt's house & he became very sleepy and fell asleep outside. I nudged him to see if he was okay and he couldn't lift his head up all he said was "I hate you" (he didn't want the shot and I had a feel well) I kept nudging him to go inside and he didn't react. Finally after 25 min I had my brother in law carry him upstairs. He didn't wake up for it (the kid is 13 that never happens). Every hour I checked on him and he wouldn't wake up. I am a nurse do figured the shot made him tired but I did start to get anxious I even sternal rubbed him and he reacted to pain but would not wake up. Finally around 445 I told my husband we need to make him drink something and I stood him up he would not wake up. I was trying everything but we got him up enough to gulp down some gatorade. We put on his sneakers and he basically sleptwalked down the stairs went right to car and fell asleep again. It was like he was too tired to stay awake. We got him home and around 515 kept him sitting up in kitchen. Took him about 20 min to fully open eyes and wake up. When he was fully awake he said it was like the shot moved from his arm to his whole body when it happened and that was it. He was sore and achy after that and even today to generalized body. But he was fine as far as not lethargic after.
13 2021-05-23 tingling Approximately 5 minutes after receiving first dose of Pfizer, patient became disoriented, eyes began... Read more
Approximately 5 minutes after receiving first dose of Pfizer, patient became disoriented, eyes began rolling back in the head, loss of skin color, hands tingling, and altered hearing. We administered 25 mg of benadryl and patient began to feel better within 5 minutes. Patient stayed an additional 30 minutes and continued to improve to normal per parents.
13 2021-05-23 tremor Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shak... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Medium
13 2021-05-23 tremor Patient took his daily Zyrtec for environmental allergies and that was 4 hours prior to vaccine. He ... Read more
Patient took his daily Zyrtec for environmental allergies and that was 4 hours prior to vaccine. He started complaining at 12:22 am on May 15, 2021 (13 hours after vaccine of a slight headache. We did not have Tylenol so gave him 4 chewable aspirins. Shortly after taking the aspirins, i.e. 20 minutes he started having involuntarily muscle tremors in his legs. I gave him 20 ml of Benadryl at 1:04 am and by 1:16 the tremors stopped and he told us that he felt completely fine. He slept soundly after the Benadryl. I think he is allergic to aspirin as he has never had it before.
13 2021-05-24 pain in extremity Bilateral lower leg mild swelling and moderate pain, pain worse to right leg Pt is taking Tylenol an... Read more
Bilateral lower leg mild swelling and moderate pain, pain worse to right leg Pt is taking Tylenol and ibuprofen with good pain relief Pt is raising legs while sleeping at night which helps reduce the swelling
13 2021-05-25 cold sweat stabbing pain in stomach, clammy, sweats, and diarrhea. Started approximately
13 2021-05-25 tremor Patient became nauseous 15 minutes after receiving vaccine,then vomited,then fainted. We lowered him... Read more
Patient became nauseous 15 minutes after receiving vaccine,then vomited,then fainted. We lowered him to floor with legs raised. He regained consciousness after a few seconds,but was still not clear-headed. He was very anxious and shaking and pale. 911 was called . He was taken to ER.,but was clear headed,with heartrate slightly elevated.
13 2021-05-26 flushing, weakness, unresponsive to stimuli Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Weakness-Severe, Additional Details: pt was mostly unresposive and turning white and motionless; throat closing up; no other choice but to give the epi-jr shot; after administering the shot the patient started to feel better but we decided to still call 911 to be on the safe side
13 2021-05-26 flushing Pt brought to obs room after getting vaccinated. Pt vomited, flushing, sweating. BP 103/61, HR 67, ... Read more
Pt brought to obs room after getting vaccinated. Pt vomited, flushing, sweating. BP 103/61, HR 67, RR 14. 12min later, pt reports feeling better w/o symptoms. Able to drink 16oz of water. Pt reports fear of needles. Educated pt to let staff know for 2nd dose to be taken to obs room for vaccination. Pt and family verbalize understanding. Pt stable and released from vaccination site w/ family.
13 2021-05-26 tenderness Pt. has history of Lymphangioma. Pt. presented with lump on chest that became inflamed and red after... Read more
Pt. has history of Lymphangioma. Pt. presented with lump on chest that became inflamed and red after 9 days of receiving Covid-19 vaccine. Pt. presented with itchiness, swelling, bruising, redness, fever, hot to touch and headache. Pt. used ice packs and Ibuprofen for treatment.
13 2021-05-26 unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
13 2021-05-27 unresponsive to stimuli C/O "not feeling well today" became unresponsive for less than 1 second, became pale was given juic... Read more
C/O "not feeling well today" became unresponsive for less than 1 second, became pale was given juice, color improved and he stated he was 'stressed out prior to vaccine
13 2021-05-28 tingling Patient experienmced some tingling in his finger on his left hand started about 3 minutes after rece... Read more
Patient experienmced some tingling in his finger on his left hand started about 3 minutes after receiving the vaccine. mom allowed pt to take a 25 mg benadryl. pt the brought up to clinic. The nurse practioner up there said pt did fine and she sent him home with mom after monitoring for about 20 minutes.
13 2021-05-29 tenderness, burning sensation Complained of sob and chest pain on the same day of his shot, but resolved on its own, later that ni... Read more
Complained of sob and chest pain on the same day of his shot, but resolved on its own, later that night started with new-onset fever/chills, headaches, myalgias, and a new onset rash spreading from face to trunk, early lesions described as red papules and eventually dry up, no dermatomal distribution, spread throughout, not itchy, refers some tenderness/burning feeling upon palpation. Only treatment received is Tylenol.
13 2021-05-31 concussion 5/15 vaccination 5/25 He got up and go dressed, ate breakfast, was ready to do work out in yard. We... Read more
5/15 vaccination 5/25 He got up and go dressed, ate breakfast, was ready to do work out in yard. Went to walk across the room to his brother, turned to look out the window, and all of a sudden fell straight back. Came to 10 seconds later, didn't know where he was, felt like he had had a bunch of dreams, 'everything turned white', doesn't remember much, didn't know where he was (thought he was in bed). He had hit his head on the wood floor, back of head (standing to smacking head). We live on an island, had to take ferry to town. Possible concussion. We went to Hospital in town. We worked with Dr. They gave us the verbal instructions if HA gets worse, anti nausea meds, rest, ibuprofen; concussion.
13 2021-06-01 muscle spasms, tremor Impact was not right away. Patient displayed uncontrollable unilateral leg tremors sporadically (2-3... Read more
Impact was not right away. Patient displayed uncontrollable unilateral leg tremors sporadically (2-3 events) over the course of one day. No prior history. Patient also complains to muscle cramps in his arms and legs 2 weeks after vaccination.
13 2021-06-01 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Mom reports that patient has a history of fainting after vaccine administration. Patient complained of feeling dizzy and lightheaded after receiving Covid vaccine. Patient fell from standing position and hit his forehead against store aisle. NP was called by Pharmacist, to assist/evaluate. Patient alert and oriented upon NP arrival. BP 116/60, pulse 76, O2 sat 99% on room air. Patient with normal neuro exam. Patient returned to baseline.
13 2021-06-03 tremor After getting vaccinated , pt sat in the waiting room for 15 minutes. While sitting he fainted and a... Read more
After getting vaccinated , pt sat in the waiting room for 15 minutes. While sitting he fainted and another customer caught a hold of him. I was called out and I see the boy on the floor . I told him to sit still and rest and not to do anything. I went back in pharmacy to call manager to see if we can get some water for him. I also had someone page mom because mom went shopping. When I went back out to see the boy, his mom was there and he was drinking some water. I came out to talk to mom. while I was there, the boy started to shake and complained of chill. He look pale, so, I went and called 911. They transfer me to the fire department. They said to have him stay where he is and not have anything to eat or drink just incase her may throw up.I told mom. After that , I went about doing my things . Then emergency came . Then they all left. About 7 pm that day I called mom for follow up and she said he was doing ok.
13 2021-06-05 weakness Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium, Additional Details: patient was given 2nd dose of phizer covid 19 vaccine. patient was fine intially and became lifeless and pale after 5 minutes. Patient was disoriented , pale, and complained of blackened vision and huge sound in his ears. paramedics were contacted and patient was arousable. after 15 min patient was ok and documented color restored to complexion. paramedic deducted anxiety due to needles and patient was taken home by parents
13 2021-06-05 tingling, cold sweat, cold extremities Immediately following the vaccine, my son felt totally fine. The pharmacist told us to walk around t... Read more
Immediately following the vaccine, my son felt totally fine. The pharmacist told us to walk around the store for 15 minutes. 8 minutes after the vaccine, my son said his arm felt tingly. He immediately began sweating profusely and said that he felt dizzy. I made him sit down and he then said that he felt nauseous. Within 5 minutes of the onset of symptoms, he vomited. He was pale and his forehead was cold/clammy. The pharmacist said it was anxiety and nothing to be concerned about. However, my son said that he did not feel worried, anxious, etc. prior to or immediately following the vaccine.
13 2021-06-06 pain in extremity 13 year old male presents with chest pain. Pt describes pain as achy. Pt feeling dizzy "seeing stars... Read more
13 year old male presents with chest pain. Pt describes pain as achy. Pt feeling dizzy "seeing stars" and has headache as well. Aches located on both arms and neck. Chest pain worsens with deep breathing. Neck pain worsens with neck movement. Pt had second dose of Pfizer 2 days ago; parents are concerned because a relative contracted myocarditis 5 days after receiving vaccine. No recent chest trauma. NBNB Vomit 1 month ago. Taking ibuprofen at home. No fever. Differential Diagnosis: flu like illness, post vaccine syndrome, myocarditis, doubt meningitis, myositis. Cardiology consulted, Agrees with workup and add CMV and EBV antibodies as well as enterovirus if elevated troponin. Troponin = 6.84. Will be admitted to CVICU.
13 2021-06-06 pain in extremity Patient described chest pain (pain scale of 6.5, from 0-10 with 10 being the highest) located centra... Read more
Patient described chest pain (pain scale of 6.5, from 0-10 with 10 being the highest) located centrally near the heart, extreme headache and sore arm. The chest pain lasted about 24hrs until patient took acetaminophen.
13 2021-06-06 tenderness My son experienced under his left arm he had swelling of lymph nodes, on the middle of his armpit. T... Read more
My son experienced under his left arm he had swelling of lymph nodes, on the middle of his armpit. The next day it was bigger and it was tender to touch, very painful. He also had some swollen lymph nodes on his neck, left side, near the collar bone and side of his ear. His lymph nodes got bigger on Saturday, the one on his left arm was getting smaller and the one on his neck today is going down in size as well. My son was by a nurse practitioner, and she said that my son did not have any fever, he said it was consistent with the vaccine he received. To this day his lymph nodes are still present but getting smaller in size.
13 2021-06-07 facial paralysis, bell's palsy On 05-20-21 We received a text message from the pts mother stating that the pt was experiencing droo... Read more
On 05-20-21 We received a text message from the pts mother stating that the pt was experiencing drooping of the face , pain in jaw all on left side and dizziness.
13 2021-06-07 feeling hot, seizure, tremor Mother told me he sometimes passes out with shots - gave vaccine and after about five seconds patien... Read more
Mother told me he sometimes passes out with shots - gave vaccine and after about five seconds patients head shook like a seizure with lasted less than 5 seconds then he went unconscious - the mother and I laid him on the floor and he become conscious after 15 to 20 seconds but was confused and didn't remember what happened - we helped him back to chair and he said felt a little shaky and warm - we had him sit for 5 to 10 minutes - he felt better so we moved him to a chair outside counseling room - They waited an additional 15 minutes and said felt fine - mother said had never had the seizure symptom before - advised her to call Dr and make him aware and to ask Dr about second dose - she said would get his second dose with the Dr present.
13 2021-06-07 pain in extremity He had hives all over his torso and legs,. Gave him a dose of Benadryl and within a few hours the h... Read more
He had hives all over his torso and legs,. Gave him a dose of Benadryl and within a few hours the hives were gone. He continued to have soreness in his arm and felt achy and not well for two days following the shot.
13 2021-06-07 pain in extremity right axillary lymphadenopathy, fever for 7 days (low grade), fatigue, lower leg pain
13 2021-06-07 seizure While giving a Pfizer Covid vaccine today, a patient appeared to be fine but after a few minutes sud... Read more
While giving a Pfizer Covid vaccine today, a patient appeared to be fine but after a few minutes suddenly passed out and had a short 3-4 second seizure on the ground. He did hit his head and appeared to be hypoxic. We called 911 immediately and informed store management. The paramedics asked him to walk off on his own power, but they did offer to escort the family to Hospital which I believe was accepted. His mother and sister were present too.
13 2021-06-08 numbness numbness in fingers with contraction. lips and tongue swelling. later on with aphagia. next day with... Read more
numbness in fingers with contraction. lips and tongue swelling. later on with aphagia. next day with low grade fever
13 2021-06-09 involuntary muscle movements, tremor The patient started falling over, our staff caught him so he did not fall out of the chair. His eyes... Read more
The patient started falling over, our staff caught him so he did not fall out of the chair. His eyes were rolling back, he was shaking and his throat was making abnormal movements. His mother rushed over and bear-hugged him, and its like he came back to reality and was okay. We got him a cold pack, water, fruit snacks, a mat to lay on and a fan and the patient walked out okay. His reaction was directly after the shot and lasted about 5-10 seconds. Patient walked out of the facility fine and had his mother with him.
13 2021-06-09 feeling cold, flushing, tremor, cold sweat Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-M... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient felt dizzy, unstable upon standing, skin became pale, sweaty, cool and clammy. Hospital treated for potential shock - moved from sitting in chair to reclining position with legs elevated, cold compress applied to back of neck. BP was low upon initial reading, but improved to within normal limits after 10 minutes. Patient remained under observation for additional 30 minutes. Follow-up phone call to patient's mother (patient is minor) by hospital, mother reported no additional problems
13 2021-06-09 feeling of body temperature change Nauseous, headache, chills, feeling warm to cold
13 2021-06-09 pain in extremity Vomiting, can't eat or drink without vomiting 1 day after shot. When tried to eat, vomited repeatedl... Read more
Vomiting, can't eat or drink without vomiting 1 day after shot. When tried to eat, vomited repeatedly. Other symptoms include fever, achy limbs, and a severe headache and sleepiness.
13 2021-06-10 pain in extremity Headache; Arm hurt; This is a spontaneous report received from a non-contactable consumer. A 13-year... Read more
Headache; Arm hurt; This is a spontaneous report received from a non-contactable consumer. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jan2021 as unknown, single dose for COVID-19 immunisation (Age at the time of vaccination 13-year-old). The patient medical history and concomitant medications were not reported. It was reported that, the patient had COVID shot on 03Jan2021, on the next day (04Jan2021) patient arm hurt with headache. Cleared by next day. The outcome of events was recovered on 05Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
13 2021-06-12 numbness Patient's mother called explaining that within 24 hours of receiving the vaccine, the patient had br... Read more
Patient's mother called explaining that within 24 hours of receiving the vaccine, the patient had bright/flashing light in both eyes, numbness in his fingers and toes, chest pain, and stomachache. These events did resolve by June 9th when she called me however he still had a stomachache. I told her that these events would not be expected and that she needed to follow up with his primary care doctor. He received his first shot from us as well with no complaints
13 2021-06-13 seizure, unresponsive to stimuli My son received his 1st shot of the vaccine on 5/15/21 lot # ew0177. On 5/27/21, my wife found my so... Read more
My son received his 1st shot of the vaccine on 5/15/21 lot # ew0177. On 5/27/21, my wife found my son in his bedroom unresponsive to verbal commands. He was dazed and confused and stared off into space when my wife tried to talk to him. After a minute or so, he stood up and tried to walk but he was staggering and ended up fainting and falling down. My wife took my son to the emergency room. The doctors examined him and ran blood tests, including a tox screen, but could find nothing wrong with him. We followed up with his family doctor the following week and she found nothing wrong other than dehydration. On 6/5/21, my son received his 2nd dose of the vaccine lot #ew0202. On 6/11/21, my son had a major seizure at home with convulsions, was unresponsive and had to be taken from our home by ambulance to the hospital. The emergency room doctors performed a CT Scan and other tests and again could find no reason for the seizure. My son has been healthy his entire life and has never experienced anything like this before. My son is very active with travel soccer and in very good health. I do not know if the vaccine was the cause of these two episodes but it seems to be the only common thread
13 2021-06-13 speech disorder injection site pain, headache, daytime sleepiness, sleep excessive, sore throat, swallowing difficul... Read more
injection site pain, headache, daytime sleepiness, sleep excessive, sore throat, swallowing difficult (because of throat pain), difficulty talking because of pain, lethargy, nasal stuffiness, nasal drip, swollen cervical glands, cough lasted 5 days, left cheek swelling
13 2021-06-13 tremor, feeling hot, seizure like phenomena 13 yo M with a history of autoimmune hepatitis who presents with 1 day of fever, headache, altered m... Read more
13 yo M with a history of autoimmune hepatitis who presents with 1 day of fever, headache, altered mental status, and vomiting. He received his 2nd Pfizer Covid vaccine on 6/12 and began having symptoms the next night. He began taking ibuprofen for headache and fever. His symptoms worsened through the day until he had vomiting. He was saying strange things and behaving oddly. He became very hot and agitated at home, prompting mom to bring him into an outside hospital ED. There, rectal temperature was 106F and he was noted to be combative. A CMP was obtained, which was mostly normal. CT of his head was obtained, during which he had an episode of left upper extremity shaking concerning for seizure. He was reportedly alert throughout. Patient is a 13 yo M with a history of autoimmune hepatitis who presents with 1 day of fever, headache, altered mental status, vomiting, found to have cerebral edema and elevated CRP. There is no acidosis, elevated lactate, or metabolic derangement, and utox is neg. The etiology could be related to the vaccine. Ingestions are also possible given the high fever and altered mental status - particularly serotonin syndrome. Infectious etiologies are also possible given the fever. Treatments: hypertonic saline given x1 EEG started Tox screen negative Ceftriaxone and vanc given
13 2021-06-15 pain in extremity Inappropriate age at vaccine administration; fever at 100.2F; Pain in arm; headache; nausea; This is... Read more
Inappropriate age at vaccine administration; fever at 100.2F; Pain in arm; headache; nausea; This is a spontaneous report from a contactable consumer or other non HCP. A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167) intramuscular, administered in Arm Left on 15May2021 17:00 (at the age of 13-years-old) as 1st dose, single dose for covid-19 immunisation at store. The patient had no other medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date of May2021, the patient experienced pain in arm, headache, nausea, fever at 100.2F. The patient did not received treatment for the adverse event. The outcome of the events was unknown.
13 2021-06-15 pain in extremity Sore arm started on same day as vaccines, mild left sided chest pain and mild shortness of breath th... Read more
Sore arm started on same day as vaccines, mild left sided chest pain and mild shortness of breath that started the next day.
13 2021-06-15 pain in extremity sore arm, swollen armpit gland, headache, fever 101, chills, nausea, tired
13 2021-06-16 weakness On the night of the vaccine, patient developed fever (Tmax 104), chills, and myalgias. He had an out... Read more
On the night of the vaccine, patient developed fever (Tmax 104), chills, and myalgias. He had an outbreak of herpes on his shoulder. Continued to feel very fatigued. Three days after the vaccine, he started having chest pain and shortness of breath with exertion. He continued to be fatigued. Chest pain was intermittent. Saw pediatric cardiologist at outpatient appointment on 6/15/21 where he had a normal EKG and ECHO. High sensitivity troponin on 6/15/21 was 0.08. He had a Holter monitor placed. He was asked to do activity while wearing Holter monitor and self-limit based on symptoms. He played basketball that night and had to press the Holter button 8 times while playing when he was experiencing chest pain. When he got home from practice, he felt weak and dizzy with associated chest pain. Mom notes his nails were blue/purple, and he was "lethargic" . Symptoms improved with ibuprofen. Patient did not want to do usual activity, mom called cardiology who recommended going to ED. Patient has not had chest pain since coming home from practice on 6/15/21. He was admitted to hospital on 6/16/21. Repeat high sensitivity troponin was 0.82 on 6/16/21 and repeated on 6/17/21 was 0.41. Cardiology consulted. Cardiac MRI performed with normal results. He was dizzy on 6/17/21 when he got up to use the restroom, self-resolved. Cardiology evaluated him and cleared him for discharge with outpatient follow-up and self-limitation with activity.
13 2021-06-16 cold sweat, concussion This is a dangerous shot. My son woke up early in the morning in terrible pain and in a cold sweat. ... Read more
This is a dangerous shot. My son woke up early in the morning in terrible pain and in a cold sweat. This has NEVER happened before! Then he fainted. The next day he was still sick, fainted again and hit his head, needed stitches next to his eye and had a mild concussion from it. He could have been blinded in that eye. This website was a goose chase to get to! There are probably tons of parents who can?t report the adverse reactions their kids are suffering because of how complicated it is to even figure out where to report it. You should be ashamed of this process which lends itself to the under reporting of adverse reactions to COVID-19 vaccinations!
13 2021-06-16 pain in extremity Immediately had an pain at injection site, then 16 hours later had moderate to severe pain requiring... Read more
Immediately had an pain at injection site, then 16 hours later had moderate to severe pain requiring ibuprofen, repeated ibuprofen 6 hours later and then again 6 hours later for arm pain. Generalized fatigue and headache throughout starting 16 hours out from vaccine.
13 2021-06-16 pain in extremity feeling horrible; Since the first dose he woke up with what mother states is herpes zoster on his li... Read more
feeling horrible; Since the first dose he woke up with what mother states is herpes zoster on his lips; Arm hurt; headache; Tonsils hurt; didn't feel well; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EW0167, expiry date: Aug2021), dose 1 via an unspecified route of administration, administered in left arm on 13May2021 at 12:15, as 1st dose, single for COVID-19 immunization. The patient's medical history and other allergies compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity were none. The patient's concomitant medications were not reported. The patient had no family medical history relevant to AE. The patient received no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No additional vaccines administered on same date of the Pfizer Suspect. On 13Jan2021 at 20:00, 8 hours after getting the shot, the patient experienced tonsils started hurting. He didn't feel well and had headaches. On 14Jan2021, he had some pretty bad symptoms on Saturday morning, he woke up with herpes zoster on his lips and his mother called to pediatrician and he was very dismissive about it and said that if the body was under stress it can come out, but he never had anything like this before. It looks like little pustules around his mouth and looks like when my mom had shingles. He did mention his arm hurt a little but went to soccer practice. Clarifies the herpes zoster didn't show up until Saturday evening/night and it was starting to go away. She took son to get Covid PCR testing on 14Jan2021 and it was negative and was told that the herpes zoster was probably a reaction to the vaccine. The patient received treatment with Abreva. The outcome of the events Since the first dose he woke up with what mother states is herpes zoster on his lips was not recovered, and the other event feeling horrible was unknown, and all other events was recovering. PSCC Communication: PC Filed Product Complaint: Yes, Description of Product Complaint: Description of complaint: Asks if this could be a bad one since he was so sick and took him to get Covid PCR testing and it was negative. Thought was weird since she and her husband both had the Pfizer Covid shot and did not have any reactions. This was son's first Covid vaccine, Lot number: EW0167, expiry.
13 2021-06-18 numbness PATIENT MOM CALLED AND SAID AFTER ABOUT 2 HOURS POST VACCINE ALL 10 FINGERS WERE NUMB
13 2021-06-19 tingling Few minutes after getting the shot, Mom knocked on the Pharmacy door. The child was on the floor and... Read more
Few minutes after getting the shot, Mom knocked on the Pharmacy door. The child was on the floor and the Dad's hand was supporting his head. Patient was totally alert and spoke perfectly fine. He demonstrated and said that he has some tingling in his hand and something in his stomach. Child slightly diaphoretic. We called 911- vitals normal and "everything checking up good" paramedics left. When leaving patient said he is feeling anxious, nothing else.
13 2021-06-19 tremor, seizure like phenomena, weakness On 06/19/2021 was noted to have decreased energy and temp was ~100, tylenol given. A few hours late... Read more
On 06/19/2021 was noted to have decreased energy and temp was ~100, tylenol given. A few hours later after completing his morning therapies he showered and went to take a nap. At this time he was febrile to 103.6. At 1600 he had seizure-like activity with trunk and upper extremity shaking as well as eyes rolling back and drooling. Parents put him in car and transported him to an outside hospital. He did stop seizing prior to getting to that hospital. Parents reported seizure lasted approximately 15 minutes with no loss of bowel or bladder control. By time he arrived at local emergency room he was back at his neurological baseline. At the outside hospital our PICU was consulted and he was given ceftriaxone and vancomycin in meningitic dosing.
13 2021-06-22 bell's palsy, mild one side paralysis Headache (for the past 2 weeks), and Rash (neck) Bell's Palsy-Patient presents with mild worsening ... Read more
Headache (for the past 2 weeks), and Rash (neck) Bell's Palsy-Patient presents with mild worsening weakness of the right side of the face.
13 2021-06-22 pain in extremity Pain at injection site and entire leg, Nausea, severe exhaustion, chills, general feeling of sicknes... Read more
Pain at injection site and entire leg, Nausea, severe exhaustion, chills, general feeling of sickness
13 2021-06-22 tenderness Left testicle pain. Went to ED on 6/21 night. Ultrasound showed good blood flow. Urologist felt t... Read more
Left testicle pain. Went to ED on 6/21 night. Ultrasound showed good blood flow. Urologist felt this was not a case of torsion and discharged us with diagnosis of "inflammation". We follow up with pediatric urologist tomorrow. Symptoms have improved with Ibuprofen, but testicle is still sore to touch. No obvious heat, swelling, or redness. Just extremely sore to touch and move testicle around.
13 2021-06-22 tremor After patient received COVID Pfizer shot patient went to sit on stool in waiting room. Patient didn'... Read more
After patient received COVID Pfizer shot patient went to sit on stool in waiting room. Patient didn't sit on regular chair to sit closer to sister and mom. After a few minutes patient got lightheaded and fainted falling back and to the right, hitting head against wall and blood pressure machine and floor. Mom and sister tried to catch patient during fall. Patient had light shaking for a few seconds before becoming conscious again. I went out and called 911 for paramedics, lifted patient legs up to improve blood flow to head. After a few minutes and after finishing call with 911 had other employees help lift child onto regular chair to sit. Patient got a small bottle of water to drink. Paramedics soon arrived after and evaluated patient. Paramedics determined child fine and mom decided to take child home. Called mom for follow up a few hours later and child doing fine per mom.
13 2021-06-23 pain in extremity Patient had the vaccine Friday morning (6/4/21). He had typical side effects that afternoon (tired, ... Read more
Patient had the vaccine Friday morning (6/4/21). He had typical side effects that afternoon (tired, achy arm). He woke up the next morning, 6/5/21, complaining that his chest hurt (with a stinging. constant pain), his heart was beating rapidly, 102.5 degree fever, and he said it was hard to breathe. I gave him 200mg Ibuprofen and he rested. Symptoms resolved in about 2-3 hours and did not return. I contacted the advice line at, and they set up a video appointment for mid afternoon on that same day, Saturday 6/5. By the time of the visit, symptoms were completely gone. PA recommended he have a Covid test as it was possible those symptoms were from having Covid ( coincidentally and simultaneously). The test was negative.
13 2021-06-25 seizure, inability to speak Seizures developed after 1 week. He continues to have seizures that are possibly vaccine related but... Read more
Seizures developed after 1 week. He continues to have seizures that are possibly vaccine related but not for certain. After one seizure has temporary loss of speaking ability
13 2021-06-26 pain in extremity Chest pain (achy, severe) with radiation to the left arm, chills, sweating, subjective fever, cough.... Read more
Chest pain (achy, severe) with radiation to the left arm, chills, sweating, subjective fever, cough. Patient is a 13 year old male with a history of a neck dislocation who currently presents with 2 days of chest pain after receiving the second COVID-19 vaccine. His first vaccine was on June 2, 2021. He tolerated that vaccine well except for some mild left arm pain where he received the vaccine. The second dose was on 6/24/2021 around 3 pm. He felt well that first day, but on 6/25/2021 he started to have achy chest pain when trying to go to sleep. The pain radiated to the left arm and severe. It was worse when lying flat. It prevented him from falling asleep at night. The following day he did okay and went about his normal day. He even was able to play basketball (mostly shooting) and had to play with only his right arm because of pain in the left arm. Last night he again started to feel the achy chest pain with radiation to the left arm thus came to the hospital for evaluation. He states that the pain is associated with chills/sweating, subjective fever, and a cough. Denies any shortness of breath, headache, lightheadedness, dizziness, changes in appetite, nausea, vomiting, diarrhea, muscle aches, or swelling of extremities/face.
13 2021-06-29 feeling hot, cold sweat, weakness Patient became light headed and nearly passed out. Patient also vomitted twice. Patient was weak a... Read more
Patient became light headed and nearly passed out. Patient also vomitted twice. Patient was weak and feeling warm and clammy for about 15 minutes.
13 2021-06-29 pain in extremity high fever 101.3 for 2 days, arm hurting, chills
13 2021-06-30 hypersensitivity of all senses bilateral hyperalgesia to the feet constant treated with gabapentin, toradol, PRN morphine, oxycodon... Read more
bilateral hyperalgesia to the feet constant treated with gabapentin, toradol, PRN morphine, oxycodone, and tylenol
13 2021-06-30 pain in extremity Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Second do... Read more
Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Second dose of Covid-19 vaccine administered greater than 6 hours after vaccine was mixed; Sore arm; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. This report has similar events for 3 patients. This is 2 of 3 reports A 13-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 2nd dose. Formulation: solution for injection, Lot number EW0217) via an unspecified route of administration, on 09Jun2021, single dose (at the age of 13-years-old) for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 09Jun2021, the patient experienced product temperature excursion issue, poor quality vaccine administered, product preparation error and in Jun2021 the patient experienced pain in arm. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of the events was unknown. Information on Lot/Batch number has been requested. Follow up (14Jun2021): This is a follow up spontaneous report from a contactable pharmacist. This pharmacist reported for a 13-year-old male patient that: Duplicate AE E-transmitted for report of inadvertent dosing of the vaccine past 6 hour storage in syringe. Caller would like written document sent to email address. Caller states she has not received previous email request. Response: Disclaimer Provided Pfizer has conducted physical and chemical stability studies which have shown that the vaccine maintains all its measured quality attributes when diluted vaccine is stored in polycarbonate or polypropylene syringes for 6 hours at 2 degree C to 30 degree C. Microbiological risk must be considered. Degradation of RNA in the vaccine has been observed when stored for longer than 6 hours in syringes.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021683146 same reporter, AE and product, different patient;US-PFIZER INC-2021684836 same reporter, AE and product, different patient
13 2021-06-30 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: pt passed out for less than 1 min after administration. mother was advised to report to md office for follow up and to recieve 2nd dose
13 2021-07-02 difficulty speaking, slow speech, tingling Tingling feeling in fingers and lip on one side and minimally in one leg, slowed speech, using words... Read more
Tingling feeling in fingers and lip on one side and minimally in one leg, slowed speech, using words that didn't fit (ie said "brushtooth" instead of "toothbrush"), voice sounded different to himself. No treatment. Happened late in the evening so he went to sleep under supervision and woke up completely back to normal. He remembers everything about the event. These symptoms repeated 22 days after the second dose. He is scheduled with a neurologist for Aug 9. 2021 for follow up.
13 2021-07-02 tremor After vaccine administration, patient sat back and fainted. He was out for under one minute but had ... Read more
After vaccine administration, patient sat back and fainted. He was out for under one minute but had multiple tremors.
13 2021-07-04 cold sweat 15:08 - Attendee received second dose Pfizer vaccine in the left arm. Lot# ER8734. Attendee was dir... Read more
15:08 - Attendee received second dose Pfizer vaccine in the left arm. Lot# ER8734. Attendee was directed to observation area. 15:10 – Attendee voiced complaints of dizziness and darkened vision. Attendee's skin was pale and clammy. Attendee denied that anything like this had ever happened to him before. Attendee assisted to the cot to lie down. 911 called. HR: 96 BP: 100/59 RR: 24 O2Sat%: 96 15:15 – EMS arrived. Attendee's brother who had come with him, called their mother. 15:22 - Attendee symptoms had not changed. EMS caring for attendee. HR: 92 BP: 108/70 RR: 24 O2Sat%: 98
13 2021-07-05 bell's palsy Bells Palsy in right side of his face. Pain in jaw, eye twitching and fatigue. Went to ER same morn... Read more
Bells Palsy in right side of his face. Pain in jaw, eye twitching and fatigue. Went to ER same morning of 6/28/21 and received 10 day dose of Prednisolone.
13 2021-07-05 pain in extremity Severe headache, 10 days after vaccination he started having a rash at the injection site. Soreness ... Read more
Severe headache, 10 days after vaccination he started having a rash at the injection site. Soreness in the arm, chills, fever, fatigue.Took tylenol.
13 2021-07-08 grand mal seizure Dose #1 recieved May 27th, 2021. Dose #2 recieved June 17th, 2021. 6/26/21 2:00pm Grand Mal seizure ... Read more
Dose #1 recieved May 27th, 2021. Dose #2 recieved June 17th, 2021. 6/26/21 2:00pm Grand Mal seizure (Full body convulsions, foaming at the mouth, eyes twitching and rolled back/up. Postictal immediately following seizure activity for roughly 10-15 minutes) on June 26th, 2021, with no history of seizures or any other comorbidities. Resulted in an ER visit on 6/26/21. MRI and EEG ordered for testing. Lab worked ordered on 7/8/21. Rescue medication ordered in the event that he has another seizure. Outcomes: EEG showing absence seizure activity however that remains undetermined at this time due to the fact that the patient never displayed any physical evidence of an absence seizure during the test as he remained alert, responsive followed directions and was able to recall information, during the part of the test that displayed absence seizure activity. MRI: No acute infarct, intracranial hemorrhage or mass effect. Referral to pediatric neurologist.
13 2021-07-09 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: CALLED EMS PATIENT WAS ATTENDED TO BY EMS
13 2021-07-10 weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Addit... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: Occurred about 2 minutes post injection. Patient felt dizzy and couldn't walk. Paramedics were called, but mother did not feel patient needed emergency service and will be monitoring her son at home. Called 2 hours afterwards, and mother reported son is feeling much better.
13 2021-07-11 weakness Immediately after receiving this vaccine the patient felt weak and lethargic. They lost balance and ... Read more
Immediately after receiving this vaccine the patient felt weak and lethargic. They lost balance and fell on floor and lost consciousness for a few minutes. After a couple of minutes they gained consciousness and recovered.
13 2021-07-11 unresponsive to stimuli Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Syste... Read more
Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Additional Details: The patient felt dizzy about 3 minutes after receiving vaccine (after walking and sitting in observation area). Pharmacist ran out and caught patient as he lost consciousness and the patient was not injured. Patient regained consciousness after ~10 seconds. Pharmacist and Technician helped patient to lay on the floor and elevated feet. Vitals taken every 5 minutes. Lowest BP reading was 98/60. Patient offered water and drank some. Patient laid down for ~25 minutes, BP came up to 116/84.
13 2021-07-12 inability to speak Father called for help and I ran out to see the patient in his father's arms I helped ease him on th... Read more
Father called for help and I ran out to see the patient in his father's arms I helped ease him on the floor. He was able to speak but not clearly. 911 was activated and they arrived. The patient and the father left with them.
13 2021-07-16 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Naus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild
13 2021-07-17 pain in extremity Experienced blurriness of the vision; Sore arm; This is a spontaneous report from a contactable cons... Read more
Experienced blurriness of the vision; Sore arm; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Jun2021 (Lot Number: EW0179) as dose 2, single for COVID-19 immunization at the age of 13-year-old. Medical history included ongoing acne. Concomitant medication included isotretinoin (ACCUTANE) taken for acne from Apr2021 and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Jun2021 (Lot Number: EW0183) as dose 1, single for COVID-19 immunization at the age of 13-year-old. On 28Jun2021, the patient experienced a sore arm but felt better after taking Tylenol. When the patient woke up the next morning, on 29Jun2021, his vision was blurred for about 15 minutes to half an hour. He was unsure if it was a side effect from the shot that he got the day before. The patient's mother mentioned that she was going to check with his dermatologist because he was on Accutane and they were forewarned of blurry vision and a headache with Accutane, but the patient said that he did not have a headache. He had been on it for two months and was put on 30 mg because of his bloodwork that came back normal after the first round. The outcome of event blurriness of vision was recovered on 29Jun2021. The outcome of event sore arm was recovering.
13 2021-07-17 tingling sweaty; heart rate became rapid; not to feel well; his arms and legs got tingly; This is a spontaneo... Read more
sweaty; heart rate became rapid; not to feel well; his arms and legs got tingly; This is a spontaneous report from a contactable consumer. This consumer (patients Grandmother) reported for a 13-year-old male patient (reporters Grandson) that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: EW0181 and Expiry date was not reported) via an unspecified route of administration in the right arm on 30Jun2021 (age at vaccination was 13-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On 30Jun2021 reporter stated on behalf of her 13-year-old grandson who received the Pfizer COVID-19 vaccine yesterday and did not experience any side effects until 7 pm that night when he went to an exercise class. She states that he started not to feel well, and his arms and legs got tingly, he became sweaty and rapid heartbeat for a short period of time. She states that by the time he got home he was feeling better. The patient took couple of tylenol and went to sleep and seem to be fine. Unspecified treatment received for the events. The outcome of the events was recovered on an unspecified date in 2021. Follow up information has been requested.
13 2021-07-19 flushing Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Additional Details: at 4:08pm 5 mins... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Additional Details: at 4:08pm 5 mins after giving shot, pt and mom complained of sweating and headache, put fan on pt while sitting and was fine after few minutes pt left with mom 4:18pm no issues
13 2021-07-21 numbness Client was in observation room with Grandmother and reported to EMTs he was feeling numbness to left... Read more
Client was in observation room with Grandmother and reported to EMTs he was feeling numbness to left arm. EMT alerted RN. RN arrived at 1631, client alert and oriented x4, sitting upright in chair. Vitals at 1635: blood pressure 146/88, pulse 80, oxygen 98%. Medical history of ADHD, no current medication and no known allergies. Per client it has been 2 years since taking ADHD medication. Client reports no history of arm injuries to left forearm in the past. RN assessed for sensory and motor of arm. Client able to move arm and reported feeling stimuli. Per client only numbness to left forearm. Vaccine administered to left Deltoid at 1609. RN gave client Capri-Sun and client drank slowly. EMT's stayed with client remaining of observation time. Vitals at 1643: blood pressure 138/76, pulse 96, oxygen 97%. Per client arm numbness improving. At 1651 client and Grandmother approached EMT table and stated he wanted to leave. EMT educated client and Grandmother member present of ER precautions and following up with medical provider. Client left facility at 1652 with steady gait.
13 2021-07-21 seizure Patient stated he felt light headed and dizzy with the first Pfizer vaccine and requested to lay dow... Read more
Patient stated he felt light headed and dizzy with the first Pfizer vaccine and requested to lay down to have the Vaccine administered. The nurse took the patient to a private area, with the mother and brother. The nurse vaccinated the patient at 1423, patient then had a seizure at 1425, I was called to assisted. Patient at the time was crying and felt sick. I asked for the nurse to place the patient on his left side while I obtained the necessary equipment for vital signs. Patient then became no verbal, I Immediatley asked for the staff to call 911. Patient was cool, diaphoresis, not responding. I sternal rubbed the patient as he was not responding. He was breathing, O2 saturation was 98%, HR 59. Vital signs 100/60 RR 16. Patient remained non-verbal. I asked the mother if the patient had any medical conditions and she stateed no. I asked about seizures and then the brother stated the patient had seizure when he was child about 3 years ago and the patient currently is not on any seizure medication. EMS was called at 1427 and are in route. Vital signs again, 110/78, HR 78, resp 18. I continued to ask the patients questions and the patient remained no-verbal. The patient followed directions, but remained non verbal. EMS arrived 1435 and took over. Patient did awake a little more and stated he didnt want to go to the hospital. EMS took the patient to the nearest Hospital
13 2021-07-22 feeling hot That evening of the vaccination, he had fever- Ibuprofen was given The next morning- Really hot, blu... Read more
That evening of the vaccination, he had fever- Ibuprofen was given The next morning- Really hot, blurred vision, 102.8 fever, sweating really bad, headaches Called doctor and was informed to take him to the hospital.
13 2021-07-23 weakness idiopatic syncope, patient fainted immediately after injections awoke in about 15 seconds was weak a... Read more
idiopatic syncope, patient fainted immediately after injections awoke in about 15 seconds was weak and a little unstable we called 911 at moms request, paramedic concurred with a diagnosis of ipiopathic syncope
13 2021-07-24 feeling hot About 1-2 minutes after giving vaccination the patient fainted while sitting in the chair. We laid ... Read more
About 1-2 minutes after giving vaccination the patient fainted while sitting in the chair. We laid him on the floor. He was feeling light-headed, hot, and achy all over. He felt better after several minutes with a cold pack and had some water to drink. The paramedics were called to check him out. He was able to sit and stand and left after about another 15 minutes.
13 2021-07-26 feeling cold Heaviness and discomfort left arm. Little bit of pain in the vaccinated area. July 27 2021 he said h... Read more
Heaviness and discomfort left arm. Little bit of pain in the vaccinated area. July 27 2021 he said he was cold and axillary temperature was taken it was 37.66 Panadol was given and cream was applied on vaccinated area for discomfort. Since it is the first reaction and is early morning and is not a complication at the moment he will continue under my observation and then I will call his doctor.
13 2021-07-26 muscle twitching APPROX 8-10 hours after receiving 2nd dose patient started to become noticeably disengaged in social... Read more
APPROX 8-10 hours after receiving 2nd dose patient started to become noticeably disengaged in social activity The following days a major loss of apatite and further withdrawal in even the most intimate and immediate family social functions Complaints of delusions. voices giving him" bad" thoughts and" bad" visions. voices come as either "monsters" or "a little boy" We have noticed when he seems to be battling with these thoughts his eyes tend to go absent and twitches his mouth as if wanting to speak but at the same time not.
13 2021-07-26 unresponsive to stimuli Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Additional Details: Patient fainted shortly after receiving dose one of Pfizer vaccine. Parmedics came, and monitored vitals. They felt his faining was the result of a Vagal nerve response. His mom later explained he often is nervous about needles, receiving shots. I spoke with mom and dad, and let them know I'd be reaching out later in day to check on Patient and submitting the VARES,
13 2021-07-27 weakness, burning sensation He woke up with a lot of chest pain; It was a burning sensation and he did not feel okay; He feels w... Read more
He woke up with a lot of chest pain; It was a burning sensation and he did not feel okay; He feels weak; He's got a sore throat; This is a spontaneous report from a contactable consumer (patient's parent). A 13-year-old adolescent male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20May2021(at the age of 13 years old) as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On a unspecified date in May2021, reported as, four days ago my son received the Pfizer Covid 19 vaccine. This morning he woke up with a lot of chest pain, he said it was a burning sensation and he did not feel okay. He feels weak, he's got a sore throat and chest pain. It was also reported his chest started hurting. Outcome of the events were Unknown. Information on the lot/batch number has been requested.
13 2021-07-27 tremor Patient was a 13 y/o who presented at center with his mother at 9:15 am for vaccination. Mom confirm... Read more
Patient was a 13 y/o who presented at center with his mother at 9:15 am for vaccination. Mom confirmed pt has several food allergies which include nuts and shellfish. Pt received the covid-19 Pfizer vaccine on the right arm . The patient leaned back on the chair shaking, pale. Mother administered EpiPen @0923, 0.3mg. Pt opened his eyes talking, HR 80-86, RR 24. Patient was encouraged to drink cold water. 911 call ambulance on the way.0930 ambulance arrived patient pink/pale 02 sats. 80s, sats. rechecked on thumb 02 sats. 98.Squard arrived. reports given to them, pediatric 02 monitors applied 02 was 98%, oxygen applied, BP within normal limits. About 9:38 patient was put on the stretcher in the company of mother to Emergency Department.
13 2021-07-27 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Det... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt informed to sit after receiving vaccine mom walked away then pt got up and started walking and passed out in aisle walking to mom and scraped his elbow. pt seated and had something to drink, felt dizzy and felt vision was blurry upon awake. Informed mom we could call paramedics but mom felt he was okay. Observed for 30 min after fainting incident, felt much better, vision no longer was a problem and no longer light headed. Mom told to call Dr. in case pt hit head, said to observe him
13 2021-07-28 unresponsive to stimuli, seizure Mom states she found her son around 9 PM in the bathroom vomiting. She stated she moved him to the c... Read more
Mom states she found her son around 9 PM in the bathroom vomiting. She stated she moved him to the couch and he continued to vomit. She stated he fell off the couch and he was seizing. She called 911, when they arrived he was no longer seizing. When her arrived at the hospital, it was documented he was postictal and would not respond to painful stimuli. The hospital kept him overnight and are discharging him home today. He has fully recovered.
13 2021-07-29 pain in extremity Right eye had light streaks; Soreness in arm; This is a spontaneous report from a contactable consum... Read more
Right eye had light streaks; Soreness in arm; This is a spontaneous report from a contactable consumer (patient mother). A 13-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on 17May2021 (Batch/Lot Number: EW0171, Age at the vaccination: 13-years-old) as single for covid-19 immunization. The patient medical history and family history was reported as none. Concomitant medication included multivitamin (he had been taking forever, it was a generic Flinstone brand). The patient was healthy before vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect and prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Consumer stated that her 13-year-old son had the vaccine yesterday and today he had regular soreness in the arm and things like that. For an hour today, he had, she does not know, like he would see light streaks in his right eye. Reporter added that her son was given the shot in his left arm. He had the light streaks in his right eye, not his left eye. His left eye was fine, and the right eye was doing that. It slowly started dissipating and he would see it when he looked down and to the right. He would see it and it slowly went away. First, it was all of the eye. He was panicking because he thought he was going blind. She did tests without his glasses on, with lights off. He could see better with lights off so maybe it was light sensitivity. Right eye had light streaks: started about 30 minutes ago, or within the last couple of hours. It completely went away. Reporter added that soreness in arm started yesterday. He had the shot probably about 6 or 5:30 when he got it. By about 8, he started feeling soreness in the arm. He still has soreness today. Just a little bit worse than it was yesterday. She guesses it was from getting stiff overnight. The outcome of event Right eye had light streaks recovered on 18May2021 whereas, for other event not recovered. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
14 2021-05-12 slurring Patient was vaccinated at 1:02 and within 5 minutes of been vaccinated, patient started complaining ... Read more
Patient was vaccinated at 1:02 and within 5 minutes of been vaccinated, patient started complaining of headache and thirst but denies palpitation or difficulty breathing. O2 sat 98% on room air, HR 128. Although patient was alert and oriented to person, place and event, his speech was slightly slurred and he was pale, Vital signs O2 sat 98% on room air, HR 76, BP 132/70. Patient was injected with 0.15 mg of Epi at 1:10 Pm on the right thigh and again at 1:15 pm on the left thigh. At 1:20 pm patient was still oriented to person, place and event and was able to do serial math. Patient was still pale when the ambulance arrived, O2 sat remained at 98% on room air and patient was taken to the ER for observation.
14 2021-05-13 inability to speak 95% Room air, 64 pulse, BP 112/72. Patient noticed to be less talkative. He had an almost syncopal e... Read more
95% Room air, 64 pulse, BP 112/72. Patient noticed to be less talkative. He had an almost syncopal episode. Patient never lost consciousness. Provided water. Patient recovered at vaccination table.
14 2021-05-13 feeling hot 45 minutes after vaccine patient got dizzy and felt like he was about to faint. Felt nauseous and h... Read more
45 minutes after vaccine patient got dizzy and felt like he was about to faint. Felt nauseous and had to lie down. Then he felt very hot but no fever. Three hours later he felt better but said he would have crashed a car if he had been driving..
14 2021-05-13 tremor Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Medium
14 2021-05-14 cold sweat Adverse event: RN called to vehicle by father who was yelling for help. Once RN arrived at vehicle o... Read more
Adverse event: RN called to vehicle by father who was yelling for help. Once RN arrived at vehicle opened passenger door to find patient fluttering eyes after father stated he had just passed out. Patient was clammy, pale, and diaphoretic. RN advised patient to take slow deep breaths. Patient followed instructions, stated his name and said he felt 'funny'. Pulse taken and was HR 58. Then vehicle was moved to the side and vital signs were taken at 1301. BP 82/42, HR 80, RR 13. Patient was alert, oriented and answered questions appropriately. Treatments: RN and Charge RN present and spoke to both Father and patient about potential contributing factors to episode. Patient given water and gatorade. Able to finish bottle of gatorade and stated his symptoms had improved. Second set of vitals taken at 1324. BP 116/72, HR 82, RR 16. Patient also stated he had a banana for breakfast. Advised patient to stay hydrated, eat lunch, and rest. Advised father to reach out to pediatrician if any further events or questions about today event
14 2021-05-14 cold sweat Within minutes of getting 1st Pfizer vaccine he had a presyncopal episode. Stable vitals but felt d... Read more
Within minutes of getting 1st Pfizer vaccine he had a presyncopal episode. Stable vitals but felt dizzy/lightheaded, no LOC. Felt clammy and sweating on his forehead. Mom thought his color was draining from his face. Returned to baseline after 10 minutes of lying flat with feet elevated, cold water to drink, cold rag on face, and some fruits snacks.
14 2021-05-14 tingling, cold extremities, numbness, tremor, feeling cold Patient is a 14 YO male with no previous medical history that received the Pfizer vaccine administer... Read more
Patient is a 14 YO male with no previous medical history that received the Pfizer vaccine administered into his left Deltoid at 1406. He was sent to the observation area where the nurse noted him looking pale at 1410. His mother was present during this whole event. He was taken over to the medical tent for privacy and further evaluation. He was complaining of being light headed. He was given apple juice and crackers as he had stated that he had not eaten or drank anything all day. At 1430 his VS read BP 132/80, HR 145, O2 99%. At this time he was lying down and feet elevated, shaking, pale, and cold. Lung sounds clear. Nausea but not needing to throw up he was covered up to try and keep him warm. At 1440 his blood pressure was 130/82, HR 130, 02 98% At this time he was lying flat with feet elevated, shaking, pale, and cold. His lung sounds clear. Nausea, but not needing to throw up. At 1450 BP 138/74, HR 120-135, 02 98%. Symptoms had not changed at this point except he mentioned his ears felt cold, although they were warm to touch. He was laid on his left side at this point to try and lower his HR, which did come down to 115-125 when on his L side. We did not take a BP at this point as we wanted him to be on his back when taking them. At 1515 he was laid back on his back to see how his HR would do and how his BP was. BP 138/60, HR 135, 02 98%. Again symptoms were the same except he was complaining of colors being more ?dull?, and his teeth being numb. At this point his pupils were noted to be +8, equal and reactive. 1521 VS read 138/50, HR 135, 02 98%. Vision still dull and pupils unchanged from 1515. He was laid on his R side to see if this would lower his HR. It was brought down to 120-130 on his R side. We gave him a cookie to snack on to see if that would help with any of the paleness, shakiness, and light headiness. He was able to take a few small bites. Hands pale and washed, with +1 bilateral radial pulses. 1529 he was sat up slowly to try to get him to hydrate, as it was apparent he needed fluids onboard. His BP read 142/80, HR 124, 02 98%. He was still complaining of lightheadedness. After sitting up and drinking half a bottle of water and some cookie, he stated that colors were becoming more vibrant. He noticed my eyes were very blue, which previously he had stated they were grey. He stated his lightheadedness had improved and that he was feeling better. We had him sit up for a while and his color started to come back, although his L arm was still pale, of note this was the Vaccinated arm. At 1546 his VS read 150/82, HR 117, O2 99% while sitting. His only complaint was feeling like the air he was breathing ?was cold?. At 1607 he was stood up and when doing so his HR went to 140. After standing for about 4 minutes his BP read 120/82, HR 114, O2 98%. His pupils +6 , equal, round, and reactive. He was feeling way better and his color in his L hand was back equal to his right. He was slowly walked around a chair just to see how he would do with activity. His HR was anywhere from 94-120 when walking around the chair, he complained of no dizziness, or other symptoms. At this point he had finished 2 apple juices, crackers, a cookie, and a bottle of water for a total of 1.5 L of fluid. He was sat back down in the chair to rest and see how things went for a while. His HR was anywhere from 109-120 when in the chair, although he did appear very anxious through this whole process. When he was given a task it appeared that his HR was a few points lower. His final HR was 109, BP 130/82, O2 98%. Of note he did complain of his feet and fingers feeling tingly a few times during this process. Sometimes his feet would be tingly when elevated and then when the garbage can holding them up was readjusted it resolved. These were intermittent complaints. At this point it is 1630. He has responded to fluids and is stable to go home with his mom. It was recommended for him to increase his fluids tonight, and to eat something. He was sent with a bottle of water. It was also recommended to get a pulse ox machine from a pharmacy so that his HR could be monitored and if it does not come down under 100 by tomorrow to make an appointment with his MD to follow up. If any of these symptoms were to come back or if his mom had any concern at all it was recommended to take him to the ED for observation. It was also recommended to follow up with his primary even though he left stable. Throughout this process, I considered administering Epinephrine. The problem was his BP was not low and we could not get his HR to come down. I did not want to increase his HR any more than it already was unless I was absolutely necessary. Given that he responded to fluids, it was decided not to administer it. Given that it took him 2.5 hours to recover from this vaccine, I strongly recommend that he does not get his second dose. I consider this to be an adverse reaction, and his mom was in agreement.
14 2021-05-14 tremor Patient sat down immediately after vaccination in waiting room and starting shaking. Pharmacy staff ... Read more
Patient sat down immediately after vaccination in waiting room and starting shaking. Pharmacy staff called 911. Shortly after, the patient stated he was feeling better but then said he was having vision darkness. EMT then came to evaluate patient.
14 2021-05-14 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Additional Details: Patient receive... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Additional Details: Patient received injection and got up from chair. After standing for a few minutes he fainted and lost conciousness. His mom and I got him to the floor and he regained conciousness within a minute. He said he felt thirsty and nauseated. His mom gave him water. He laid on the floor for 20 minutes and then sat up for a few minutes. Then he walked out of the dressing room and left the store.
14 2021-05-14 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted 5 minutes after administ... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted 5 minutes after administration during 15 minute post-vaccine observation period. Per witnesses he slumped over to his left side and fell onto the floor to his left side loosing consciousness briefly. He was assessed by immunizing pharmacist and nurse practitioner and was found to have normal regular pulse & was pale in color. He regained consciousness shortly after a few seconds, EMS came over and assessed him later and was deemed ok to go home after 30mins.
14 2021-05-15 weakness 14 year old male reported not being able to see after receiving vaccine. writer noted the boy's ski... Read more
14 year old male reported not being able to see after receiving vaccine. writer noted the boy's skin pale in color. The boy is able to follow command but has unclear speech. Paramedic on site. Per paramedic the boy has body weakness, mild headache, and blurred vision. Per paramedic vital signs are BP 107/63, R 16, PR 66. The boy recovered under the care of the paramedic.
14 2021-05-15 slurring Systemic: Ringing of the ears, slurred speech-Severe, Systemic: Tinnitus-Severe
14 2021-05-15 tremor, seizure About 5 min after receiving shot, his head went to the side, lost consciousness. His legs, arms, han... Read more
About 5 min after receiving shot, his head went to the side, lost consciousness. His legs, arms, hands went stiff and he started shaking. His eyes rolled back in his head, textbook seizure. Lasted a little less than a minute. When came to he said he couldn?t see anything. After about 30 seconds he could start to see. He turned pale, felt like he was going to throw up. But never did. A few minutes later he started to get a little color back in his face. He is tired but was better.
14 2021-05-16 flushing Flushing/sweating. BP 97/54, HR 78, RR 22 -- > 101/60, 87, 18. Pt stable and released from the vac... Read more
Flushing/sweating. BP 97/54, HR 78, RR 22 -- > 101/60, 87, 18. Pt stable and released from the vaccination site.
14 2021-05-16 numbness Pt was given COVID vaccine #1. Approximately 10min after vaccine administration pt reported losing h... Read more
Pt was given COVID vaccine #1. Approximately 10min after vaccine administration pt reported losing his vision, having difficulty breathing and numbness in left arm. Denied chest pain, headache, nausea. Pt pulse 59. SpO2 91-96%. Pt pupils dilated. Pt alert x2. This RN called 911 with mother's permission. EMS arrived @1800. At that time pt alert x3, no longer pale, numbness decreased, difficulty breathing resolved. Pt walked out of the office on his own. He was not taken to ED via Ambulance.
14 2021-05-16 muscle twitching, muscle spasms Patient passed out immediately following administration of the vaccine to the left deltoid. His head... Read more
Patient passed out immediately following administration of the vaccine to the left deltoid. His head fell backwards and limp. The Rph administering the vaccine moved in front of the patient and gently moved his head into an upright position. The patient had mild muscle spasms and twitches while passed out but when he regained consciousness he immediately began talking saying he was ok. Father came into the consultation room at that point and Rph explained what had occurred. Patient looked a little pale and eyes were having a hard time staying open so with the help of his dad Rph helped him down to the ground in the corner of the room so he could have back and head support from the wall. Patient was given a glucose tablet and water, and later orange juice. Patient stayed in the consultation room for about 20 minutes before leaving on his own and saying he was feeling much almost back to normal.
14 2021-05-16 pain in extremity left arm soreness
14 2021-05-17 flushing Pt received shot and after shot pt complain of feeling flushed and "nervous". Pt was given water wi... Read more
Pt received shot and after shot pt complain of feeling flushed and "nervous". Pt was given water with gatorade packet. No acute distress noted. Pt given extra 15 minutes for wait time. A/Ox3. Pt tolerated well.
14 2021-05-17 tingling, pain in extremity He noted his skin was sensitive/tingly in his trunk/abdomen and that he felt a little achey when he ... Read more
He noted his skin was sensitive/tingly in his trunk/abdomen and that he felt a little achey when he woke up yesterday morning (5/17/2021) but nothing severe, I just assumed is was post injection soreness, he also had some left arm soreness about 18-24 hours post injection. Around 5pm yesterday (5/17/2021) he has sudden onset of fever (103 degrees) and he had just been checked for volleyball practice at 2:30pm and was afebrile. Fever continued through the night between 102 and 104 with Tylenel every 4 hours and one episode of Ibprofen. Fever down to 99 degrees by 7am this moring (5/18/2021). Did rapid COVID test from drug store and was negative. Pediatricians office said to monitor through day, call back if high fever returned and to notify VAERS.
14 2021-05-17 seizure After receiving vaccine in the left deltoid, patient fell face down on to the floor. Patient was n... Read more
After receiving vaccine in the left deltoid, patient fell face down on to the floor. Patient was noted with what appeared to be two seizures lasting 10-15 seconds in duration. Patient received immediate attention, contacting EMS and recording vital signs. Blood pressure noted at 105/64, heart rate 55, 02 saturation noted at 99%. EMS arrived and provided immediate attention. Parental guardian (Mother) refused transportation to the emergency room. Mother was provided patient education in the risk of refusing medical care. Mother signed AMA form and stated she would take patient to the hospital.
14 2021-05-17 seizure Vasovagal syncope with mild convulsion for 5 seconds.
14 2021-05-17 unresponsive to stimuli, tingling, numbness, tremor Client complained of palpitations 20mins after receiving vaccine. First vitals at 1637: pulse 147, b... Read more
Client complained of palpitations 20mins after receiving vaccine. First vitals at 1637: pulse 147, blood pressure 124/78, oxygen 99%. Alert and oriented x4. Client denied chest pain, shortness of breath, headache, or blurry vision. Per Father client had asthma that resolved years ago, no current medications or allergies. Pulse at 1638: 127. Vitals at 1640: blood pressure 118/70, pulse 124, oxygen 100%. Per client palpitations improving. Alert and oriented. 1644: client hands shaking, client stated only had breakfast. RN brought client juice and snack. Client began to eat. Father denied client having diabetes. 1648 vitals: blood pressure 122/80, pulse fluctuating from 110-low 120s, oxygen 97%. Symptoms the same with new onset o blurry vision, per client could not focus image. PHN offered Father to call paramedics for further assessment and he declined. PHN advised for client to follow up with provider. Per Father client's sugar lowers when he skips meals. PHN asked Father is he has followed up with provider or checks client's sugar at home, Father denied. Per Father he knows his son and "he needs to eat or sugar goes low". At 1656 client stated he wanted to vomit, emesis bag given. 1658 client pale, PHN asked client how to was feeling. Per client feeling like he "was going to pass out". At 1700 client stated he could not feel legs, RN assessed for sensory and motor. Per client felt like legs "were asleep". PHN assessed for level of consciousness, client unable to answer, client lethargic. 1701 client lost consciousness. PHN and RN lowered client to floor from chair. EMT called 911 at 1703. RN did sternal rub, client unresponsive, breathing normal, pupils reactive. 1704 client woke up with urge to vomit. PHN and RN turned client on side. EMT able to place emesis bag near. Client had 1 small vomit episode. Client's eyes open, blank stare, not answering questions. At 1707 client went unresponsive again. Paramedics arrived at 1709 and assumed care. Client transported to hospital at 1717
14 2021-05-19 involuntary muscle movements Immediately after administration, patient became pale diaphoretic, lost consciousness, had jerking b... Read more
Immediately after administration, patient became pale diaphoretic, lost consciousness, had jerking body movements, maintained pulse and airway. Once regained consciousness, vomited 3 times. Pt was given pepcid with fathers consent. After about 10 minutes started to complain of tightness of chest, short of breath. With consent from father administered 25 mg of benadryl. Monitored for 30 minutes. Patient status returned to baseline at the end of the 30 minutes observation. encouraged to follow up with pc prior to next vaccination to weigh the risk and benefits. Afterwards, dad said patient had reactions like this in past with vaccination. Asked multiple times if wanted EMS called or transport to medical facility. Declined by father.
14 2021-05-19 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient developed sweating, pale lips, fatigue/lethargy, eyes closing and hard to remain concious. pharmacist called 911 and paramedics came, evaluated patient and blood pressure / heart rate normalized. patient able to sit down. after 30min post vaccination. patient and patient's father agreed to go home and refused ER service from paramedic.
14 2021-05-19 flushing Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Medium
14 2021-05-19 flushing Pt experienced headache, blurry vision, "muffled sounds," flushing/sweating & experienced dizziness... Read more
Pt experienced headache, blurry vision, "muffled sounds," flushing/sweating & experienced dizziness. Juice was given, mom stated this happens for all shots, crackers given, pt lay down & rested. Provider cleared pt, pt stable & released from vaccination site
14 2021-05-19 muscle twitching 10 minutes after his vaccination, the patient was sitting with his mother and sister in our waiting ... Read more
10 minutes after his vaccination, the patient was sitting with his mother and sister in our waiting room per protocol after a vaccine. I heard a mom scream while I was giving another patient a vaccine. I ran out with an epipen but he was awake, alert, and breathing normally. I asked what happened and she said he fainted for a second and seized or twitched a little. I did not give him any epinephrine because he was not having any issues breathing and was able to tell me he felt fine. We did call 911 per moms request and they came and checked him out.
14 2021-05-19 pain in extremity Sore arm, stomach ache/nauseous, dizzy
14 2021-05-19 pain in extremity At about 24 hours after received Pfizer COVID vaccine #1 he started c/o pain along the cephalic vein... Read more
At about 24 hours after received Pfizer COVID vaccine #1 he started c/o pain along the cephalic vein starting at antecubital fossa and spreading distally. Yesterday mother said she could feel a ropy feel c/w phlebitis. She had him take an aspirin and put heat on it. Today it is a little better. He still has pain along that vein and it hurts to fully extend and flex his arm. Presumptive left UE phlebitis that occured within 24 hours of the first Pfizer COVID vaccine in teh sme arm, possibly reaction to vaccine. Treatment of LUE with heat, compression adn ibuprofen (avoid ASA due to age <18). If worsening pain, swelling, redness or fever; f/u and will consider US.
14 2021-05-19 seizure As per father the pt had 3 convulsions, became very disoriented. Upon my arrival he was extremely p... Read more
As per father the pt had 3 convulsions, became very disoriented. Upon my arrival he was extremely pale and somewhat disoriented. His heart rate was 47 as per the pulse ox and he had no palpable radial pulse. His initial blood pressure was 101/60. During our interaction his pulse increased to 60 and became palpable at the radial. His pulse was irregular. His color improved as did his mentation. Pt was transported to hospital
14 2021-05-19 tremor, unresponsive to stimuli Pfizer vaccine given 5/20/2021 Per mom/ pt the shot was given at 11:02 around 11:07 he leaned for... Read more
Pfizer vaccine given 5/20/2021 Per mom/ pt the shot was given at 11:02 around 11:07 he leaned forward and became unresponsive. He was slightly drooling from the mouth. Mom says that his body was tight and that he was shaking a little. His eyes were closed and did not appear to be rolling back in his head. This episode lasted for less than 1 minute. He did not remember what happened and thought he wet himself after; which he did not. About 1-2 min after that episode mom states that he appeared to " passed out" for less than a minute. The ambulance was called and he was taken to hospital. He was evaluated and appeared well at that time. No fever. EKG was done and per pt it was normal. No EEG was done. He was discharged without admit That evening he has multiple episodes of vomiting > 10 times. No diarrhea or fever. Seen today at medical office for follow up. Vaccine not given at our clinic
14 2021-05-20 seizure Within 30 secs to 1 minute following vaccination patient started to seize. He came out of the seizur... Read more
Within 30 secs to 1 minute following vaccination patient started to seize. He came out of the seizure quickly (approx 20-30 sec). EMS was called and on site in minutes. Patient was breathing on his own but breathing was rapid. He lost color in his face/lips. When EMS arrived they noted that he was hypotensive and bradycardic. He began to regain color while EMS was on site. They opted to take him in for further evaluation. No history of seizures.
14 2021-05-21 feeling hot After 3 minutes of observation in a chair, he got up to move to the observation area in clinic and t... Read more
After 3 minutes of observation in a chair, he got up to move to the observation area in clinic and then fainted. He fell backward against a closed door and slid down. He quickly regained consciousness and his vitals were stable. within 10 minutes he was no longer dizzy or hot. He was able to sit up right without issues. Per dad, this is the same reaction he had to the flu vaccine in fall of 2020.
14 2021-05-21 seizure, tremor Seizure. He was stiff, shaking uncontrollably, gasping for air. Seizure lasted 2-3 minutes. Rescue w... Read more
Seizure. He was stiff, shaking uncontrollably, gasping for air. Seizure lasted 2-3 minutes. Rescue was called to the house. Had to be taken to ER. ER conducted CBC test. Results came back normal. Was prescribed as needed Valium suppository bc this was his first seizure ever
14 2021-05-21 seizure Situation: 14yo male came in for first dose Pfizer vaccine. Within 5 mins after receiving vaccine, p... Read more
Situation: 14yo male came in for first dose Pfizer vaccine. Within 5 mins after receiving vaccine, patient had a seizure for approximately 1 minute. During seizure, patient was incontinent of urine. RN was able to get to patient's side before he fell. Background: Patient did not alert vaccinator or RNs that he had a history of seizure. Mom informed staff after the event that he had a febrile seizure when he was a young child. She did not disclose what age he was at the time of the previous seizure. Assessment: RN observed patient in an active seizure for 1 minute in which his body contracted out and his eyes rolled back. She was at his side to prevent him from falling. He was placed on a gurney and moved to room 6 for closer observation for 30 mins. Pfizer vaccine administered on 5/22/21 at 12:52PM 1255 vitals ? 121/64(83), 97.3F 1257 vitals ? 122/75(90) 1311 vitals ? 116/76, HR 68, 100% O2 1318 vitals ? 112/75, HR 68, 100% O2 1325 vitals ? 111/61, HR 68, 99% O2 Recommendation: MD on call, was called and notified of the event. Her recommendation was for the patient to go to the ED for evaluation and labs. RN called the ED to notify them of the patients intended arrival. The mom agreed to take the patient to ED for further evaluation. The patient was taken out via wheelchair.
14 2021-05-22 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
14 2021-05-23 weakness Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
14 2021-05-23 weakness Patient (14 years old) fainted in the observation area receiving the first dose of the Pfizer vaccin... Read more
Patient (14 years old) fainted in the observation area receiving the first dose of the Pfizer vaccine. Patient fell from chair and had some scratches to right temporal region. Patient was accompanied by his mother. Patient was assisted to chair and appeared very pale and disoriented to time and place. EMS was called at 1138. Patient also stated his vision was blurred, reported nausea (emesis x1), and reported feeling very weak and ?really weird?. Patient also reported he was very sleepy and wanted to go to sleep. Patient was kept awake. Mother stated patient had history of ADHD and anxiety but no other past medical history. Paramedics arrived at 1145 and assessed patient. Blood glucose and VS were normal. Patient continued to report feeling unwell and wanted to go to the hospital but also wanted to ?stop for food?. Patient?s mother reported that patient was starting to sound like his normal self and that his color was returning. Patient?s mother agreed for the paramedics to transfer patient to ED for further evaluation. Patient left in ambulance at 1157.
14 2021-05-23 feeling hot Pt received vaccine and felt light headed and nauseated. He vomited and felt warm. BP 108/68, hr 98... Read more
Pt received vaccine and felt light headed and nauseated. He vomited and felt warm. BP 108/68, hr 98. pulse ox 96-99% Placed cool rags at neck and head, and given water, within minutes pt felt better. Was accompanied by mother.
14 2021-05-23 flushing Pt had a vasovagal episode right after the vaccine was administered. Pt c/o Flushing/sweating and d... Read more
Pt had a vasovagal episode right after the vaccine was administered. Pt c/o Flushing/sweating and dizziness. Initial BP 88/31 -- > 124/66, 76, 16 -- > 135/68, 67, 18. Pt recovered and was stable. Released from the vaccination site.
14 2021-05-23 flushing Pt c/o flushing/sweating and lightheaded/dizziness immediately after vaccination. H/o lightheadedne... Read more
Pt c/o flushing/sweating and lightheaded/dizziness immediately after vaccination. H/o lightheadedness with flu vaccine in the past. Pt ate rice and eggs at 2pm today, no breakfast. Pt's symptoms resolved after drinking 500mL apple juice and laying down with knees bent. Advised taking 2nd dose supine. BP 109/69, HR 63, RR 18 -- > 108/68, 64, 16 -- > 112/79, 75, 16. Pt stable and released from the vaccination site.
14 2021-05-23 numbness 14 year old, accompanied by parents, got his first Pfizer vaccine. After 15 minute observation, the... Read more
14 year old, accompanied by parents, got his first Pfizer vaccine. After 15 minute observation, the parents and child left the site. The parents returned within minutes from leaving and requested the child be checked out by EMS. The child was feeling numbness in the let arm, face, and neck. EMS responded and his vital were normal, but parents insisted EMS transport him to the hospital.
14 2021-05-24 discomfort 05/17/21; Patient attended school, orthodontist, baseball training and practice. Mother picked patie... Read more
05/17/21; Patient attended school, orthodontist, baseball training and practice. Mother picked patient up from baseball practice at approximately 07:30pm and both of patients legs were a pale pink color and developed into a deep red over the next hour. Patient started developing hives that were itchy, red, and uncomfortable, "all over body" per Mother. Mother states hives were mostly on his trunk, both legs down to calf/shin area, thighs, both arms (notably more irritated on the same arm where patient received injection). Mother took patient to the Emergency Room between 9:30-10pm. Patient was seen by ER Physician, who stated rash did not appear to be poison ivy, mother denied any recent changes in laundry detergent, soap, lotion, etc. ER Physician informed mother and patient that he thought the reaction was to the COVID-19 vaccine and advised against receiving the 2nd dose. Patient was prescribed 40mg Prednisone for 8 days, and mother is giving patient Benadryl as needed.
14 2021-05-24 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pat... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was sweating and feeling dizzy after the administration of the vaccine. patient felt better after drinking water and resting for 15 minutes
14 2021-05-25 weakness Upon arrival a 14 y/o male with the chief complaint of general weakness and dizziness was found sitt... Read more
Upon arrival a 14 y/o male with the chief complaint of general weakness and dizziness was found sitting upright in a POV. Vitals were as followed B/P 84/58, HR 68 O2 97%. A second ser of vitals were taken as followed B/P 120/75 HR 70 O2 99%. Lung sounds were clear and equal bilaterally, PERRL was present, PT skin was warm and dry. PT was COAx4. EMS personnel observed PT until he was stable and was returned to parental care.
14 2021-05-25 feeling hot My son started sweating profusely few seconds after the vaccine injection was administered. He felt ... Read more
My son started sweating profusely few seconds after the vaccine injection was administered. He felt intense heat all over his body and his vision blurred. The symptoms lasted for about 20 minutes.
14 2021-05-25 seizure Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seiz... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Additional Details: AFTER SHOT ADMINISTERED,PATIENT WAS WALKING TO WAITING AREA FOR OBSERVATION, WE FAINTED AND HAD 2 SEIZURES ABOUR 40 SECONDS LONG. NO PULS OR BREATHING. GAVE 10 CHEST COMPRESSIONS AND 2 BREATHS. EMERGENCY WORKER SHOPPING IN STORE HELPED ROLL TO RESCUE POSITION AFER FEEELING PULSE IN THE WRIST. HE SPIT UP A SMALL AMOUNT OF SPIT. HE SHORTLY CAME AORUND IN ABOUT ANOTHER MINUTE. NO EPINEPHRINE WAS ADMINISTERED.
14 2021-05-26 cold sweat Pt c/o dizziness, clammy UEs. BP 104/68, HR 88, RR 20 -- > 104/68, 90-105. Symptoms resolved, VSS,... Read more
Pt c/o dizziness, clammy UEs. BP 104/68, HR 88, RR 20 -- > 104/68, 90-105. Symptoms resolved, VSS, A&Ox3. Pt stable and released from the vaccination site.
14 2021-05-26 involuntary muscle movements My son started having involuntary muscle movements the day after his first covid shot. He seems to b... Read more
My son started having involuntary muscle movements the day after his first covid shot. He seems to be getting worse.
14 2021-05-26 mild one side paralysis, inability to speak Received COVID vaccine on 5/17/21 5/25/21 around 0100 patient collapsed with acute onset right sided... Read more
Received COVID vaccine on 5/17/21 5/25/21 around 0100 patient collapsed with acute onset right sided weakness and expressive aphasia. Brought to an ED where CTA found an occlusion of the L MCA which was confirmed as a ischemic stroke. He received TPA and underwent a IR guided thrombectomy. Patient continues to be admitted to the PICU with intermittent expressive aphasia and mild right sided weakness.
14 2021-05-28 feeling hot Patient received 1st dose Pfizer COVID vaccine at a store/pharmacy on 5/25/21. Presented to ED with... Read more
Patient received 1st dose Pfizer COVID vaccine at a store/pharmacy on 5/25/21. Presented to ED with chest pain on 5/28. Diagnosed with myocarditis and admitted to the hospital. ED attending note: Patient presents with acute onset of chest discomfort in the sternal area 2 days after the first dose of Covid vaccine. Patient's not had any fevers. No respiratory symptoms. No difficulty with respirations or any pleuritic chest pain. Denies any cough. No chest wall trauma. No back pain. No palpitations or syncope. No orthostasis. No peripheral edema. On physical exam he was mildly tachycardic in the 80s to low 90s with no murmur and no gallop. No JVD. Clear lungs. No rub. Bedside ultrasound performed by HCP had bilateral lung sliding and normal gross function based on 2 views. No pericardial effusion. EKG had ST changes. Chest x-ray was obtained without any effusions or pulmonary infiltrates. Normal cardiac silhouette. Troponin sent elevated. Cardiology consulted for possible postvaccination myocarditis. Child remained stable. Resting heart rates in the 70s and low 80s. Cardiology came to see the patient. Plan to admit to cardiology service. Presumed diagnosis of myocarditis. Cardiology admitting note: Pt. is an otherwise healthy 14yM who presents with acute onset atraumatic chest pain i/s/o recent covid vaccine, found to have mildly elevated inflammatory markers and troponin with borderline ST changes on EKG most consistent with mild peri/myocarditis at this time given overall well appearance on exam without hemodynamic or respiratory compromise and grossly normal function on POCUS, though plan for formal echo in AM. EKG w/ non-specific ST-T wave changes in precordial leads, no evidence of strain or block. Admitted to the cardiology service for serial troponins, ECHO, and close monitoring. HPI per cardiology consult note: "Patient is a healthy 14 year old with a history of alopecia who presented to the ED with mild chest pain 4 days following his first Covid vaccine (Pfizer). He had no symptoms in the days immediately following vaccine, and played basketball the day following with no symptoms, but after waking up today began having dull mid sternal chest pain. It was a 4/10, worse with lying down, non pleuritic, not sharp, and not radiating pain and not associated with any other symptoms including SOB, numbness, GI pain, cough, or anything else. Has not taken any meds for the pain. Has not exercised today. Felt "warm" this AM, but didn't check temperature and felt better throughout the day. No palpitations, dizziness. Denies ever having chest pain before and no recent illnesses or sick contacts. No notable fhx of cardiac disease. In the ED, troponin mildly elevated to 0.12 ng/mL and CRP 5 with low ESR and BNP. Bedside point-of-care US reportedly showed no clear effusion with grossly normal function. HR mainly in 70s in ED and normotensive. EKG with borderline nonspecific ST elevation in V3-V6."
14 2021-05-29 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient has long history of fainting w... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient has long history of fainting whenever getting vaccines. No history of seizures, per mom.
14 2021-05-30 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
14 2021-05-31 pain in extremity, night sweats My son experienced after the Pfizer vaccine and by the next day he had extremely left sore arm, by t... Read more
My son experienced after the Pfizer vaccine and by the next day he had extremely left sore arm, by the evening he developed a fever of 101.F. The next day he still had with the fever of 101F getting some fatigue, then his fever was going up to 102.4F, on Tuesday, Wednesday and Thursday of that week. He also got chills, with the fever and then on one on the nights, Wednesday he had extreme sweat profusion, his clothes were drenched. We saw his doctor on Wednesday of that week, cheek his vitals, lab work, his WBC was low and platelets were low. On Friday 05-21-2021, his fever was 99.0F and then by the afternoon then he was fever free and started to feel better. His doctors did a second lab work, WBC, was normal and his platelets went form 1129 to 373. His due for his second vaccine on 06-05-2021.
14 2021-05-31 tremor PT STARTED TO FEEL NERVOUS. PT SAID HE FELT HE NEEDED SOME AIR SO HE WALKED OUTSIDE. MOTHER WITNESSE... Read more
PT STARTED TO FEEL NERVOUS. PT SAID HE FELT HE NEEDED SOME AIR SO HE WALKED OUTSIDE. MOTHER WITNESSED HIS FALL. PT FELL ON HIS ELBOWS, HANDS SHOOK FOR 2 TO 3 SECONDS. PT DID NOT RECALL FAINTING. REPORTED HAVING A HEADACHE IMMEDIATELY AFTER.
14 2021-06-01 weakness Patient received the Pfizer COVID-19 vaccine 3 days prior to admission, and felt weak with complaint... Read more
Patient received the Pfizer COVID-19 vaccine 3 days prior to admission, and felt weak with complaints of headache the following day, and the symptoms have since resolved. Mother mentioned that he has been complaining of intermittent midsternal chest pain that worsened after eating since the day prior to admission. She had been giving him peptobismol, thinking it was gas related pain. However, due to him persistently complaining of the pain after eating, she brought him to. She denied any fever, shortness of breath, weakness/fatigue. Of note, mother had COVID in march 2020 and she believed he might have been sick around that time as well. Patient is still in the hospital and continues to receive pain medication and treatment for myocarditis (NSAIDS and opioids)
14 2021-06-01 cold sweat Client received his 1st Pfizer vaccination (Lot# EW0187, EXP 08/31/21) in his left arm at 19:15 from... Read more
Client received his 1st Pfizer vaccination (Lot# EW0187, EXP 08/31/21) in his left arm at 19:15 from RN. Client?s parents and sister were with him. Client?s parents only spoke Spanish and an interpreter was present. After receiving his shot, client sat in a chair next to his sister while RN administered a shot to her. Five minutes later client stated he felt nauseous. RN immediately called out to Vaccine Runner RN and Check-in Nurse who were in the hallway to get an EMT. Check-in Nurse radioed for an EMT to come to station 3 while Vaccine Runner RN rushed to the EMT room to ensure an EMT got the call. Check-in Nurse stayed with the client and placed a trash can next to him in case he vomited. RN stated the client looked pale and clammy. At 19:26 EMT1 arrived at station 3 and collected the client?s medical history. Interpreter was also translating the EMT?s questions and statements to the client?s parents. Client stated he had no known allergies, no underlying conditions, and is not currently taking any medications. Client also stated he was not experiencing shortness of breath, chest pain, or having trouble breathing. EMT2 arrived at station 3 at 19:27 and brought the client a vomit bag. The client had not vomited, but still felt nauseous. EMT1 gave the client a bottle of water and juice, and took client?s vitals at 19:28 (HR: 64, BP: 120/70). Client stated he felt a lot better. While walking out of station 5 Lead RN saw individuals grouped together at station 3 with the EMT and arrived at station 3 at 19:28. Lead RN was updated on client?s status. Lead RN observed that the client was mildly pale and clammy and asked client?s mother if his current coloring was normal for the client. Interpreter translated to both parents and client?s mother stated that the client did look a little pale. Client stated he felt better and was just nervous about getting the shot. At 19:30 Lead RN asked client to try and stand up. Once client was standing, Lead RN asked client if he felt dizzy and client stated no. Client stated he felt just fine. Lead RN and EMT?s directed the client to the observation room to sit in a zero-gravity chair for additional monitoring of 30 minutes. EMTs walked the client and his family to the observation room and sat him in the zero-gravity chair. Client stated he felt much better and at 19:47 EMT1 took client?s vitals (HR: 66, BP: 100/70, SpO2: 98). EMT1 stated client?s color was returning. EMT1 took client?s vitals again at 20:04 (HR: 67, BP: 104/78, SpO2: 99). Lead RN arrived in observation room at 20:10 with Lead Ancillary to check on client who stood up and stated he felt good. Lead RN observed that client was no longer pale or clammy. Lead RN educated parents and client on potential side effects vs adverse effects of the vaccine. Lead RN further instructed client and parents to see the client?s HCP or visit urgent care if client started to experience additional common side effects for more than 24-48 hours and to call 911 if the client began to experience trouble breathing, shortness of breath, or chest pain. Lead Ancillary translated all the information to the client in Spanish. Lead RN observed the client leaving with his family at 20:15. Client left walking with a steady gate.
14 2021-06-01 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient recovered and mom says she was taking him to the doctors office for follow-up
14 2021-06-01 flushing pt mom yelled for help. other employee dialed 911. mom reporting that patient keeps fainting/feeling... Read more
pt mom yelled for help. other employee dialed 911. mom reporting that patient keeps fainting/feeling nausea. used smelling salt x 2. then had patient have small sips of orange juice. patient began feeling nausea again and threw up. pt started breathing heavy/flushed/wheezing administered epi-pen (1st dose incomplete- bent needle) 2nd dose successful in muscle of right thigh. patient reported feeling better. took bp 94/54 pulse 88. ems arrived and took over. patient left with ems
14 2021-06-02 weakness Pt did well before and after vaccination. A few minutes later in the waiting area he started feelin... Read more
Pt did well before and after vaccination. A few minutes later in the waiting area he started feeling ill and his mom had him sit down and she called 911. He complained of weakness, diminished sight and hearing and lightheadedness. He was very pale and sweaty. With his mom's permission I activated an ammonia inhalant near his nose. He said he felt better after the 2nd sniff. After a couple minutes he said his symptoms were greatly diminished and he was ok. The paramedics arrived and pt was able to walk to the ambulance for further evaluation. A paramedic came back and said the patient is feeling much better and declined to go to the hospital. I talked to the mom a couple hours later and she said he is all better.
14 2021-06-02 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
14 2021-06-02 seizure Seizure for 2 second, blurry vision, pale skin, fatigue, and drowsiness
14 2021-06-03 weakness Patient(pt) received the first dose of Pfizer vaccine around 15:30pm. Pt had symptoms of weakness, d... Read more
Patient(pt) received the first dose of Pfizer vaccine around 15:30pm. Pt had symptoms of weakness, dizziness, and lightheadedness right after the vaccination. Pt's father, coordinator, and I assisted pt to sit down on the closest chair. I checked pt's blood pressure (BP) immediately with reading of 71/33 mmHg, HR 50. 8 ounces of water was given to pt. Patient declined to lie down. put another chair to have pt leaned on. Pt was alert and oriented during the observation. About 10 minutes later, pt stated he felt a little better and started to drink water and eat candy bar, Pt finished 8 ounces of water and one candy bar. Second bottle of 8 ounces of water given to pt. BP checked again with reading of 113/73mmHg, HR 71, O2 Sat 98%. No nausea, vomiting, accessory muscle use, labor breathing, facial edema, edematous lips, or rash noticed. Pt was alert and oriented with clear speech. Pt finished the second bottle of 8 ounces water. 20 minutes after receiving Pfizer covid vaccine, pt was able to ambulate without assistance. Re-checked pt's BP with reading of 95/59 mmHg, HR 70, O2 Sat 98%. Pt's father denied that pt has any type of allergy to medications or vaccines but stated patient is always afraid of needles, and he fainted last time with his mother after receiving vaccine. Patient stated he wanted to go home. ER precautions given to pt's father. Side effects and allergy reactions of Pfizer covid vaccine discussed with pt's father and educated pt's father to give pt Tylenol for fever, body aches, or arm pain as needed, increase water intake, have enough rest, and avoid NSAIDs use. Pt's father verbalized understanding. Patient ambulated with steady gait to their car. Pt and his father left at 15:53pm.
14 2021-06-03 flushing, numbness, weakness Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Dizziness / L... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium
14 2021-06-03 tremor after dose was administered by began to shake and then lost consciousness, patient was laid on floor... Read more
after dose was administered by began to shake and then lost consciousness, patient was laid on floor were he immediately regained consciousness, when he felt up to it he was sat in his chair, given energy drink and water and instructed to place his head between his knees if he felt light headed, he was then monitored for the next 30 mins without further incident
14 2021-06-05 weakness, seizure Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient fainted, seized for less than a minute and then vomited. 911 was called. Patient was examined and felt normal after medics left the store.
14 2021-06-05 feeling hot, weakness 6/2, complained of feeling hot and sick, no fever. Joint aches and leg weakness 6/3 had a strange br... Read more
6/2, complained of feeling hot and sick, no fever. Joint aches and leg weakness 6/3 had a strange bruise like spot on the back of his neck. Continues leg aches and weakness 6/4 had a strange bruise like spot near corner of mouth. Neck was better though. Never pain at the bruise like spot sites Spot on face is fading, but still present on the face as of today. All other symptoms resolved besides the spot on his face
14 2021-06-05 tremor Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadedness-Mild, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadedness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Mild, Additional Details: Patient received the shot in the left arm. After he passed out his left wrist bent and twisted.
14 2021-06-06 flushing Patient complained of facial flushing, tingling lips, and his throat feeling like it was tightening.... Read more
Patient complained of facial flushing, tingling lips, and his throat feeling like it was tightening. Nurse administered 25mg IM Benadryl per clinic protocol. The reaction resolved after administration of IM Benadryl.
14 2021-06-06 hot flush Headache, Nausea, hot cold flashes, fever, dizziness, foggy thought and trouble concentrating
14 2021-06-06 pain in extremity, discomfort Fever for 24 hours (99, 100.6), sore arm, chills, discomfort, muscle aches/pains, sensitivity to lig... Read more
Fever for 24 hours (99, 100.6), sore arm, chills, discomfort, muscle aches/pains, sensitivity to light/eye strain, headache --- treated with Tylenol.
14 2021-06-06 tremor, weakness Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-M... Read more
Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Medium
14 2021-06-07 feeling hot My son initially had side effects (tired, hot, sweaty) about 24 hours after receiving his first dose... Read more
My son initially had side effects (tired, hot, sweaty) about 24 hours after receiving his first dose. About 58 hours after the first dose, he started having trouble breathing. He called me in a panic and asked me to come home because he couldn't breathe. It took me ~15 minutes, and by the time I arrived, he was having some trouble breathing so we took him to the emergency room. They did some tests and sent him home. By that point, the symptoms seemed to have resolved on their own. But then he had some labored breathing later that night.
14 2021-06-07 limb paralysis, weakness On the 4th - woke up weak; light headed; and a lot of discomfort - his arm really hurt. General body... Read more
On the 4th - woke up weak; light headed; and a lot of discomfort - his arm really hurt. General body achiness. After a little while, he got up and was able to take some Tylenol and attend his video school day with frequent breaks. In afternoon, he started to feel worse. 102. 6 fever - we called Tele-doc appt. His throat was sore and he had some chest pain. The doctor recommended that we go to ER to have him fully evaluated. Pain and fever got better with the Tylenol. He took another couple of dose. Next morning, he had a lot better but continued to have a low fever 100.2 - on and off that day. His lymph nodes under his left arm were quite swollen and painful. The fever did not continue yesterday but the swelling has and the pain has. He was very light-headed and brain fogged on Sunday and Monday. Seems to be better today - the lymph nodes have gone down a lot but are still swollen today. He is in process of recovering.
14 2021-06-07 muscle spasms, tremor a point of hyperventilation; Breathing started to get rapid; Hands and stomach muscles cramped up as... Read more
a point of hyperventilation; Breathing started to get rapid; Hands and stomach muscles cramped up as the heart continued to race; Hands and stomach muscles cramped up as the heart continued to race; suddenly both hands started shaking; heart rate increasing, reaching higher than 166; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 12May2021 at 17:00 (at the age of 14-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as no. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 24 hours after the vaccine on 13May2021 at 17:00, while seate, suddenly both hands started shaking followed by heart rate increasing, reaching higher than 166 bpm. Breathing started to get rapid to a point of hyperventilation on 13May2021 at 18:00. Hands and stomach muscles cramped up as the heart continued to race on 13May2021 at 18:00. Called 911 and they were able to decrease the hyperventilation through slowed box breathing. They stayed for about 30 minutes as the heat rate slowly decreased to just over 100 bmp on 13May2021. Two other incidents of increased heat rate have happened since in May2021. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all events included hydroxyzine prescribed to induce calming effect as. The outcome of events heart rate increasing, hyperventilation and breathing started to get rapid was recovering; outcome of the other events was unknown. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. No follow-up attempts are needed. No further information is expected.
14 2021-06-07 pain in extremity Patient presented to ED on 6/8/2021 with sub-sternal chest pain 9/10 with mild radiation down his le... Read more
Patient presented to ED on 6/8/2021 with sub-sternal chest pain 9/10 with mild radiation down his left arm which was worse with breathing nd moving. Per patient he had 2 less severe episodes of chest pain on 6/7 which were short in duration and resolved on their own. ED evaluation was significant for mildly elevated troponin at 1.88, EKG with diffuse ST elevation, elevated CRP of 1.9, mild hyperglycemia. He had a normal chest xray. Echocardiogram demonstrated normal biventricular function with no obvious pericarditis. ***
14 2021-06-07 tremor Approximately 10 hours after the administration of the shot, my son began shaking uncontrollably. He... Read more
Approximately 10 hours after the administration of the shot, my son began shaking uncontrollably. He also described visual and tactile disturbances - a sort of hyper awareness as if a precursor to hallucinations - and a racing mind. The shaking and visual and tactile sensations resolved after roughly two hours. He then developed a fever of 100.8, that lasted another 4-5 hours. His symptoms resolved completely within about 14 hours of onset.
14 2021-06-08 feeling hot -Large red blotch on neck immediately after injection; resolved within 20 minutes, no shortness of b... Read more
-Large red blotch on neck immediately after injection; resolved within 20 minutes, no shortness of breath or other signs of allergic reaction - Extreme fatigue next day (slept 15 hours) - diarrhea (moderate, x4 day on Day 2 and Day 3 after injection ) - stomach/abdominal cramps - feeling unwell day of injection, and on Day 2 and Day 3 after injection - headache - feeling hot (but no fever) - severe arm pain (injection site) - no appetite Note: it is now the end of Day 3 after the vaccine, and my son feels well.
14 2021-06-08 feeling hot The morning after the second dose of the vaccine he woke up and felt hot and my head hurt. He had wo... Read more
The morning after the second dose of the vaccine he woke up and felt hot and my head hurt. He had woken up feeling similar a few times during the night. When he got up he felt really queasy and threw up. He felt really warm and continued to throw up. With Tylenol the fever was 104 degrees and it continued for several hours even after two doses of Tylenol. I was told to give Benadryl and Ibuprofen. The fever returned to 102 degrees and four later the fever broke. It was almost 10 hours where he was throwing up and the fever fluctuated between 102-104. It is very unusual for him to have any fever. We continued the Benadryl and Ibuprofen the following day because he still had a low grade fever and some dizziness followed by diarrhea. The dizziness and Diarrhea occurred again the next day three after the vaccine. It has been five days and he feels better but his stomach is still a little sensitive. It is possible that he had Covid-19 last year.
14 2021-06-08 flushing Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: Five minutes after the 1st shot, patient passed out. we laid him down on floor, he came back but very tired, pale, sweating and shortness of breath. we gave him water to drink, one dose of Epipen Jr and called 911. The Epidemics arrived, he did feel better then, can sit on chair for them to check up. His vital signs came up normal, he was observed for 15 more minutes before allow to go home
14 2021-06-09 weakness Flu-like symptoms: fever (101.7), generalized weakness, nausea, malaise
14 2021-06-09 pain in extremity Arm hurt, could barely move it. Then he got the chills and a fever, and really tired. Hours later, h... Read more
Arm hurt, could barely move it. Then he got the chills and a fever, and really tired. Hours later, he said his tongue started to hurt. I tried to log this on the daily check in but by the time I clicked on the link it said it expired - 12 hours after receiving - why wouldn't they give you 24 hours?
14 2021-06-09 tingling Dizzy, low blood pressure, tingling in hands and feet. Patient was placed in supine position, legs ... Read more
Dizzy, low blood pressure, tingling in hands and feet. Patient was placed in supine position, legs elevated. Oxygen was administered. BP slowly returned to normal, he was slowly transitioned from supine to sitting then standing and was able to walk out of office on his own. Event lasted about 1 hour.
14 2021-06-10 cold sweat Patient received the Covid-19 vaccine. He fainted immediately after receiving the vaccine. Pt regain... Read more
Patient received the Covid-19 vaccine. He fainted immediately after receiving the vaccine. Pt regained consciousness within a few seconds. Pt looked clammy and pale but denied any dizziness. VS as follows: At 1435: BP 98/39, HR 50, O2: 100 1440: BP 105/48, HR 48, O2: 99% 1450: BP 100/58, HR 54, O2: 100% Pt discharged home at 1450 in stable condition accompanied by mother
14 2021-06-10 numbness COVID vaccine (Pfizer) given 5/13/21 and 2nd vaccine given 6/3/21. Both given in L-upper arm. No u... Read more
COVID vaccine (Pfizer) given 5/13/21 and 2nd vaccine given 6/3/21. Both given in L-upper arm. No urticaria after 1st vaccine. Initially after 2nd vaccine he developed symptoms of tired, fever Tm 101.1 F, upset stomach, headache, body aches, chills and sensation that arms and legs were "numb" about 12 h after vaccine. The "numb" sensation lasted 30 min and no longer present. Denies enlarged lymph nodes, extremity edema. No hx/o COVID in the past. Went to Urgent care on 6/7/21 due to full body hives, so given benadryl and topical steroid triamcinolone. It continued to worsen during the day so taken to ER later that day and given Pepcid, steroid IM and benadryl. Discharged home on PO prednisone 20mg x 5 days. No Epi was given. Given benadryl every 6 hours and by the 4 hour mark it would come back. Given zyrtec twice daily 10mg/dose on 6/8/21 evening, 6/9/21 BID. Overnight didn't wake him for benadryl (last dose 8pm). On 6/10/21 given steroid, pepcid and zyrtec and seen by PCP in clinic for ER follow-up. No hives present on exam on 6/10/21 (present the night before). Hives would fade and then come back and were migratory. Hives were pruritic. Also used calamine. Once his lips were swollen, but denies any tongue swelling, itchy throat, cough, wheeze. Denies N/V/D. Mother cooked with a new crock pot seasoning at Farmer's market used at dinner the night before the hives developed. Also had strawberry short cake for dessert the night before. The day he had hives he also had strawberries and complained of stomach pain after eating them. No hx/o strawberry allergies or food allergies in the past. No knew meds, detergents, lotions, soaps prior to hives. No recent illness.
14 2021-06-10 pain in extremity Within 5 minutes of vaccination he was in the waiting room and became very dizzy, sweating and was ... Read more
Within 5 minutes of vaccination he was in the waiting room and became very dizzy, sweating and was having trouble breathing. I reported to the closest worker and she called in another person, assuming one was a nurse and one was not. She had him look into her eyes, which was difficult, then she had him out his head between his knees for a minute and he was then able to come out of it. Still a bit dizzy, they moved him to a room with a bed where he could lie down and they put a cold, wet paper towel in his forehead. He rested there for an additional 10 minutes. They had him get up and walk before they allowed him to leave. He had not eaten anything since the night before and he has severe ?needle anxiety ? which both could have contributed to the reaction. He has not had any issues since, except for a sore arm.
14 2021-06-10 pain in extremity June 8th- received vaccine. Fatigue, arm soreness. June 9th- headache, decreased appetite June 10th... Read more
June 8th- received vaccine. Fatigue, arm soreness. June 9th- headache, decreased appetite June 10th- pain of both upper arms, substernal chest pain. One episode of emesis. Was admitted to our hospital for presumed COVID-19 vaccine related myocarditis.
14 2021-06-10 tremor 1258 Called to lobby. Pt pale, diaphoretic, and having tremors of extremities. Per mom he does this ... Read more
1258 Called to lobby. Pt pale, diaphoretic, and having tremors of extremities. Per mom he does this with vaccines. She did not say anything thinking it was psychological and if she did not mention it he would be OK. C/O dizzy. Transferred by parents to wheelchair then to treatment room. Two person standby assist to treatment table and lying in supine position. Verbalizes had not eaten and feels better lying down. 1300 VS 117-67 HR 76, Resp 14, O2 sat 97% room air. 1314 Skin color improving. Skin dry. Assisted to sitting position. 1315 VS 116/71 HR 71 R 14 O2 sat 98% room air. Dad assisted with ambulating to lobby waiting area. Instructed to sit for 20 min and will reassess. If dizziness returns to not stand up and let parent know. Verbalizes understanding
14 2021-06-11 feeling hot About 3-5 min after vaccination patient felt unwell, hot, dizzy, feeling of passing out, had his hea... Read more
About 3-5 min after vaccination patient felt unwell, hot, dizzy, feeling of passing out, had his head down between hands. Pharmacist and patients mom got patient down on the ground flat with legs elevated on chair, a cold pack and water. Pharmacist did not witness loss of conscientious. Patient was nervous about getting vaccine. We called 911, emergency services came, did a work up. It appeared to be a vagal response, possibly from fear of needles. When emergency services got patient up he seemed a little nauseous. They took him to hospital.
14 2021-06-12 electric shock sensation Sudden chest pain, about 30 hours after the 1st dose of the Pfizer-BioNTech vaccine. Described as an... Read more
Sudden chest pain, about 30 hours after the 1st dose of the Pfizer-BioNTech vaccine. Described as an intense, clawing sensation inside the chess. Diminished upon calm, deep breathing, but persisted on-and-off for about an hour, until patient fell asleep. A few hours later, at night, woke up with a sensation of an electrical streak across his chest and back. It diminished/disappeared quickly. Some remnants in the morning. No problems reported afterwards.
14 2021-06-12 feeling hot, tremor 5 minutes after injection: reported feeling hot + dizzy, then passed out momentarily. Recovered to n... Read more
5 minutes after injection: reported feeling hot + dizzy, then passed out momentarily. Recovered to normal within seconds. Approx 90 minutes after injection: rapid onset of extreme headache (outward pressure), difficulty breathing, chills, shaking, extreme fatigue, feeling of racing heart, mildly impaired vision, mildly impaired thought. These symptoms continued in waves over the subsequent 2-3 hours. Between waves, reported feeling fine.
14 2021-06-13 weakness, feeling hot, flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Pt reported feeling hot, tired, weak. Gave water, provided fan, and patient rested. Offered to call ambulance if needed (pt refused and mom ok with refusal). Called mom on phone after patient went back home. Per mom, pt ate and drank at home and felt much better (no symptoms).
14 2021-06-13 pain in extremity This patient received their second Pfizer COVID-19 vaccine on 6/4/2021. The patient began experienc... Read more
This patient received their second Pfizer COVID-19 vaccine on 6/4/2021. The patient began experiencing arm pain which migrated to his chest on 6/6/2021. The pain resolved but returned with increased severity on 6/7/2021, prompting medical evaluation. The pain was described as a pressure sensation in the center of the chest and in bilateral arms. Upon initial evaluation, he was found to have an abnormal EKG with ST segment changes. Troponin was significantly elevated. He was transferred to the hospital. A transthoracic echo was obtained and was normal. He was hospitalized on the pediatric cardiology service, admitted on 6/8/2021. Troponin trended down during his stay. He was started on lisinopril. He was discharged home on 6/9/2021 with plan for outpatient pediatric cardiology follow up. Given the proximity of his second Pfizer COVID-19 vaccine to onset of his symptoms, and given similar reported events, the chief concern is whether his episode of myocarditis is related to administration of the Pfizer COVID-19 vaccine. I was on call as attending physician when this patient was admitted. Physician cared for this patient as the pediatric cardiology inpatient attending during his hospital course.
14 2021-06-13 pain in extremity Immediately following vaccination on 6/11 the patient developed left arm pain which became bilateral... Read more
Immediately following vaccination on 6/11 the patient developed left arm pain which became bilateral and a headache. These symptoms resolved with Advil. On 6/13 he developed self-limited epigastric pain and later that evening he developed acute midline inferior sternal pain, which prompted ED evaluation.
14 2021-06-14 pain in extremity a 14 year old male with no significant past medical history who was in his usual state of health unt... Read more
a 14 year old male with no significant past medical history who was in his usual state of health until he after his 2nd dose of Pfizer COVID-19 vaccination on Friday afternoon 6/11. On Saturday 6/12 he had headache, fever in the AM and had poor oral intake during the day and in the afternoon had developed mid sternal chest pain that Described as thumping and wrapped around his chest under his arms. He felt that it was worse with inspiration and continued to worsen despite tylenol. He went to a medical center where his workup on Saturday evening 6/12 was normal (including EKG and blood work). He also had some dizziness at that time but no syncope. He was changed from as needed tylenol to as needed motrin and instructed to take famotidine. On Sunday his chest pain persisted but was stable and he continued on motrin. On Monday 6/14 he had chest pain that felt like pounding this AM, headache, body aches, and pain in his bilateral arms, mouth and throat. He had some nausea but no vomiting or diarrhea. He represented to a medical center where his troponin was 0.25 ng/ml (normal 0-0.03 ng/ml) pro-BNP 324 (normal 0-125 pg/ml); ESR 9; CK 359; CK-MB 20.3; WBC 3.9; Hgb 14.1; plts 181. And he was noted to have ST elevations on EKG. He received toradol at 2:30pm with some improvement in his pain. His pain level has been variable 5-10/10; currently reporting that his chest pain is resolved. He has had no shortness of breath, palpitations, sick contacts, URI symptoms including cough, congestion, runny nose; no travel.
14 2021-06-15 weakness Assistance request in lobby due to patient blood pressure dropping and patient feeling weak, pale in... Read more
Assistance request in lobby due to patient blood pressure dropping and patient feeling weak, pale in color
14 2021-06-15 numbness Around 3 am he woke me up saying he couldn?t feel his legs and had a stomach ache. He got up in the... Read more
Around 3 am he woke me up saying he couldn?t feel his legs and had a stomach ache. He got up in the morning to use the bathroom and almost passed out. Headache stomach ache , slight nauseous feeling lasted until about 12/1 pm. Very tired slept all day until around 6 pm. Very tired into the next day. Around noonish the following day he seemed to be back to normal.
14 2021-06-15 pain in extremity Headache Arm soreness After COVID vaccine
14 2021-06-17 cold sweat He had soreness at the site, he is extremely tired and fainted upon standing. He additionally has a ... Read more
He had soreness at the site, he is extremely tired and fainted upon standing. He additionally has a headache and is clammy/sweaty.
14 2021-06-18 cold sweat fever to 101 F on 6/17/2021 at 8am which persisted. Chest pain started 6/18/2021 at 3am and has be... Read more
fever to 101 F on 6/17/2021 at 8am which persisted. Chest pain started 6/18/2021 at 3am and has been constant. sharp chest pain lower chest midline, worse with laying, better with sitting or walking. Shortness of breath with laying also. Also has palpitations, light headedness, dizziness, nausea, feels clammy. Chest pain worse on 6/19/2021 at 1:30 am and came to the ED for further evaluation and treatment. Just got admitted and full evaluation in progress.
14 2021-06-18 seizure Systemic: Nausea-Medium, Systemic: Seizure-Severe, Additional Details: Patient received vaccine and ... Read more
Systemic: Nausea-Medium, Systemic: Seizure-Severe, Additional Details: Patient received vaccine and within 2 minutes complained of nausea& lightheadedness to his mother then passed out. Upon putting him on the ground he began to seize. Paramedics called & came & took vitals. All within normal limits. Patient was alert & talking & stated he felt fine. Upon being sat up in a chair his eyes rolled back & he began to seize again, more violently. He was then placed on strecher & taking to ER.
14 2021-06-19 weakness, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Severe, Systemic: Weakness-Mild
14 2021-06-19 weakness Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Chills-Severe,... Read more
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe
14 2021-06-20 feeling cold, feeling hot Patient sat for a few minutes. Got up to go to the restroom and felt light headed and dizzy. He wa... Read more
Patient sat for a few minutes. Got up to go to the restroom and felt light headed and dizzy. He was hot then cold.
14 2021-06-20 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
14 2021-06-20 pain in extremity developed myalgias, bodyaches two days after vaccine. seen in clinic on 6/18/21 due to worsening b/l... Read more
developed myalgias, bodyaches two days after vaccine. seen in clinic on 6/18/21 due to worsening b/l thigh pain. Found to have elevated CK levels concerning for mild rhabdomyolysis (CK level on 6/18/21 was 1600). Treated at home with oral fluids, rest and ice compressions. Symptoms resolved by follow up in clinic today on 6/21/21.
14 2021-06-21 unresponsive to stimuli About 18 minutes after receiving the vaccine, the patient collapsed on the elevator and was unrespon... Read more
About 18 minutes after receiving the vaccine, the patient collapsed on the elevator and was unresponsive for a couple minutes. He reported feeling dizzy and nauseated, and he appeared pale. His blood pressure was 103/69, and his heart rate was 52. Of note, he had not eaten breakfast, nor had any water to drink on the morning of the event. He was given apple juice and some crackers, and his symptoms resolved within about 20 minutes.
14 2021-06-22 feeling cold We went to pharmacy for second COVID-10 P-fizer dose. Around 12:15 PM on 06/23/2021 my son Vaccinate... Read more
We went to pharmacy for second COVID-10 P-fizer dose. Around 12:15 PM on 06/23/2021 my son Vaccinated and with in one minute my son have start problem. he feel Dizziness. I hold my son very quickly and close his eyes. During dizziness he also complained his vision is low and with in 15-20 second he complained he can see anything with his open eyes. He can listen my word but he can not see. I check his body and it is cold. Nurse check his body temp and it is normal. After 10 minute rest he is ok . He can see everything and he feel little laziness. This is a full story. He drink water after his dizziness gone. I am still watchin him in case if anything. Thanks.
14 2021-06-22 flushing Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
14 2021-06-23 flushing Patient started with facial flushing at about 5pm which progressed to swelling of the face and right... Read more
Patient started with facial flushing at about 5pm which progressed to swelling of the face and right lower eyelid and left ear, flushing of chest, patient began scratching. NO RESP symptoms, patient was happy, laughing.
14 2021-06-23 pain in extremity Exactly one week after the 2nd shot, patient was at a track meet and suddenly had a sharp pain in hi... Read more
Exactly one week after the 2nd shot, patient was at a track meet and suddenly had a sharp pain in his chest. It hurt when he inhaled, and he didn't compete. He has never experienced this kind of chest pain before. We thought it was an allergic reaction (hayfever?) because it seemed harder to breathe, so we gave him a benadryl and later went home. He was tired and took a long nap. Later he felt better. But it was scary. I think he underreported how he felt, to not alarm us parents. He admits this now. There's not logical cause other than the vaccine ( no new foods, medications, experiences). However, he didn't have any other notable side effects from the 1st or 2nd dose, except tiredness and arm soreness the first days.
14 2021-06-23 seizure One week to the day of the second injection, Pt collapsed and had a seizure while on a scout trip. W... Read more
One week to the day of the second injection, Pt collapsed and had a seizure while on a scout trip. Was feeling fine one minute and then out the next. Taken to ER. EKG, Chest X-Rat and CT all came back fine. Was referred back to his doctor.
14 2021-06-23 speech disorder, grand mal seizure 14yo M initially presented to the ED with headache, fever, myalgia, abdominal pain, NBNB emesis, uns... Read more
14yo M initially presented to the ED with headache, fever, myalgia, abdominal pain, NBNB emesis, unsteady gait and soft/garbled speech, 6 days after returning from a recent trip to Mexico and 4 days after receiving 2nd dose of Covid-19 vaccine. In the ED patient had multiple tonic clonic seizures, total episode lasting about 5 minutes requiring ativan and keppra. Pt was admitted to PICU for management, found to have continued seizures on EEG resolved with fosphenytoin
14 2021-06-24 tremor, seizure Systemic: Seizure-Medium, Systemic: Shakiness-Medium
14 2021-06-25 flushing, cold extremities, tingling Client 5 minutes after receiving Pfizer 1 st dose vaccine client felt lightheaded. Client laid dow... Read more
Client 5 minutes after receiving Pfizer 1 st dose vaccine client felt lightheaded. Client laid down to floor supine and was awake and alert. Client face was flushed and client appeared anxious--HR 80bpm. Client's extremities cool and client reported tongue was swelling and bilateral arms were tingling. Epi pen 0.3 mg IM administered in left thigh and 911 called. Client remained alert until paramedics arrived--breathing labored and hands clenched down. Mother at side
14 2021-06-25 seizure, tremor Had seizure. Fell in shower, started shaking uncontrollably, had difficulty breathing. He had a seiz... Read more
Had seizure. Fell in shower, started shaking uncontrollably, had difficulty breathing. He had a seizure for the first time in his life 6 days after first dose (already reported). This one was his second seizure ever.
14 2021-06-25 seizure The patient received the vaccine and 4-5 minutes later he fell out of his chair, facedown. He appear... Read more
The patient received the vaccine and 4-5 minutes later he fell out of his chair, facedown. He appeared to be convulsing. He was pale, diaphoretic, and disoriented. His blood pressure was 76/36 and his pulse was 84. Radial pulse was 2+. EMT was called. His EKG appeared to have a slight elevation in his inferior leads. He and his guardian deny any significant history. Upon discharge with EMT, the patient was alert and tolerating liquids well. The patient's guardian states that he has had a similar reaction prior when he was the age of 6. She states that he also felt slightly lightheaded from the first Pfizer vaccination.
14 2021-06-26 pain in extremity, migraine patient experienced a migraine, legs became so painful he could not get out of bed. He had a fever,... Read more
patient experienced a migraine, legs became so painful he could not get out of bed. He had a fever, congestion, runny nose. He went to the hospital and was diagnosed initially with an upper respiratory virus. Another physician attributed his symptoms to the Pfizer covid vaccine.
14 2021-06-27 discomfort Patient c/o dry mouth, difficulty swallowing, chest felt heavy and fogginess. Spoke to Mother of pt... Read more
Patient c/o dry mouth, difficulty swallowing, chest felt heavy and fogginess. Spoke to Mother of pt she stated pt is fine, she gave him claritan and the symtoms resolved. I advised he shoud wait 30 minutes when recieving dose #2
14 2021-06-27 pain in extremity My son experienced severe bruising about one week later after receiving his Pfizer vaccine. My son r... Read more
My son experienced severe bruising about one week later after receiving his Pfizer vaccine. My son right arm was very sore as well. He also had little bumps, petichae all over his body. He still has the bruising and he had a sore, scab where he fell down before the vaccine and he could not stop the bleeding at the site. I took him to ER, performed a complete blood work and platelet count. On 06-22-2021, his platelet count had dropped to 15,000. The ER did not admit him and we had to go back to the ER last Thursday 06-24-2021 and his platelet count 13,000.
14 2021-06-28 flushing My son experience after the vaccine around 03:40pm, he felt dizzy, started to black out and passed o... Read more
My son experience after the vaccine around 03:40pm, he felt dizzy, started to black out and passed out. I gave him fluids and called his PCP. I made him eat since he did not eat earlier that day. He states he felt off, I gave him some Tylenol medication. He also had a headaches and started with diarrhea. The next day he stayed in bed, continued with flushed bright red cheeks, diarrhea and the headaches. The day after that he started to feel bit better, I think his symptoms lasted between 36-48 hours. His glucose level was 90.
14 2021-06-29 weakness Pfizer COVID vaccine (6/23 dose 2). That evening he developed chills. . He developed body aches, de... Read more
Pfizer COVID vaccine (6/23 dose 2). That evening he developed chills. . He developed body aches, decreased energy level, and decreased appetite. He woke up with extreme chest pain that radiated to the lower portion of his neck. He felt his heart racing and found it hard to take deep breaths secondary to pain. Brought to ED for further evaluation. He was afebrile, 99.4. Cardiologist on-call, was contacted and recommended transfer to another facility. In the hospital ED
14 2021-06-29 tremor Patient received vaccine together with his family (he was 3rd out of 4). He said the shot hurt. Afte... Read more
Patient received vaccine together with his family (he was 3rd out of 4). He said the shot hurt. After all were vaccinated, he said he felt weird. I had him sit for monitoring with his family. His parent told me he still felt weird, and that they walked around the store, but now he has a bad headache and feels a little winded. I had him sit in the immunization room with mask off for further monitoring. After a few more minutes, he said it felt like he was suffocating. I administered 1 Epi-Pen at 10:08PM in his left thigh and called an ambulance. Soon after, he was shaking/shivering, but said it was getting easier to breathe. EMT arrived shortly after, noted the hives on his back, and took him to the hospital.
14 2021-06-30 tingling, cold sweat Patient vaccinated with Pfizer at 11:03 am and started to exhibit symptoms at 11:08. Patient had col... Read more
Patient vaccinated with Pfizer at 11:03 am and started to exhibit symptoms at 11:08. Patient had cold, clammy skin and tingling in both hands. Vitals were 120/80; HR 52; R 17; SAT 100% on RA.
14 2021-07-02 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
14 2021-07-04 pain in extremity Sore arm & swollen lymph nodes in the lt arm that are tender upon palpation.
14 2021-07-05 bell's palsy, facial paralysis Received COVID #2 on 6/12 and developed cold symptoms with ear pain and loss of taste. On 6/22/2021,... Read more
Received COVID #2 on 6/12 and developed cold symptoms with ear pain and loss of taste. On 6/22/2021, developed right facial droop and was seen in the ER - diag with Bell's palsy and placed on Abx, Prednisone, and acyclovir. Lyme came back negative. Was seen in f/u 6/25 in clinic with improved but still apparent right facial droop. Abx discontinued at that point. He is doing much better now (7/6) with some residual facial droop.
14 2021-07-05 flushing Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, ... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: initial bp: 99/60 hr 65 and 10 minutes later 112/73 and hr70
14 2021-07-05 tingling PATIENT EXPERIENCED NAUSEA APX 5 MINUTES AFTER HIS VACCINATOIN. HE VOMITED. HE COMPLAINED OF COLD CH... Read more
PATIENT EXPERIENCED NAUSEA APX 5 MINUTES AFTER HIS VACCINATOIN. HE VOMITED. HE COMPLAINED OF COLD CHILLS AND A TINGLING IN HIS ARM. WE OBSERVED HIM FOR APX 30 MINUTES AND HE WENT HOME WITHOUT MEDICAL INTERVENTION.
14 2021-07-05 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: Pharmacy administered vaccine & follow... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pharmacy administered vaccine & followed normal routine, including keeping a hand on pt the whole time until finished pt slumped over & rolled to his left & rolled out of chair onto the ground, on his stomach. He didnt hit the wall or the chair. Father & I both knelt to ground to roll him to his side and he immediately came to & sat up against wall. Dad said he had not had anything to eat any time recently, unconcerned & proceded to move to the next child, who was too scared to do it.
14 2021-07-06 feeling hot Patient received dose 1 of Pfizer Covid vaccine on 7/7/21 at 1115AM. After two or three minutes, pat... Read more
Patient received dose 1 of Pfizer Covid vaccine on 7/7/21 at 1115AM. After two or three minutes, patient lost consciousness and fell off the chair in the waiting area and recovered a few seconds later. Patient felt very hot and vision became blurry. No airway restriction observed. 911 was called and paramedics transported patient (completely awake and coherent) to local hospital for further evaluation
14 2021-07-07 tremor Fever of 102 F, body tremors, fatigue, muscle ache, trouble walking, (stiffness)
14 2021-07-08 facial paralysis, bell's palsy Thursday morning the patient woke up with the left side of his face droopy, eye closed. The patients... Read more
Thursday morning the patient woke up with the left side of his face droopy, eye closed. The patients mother took him to the ER and the patient was diagnosed with Bells Palsy. The patient was prescribed from the hospital valacyclovir 1gram and prednisone taper. The patient did not have any reactions to the first dose in the vaccine series.
14 2021-07-08 numbness, bell's palsy, weakness Emergency Medicine Bell's palsy, swelling Reason for Visit Reason for Visit Swelling Pt states... Read more
Emergency Medicine Bell's palsy, swelling Reason for Visit Reason for Visit Swelling Pt states having 2nd pfizer shot last 7/7 and facial swelling on left side with left eye watering started 7/8 AM. Pt states lips feel swollen as well. Progress Notes Emergency Medicine A 14 year old male.with a chief complaint of Swelling (Pt states having 2nd pfizer shot last 7/7 and facial swelling on left side with left eye watering started last 7/8. Pt states lips feel swollen as well. ) History of Present Illness: This is a 14-year-old male who presents with his mother complaining of weakness and numbness of the left side of his face since yesterday morning. He states that he has difficulty closing his left eye as well as sipping from a cup or through a straw. Mother states that he had his second Covid vaccine the day prior to the onset of his symptoms. Patient states that his symptoms have improved slightly since yesterday. He denies any associated headache or extremity weakness, numbness, paralysis, paresthesias, fever, chills or other complaints.
14 2021-07-08 pain in extremity Pfizer vaccine was administered on 6/30/21. On 7/1/21 mother reported that the patient was feeling f... Read more
Pfizer vaccine was administered on 6/30/21. On 7/1/21 mother reported that the patient was feeling fine, just a sore arm. On 7/9/21 mother reported that the patient is experiencing malaise and a sore arm.
14 2021-07-08 pain in extremity Approximately 1 month (on 7/5/2021)following 2nd COVID-19 vaccination, patient developed acute focal... Read more
Approximately 1 month (on 7/5/2021)following 2nd COVID-19 vaccination, patient developed acute focal myositis of left arm--swelling occurred in left forearm (proximal) but patient reported "soreness" along L/arm and forearm. Patient had significant elevation of creatine kinase enzyme. Edema and soreness have resolved and creatinine kinase is closer to normal by 7/9/2021.
14 2021-07-13 muscle spasms, involuntary muscle movements My son was given the Pfizer Vaccine on 6-24-2021 and a few days later his back being having involunt... Read more
My son was given the Pfizer Vaccine on 6-24-2021 and a few days later his back being having involuntary movements (spams) and than he told me a day or so later his left arm where he had the shot started to have involuntary movements as well. On Sunday July 11th I noticed his arm jumping and I asked him why is he jerking his arm he said it?s doing it on it?s own. I scheduled an appointment for him to be seen by his doctor. He was seen on July 13th, they saw him and gave us these forms to fill out and asked us a series of questions. He was scheduled to take the second dose of the Pfizer Vaccine on July 15th but I will not take him until I?m sure this is not a side effect of the Vaccine. Any information would be very helpful.
14 2021-07-13 seizure Patient received the vaccination at approximately 7pm 07/08/2021. He had a prolonged blood glucose f... Read more
Patient received the vaccination at approximately 7pm 07/08/2021. He had a prolonged blood glucose from 6am-9:18am and consumed 75 grams of Carbohydrates and had a bg reading of 64 and steady on his continuous glucose monitor. Patient lost consciousness and had a seizure at approximately 9:20 am 07/09/2021. The seizure lasted approximately 3 minutes. Glugagon was administered due to the thought that it was Diabetic hypoglycemic. He was taken to medical facility and released. He was taken to another medical facility on Sunday July 11 to be evaluated for neurological issues. He is continuing to have symptoms of fatigue and overall lethargy, body aches and runny nose and his ability to focus is impaired.
14 2021-07-14 numbness, tingling Felt faint, hand numbness/tingling, turned pale in color, nausea 15 minutes after receiving 1st dose... Read more
Felt faint, hand numbness/tingling, turned pale in color, nausea 15 minutes after receiving 1st dose of Pfizer COVID vaccine. Patient put head between legs and a cold compress on neck. Took blood pressure 20 minutes, 30 minutes, and 35 minutes after vaccination. Blood pressure range 93-102/62-68. Pulse range 76-104.
14 2021-07-15 pain in extremity After about 15 hours, my son was experiencing injection site pain, was feeling tired, had a mild hea... Read more
After about 15 hours, my son was experiencing injection site pain, was feeling tired, had a mild headache, muscle pain (mostly in his legs), some mild chills, some joint pain, arm pain, feeling "unwell", and was running a fever of approximately 100 degrees. After 24 hours of rest, drinking water and Gatorade, and three doses of over the counter Acetaminophen (one full adult dose followed by two half-doses) he awoke the next morning feeling much better. He continues to do well as I am writing this, which is now 50 hours since the injection.
14 2021-07-15 pain in extremity Left arm pain, vomiting, Sickle Cell Crisis. Was admitted 7/10 thru 7/12 to hospital for pain manage... Read more
Left arm pain, vomiting, Sickle Cell Crisis. Was admitted 7/10 thru 7/12 to hospital for pain management and IV fluids and bloodwork.
14 2021-07-16 cold sweat Pt began complaining of dizziness after receiving Pfizer vaccine, while sitting in recovery area. P... Read more
Pt began complaining of dizziness after receiving Pfizer vaccine, while sitting in recovery area. Pt was pale and clammy to touch. Pt's father stated that Pt did not eat anything today prior to coming in for vaccination. Pt was evaluated by staff, and given a bottle of water and a granola bar. Pt ate and drank what was provided, stated he felt better, and left clinic in care of his parents without further incident.
14 2021-07-19 bell's palsy, facial paralysis My son woke up on thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine ... Read more
My son woke up on thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bells palsy; My son woke up on thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bells palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 14-year-old male patient received second dose of BNT162b2 (CONMINTARY, Solution for injection, Lot No: EW0196), via an unspecified route of administration, administered in Arm Left on 30Jun2021 17:45 (at the age of 14-year-old), as 2nd dose single for COVID-19 immunization (Administered at Pharmacy or Drug Store). The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2(CONMINTARY, Solution for injection, Lot No: EW0191), via Left arm on 23May2021, 01:00 PM (at the age of 14-year-old), for 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. No other medical history was reported. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The reporter stated that their son woke up on Thursday 01Jul2021 the day after he received the 2nd dose of the covid 19 vaccine with partial facial paralysis and was diagnosed with bell's palsy. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of facial paralysis and bell's palsy. Treatment received included prednisolone. No seriousness criteria was reported. Outcome of the events was not recovered at the time of reporting. Device Date was 09Jul2021. No follow-up attempts needed. No further information expected.
14 2021-07-19 pain in extremity, cold extremities, tingling Patient was vaccinated with his first dose of Covid Pfizer vaccine and approximately 10-11 minutes l... Read more
Patient was vaccinated with his first dose of Covid Pfizer vaccine and approximately 10-11 minutes later his mother stated that he no longer felt like sitting. He went to stand by her and 3-4 minutes later patient had a syncopal episode, fell back, and hit his head on a wall. The patient had recovered consciousness by the time staff reached him. Our staff came to his aid and had him sit up, assessed for any signs of bleeding, which there were not, and checked vitals (results below). Patient had no complaints of headache, no dizziness, was alert and oriented (was able to repeat name, DOB, address, and where he was), no nausea, no neck or back pain, just mentioned that he was standing then everything went dark. He mentioned that his left arm was tingling and sore but nothing he would be alarmed about. At the time, we suggested we monitor him an additional 15 minutes and for him to inform us if he felt any additional side effects. At approximately 3:55pm, patient mentioned that his hands felt cold, but otherwise he had feeling and no numbness. Patient mom was concerned and agreed to call emergency services. Ambulance arrived and took patient to hospital at approximately 4:09pm.
14 2021-07-19 unresponsive to stimuli after vaccine was administered, patient was told to wait in the store for 15 minutes. Within 2 minu... Read more
after vaccine was administered, patient was told to wait in the store for 15 minutes. Within 2 minutes, patient told their mom, he felt "woozy". Patient dropped to his knees. Pharmacist was alerted by immunizing technician. Pharmacist went to the lobby to assist. Patient was alert but stated he did not feel good. Pharmacist helped patient to a chair. within another minute, patient stiffened and would not answer to his name. 911 was called. ambulance arrived within 5 minutes. Patient was alert, but pale, said felt sweaty, and dizzy. paramedics took blood pressure and place the patient on the gurney. blood pressure was normal. paramedics stated they would run a few tests in the ambulance, and mom agreed to going to hospital after. patient left the store with paramedics.
14 2021-07-22 unresponsive to stimuli Pt received vaccine at 1600 today, pt returned home with mother without incident. At approx 2330 la... Read more
Pt received vaccine at 1600 today, pt returned home with mother without incident. At approx 2330 later that night pt mother removed bandage from vaccination site, pt then reported to mother that "he had blurred vision and so I had him sit down. Once he was sitting down he got really pale and his eyes closed. He stopped responding for a few seconds and then he came to."
14 2021-07-23 muscle twitching Syncopal episode with twitching for about 30 seconds. HR 50, BP 182/49, 100% O2 Sat
14 2021-07-23 pain in extremity Chest pain, tiredness, arm pain, difficulty lifting arm,
14 2021-07-23 tenderness a few hours after getting vaccine pt developed swelling and tenderness along L lateral scapula and e... Read more
a few hours after getting vaccine pt developed swelling and tenderness along L lateral scapula and extended under L arm. Along latissimus dorsi. I saw patient on 7/19/21 and pt was still complaining of mild swelling and tenderness. No redness or induration. No signs of infection.
14 2021-07-25 face paralysis Presented with bilateral facial weakness on 7/11. Prescribed 3 day course of steroids (7/14-7/16) wi... Read more
Presented with bilateral facial weakness on 7/11. Prescribed 3 day course of steroids (7/14-7/16) without improvement. Presented again on 7/18 with worsening facial weakness in addition to bilateral upper and lower extremity weakness and difficulty walking. Admitted to hospital on 7/19. On the second day of his hospitalization he was no longer ambulatory. Diagnosed with likely AIDP based on CSF studies (albuminocytologic dissociation, negative infectious work-up). Treated with 3-day course of IVIG (7/21-7/23), after which he showed significant improvement in his upper/lower extremity and facial strength and ambulation. He is being discharged with ongoing outpatient physical therapy.
14 2021-07-25 tremor Adverse Event: Guest had complaints of shakiness, Nausea, "Out of body experience". Treatment: Gues... Read more
Adverse Event: Guest had complaints of shakiness, Nausea, "Out of body experience". Treatment: Guest assisted to the floor, then transferred to medical area, provided two apple juices - reported he had not eaten and he experienced the above adverse event after he saw blood from his injection site. Outcomes: Guests reports feeling better after after 15 minutes and above interventions. Left facility with his mother via POV.
14 2021-07-26 pain in extremity First dosage: sore arm Second dosage: Headaches, chills, body aches, nauseated, sore arm, and dizz... Read more
First dosage: sore arm Second dosage: Headaches, chills, body aches, nauseated, sore arm, and dizziness,
14 2021-07-27 pain in extremity 24 hours after the shot he had nausea, stomach pain, headache and a sore left arm. He felt completel... Read more
24 hours after the shot he had nausea, stomach pain, headache and a sore left arm. He felt completely fine by the next day, about 48 hours after the shot.
15 2021-03-28 seizure About 10-12 hours after receiving the vaccine, patient had a significant increase in seizures - had ... Read more
About 10-12 hours after receiving the vaccine, patient had a significant increase in seizures - had seizure clusters (never had them previously). Patient had to be admitted to the hospital. Received rescue anti-seizure medication en-route via EMS, then additional Levetiracetam Bolus after arriving to the ER and subsequently additional dose of IV lacosamide following admission. seizures returned to baseline frequency about 3 days later.
15 2021-04-13 pain in extremity No adverse reaction to dose 2. Nurse administering contacted Dr. prior to administering the vaccine ... Read more
No adverse reaction to dose 2. Nurse administering contacted Dr. prior to administering the vaccine due to vaccine is not authorized for 15 year olds. Nurse found dose 1 was administered in error on 3/20/2021 lot EN6205. Mom reported that "someone approved it the first time." Doctor approved dose 2 after confirming dose 1 was recorded as given in the immunization registry. Doctor told nurse to give the vaccine and report a VAERS due to child is only 15. Mom reports child had a slight headache after dose 1 and a metallic taste in his mouth. She reported on 4-13 that following dose 2 he had a sore arm and so far no other symptoms.
15 2021-04-22 unresponsive to stimuli, depressed level of consciousness Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting-Mild, Additional Details: Patient had fading consciousness 5 minutes after vaccine administration. When patient became unresponsive to questions and care, Epipen was administered. Patient recovered quickly, ambulance was called. Patient went with ambulance.
15 2021-05-12 cold extremities, cold sweat Patient was anxious and scared "worked up" prior to vaccine per mom. The patient received Pfizer vac... Read more
Patient was anxious and scared "worked up" prior to vaccine per mom. The patient received Pfizer vaccine at 3pm and at the vaccine table he was verbalizing he was scared,nervous and his hands were cold and clammy, he felt dizzy. He sat at the vaccinator table and we gave him water and crackers, VS 2:57 BP 129/70, HR 78, O2sat 1005. VS 2:58pm 129/80, HR 78, O2sat 98%. VS 3:01pm BP 125/69, HR 70, O2sat 100%.Patient taken to observation area,stated feeling better, walked without feeling dizzy and continued monitoring VS 3:03pm. BP 123/64, HR 68, O2sat 100%. 3:06pm eating cookie VS BP 122/69, HR 64, O2sat 100%. 3:12pm VS BP122/64, HR 60 and sat 100%. Patient stating feeling better, not lightheaded or dizzy. VS 3:16pm BP 124/62, HR 58 and O2sat 100%. Patient left at 3:20 with mom "feeling good".
15 2021-05-13 tremor PATIENT RECEIVED PFIZER COVID VACCINE AND WENT TO WAITING AREA. PATIENT COMPLAINED THAT HE FELT FAIN... Read more
PATIENT RECEIVED PFIZER COVID VACCINE AND WENT TO WAITING AREA. PATIENT COMPLAINED THAT HE FELT FAINT. PATIENT DIAPHORETIC AND SHAKING. CLOSED EYES. APPEARED TO LOSE CONSCIOUSNESS FOR ABOU A MINUTE. GAVE PATIENT COLD WATER. PATIENT REVIVED QUICKLY. MOVED HIM FROM CHAIR TO WAITING AREA TO LAY FLAT. HE WANTED TO RISE TO HIS FEET WITHIN MINUTES. PATIENT'S MOTHER IS PHYSICIAN AND WAS ON PHONE WITH FATHER ACCOMPANYING HIM.
15 2021-05-14 weakness Patient brought to medical tent after collapsing after he got vaccinated. Nursing reports he has bee... Read more
Patient brought to medical tent after collapsing after he got vaccinated. Nursing reports he has been unconscious for 2 minutes after standing up and was caught by nurse. Pt was sweaty which got better when supine. Pt felt weak, headache, dizziness and pale. no difficulty swallowing. attempted to sit up and dizziness worsened. Pt's symptoms did not improve so EMS initiated.
15 2021-05-14 depressed level of consciousness, cold sweat, cold extremities pt became cool, clammy and in and out but alert and orientated to person, place and time. Pt started... Read more
pt became cool, clammy and in and out but alert and orientated to person, place and time. Pt started getting sweaty, pt paramedic arrived almost immediately after blood pressure and temp checked
15 2021-05-14 feeling hot Patient felt dizzy, hot, nauseous and subsequently fainted approximately five to ten minutes after v... Read more
Patient felt dizzy, hot, nauseous and subsequently fainted approximately five to ten minutes after vaccine administration. He regained consciousness within a few seconds. They had him lay on the floor with feet elevated. Dizziness and lightheadedness resolved. He remained under observation for 30 more minutes.
15 2021-05-14 numbness, tremor Administered Pfizer COVID vaccine #1 to 15 year old patient. During his 15 minute wait time, patien... Read more
Administered Pfizer COVID vaccine #1 to 15 year old patient. During his 15 minute wait time, patient's eyes began to flutter and he slumped over. Pharmacist responded and lowered patient to floor and elevated legs. He regained consciousness and was able to repeat his name and his location. First BP was 108/68. Pt was able to sit in chair and drank an orange juice, but began to shake and tremble and stated his extremities were numb. Repeat BP was 80/48 and EMS was called. Upon EMS arrival, his pulse and BP had returned to normal. EMS evaluated and advised that he was ok to return home.
15 2021-05-14 pain in extremity First day after sore arm
15 2021-05-14 tingling, throat numbness About 15-20 minutes after receiving the vaccination patient complained of numbness in throat and sli... Read more
About 15-20 minutes after receiving the vaccination patient complained of numbness in throat and slight swelling. Said he had no difficulty breathing. I gave patient 50mg of diphenhydramine and observed patient for an additional 15 minutes, at the end of this time patient said numbness had resolved and the swelling was gone. I counseled both mom and patient to call 911 if patient were to experience difficulty breathing later in the day or if throat swelling/numbness returned. About 6 hours after vaccination patient complained tingling in legs and feet but no throat numbness or swelling, advised patient to go to urgent care. of Also advised patient to follow up with pcp.
15 2021-05-14 cold extremities Pt had just received vaccine, was walking to waiting area and experienced a syncopal episode, head s... Read more
Pt had just received vaccine, was walking to waiting area and experienced a syncopal episode, head stuck floor. Pt appeared to posture, skin was cool, pale, and diaphoretic. C collar applied by ems, PT TF to stretcher from floor and TF to EMS room. Vitals obtained, BP 150/90, HR 76, RR 20, SpO2 98% RA, pupils PEARL. Pt complaint of head pain and nausea. Pt's father advised that Pt needs to be TP to hospital by Rescue and father agreed. PT care TF to Rescue crew.
15 2021-05-14 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Additional Details: while patient was waiting out in the w... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: while patient was waiting out in the waiting area for their 15 minute monitoring session the patient passed out and fell to the floor. The patient did not injure himself with falling to the floor and woke up immediately after he passed out. We immediately put ice packs on him and had him drink a bottle of water while sitting on the floor and made him stay in the waiting area until his color came back in his face and felt fine to go home. He was extremely nervous about getting the vaccine.
15 2021-05-15 flushing, unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
15 2021-05-15 pain in extremity AFTER RETURNING TO WAITING AREA, PATIENT BEGAN TO FAINT. IMMEDIATELY REGAINED CONSCIOUSNESS AND STA... Read more
AFTER RETURNING TO WAITING AREA, PATIENT BEGAN TO FAINT. IMMEDIATELY REGAINED CONSCIOUSNESS AND STAYED IN AREA. PATIENT WAS VERY PALE AND HAD BRIEF NAUSEA. BOTH HAD SUBSIDED WITHIN ABOUT 5 MINUTS. PATIENT CONTINUED TO STAY IN THE AREA FOR 20-25 ADDITIONAL MINUTES AND SINCE HAS ONLY A SORE ARM. PATIENT WAS VERY NERVOUS AND ARM WAS VERY TENSE UPON ADMINISTRATION.
15 2021-05-15 pain in extremity Rash on arms and feet. Swelling and pain in feet. Taking Benadryl. Ongoing for the last 24 hours.
15 2021-05-15 seizure Syncope and alleged seizure as reported by mother and bystanders (Pharmacist did not witness event)
15 2021-05-16 seizure, unresponsive to stimuli Vaccine given to patient and had a reaction to the vaccine. Patient appeared to have a vaso-vagal re... Read more
Vaccine given to patient and had a reaction to the vaccine. Patient appeared to have a vaso-vagal reaction color drained from his face and broke out in a sweat and then became unresponsive, then woke up. Moved to stretcher and vital signs monitored, heart rate to 40,appeared to have a seizure and post ictal. Mom present, instructed to call pediatrician and ask about second dose administration. Patient given OJ and banana, monitored for over an hour, color and VS improved, discharged with Mom.
15 2021-05-17 weakness Client received the 1st COVID vaccine of Pfizer (Lot#EW0185 expiration 05/22/21) At 4:28PM client re... Read more
Client received the 1st COVID vaccine of Pfizer (Lot#EW0185 expiration 05/22/21) At 4:28PM client reported dizziness, lightheaded, headache, no blurred vision, no chest pain, no shortness of breath. Client has been waiting for 20 minutes in the observation area. at 4:33PM RN responded to event. Vital signs are blood pressure 100/62, hear rate 73, oxygen saturation 99%. Client reports slight headache towards the frontal lobe. Per client and client's father, there is a history of asthma and no known allergies. At 4:38PM EMT obtain vital signs that are blood pressure 110/60, heart rate 74, oxygen saturation 99%. Client reported feeling weak, no dizziness, and no lightheaded. Provided supplemental nutrition and fluids to client. Client accepted. RN educated client and father about ED precautions and common adverse effects of COVID vaccine. At 4:47PM vital signs are blood pressure 100/60, heart rate 82, oxygen saturation 99%. Client reports not feeling symptoms. All symptoms had resolved. Client has steady gate and is waiting for other siblings to complete observation time.
15 2021-05-17 feeling hot, seizure Pt was given vaccine and began telling his brother he felt lightheaded. Pt's brother began to inform... Read more
Pt was given vaccine and began telling his brother he felt lightheaded. Pt's brother began to inform his mother. Pt then slumped in chair and began to fall to the floor. Mother tried to brace pt's fall. Pt still hit the floor and lightly hit his head. LPN's stated pt had a 5 second episode of convulsions that appeared to be a seizure. Pt did lose LOC for about 15 seconds and came to. Pt did not realize what had happened. Pt was placed on a cot. Pt stated he felt warm and lightheaded. Pt's VS were taken at 1640 - BP 136/70, HR 61, RR 18, 99% O2. EMS were called and in route. Pt began feeling better. Another set of VS were taken at 1645 - BP 127/76, HR 80, RR 16, 99% O2. Pt had ice packs placed on his neck and forehead. Pt sat up on cot after another 5 minutes and another set of VS were taken at 1650 - BP 123/82, HR 89, RR 16, 99% O2. Pt stated he was feeling better but still had a minor headache. EMS arrived and advised pt to be checked out. Mother agreed to take her son to the hospital herself not via EMS. Refusal form was signed by mother from EMS. Pt, mother, and brother left to go get checked out.
15 2021-05-17 flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium
15 2021-05-17 tingling Patient received vaccine at 5:30pm and started to feel dizzy. Patient was given water, juice and sna... Read more
Patient received vaccine at 5:30pm and started to feel dizzy. Patient was given water, juice and snack. Patient after 5 minutes felt tingling in the arms and lips. EMS was called to take patient to the hospital.
15 2021-05-17 seizure Systemic: Seizure-Mild, Additional Details: AFTER 5 MINUTES OF ADMINISTARTION VACCINE PATIENT BEGIN ... Read more
Systemic: Seizure-Mild, Additional Details: AFTER 5 MINUTES OF ADMINISTARTION VACCINE PATIENT BEGIN A SEIZURE OF LESS 1 MINUTE MOTHER DESCRIBED TONIC SEIZURE PATIENT NOT HAD PAST HISTORY OF SEIZURE
15 2021-05-17 unresponsive to stimuli Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lig... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: sweating profusely, EMS called and came to pharmacy, checked on pt and all clear for him to leave, parents had no problem and said they didnt need anything before they leave
15 2021-05-18 flushing, tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient became very pale after receiving the vaccine as well
15 2021-05-18 muscle spasms, tremor, tingling, numbness, flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilat... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient started experiencing numbness, tingling, and hand cramps minutes after receiving his pfizer vaccine. We sat him down in the chair and had him relax. I called EMS shortly after and they arrived quickly. They worked him up and concluded that he was having a panic attack related to being give the vaccine. Patient states that he wasnt anxious about it previous to administration nor did he seem anxious as well. He was calmed down by the EMS personnel and then was able to walk out of the store
15 2021-05-18 seizure patient felt dizzy right after the shot and had a seizure about 2 minutes later
15 2021-05-19 pain in extremity Sunday afternoon(5/16) got Pzifer COVID vaccine Dad says on Monday am early they woke him for school... Read more
Sunday afternoon(5/16) got Pzifer COVID vaccine Dad says on Monday am early they woke him for school and he was asking where was he and why they were waking him up- kinda like in a dream like state and confused looking; they told him to just get up- he was able to get out of bed but seemed out of it -this lasted a few hours- he went back to sleep and when he woke back up he was not confused anymore but very tired; he also had some nausea and vomited; No fever; no cough; no body aches; L arm is a little sore- not as much today; each day a little better has had a little headache- but not much of one; Last night had better appetite so ate a lot of food then vomited again; has not really have an appetite before last night ; this am able to eat and kept food down today; Sleeping more but was restless sleep until last night as well Back in school for the past month; No school work this week- tried some math this am but trouble focusing so just stopped doing work
15 2021-05-19 tingling, cold sweat Client felt clammy, almost faint. Tingle in legs and felt nauseous. Evaluated by EMS. BP 100/60 P 72... Read more
Client felt clammy, almost faint. Tingle in legs and felt nauseous. Evaluated by EMS. BP 100/60 P 72 Felt better and went home with mom.
15 2021-05-19 seizure After receiving vaccine, we were told to sit and wait 10 minutes before leaving. About 7 minutes in... Read more
After receiving vaccine, we were told to sit and wait 10 minutes before leaving. About 7 minutes into waiting, my son said he was thirsty and not feeling that good. we started to walk to get a water and he totally blacked out and exhibited mild like seizure activity. After he "came too", he complained of blurry vision and still didn't feel good as we waited for ambulance. Once ambulance came he was feeling a little better. Vitals all checked out good and were declined going to hospital. He doesn't remember anything that happened in Pharmacy, except that he thought he was going to die.
15 2021-05-19 unresponsive to stimuli Dad present for vaccine, after a few minutes post vaccine, pt ws unresponsive and had a syncopal rea... Read more
Dad present for vaccine, after a few minutes post vaccine, pt ws unresponsive and had a syncopal reaction, sterna rub, unresponsive to name, pale, diaphoretic., weak pulse of 40, legs raised 0947 81/43-41-12- then 107/56-77-18 responded to voice comands, oriented times 3 and transfered to cot and observation area. Parent instructed to call pediatrician and have him seen for a work up. Parent advised to have him laydown for immunization when he returns. 1015 home to the care of parent.
15 2021-05-19 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: possibly seizure related. patient fainted and hit head on wall upon fall. came to and went in and out a couple times. stable until EMS arrival
15 2021-05-20 slurring, unresponsive to stimuli Patient and Patient Mother denied that patient had any history of fainting or dizziness with needle ... Read more
Patient and Patient Mother denied that patient had any history of fainting or dizziness with needle puncture. Patient was administered First dose of Pfizer vaccine 11:23am. Patient was seated in observation area with mother and sibling at 11:24am. At 11:25 am patient began to verbalize that vision was disturbed and mother notified staff who informed me. When I approached patient the patients eyes were closed and patient was unconscious and unresponsive. I administered a sternal rub and patient opened eyes and tried to speak but sounded slurred. Patient was unconscious for less than ten seconds. At 11:27am patient was able to answer all LOC questions appropriately and community health worker was instructed to get Wheel chair. Patient was able to help with transfer and patient was placed in wheel chair with minimal effort. At 11:28 Patient was taken to room 8 with recliner chair. Patient was placed in recliner with minimal assistance with legs raised and patient was given water which patient sipped. Pt was encouraged to rest and patient closed eyes and laid head back. At 11:32 am Vital signs machine was unable to be used due to power outage so E-cart had to be opened to remove stethoscope and BP cuff. At 11:34 am Vitals signs were taken: BP-92/57 HR: 65 RR: 16 and patient denied any lightheadedness, dizziness, or fainting feeling. Pt requested to have mask off during observation. Patient and patient mother were instructed that a thirty minute wait time would be recommended and both verbalized understanding. MD was not notified since patient was talking appropriately and vision disturbance was resolving. Mother agreed that because patient condition was improving, that there was no need to involve MD. Patient continued to sip water and rest. Patient continued to close eyes periodically but began to keep eyes opened longer. At 11:46 am patient stated ?I feel a little tired, but I feel better.? Vital signs were taken: BP- 96/59 HR:65 RR:16 and patient denied any symptoms. At 11:53 a Patient stated felt well enough to leave. Patient was instructed to stand up and stay standing for a few seconds to ensure patient did not become dizzy. Patient was able to walk around the room with no gait or stability issues. Patient and patient mother were instructed to relay this occurrence to RN for second Dose of Pfizer COVID-19 Vaccine to ensure that staff can take the proper safety precautions. Patient and patient mother verbalized understanding. Patient left with mother and sibling awake and oriented x4 with no issues.
15 2021-05-20 feeling hot About 3 min after giving vaccine, pt was seen potentially having a seizure. Unconscious for about 5... Read more
About 3 min after giving vaccine, pt was seen potentially having a seizure. Unconscious for about 5 seconds. Came to. Hot, sweating, dizzy. Dizziness continued for approximately 45 minutes.
15 2021-05-20 cold extremities Patient experienced as 15- 20 second syncopy spell when he sat up frpm a sitting position after rece... Read more
Patient experienced as 15- 20 second syncopy spell when he sat up frpm a sitting position after receiving the covid vaccine initial vitals 102/60 pulse 40 after regaining conciousness BP was 111/60 pulse at 60 patient prior to fainting appeared diapharatic, pale and cool to the touch there were no signs of llegeric reaction including flushing of the face lack of hives or angiodema no wheezibg, no strider or labored breathing patient complained of dizzness upopn standind equal to 30 mins.. EMS was notrified when arrived patient was up and alert without dicculties EMS recommended patient be released to his gaurdian BP at release 112/57 pulse 62 father advised to call physician if any concerns arise or go to nearest hospital in an emergent situation
15 2021-05-20 tremor 2 minutes after administration, the patient was speaking to his father, dozed off to one side and ha... Read more
2 minutes after administration, the patient was speaking to his father, dozed off to one side and had tremors. Patient immediately was able to open eyes and was shaking. Pharmacist advised patient to take deep breaths and relax until paramedics arrived. Patient had a few sips of water while waiting. Patient was fine after 15 minutes.
15 2021-05-21 cold sweat dizziness, lightheaded, black out, cold/clammy skin, profuse sweating, ringing in the ears 911 was ... Read more
dizziness, lightheaded, black out, cold/clammy skin, profuse sweating, ringing in the ears 911 was called and responded to by both fire and medical paramedics vitals were taken and patient was observed for an additional 20 minutes before leaving when he had returned to a stable condition
15 2021-05-22 slurring slurred speech, difficulty putting thoughts into words, difficulty completing a whole sentence when... Read more
slurred speech, difficulty putting thoughts into words, difficulty completing a whole sentence when talking occurred almost immediately after receiving the vaccine (within 15 minutes or so) lasted for about 8 hours
15 2021-05-22 involuntary muscle movements Patient fainted 5 minutes after the vaccination. He regained his conscious but complained severe hea... Read more
Patient fainted 5 minutes after the vaccination. He regained his conscious but complained severe headache. Patient also had some jerky motion after fainting. Paramedics was called. Patient's vital signs were normal. He was taken to facility for further follow-up.
15 2021-05-22 seizure Systemic: Dizziness / Lightheadness-Severe, Systemic: Seizure-Mild, Additional Details: patient sudd... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Seizure-Mild, Additional Details: patient suddenly fell down, had a slight seizure last around 5 sec and regains concious. He feels fine but pharmacy still called 911 and was escort to receive emergery/urgent services.
15 2021-05-23 inability to speak Became sweaty and pale after injection. Stated felt like he couldn't hear correctly. BP 84/58, HR ... Read more
Became sweaty and pale after injection. Stated felt like he couldn't hear correctly. BP 84/58, HR 61-70, PulseOX 98%. Given 2 bottles of water, feet propped up, and he pinked up and able to converse appropriately with staff. Advised to stay for 30 minutes to monitor.
15 2021-05-23 involuntary muscle movements, unresponsive to stimuli At approximately 6 PM on 05/23/2021, family was sitting down for dinner when all of a sudden she not... Read more
At approximately 6 PM on 05/23/2021, family was sitting down for dinner when all of a sudden she noticed that he was turning his head to the left and appeared to be falling out of his chair. Mom states that eyes were darting back and forth at this time. He was not responding to her shouting his name and his left arm was curled in towards his body with the rest of his body remaining stiff. This lasted approximately 1 minute, followed by a time of confusion and drowsiness. Approximately 1 minute later mom states that patient's eyes rolled back to his head and he had full body movement consistent with tonic-clonic seizures. Family were able to lay him onto the ground during this time. Mom denies any color change, apnea, or loss of bowel or bladder. States he did have one episode of emesis following the event, and 2 episodes of emesis in the ambulance on the way to ED. Patient has no previous history of seizures or seizure-like activity. No new ingestions. Has not been sick recently and denies any new sick contacts. There has been no head trauma. Per Mom, patient's dad has a history of "partial seizures" but never required any medication for them. At arrival to the ED he continued to be drowsy and not at his normal baseline. Continue to hold his left wrist up toward his body in a contracted manner and tended to have repetitive speech. Briefly, ER course significant for a CT head and evaluation by pediatric neurology. CT head was unremarkable for acute intracranial process. A CBC, CMP, and coags were also obtained due to patient's continued contracture positioning and the possibility of a stroke. CMP was unremarkable with a sodium of 139, potassium of 3.7, chloride of 107, bicarb 25, BUN of 12 and creatinine of 0.64. CBC was also unremarkable with WBC of 10.72, hemoglobin of 14.8, hematocrit of 44.4 and platelets of 370. There was 81.77% neutrophils after evaluation by neurology it was felt that the patient remained postictal and recommended that he be admitted on continuous EEG and possible MRI in the a.m.
15 2021-05-23 seizure Approximately 1 minute after receiving vaccine, patient experienced what appeared to be a generalize... Read more
Approximately 1 minute after receiving vaccine, patient experienced what appeared to be a generalized tonic-clonic seizure, lasting 4-4.5 minutes. The patient regained consciousness and was awake, alert and oriented x3. Patient and father refused transport by EMS to ED for evaluation. The patient's father reported prior history of seizures after needlestick.
15 2021-05-24 cold sweat Patient exhibited signs and symptoms of syncope. Felt dizzy, clammy skin, nauseous. Had him lie down... Read more
Patient exhibited signs and symptoms of syncope. Felt dizzy, clammy skin, nauseous. Had him lie down for 15 minutes with legs elevated and used an ice pack on the neck to help improve blood flow. Patient recovered.
15 2021-05-24 pain in extremity, migraine The next day experienced migraine and arm soreness for approximately 24 hours. Today, 5/25/21 pati... Read more
The next day experienced migraine and arm soreness for approximately 24 hours. Today, 5/25/21 patient woke at 4am to dizziness that has continued throughout the morning, 8am. Patient is alert and virtual learning.
15 2021-05-25 feeling hot, cold sweat Patient developed a short lived near syncope spell x 30 mins after receiving Pfizer vaccine while ge... Read more
Patient developed a short lived near syncope spell x 30 mins after receiving Pfizer vaccine while getting up from exam bed no injury to report he reported feeling warm and appeared pale and clampy and diaphoretic vitals: B/P 126/90 pulse 77 oxy 99%. He showed no symptoms of allergic reaction no rash no angioedema, lungs were clear with obstruction reporting no tingling or swelling of the tongue he was observed for 30 mins walking around normally before being transitioned back to his guardian he did not lose conscience discharge vitals B/P 123/85 sat 100% pulse 82.
15 2021-05-25 flushing Syncope, Vomiting, flushing/sweating. BP 122/47, HR 51, RR 16 -- > 125/71, 54, 16. Pt fell to the ... Read more
Syncope, Vomiting, flushing/sweating. BP 122/47, HR 51, RR 16 -- > 125/71, 54, 16. Pt fell to the floor but recovered after resting. Pt stable and released from the vaccination site.
15 2021-05-25 pain in extremity Arm pain, headache and fatigue lasting less than 24 hours
15 2021-05-26 feeling cold Temporary blindness (lasted about 30 secs to a min), pale skin, sweating, feeling cold, dizziness. G... Read more
Temporary blindness (lasted about 30 secs to a min), pale skin, sweating, feeling cold, dizziness. Gave water, apple juice and Gatorade to patient and called 911. EMT came in to take he's BP, blood glucose level and both were normal. Stayed at pharmacy for about 45 minutes and patient got better but was still feeling cold. They've decided not to go to hospital but followed up with dad around at 6:30 - 7 pm ish, and confirmed he is doing okay.
15 2021-05-26 muscle spasms muscle spasms and weakness to the arm in which the injection was administered, shortness of breath a... Read more
muscle spasms and weakness to the arm in which the injection was administered, shortness of breath and chest discomfort
15 2021-05-27 feeling hot, weakness Weak and tired. He felt like he was numb. Like he couldn't really move. He slept - didn't have any f... Read more
Weak and tired. He felt like he was numb. Like he couldn't really move. He slept - didn't have any fever. Was really hot though. He had a really bad headache and his dad gave him Tylenol. He felt still tired the next day but felt better. The headache was gone. Doctor exam - physical and labs
15 2021-05-27 unresponsive to stimuli, feeling hot, flushing Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic:... Read more
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PATIENT RECIEVED VACCINE AT 2P. Sat in waiting area for about 10 minutes. Our observer noticed that the patient was sliding in his seat and looked dizzy. Patient starting to flutter his eyes and lost consciousness for about 5 secs. He complained about blurry vision, feeling hot, sweating, but with chills. Patient was given water. After he drank the bottle of water patient felt fine. The ambulance was called and arrived, patient reported he felt fine. Patient did not eat/nor drink water today.
15 2021-05-28 weakness 15-year-old patient received their first dose of the COVID-19 vaccination. Was in Post Vac 20 mins a... Read more
15-year-old patient received their first dose of the COVID-19 vaccination. Was in Post Vac 20 mins and then he stated he was feeling "weird". Nurse brought patient over to stretcher to lie down. Patient denied any symptoms of allergic reaction. No signs of allergic reaction noted. Took vitals and they were all within normal limits and a neuro check that was within normal limits as well. Patient was given juice and water. Captain notified of patient condition. He stated he was feeling better within 15 mins of lying down. Nurse raised the head of the stretcher and he began to feel "weak and shaky." Nurse lowered the head of the stretcher and continued to monitor him. Vital signs and neuro check all remained within normal limits. He felt better again lying flat, but when the head of the stretcher was lifted again, he began to feel "weak and shaky". Nurse alerted the captain and mom wanted to be taken to the hospital. 911 was called for transport to facility. Mom and sister drove to the hospital and patient was taken to facility ER via ambulance in no acute distress.
15 2021-05-28 discomfort On 5/23 two days after vaccine he was irritable, tired, fatigued, not sleeping well. He could not c... Read more
On 5/23 two days after vaccine he was irritable, tired, fatigued, not sleeping well. He could not complete his track meet . He had abdominal pain, felt bloated, and he felt this nausea & discomfort. He thought he might be constipated, so he took MiraLAX and then he had diarrhea all day yesterday. on 5/26 he had a temperature of 99.2, he had acute chest pain retrosternal and feeling of compression on the chest, head fullness as if he is going to explode. He had nausea, insomnia. Ibuprofen was given to him by his mother and this helped a lot But he woke up on morning of 5/27 , but the chest pain returned with increased pressure, very nauseous, agitated, unable to be comfortable. No fever,, the pain was a sharp pressure. He had no syncope or chest shortness of breath He was seen at Hospital ER where a chest x-ray was normal. Echocardiogram was done, ,noted to have EKG changes. Troponin was elevated. He had a cardiac catheterization done emergently at hospital through the right radial artery and was noted to have normal coronaries. He also had a chest x-ray done which was negative for pulmonary lesions, and his abdominal pain he says was relieved after the MiraLAX and the diarrhea. His twin sister who received the vaccine 15 minutes after him is completely asymptomatic.
15 2021-05-28 flushing Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
15 2021-05-29 weakness My son is very lightheaded and dizzy. Can?t get out of bed for 3 days. Nauseas and feels week. This ... Read more
My son is very lightheaded and dizzy. Can?t get out of bed for 3 days. Nauseas and feels week. This comes in waves. Went to ER 2x and they can?t find anything causing it
15 2021-05-29 weakness DOSES GIVEN TOO EARLY TOGETHER PER RECOMMENDATION DATES 1ST DOSE MAY 18,2021 2ND DOSE MAY29,2021 SO... Read more
DOSES GIVEN TOO EARLY TOGETHER PER RECOMMENDATION DATES 1ST DOSE MAY 18,2021 2ND DOSE MAY29,2021 SON MESSENGER ME MOTHER THIS MORNING MAY30,2021 WHILE BIO AT CHURCH SYMPTOMS :'I'M SICK ,RLLY SICK, BARELY SLEPT LAST NIGHT BECAUSE WHOLE BODY HURT. " "DIZZINESS WEAKNESS CAN'T STAND STRAIGHT LACK OF PERCEPTION ACHES AND SORENESS HEADACHE" PER MESSENGER FACEBOOK TO ME MOM 30,2021 9;48 AM CONVERSATION REQUESTED MEDICAL CARE AMBULANCE FOR HIM TO CALL HE SAYS JUST RESTING BIO AT CHURCH 'PLEASE GET TO DR CAN THEY TAKE YOU" mom me "they are at church"
15 2021-05-29 cold sweat Immediately following vaccine, client reported visual disturbance, couldn't see, pale, clammy, dilat... Read more
Immediately following vaccine, client reported visual disturbance, couldn't see, pale, clammy, dilated pupils. Resolved after one minute.
15 2021-05-29 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild
15 2021-05-31 concussion My son was evaluated by ER after experiencing 2 fainting episodes within an hour. ER report stated ... Read more
My son was evaluated by ER after experiencing 2 fainting episodes within an hour. ER report stated reason for visit as Loss of Consciousness with diagnoses of Syncope (Vasovagal) and Concussion.
15 2021-05-31 discomfort, weakness Three days after receiving the firts dose, my 15 years old soon started to felling bad, with fever (... Read more
Three days after receiving the firts dose, my 15 years old soon started to felling bad, with fever (between 99 to 102 f grades, muscle pain, headache, general discomfort and not energy at all. Syntomps lats for almost 3 days, My main concern is why the symphtoms showed up three days after the vaccination day, and not before.
15 2021-05-31 unresponsive to stimuli 1022am- Observed patient abruptly stand up and fall to floor, landing face down. Turned patient ove... Read more
1022am- Observed patient abruptly stand up and fall to floor, landing face down. Turned patient over on back with neck support. Patients legs elevated. Patient was unresponsive to voice, performed mild sternal rub and became responsive immediately after stimulation. Pulse strong and regular, respirations WNL - VS BP 126/82, Sp02 99% RA, P122, Temp 98.2 Infrared, AAO to person, place and time. Observed ~1" laceration above right eye, treated with bandage and bleeding controlled. EMS and parent called to scene. EMS arrival at 1033, I gave patient report and they assumed care and assessed patient. VS @1038- BP 120/68, SpO2 99% RA, P101, R17 AAOx4, Patient c/o headache. EMS sat patient up on floor, then to chair. EMS had discussion with parent and it was agreed that parent would take patient to Urgent Care for treatment and parent signed off for no EMS transport. Patient walked out with parent and EMS on own power to vehicle and left approximately 11:00 AM.
15 2021-06-01 weakness Weakness/ Lethargic Seen by EMS on site PR 52 SPO2 100% BP 88/35 BP at 10:20am 101/57
15 2021-06-01 electric shock sensation, numbness, tingling Tips of my fingers will suddenly feel like I'm touching a low-voltage battery receiving an electric ... Read more
Tips of my fingers will suddenly feel like I'm touching a low-voltage battery receiving an electric shock; then turns into numbness in my hands and arms, and sometimes face; Sometimes continued numbness accompanied by light sensations of electrical shock; my heart-rate often goes up before the ''electrical'' feeling onset.; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 04Apr2001 15:45 (Batch/Lot Number: ER8737) as 1st dose, single, dose 2 via an unspecified route of administration, administered in right arm on 04Apr2021 (Batch/Lot Number: EW0171) as 2nd dose, single for covid-19 immunisation. Medical history were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were none. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient stated "The tips of my fingers will suddenly feel like I'm touching a low-voltage battery receiving an electric shock, which then turns to pins and needles, which then turns into numbness in my hands and arms, and sometimes face. Sometimes continued numbness accompanied by light sensations of electrical shock. This lasts from 20mins-4+ hours, and happens at least once almost every day since receiving 1st dose (3 weeks past 2nd dose now) I have noticed recently that my heart-rate often goes up before the ''electrical'' feeling onset." Adverse event start date was on 05Apr2021, 06:00 AM. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Treatment received as blood test, physical examination, blood pressure. Outcome was not recovered. No follow up attempts are needed. No further information expected.
15 2021-06-01 feeling hot Within 30 seconds of administration, patient felt dizzy and lightheaded. He never lost consciousness... Read more
Within 30 seconds of administration, patient felt dizzy and lightheaded. He never lost consciousness, but he did stumble and almost faint. Mother caught him - she says he has a history of dizziness after vaccines and is nervous about needles. He was very hot and sweaty, and he did vomit once. He was given water and an ice pack. Epinephrine was on-hand, but not needed. After resting for 15-20 minutes, he felt better and mother took him home.
15 2021-06-01 grand mal seizure Unprovoked first-time seizure. Teen was sitting outside a restaurant waiting while watching phone, l... Read more
Unprovoked first-time seizure. Teen was sitting outside a restaurant waiting while watching phone, listening to music 15 days after first Pfizer COVID vaccine (no issues at time of vaccination). Parents witnessed his neck and eyes roll up and left before having a two short generalized tonic-clonic seizures. Taken to nearest ED by paramedics.
15 2021-06-02 pain in extremity, tingling, numbness it looked like the blood vessels or veins in the bend of elbow, inside of the elbow that looked like... Read more
it looked like the blood vessels or veins in the bend of elbow, inside of the elbow that looked like possibly a blood vessels that burst there.; feels sick; his body didn't feel right and he felt that way again yesterday when he felt so bad.; numbness and tingling right arm; tingling/numbness and tingling right arm; rash on the right arm; he has pain and a rash on his right arm; feeling like passing out; dizziness/lightheadedness; nausea; chest tightness/ chest was so tight and pulling.; pain in the arm at the injection site; headache; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 11:15 (Batch/Lot Number: EW0173; Expiration Date: Aug2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 15 years). Medical history included asthma, allergy, acne, pain, Gastroparesis, eczema, red blotches /bright red dots on his whole body and anaphylaxis. Concomitant medications included cetirizine (CETIRIZINE) taken for allergy; beclometasone dipropionate (QVAR) taken for asthma; mometasone furoate (MOMETASONE FUROATE) taken for allergy; isotretinoin (ZENATANE) taken for acne; paracetamol (TYLENOL) taken for pain; sodium chloride (AYR SALINE, both nasal spray and nasal gel) taken for allergy; herbal extract nos, homeopathics nos (SIMILASAN) taken for allergy, all are ongoing. The patient previously took advil [ibuprofen] and experienced anaphylactic reaction (when he was about 4 years old in about 2009 or 2010.). The reporter who is mother of patient calling regarding the Pfizer Covid 19 vaccine. States she wanted to call and report some side effects from the vaccine for her son. Reports he received the first dose of the Pfizer Covid 19 vaccine 14May2021 at 11 15 AM in the upper left arm. He stayed extra minutes after the shot because he had anaphylaxis before and had red blotches before in the past. Reports after receiving the first dose of the Pfizer Covid 19 vaccine, when they got to the car he said his chest was so tight and pulling. That lasted 1 to 2 minutes only on that day (on 14May2021, 12:00). Since then and even on the very first day he has had dizziness; lightheadedness; and felt like passing out (on 14May2021, 12:00). Adds he has been having to go to the nurse's office for headaches for the last two days (occurred on 14May2021). The reporter states her son has been very disappointed and mad at her for making him have the vaccine. Nausea - she adds her son also had some nausea (on 14May2021, 12:00). Right arm - he has pain and a rash on his right arm, the opposite arm from the shot, with numbness and tingling right arm (occurred on 17May2021); tingling. When he went to the nurse someone in that office mentioned that it looked like the blood vessels or veins in the bend of elbow, inside of the elbow that looked like possibly a blood vessels that burst there on an unspecified date. Pain in the arm at the injection site (occurred on 14May2021, 12:00) from the first day that is improved. The patient's body didn't feel right - when they started walking to the car his body didn't feel right and he felt that way again yesterday when he felt so bad. The first day and yesterday he felt his body didn't feel right (occurred on 17May2021, 11:45). Dizziness - is mostly when standing up and is lasting a lesser amount of time and getting better. Feels the sensation of like passing out with the dizziness on standing. Headaches - he has every day but yesterday was terribly bad and today were the worst. The reporter mentions that the patient stated the he feels sick on an unspecified date. Outcome of the events loss of consciousness, dizziness and vaccination site pain was recovering. Outcome of the event chest tightness was recovered on 14May2021 while outcome of the events numbness and tingling right arm was recovered on 18May2021. Outcome of the events pain in arm, vascular injury and malaise was unknown. Outcome of the remaining events was not recovered.
15 2021-06-02 pain in extremity had a light fever and sore arm after vaccine, started complaining of chest pain the night after vacc... Read more
had a light fever and sore arm after vaccine, started complaining of chest pain the night after vaccine , a few days later started complaining about not being able to breath and face was swollen, mom rushed to hospital and they said his oxygen level was low and he was having a asthma attack which he hasn't had since he was a baby. hospital had to give him 8 treatments of albuterol. my son is still not completely back to his normal self
15 2021-06-03 flushing, unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted once, then almost again. Called 911 to have evaluated before leaving. Was feeling ok upon departure
15 2021-06-03 seizure patient had dose 2 of the Pfizer vaccine. he had a seizure, after the seizure he immediately woke up... Read more
patient had dose 2 of the Pfizer vaccine. he had a seizure, after the seizure he immediately woke up. after 5 minutes he had a second seizure and he remained unconscious until EMS took him to the ER.
15 2021-06-03 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted, but was still awake and... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted, but was still awake and responsive, just lightheaded. Patient left on own accord after interaction with paramedics
15 2021-06-05 flushing, flushing Systemic: Flushed / Sweating-Mild, Additional Details: EMT came to assess and escorted patient out o... Read more
Systemic: Flushed / Sweating-Mild, Additional Details: EMT came to assess and escorted patient out of the pharmacy. Patient was standing up and said he was feeling fine by the time EMT came.
15 2021-06-05 seizure, seizure Systemic: Seizure-Mild
15 2021-06-05 tremor having tremulousness 1 week after 1st shot . It worsened after the 2nd shot.
15 2021-06-06 weakness Patient describes feeling dizzy, having visual trouble immediately receiving the vaccine, then slid ... Read more
Patient describes feeling dizzy, having visual trouble immediately receiving the vaccine, then slid onto the floor from the chair he was sitting on. Presents with mother who denies him hitting his head. LOC lasted 1-2 minutes before he was able to be roused. Upon regaining consciousness, he was pale, diaphoretic, weak. Reports feeling nervous with "needles". Observed for 30 minutes with mother. Escorted to car afterward and permitted to go home. Advised to seek medical attention if symptoms persist.
15 2021-06-06 seizure, unresponsive to stimuli Chest pain, headache, shortness of breath. Now with convulsive movements and periods of unresponsive... Read more
Chest pain, headache, shortness of breath. Now with convulsive movements and periods of unresponsiveness. Work up for seizures and encephalopathy in progress. Dx studies: troponin, BNP, EKG, chest CT, head CT (all negative), CRP (elevated). Currently in Pediatric ICU and work up in progress (6/7)
15 2021-06-06 tremor, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shak... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Additional Details: PATIENT FAINTED ROUGHLY 30 SECONDS AFTER RECEIVING COVID VACCINATION
15 2021-06-06 unresponsive to stimuli, feeling hot Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Vomi... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Mild, Additional Details: Patient briefly fainted post Covid vaccination, then vommited, stated that his head felt hot. Spoke to mother later in the evening. Patient felt much better.
15 2021-06-07 slurring COVID test result positive; Slurred speech, difficulty putting thoughts to words in complete sentenc... Read more
COVID test result positive; Slurred speech, difficulty putting thoughts to words in complete sentences; Slurred speech, difficulty putting thoughts to words in complete sentences; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 14May2021 08:00 (Batch/Lot Number: EW0177.CCC-MN, as reported) (at the age of 15 years old) as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included ibuprofen. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered at Clinic. The patient experienced slurred speech, difficulty putting thoughts to words in complete sentences on 14May2021 08:30 and COVID test result positive on 18May2021. There was no treatment for the events. No COVID prior vaccination. The patient underwent lab tests and procedures which included PCR Saliva (COVID-19 test): positive on 18May2021. The outcome of the events was recovered on unspecified date.
15 2021-06-07 feeling hot Pt had walked to the lobby from the vaccination room and was sitting in a chair with his mask on. F... Read more
Pt had walked to the lobby from the vaccination room and was sitting in a chair with his mask on. Five minutes after his injection with the COVID-19 vaccine he felt hot, nauseated, vomited a small amount of yellow emesis twice and became pale. He continued to sit up in the chair and a cool cloth was placed on the back on his neck and a fan was turned on. He was alert throughout. His BP was checked 4 minutes after the event and read 92/60 with a pulse of 74. He denied feeling lightheaded. He sat in the lobby with father by side and health department nurses monitoring him for 30 minutes. After the 30 minutes pt gets up out of chair without difficulty and ambulates around the lobby with steady gait and denies lightheadedness, nausea/vomiting or shortness of breath. Leaves accompanied by father. Encouraged to push fluid, stay out of the heat today and to take it easy the rest of the day. Checked on pt by phone through the father and he related that pt was feeling much better, denies symptoms.
15 2021-06-07 numbness 6/6-fever (102 temporal) and headache, these resolved, followed later by chest pain, went to medical... Read more
6/6-fever (102 temporal) and headache, these resolved, followed later by chest pain, went to medical center and evaluated, negative troponins. 6/7-chest pain began again, returned to medical center, found to have elevated troponin of 3.19. 6/8 at 1am-Transferred to another medical center PICU where he had sensation of numbness in left arm, a squeezing sensation of left arm, and severe chest pain. EKG showing ST elevation and troponin of 3.75. Given dose of 30mg Toradol and pain resolved. Started on Motrin q6h, trending troponins. In the morning pain much improved, but still with pain on deep inspiration relieved with leaning forward. Repeat EKG shows diffuse ST elevation, consistent with presumptive diagnosis of myopericarditis. Repeat troponin at 9am of 9.3, BNP of 197. Echo done wnl. Scheduled for cardiac MRI with contrast per cardiology recommendation to r/o myocardial edema. Viral panel sent to r/o viral etiology despite no prior symptoms.
15 2021-06-07 muscle spasms arms and legs are cramping feels nauseous, Tylenol 4:30am
15 2021-06-07 pain in extremity Extremely swollen lymph nodes in the arm pit of the injected arm. Red, hot and swollen. Sore and p... Read more
Extremely swollen lymph nodes in the arm pit of the injected arm. Red, hot and swollen. Sore and painful. Last almost 5 days.
15 2021-06-07 pain in extremity My 15-year-old son received dose #2 of Pfizer?s Covid-19 vaccine at 10:30am on 6/6/21. At 1:00am on ... Read more
My 15-year-old son received dose #2 of Pfizer?s Covid-19 vaccine at 10:30am on 6/6/21. At 1:00am on 6/8/21 he was struggling to breathe due to pain in the center of his chest upon inhalation. Nothing like this has ever happened to him before. His chest pain was worse lying down and he could not lie down or sleep and wanted to stay standing on his feet. He felt pain in both forearms too. He was crying from the pain and the difficulty of breathing, and was very tired but unable to recline in order to sleep. I called the advice nurse, who checked with the doctor on call at his pediatrician?s office, and she told us to go to the ER due to concern it may be myocarditis or pericarditis.
15 2021-06-07 seizure, tremor IMMEDIATELY AFTER PATIENT RECEIVED HIS VACCINE, HE FELT NAUSEOUS. PATIENT SAT DOWN AND SOON AFTER SI... Read more
IMMEDIATELY AFTER PATIENT RECEIVED HIS VACCINE, HE FELT NAUSEOUS. PATIENT SAT DOWN AND SOON AFTER SITTING, STARTED SEIZING (HIS FATHER REPORTS ARMS CONTRACTING AND SHAKING). PATIENT DOES NOT REMEMBER THE EVENT. UPON REGAINING CONSCIOUSNESS, THE PATIENT SAID HIS FACE FELT FUNNY BUT THERE WAS NO THROAT SWELLING OR SIGNS OF ALLERGIC REACTION. PATIENT LAID DOWN WITH HIS FEET UP FOR ABOUT 15 MINUTES AND REPORTED FEELING MUCH BETTER. NO OTHER SIGNIFICANT EVENTS OCCURRED DURING THE OBSERVATION PERIOD. PATIENT DENIES A HISTORY OF PREVIOUS ALLERGIC REACTIONS OR REACTIONS TO VACCINES.
15 2021-06-07 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium
15 2021-06-08 bell's palsy mild left sided bell's palsy- referred to Neurology for evaluation and possible treatment
15 2021-06-08 tremor, numbness Left hand went numb after receiving the vaccine. It has been numb now since 11:30 and it's now 1:25.... Read more
Left hand went numb after receiving the vaccine. It has been numb now since 11:30 and it's now 1:25. Gave him a Tylenol and put ice pack on it. And is constantly shaking it because of the numbness
15 2021-06-08 unresponsive to stimuli Pt was a little nervous before receiving the vaccine, but did fine. He was sitting with his brother ... Read more
Pt was a little nervous before receiving the vaccine, but did fine. He was sitting with his brother for the 15 minute wait period when his brother called for help. I told my staff to call 911. Pt had his head back and his legs outstretched in front of him. He was unresponsive at first and pale. Then he sat upright and said he thought he had just hallucinated. He was distraught and did not understand what had just happened to him. I asked the brother if an adult was with them. He called for his mom and she suggested we lay patient down on the floor. She sat with him until EMS arrived. A paramedic took his blood pressure and EKG. He drank some soda and was able to sit up, his color returned, and he was able to stand.
15 2021-06-09 bell's palsy 6/3/21: started having left eye watering with the inability to close the eyelid 6/6/21: received 2nd... Read more
6/3/21: started having left eye watering with the inability to close the eyelid 6/6/21: received 2nd covid vaccine 6/8/21: Developed inability to close his mouth and to smile which has persisted 6/10/21: Seen in clinic and diagnosed with left Bells Palsy and prescribed prednisone
15 2021-06-09 feeling hot On June 10, 2021 around 1:20am, child woke me up and stated that he has a headache. After feeling h... Read more
On June 10, 2021 around 1:20am, child woke me up and stated that he has a headache. After feeling his head, he felt very warm with a temperature of 102.3 using both a digital and under the tongue thermometers. I had child to take a Tylenol pill with something to drink. At approximately 4:45am took the child's temperature again and it was 99.6 degrees and I had the child to take another Tylenol pill at that time, so that the temperature wouldn't spike up. Around 9:30am, after allowing him to sleep, he woke up and stated that he felt better. Then, I was able to go to work.
15 2021-06-09 feeling hot Around 4 pm the day after receiving a COVID vaccine patient started getting tired, fatigue, headache... Read more
Around 4 pm the day after receiving a COVID vaccine patient started getting tired, fatigue, headache, and feeling hot. At 7:00 pm on Sunday with bottom lip swelling. Monday eyelid swelling. No itching. Benadryl 25 mg given in office.
15 2021-06-09 pain in extremity Headache, fever, vomiting arm soreness and fatigue
15 2021-06-09 pain in extremity Patient had headache, body aches, left arm pain, chills, fever (101 degrees) and fatigue for 2 days.... Read more
Patient had headache, body aches, left arm pain, chills, fever (101 degrees) and fatigue for 2 days. Onset of symptoms were about 8 hours after the dose. He took Tylenol and symptoms improved.
15 2021-06-09 seizure PT passed out unconscious for several seconds. poss. seizure.
15 2021-06-10 weakness PT had his first dose of Pfizer vaccine at 5pm on 21st. He looked low energy at night. We felt his f... Read more
PT had his first dose of Pfizer vaccine at 5pm on 21st. He looked low energy at night. We felt his forehead and he was warmer than usual. However, thermometer did not show he had a fever. He looked much better in the morning on 22nd. We thought that was it. Only after a week did PT tell us he had more reaction. However, because he was well then, we did not pay too much attention. When we learned of the link between Covid 19 vaccine and Myocarditis, we asked him in detail again. Here are his responses. He started feeling his throat hurt when he had dinner that around 7pm. It lasted only that night. He started feeling chest pain around dinner time too. It only hurt when he moved. That chest pain lasted longer and disappeared on the 23rd. He started feeling there were air bubbles under his skin on the flat part of his left shoulder (above the injection site and below his neck) on the 22nd. He did not see them. He just felt them. When he pressed them with fingers, he felt them popping. This feeling lasted for a total of three days. He could feel the amount of air bubbles become less over the three days. We have not seen any side effect in the news like his. We are not sure that he should get his second dose. Please someone could advise us, please send us an email. Much appreciated.
15 2021-06-10 migraine On the day after, I had chills, migraine, and other aches and pains the entire day. Next day I felt ... Read more
On the day after, I had chills, migraine, and other aches and pains the entire day. Next day I felt largely better. Today is a week after my shot and my headaches are getting worse progressively, It is a distinct type of headache I've never felt before getting the vaccine.
15 2021-06-10 speech disorder mild pain in tongue and throat/severe sore throat; mild pain in tongue and throat; Felt pain when sw... Read more
mild pain in tongue and throat/severe sore throat; mild pain in tongue and throat; Felt pain when swallowing; He could not talk normally cannot move tongue very much; He could not talk normally cannot move tongue very much; This is a spontaneous report received from Medical Information Team. A contactable physician (parent) reported that a 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22May2021 15:00 (Lot Number: EW0178, at the age of 15-year-old) as single dose for covid-19 immunisation. Medical history included seasonal allergies. Concomitant medications included loratadine (CLARITIN) taken for seasonal allergies; fluticasone propionate (FLONASE) taken for seasonal allergies. A pediatric gastroenterologist reported for his son. His son had the first dose of the Pfizer COVID-19 vaccine on 22May2021. On the next day on 23May2021, he experienced mild pain in the tongue and throat. He had no fever. The pain in the throat and tongue started on Sunday (23May2021), but it was mild and he was not concerned. His son had it on Monday (24May2021) and when he came home from school around 15:00 or 15:30, he was complaining of severe sore throat. His throat was hurting more. Severe from that time. He stayed home from school. Treated with Tylenol and Motrin. Didn't really work/helping. Pushing fluids. Felt pain when swallowing. He was not eating due to severity of the pain. Had severe pain when he tried to speak. He could not open his mouth well. Tried to keep his mouth closed. He could not talk normally cannot move tongue very much. They went to urgent care and had a strep test which came out negative on 25May2021. Reporter seriousness for pain in throat and tongue was disabling. The gastroenterologist wanted to know if his son's adverse reaction was an allergic reaction and if he should get the second dose of the vaccine. There was no prior vaccinations within 4 weeks. The outcome of the events was not recovered.
15 2021-06-11 weakness Developed fever, chills, nausea by about 9pm that night (6/12/21). Administered alternating tylenol... Read more
Developed fever, chills, nausea by about 9pm that night (6/12/21). Administered alternating tylenol/advil. Symptoms lasted approx 36 hours. Too weak and fevered to attend school the day following 2nd vax (6/13/21). Still fevered on the morning of the 14th, but given last dose of Tylenol and was then fine for school.
15 2021-06-11 cold sweat Patient became dizzy and clammy but did not lose consciousness. He began throwing up. No sign of ana... Read more
Patient became dizzy and clammy but did not lose consciousness. He began throwing up. No sign of anaphylaxis. Remained pale, dizzy, for about 5-10 minutes. EMT called to scene but was doing a lot better by the time they arrived. Treated patient with cold compress face/neck. Dad stated he has anxiety and that this same thing happened previously after having blood drawn. He was able to walk out on his own with his father approximately 30 minutes later.
15 2021-06-11 unresponsive to stimuli, feeling hot Client received the COVID vaccine (Pfizer dose 1, lot # ER8736, expiration date 7/5/2021) at 1725 fr... Read more
Client received the COVID vaccine (Pfizer dose 1, lot # ER8736, expiration date 7/5/2021) at 1725 from RN. RN escorted the client to a chair in observation area at 1730. Per RN, the client's gait became unsteady as he ambulated and the client became unresponsive as he sat in his chair. The client was observed to slump forward, and he was caught by RN and his mother. EMT and RN responded at that time. The client remained unresponsive for approximately 90 seconds. While he was unresponsive, the client's breathing was rapid and shallow, and his pulse was thready. At 1732, the client became responsive and was drowsy but oriented x4. The client was transferred to the zero gravity chair at this time by RN and RPh. The client's vital signs at that time were: blood pressure 76/40, heart rate 64, respiratory rate 24, and O2 91%. The client appeared pale and diaphoretic. The client reported dizziness and blurry vision which had both progressed to "blacked out vision" before he went unresponsive. The client reported still feeling dizzy and having blurry vision. The client denied shortness of breath, chest pain, or headache. At 1737, the client's vital signs were as follows: blood pressure 102/52, heart rate 61, O2 98%. The client's pupils were equal and reactive to light. At 1738, the client was offered water, juice, and a snack, which he started to eat and drink. Per the client's mother, the client hadn't eaten prior to his appointment but was given water and a snack while in line for his vaccine. The client's mother stated that the client has no medical conditions or allergies and that he takes no medications. The client's mother stated he does not have a history of syncope. At 1740, the client's vital signs were as follows: blood pressure 96/48, heart rate 82. The client complained of feeling hot and he was provided with a cool pack. The client's color had returned to normal at this time and his pulse was normal as well. At 1745, the client's vital signs were as follows: blood pressure 96/48, O2 99%, heart rate 65. At 1750, the client stated that his dizziness and blurry vision had resolved. He was no longer diaphoretic. At 1755, the client's pulse was 74, his blood pressure was 102/52, and his O2 was 99%. Education was provided to the client and his mother by RN regarding primary care follow up and EMS activation. At 1800, the client's vital signs were as follows: heart rate 68, O2 98%, and blood pressure 106/58. The client was able to stand up without dizziness and ambulated out to the car escorted by his mother and EMT, ambulating with a steady gait.
15 2021-06-12 feeling hot, seizure PATIENT BECAME FAINT, AND HOT AFTER RECEIVING VACCINE. PATIENT THEN WENT UNCONCIOUS, HIT HEAD ON FLO... Read more
PATIENT BECAME FAINT, AND HOT AFTER RECEIVING VACCINE. PATIENT THEN WENT UNCONCIOUS, HIT HEAD ON FLOOR AND IS BELIEVED TO SEIZED FOR APPROXIMATELY 20 SECONDS. PATIEN THEN BECAME CONSCIOS, STATED HE WAS STILL FAINT AND LIGHT HEADED AND WAS SEATED UNTIL EMT ARRIVED. EMT CHECKED PATIENTS VITALS, RECOMMEND PATIENT BE SEEN AT NEARBY HOSPITAL TO EXAMINE PATIENT. PATIENT THEN WALKED OUT OF STORE WITH EMT PERSONELL AND GOT IN AMBULANCE
15 2021-06-13 weakness Client experienced loss of consciousness for approximately 20 seconds. Reported feeling weakness, li... Read more
Client experienced loss of consciousness for approximately 20 seconds. Reported feeling weakness, light-headed. Client had loss of color to face, increased pulse followed by reduced pulse, that normalized on its own. After approximately 25-30 minutes client was feeling better, pulse normalized, color returned to face and he reported improvement in his symptoms.
15 2021-06-13 pain in extremity Mom reports that nurse/vaccine administrator injected son/patient at a higher than usual site on the... Read more
Mom reports that nurse/vaccine administrator injected son/patient at a higher than usual site on the shoulder and the needle did not go in all the way, in fact of the needle was outside his skin. The skin around the needle puncture "bubbled" up and it caused him pain (more than the 1st dose when he received it). No leakage of vaccine fluid was observed. He had some soreness in the arm. The next day he did develop some nausea, body aches, and slight fever. He is feeling a bit better today (6/14) and only has some nausea remaining. Mom will take him to PCP to evaluate his Left shoulder since it is still achy.
15 2021-06-14 feeling hot, cold sweat, unresponsive to stimuli Patient was administered 2nd dose of Pfizer Vaccine at 3:30 PM. At exactly 3:37 PM, patient was seat... Read more
Patient was administered 2nd dose of Pfizer Vaccine at 3:30 PM. At exactly 3:37 PM, patient was seated in waiting area and was exhibiting symptoms, specifically circumoralcyanosis, turning blue around the mouth. Patient was also perspiring all over the body, (arms, face, etc) Patient was also warm and clammy. Patient was disoriented and unable to respond typically. 911 was called. Patient was given a sprite and could not hold the sprite independently. Directly after, blood pressure Pulse and oxygen levels were checked and were below normal. (Blood pressure - 54/47) (Pulse - 87 BPM). Patient then became more responsive and was able to say name and specified location upon asking. Within 5 minutes of 911 call, ambulance arrived and emergency response took over care. Patient was then transported to local hospital.
15 2021-06-14 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: syncope
15 2021-06-15 seizure Per incident report: Pt stated not feeling well and Dad asked for water. At 5:41pm pt began to seize... Read more
Per incident report: Pt stated not feeling well and Dad asked for water. At 5:41pm pt began to seize in chair, 2 staff members assisted pt to ground. Seizure lasted approximately 1 minute, pt was oriented x3 after seizure. EMS was called, transported to hospital for evaluation. Staff member called next day to check on pt, pt's mom stated he saw physician and was doing well.
15 2021-06-15 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: patient has history of passing out because he gets nervous according to mom
15 2021-06-16 inability to speak, feeling cold Two minutes following vaccination, patient reports feeling light headed. Eyes began to roll back in ... Read more
Two minutes following vaccination, patient reports feeling light headed. Eyes began to roll back in head and arms became rigid and moved in a twisting motion. Patient non-verbal and slight coughing X4. Patient lowered to the supine position while supporting his head Pt had his eyes closed. Color became pale. This occurred for approximately 1 minute. Following this episode , patient opens eyes and begins to talk normally. Alert and oriented. Patient reports feeling very cold and begins to shiver. Nurse provides blankets to comfort. Nurse keeps client in observation for 30 minutes following this syncopal episode. Client drinks two small glasses of water. Denies being nauseous or hungry. Reports has not eaten today, but declines food. Patient has father and siblings with him to drive and care for him. Upon departure, patient reports feeling back to normal. Patient and family instructed to seek medical care if there are any changes.
15 2021-06-16 numbness throat swelling; numbness in knees and feet; numbness in knees and feet; This is a spontaneous repor... Read more
throat swelling; numbness in knees and feet; numbness in knees and feet; This is a spontaneous report from a contactable consumer (patient mother). A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 15-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 15May2021 11:38 (Batch/Lot Number: EW0173) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Vaccination Facility Type: Pharmacy. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Additional Information for Other Conditions: consumer stated that patient had probably mostly grown out of it. Patient was diagnosed whenever he was three years old. The patient's concomitant medications were not reported. The patient received first dose of vaccine and experienced throat swelling (his throat closed up a little bit), numbness in knees and feet about 12 minutes after vaccine on 15May2021 11:50 with outcome of recovered in 15May2021. Therapeutic measures were taken as a result of throat swelling, it recovered completely after patient took Benadryl. No investigation assessment. The events did not require a visit to: Emergency Room or Physician Office. They gave patient Benadryl there, and told reporter if patient has anymore issues to take him to the emergency room. No prior Vaccinations within 4 weeks. the consumer wanted to see if patient should get the second dose of the covid vaccine, was also going to check with patient's doctor.
15 2021-06-16 unresponsive to stimuli PATIENT PASSED OUT, AND WOULD NOT COME TO WHEN NAME WAS CALLED OR WHEN HE WAS SHAKEN. CALLED 911, A... Read more
PATIENT PASSED OUT, AND WOULD NOT COME TO WHEN NAME WAS CALLED OR WHEN HE WAS SHAKEN. CALLED 911, ADMINISTERED EPIPEN, AND PREPARED TO PERFORM CPR (DID NOT NEED TO AS THE PATIENT CAME TO WITH THE EPIPEN)
15 2021-06-17 tremor vomited like 30 times; super fatigue; pale; achy; shaky; fever of 101 °F; This is a spontaneous rep... Read more
vomited like 30 times; super fatigue; pale; achy; shaky; fever of 101 °F; This is a spontaneous report from a contactable consumer (patient mother) reported for her son. A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unspecified, Pfizer NTEC), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunization (at the age of 15-years-old). Medical history included peanut allergy (he has a peanut allergy). The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. On an unspecified date in 2021, the patient received the second dose and at 5 o clock the next morning he vomited like 30 times, had a super fatigue, pale, achy, shaky fever of 101 degree Fahrenheit. He slept but was still feeling feverish. The clinical outcome for the events was unknown. Information on Lot/Batch number has been requested.
15 2021-06-18 pain in extremity Her 15 year old son experienced a really bad headache and soreness in his arm; Her 15 year old son e... Read more
Her 15 year old son experienced a really bad headache and soreness in his arm; Her 15 year old son experienced a really bad headache and soreness in his arm; This is a spontaneous report from a contactable consumer (patient mother). A 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ENO179, Expiration Date: Unknown), via an unspecified route of administration, administered in Arm Left on 07Jun2021 (Monday) (at the age of 15-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Jun2021 (on Tuesday), patient experianced a really bad headache and soreness in his left arm and that lasted a short period. Reporter stated her son didn't really have a problem and fine already. Patient received Advil on 08Jun2021 for arm was sore. Reporter inquired the chances of the same side effects with the second Pfizer Covid 19 Vaccine. The outcome of events was recovered on Jun2021. Additional information has been requested.
15 2021-06-18 tremor, weakness Patient had a near syncopal event approximately 5 minutes after getting the vaccine. He became shaky... Read more
Patient had a near syncopal event approximately 5 minutes after getting the vaccine. He became shaky, weak, diaphoretic and felt like passing out. He was placed on the exam table and approximately 5 minutes later, he was feeling much better and was able to walk out of the clinic feeling like normal.
15 2021-06-19 pain in extremity Sore arm day of, continuing into day two. Woke at 9am day 2 feeling very achy and tired but with an ... Read more
Sore arm day of, continuing into day two. Woke at 9am day 2 feeling very achy and tired but with an upset stomach and shortly after vomited. He has a fever of around 101 and still has all other symptoms but stomach ache & nausea has subsided.
15 2021-06-20 pain in extremity The next day after the injection, my son woke up he had blurry vision in his left eye along with the... Read more
The next day after the injection, my son woke up he had blurry vision in his left eye along with the usual sore arm and tiredness. It went away after five days.
15 2021-06-21 weakness Patient is a 15 y.o. male presenting for 5 days of symptoms following his second dose of Pfizer SARS... Read more
Patient is a 15 y.o. male presenting for 5 days of symptoms following his second dose of Pfizer SARS CoV 2 vaccine culminating in an urticarial rash which prompted him to present to emergency department. Patient received the second dose of the Pfizer vaccine on June 8 (first dose was administered on may 17 without symptoms). The next day (June 9) he complained of nausea and subjective fever. On June 10 he complained of chest "weakness" and shortness of breath intermittently. He had also mild light headedness but no syncope or palpitations. All those symptoms resolved by June 11. However, he had a diffuse rash on extremities, pruritic, and non-exudative.
15 2021-06-21 migraine Vaccine triggered increased migraines. In addition to vomiting, diarrhea, nausea, headaches, fatigue... Read more
Vaccine triggered increased migraines. In addition to vomiting, diarrhea, nausea, headaches, fatigue. Migraines have not improved much. Migraines before covid shot were 1-2 events per month. After covid they were daily for the first three weeks after first covid dose. Now they are 3-5 times per week! Had to put patient back on a daily migraine medication.
15 2021-06-22 cold sweat, feeling cold Patient, a 15-year-old white, non-Hispanic male received his first Pfizer vaccine on 6/23/21 at 3:10... Read more
Patient, a 15-year-old white, non-Hispanic male received his first Pfizer vaccine on 6/23/21 at 3:10pm. After 13 minutes post-vaccination, patient passed out. Had a bit of wheezing, pale, cold, and clammy skin. Was conscious when pharmacist went out at 3:30pm. Called 911 for paramedics. Have patient drink cold water in the mean time and have legs elevated to help with blood flow. When paramedics came, vital signs were checked. O2 saturation is 98%, blood pressure is 96/60, and pulse is 88 bpm. Patient feels much better after 30-45 minutes, and was able to leave the store with mom without going to emergency room.
15 2021-06-22 hot flush 2.5 weeks after second dose. Hives all over body. High tropinin T High sensitivity test. Confusion, ... Read more
2.5 weeks after second dose. Hives all over body. High tropinin T High sensitivity test. Confusion, dizziness, lightheaded, chills, hot flashes.
15 2021-06-22 pain in extremity Patient felt like he was having an asthma attack on the night of the 21st when playing outside with ... Read more
Patient felt like he was having an asthma attack on the night of the 21st when playing outside with friends (running and climbing). He has never had asthma, but said his chest was tight and it was hard to breathe. He said when he stopped and sat for a while it seemed to get better. He went to sleep at about 2am and woke me up at 5:20am crying. His chest hurt really bad and the pain was traveling down his arm. When we took his blood pressure at home it was 205/125 and his heart rate was 112. We went to the emergency room at hospital immediately. Once there they did an EKG. The doctor said there was not reason to be alarmed, but the EKG showed signs of possible pericarditis. They then took blood work, a urine sample, an xray and did an echocardiogram. The doctor told us that the blood work did not show any signs of an actual heart attack or any damage done to the heart. She said the echocardiogram showed some fluid build up in the pericardia sac surrounding his heart. She said this is considered pericardia. She mentioned that some young men are having this happen after being vaccinated. She said we seem to have caught it early. They gave him Tordal through his IV when we were there and that took his pain away. We were told to follow up with a cardiologist within 24-48 hours. We have an appointment at Hospital tomorrow at 10:45am.
15 2021-06-22 tingling, pain in extremity, discomfort, numbness days of left arm and 1 day of acute left side chest pain following 2nd administration of COVID-19 va... Read more
days of left arm and 1 day of acute left side chest pain following 2nd administration of COVID-19 vaccine. Patient reports that 3 days ago, he received the 2nd COVID-19 vaccination (Pfizer ) in his left anterior deltoid area. Following this he developed diffuse body aches and headaches. On day prior to admission, patient developed fever at home with T-max 101.8° F. after going to sleep, he was awoken with nausea. Patient experienced episodes of vomiting, which he reported mostly consist of water, and also reported left arm and left chest pain at this time. He reports the pain felt like pressure and was a severity of 9/10. Patient also experienced numbness and tingling in his left hand. He attempted to take Tums and Motrin at home with mild relief of symptoms. Mother then brought patient in to Emergency Room. Patient denies syncope, no palpitations, pain does not worsen with deep breathing, pain unchanged by position.. emergency department course: Presented with temperature 99.7° F, heart rate 92, blood pressure 138/90, saturating 98% on room air. Laboratory work revealed elevated troponin, elevated CK-MB, and elevated creatine kinase. Chest x-ray was performed which was normal. EKG revealed normal sinus rhythm. Patient was transferred to our emergency room and subsequently admitted to the floor. Hospital Course: He was evaluated in Hospital Emergency Room and admitted to the floor for more close monitoring. His repeat labs showed elevated troponin and an echocardiogram was unremarkable. In view of the elevated troponin was case was discussed with the cardiologist who recommended a cardiac MRI which was performed which did reveal myocarditis, pericarditis. In view of this ICU service is consulted for admission closer monitoring further evaluation management.
15 2021-06-24 tremor Immediately following the vaccination, the patient told his father he felt dizzy, so he was directed... Read more
Immediately following the vaccination, the patient told his father he felt dizzy, so he was directed to a chair. He told his father he could not see anything and was experiencing vertigo. His father then said his eyes and lips on the left side of his face seemed to be shaking as if he was having a seizure and he lost consciousness for a brief moment. When he opened his eyes, he told his father he was dizzy and his head hurt, but he could see again. I brought the patient some water to drink and took his first blood pressure reading at 10:42 am, which read 67/31, pulse 43. The patient mentioned that he hadn't eaten anything that day and that he was extremely nervous about getting the vaccination. His father got some orange juice and started to give him sips of it and he remained seated. The next blood pressure reading at 10:54 am was 115/59, pulse 76. The patient said that he was feeling nauseous, but less dizzy. I gave him two cookies to eat and took his blood pressure again at 11:01 am and it read 117/73, pulse 88. At this point, the patient said he was feeling much better and the cookies even made the nausea go away. The final blood pressure reading was at 11:13 am: 122/63, pulse 76. At this point, the said he felt completely better and father was confident in taking him home, so they left. I followed up with the father two days later on 6/25/21 and he said that he didn?t have any more problems after they left the store. That evening, patient's temperature went up to 99 and his head hurt with movement, but otherwise, he was fine and did not have any more symptoms after that.
15 2021-06-24 tremor Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: V... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was given vaccine and walked to observation area, with mom. He sat down and few minutes later he started shaking, seemed to faint/was unresponsive. He slipped/was lowered to ground where he came to, but started vomiting. He vomited several times and was confused. 911 was called and the paramedics arrived. Water was offered by pharmacy staff, but was not taken. Paramedic stated to pharmacist that patient did not show signs of being post-seizure. Patient was put on strecther by paramedics
15 2021-06-26 tenderness Swollen Lymph nodes in Axilla area . Large and tender
15 2021-06-26 tremor At 1 am, my son presented with headache, dizziness, lightheadedness, shaking, ringing in ears, short... Read more
At 1 am, my son presented with headache, dizziness, lightheadedness, shaking, ringing in ears, shortness of breath, and pallor. Vasovagal symptoms and near syncopal episode. Was able to get him to the floor to avoid a fall. Vomited several times. Severe vasovagal symptoms began to resolve within one hour. Didn?t check heart rate during initial near syncopal episode but was tachycardic after initial stabilization. Headache and fatigue persisted and is still lingering today.
15 2021-06-26 unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild
15 2021-06-27 pain in extremity right before his second vaccine dose, he started have very prominent palpitations, could not lie dow... Read more
right before his second vaccine dose, he started have very prominent palpitations, could not lie down at night while sleeping, had to sleep elevated or it was difficult to get his breath, had to lean forward to breath during episodes. During the second week of symptoms, he started having pain in his left shoulder and arm Symptoms were intermittent and worse in the evenings
15 2021-06-27 seizure 1435, pt received 1st dose of covid vaccine (Pfizer) while sitting in a chair in covid vaccine clini... Read more
1435, pt received 1st dose of covid vaccine (Pfizer) while sitting in a chair in covid vaccine clinic. NKDA. No known history of seizure per pt's mother. Mother with pt, stated pt started feeling unwell, pale, then losing consciousness. Patient's mother stating patient's eyes started to roll back. 1436, pt had seizure activity, staff lowered pt on the floor, laying on side, no n/v noted, lasted for 25 seconds. VS taken, Oxygen applied. Initial BP 77/26, 100% with 2 L NC oxygen. BP improved to 139/81, HR 74, 100% 2 L NC oxygen after sitting. Pt regained his consciousness, aao x4. 1445, 911 placed. BP 127/64, HR 66, 100% with 2 L NC Oxygen 1500, EMT arrived and transported pt to ER, accompanied by pt's mother
15 2021-06-28 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after first dose of Pfizer. Called ambulance and they came to check him out. His blood pressure was very low do they took him to the ER.
15 2021-06-30 inability to speak eyes rolled to back of head sweating: could not answer questions vomited juice
15 2021-06-30 pain in extremity Heat exhaustion; He got sick during the night; Sore arm; This is a spontaneous report from a contact... Read more
Heat exhaustion; He got sick during the night; Sore arm; This is a spontaneous report from a contactable nurse. This case refers to the first vaccination of two vaccines. A 15-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: ER8733 and expiration date was not provided), via an unspecified route of administration, in the left arm on 27May2021 at 14:00 (at the age of 15-yaer-old) as single dose for COVID-19 immunization. Medical history included Lyme's disease from 04Jul2020 (reporter said it was also called Anaplasmosis and Tick Bite Disease. It was treated with antibiotics and then that was it. A recheck showed nothing), ongoing High Level Autism Spectrum from 2008, ongoing Vitamin D decreased from on an unknown date in Aug2019 to 02Jun2021 (He had it about 9 months ago when reporter took him for his school physical, clarified it was Aug2019 and ongoing difficulty getting to sleep. Patient had high level on the autism spectrum. His last labs come back normal, so he did not have to take Vitamin D anymore. Patient did not have any family medical history relevant to AEs. Concomitant medications included ongoing melatonin (strength: 10 mg) at 10 mg once a day (every night) for difficulty getting to sleep (taking for about 4 months) and ongoing VITAMIN D NOS for VITAMIN D decreased (His Vitamin D had been low, and he had been taking Vitamin D). Patient experienced sore arm on 28May2021 (after first vaccine). Patient had Heat exhaustion (10 days ago) and got sick during the night on an unspecified date in Jun2021. Reporter stated the sore arm was completely resolved. He got sick during the night and he was taken to the emergency room. He had 2 bags of fluids and supposed that was 2 liters. He was ok after that. Patient was required a visit to emergency room for events Heat exhaustion and got sick during the night. Patient was very careful. He wore a mask. He washed his hands and used hand sanitizer. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. His last physical was on 02Jun2021, he had his blood drawn and it came back within normal limits. Seriousness of the event Sore arm was reported as non-serious and for other events it was not reported. Outcome of the event sore arm after first dose was recovered on an unknown date in 2021 and outcome of the other events was recovered in unknown date in Jun2021. Reporter stated that Pfizer Covid-19 Vaccine was related to Sore arm (first dose). Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on the reported information, a causal association between the reported events of heat exhaustion, illness and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
15 2021-06-30 tremor, feeling hot, cold sweat, seizure received his first dose of the Covid Vaccine on 27MAY2021, and he was scheduled for his second dose ... Read more
received his first dose of the Covid Vaccine on 27MAY2021, and he was scheduled for his second dose yesterday, so he already missed the 21 days; lost consciousness; Faint; shaking like a seizure; shaking like a seizure; clammy; patient was hot; This is a spontaneous report from a contactable pharmacist. A 15-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EW0187, expiration date: Aug2021), dose 1 via an unspecified route of administration, administered in arm left on 27May2021 (age at vaccination 15 years) as dose 1, single for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was none. As per she knows she did not take any vaccine prior vaccinations (within 4 weeks). On 27May2021 the patient experienced lost consciousness, faint, shaking like a seizure, clammy, received his first dose of the covid vaccine on 27May2021, and he was scheduled for his second dose yesterday, so he already missed the 21 days, patient was hot on 27May2021. Patient reported that he lost consciousness and was shaking like he had a seizure, but the pharmacist states when she saw the patient, he appeared to faint but never lost consciousness and was also clammy but not shaking at all. Also states the patient was hot and clammy and sat for half an hour after the dose and then was fine. Reporter wondering if there are any records of people fainting after receiving the vaccine. The patient had loss of consciousness, and yesterday he came back to get his second dose that was scheduled and went back to the clinic and they decided not to take the second dose, because after the first he experienced shaking with seizure. He drank some cold water and started to feel better and sat there for half an hour and they never mentioned anything about shaking or seizures. Reporter states when she saw his reaction, should thought it was not serious, but the way he describes it, it would be medically significant. The patient not visited emergency room or physician office. The patient did not receive any treatment. The outcome of event received his first dose of the COVID vaccine on 27may2021, and he was scheduled for his second dose yesterday was unknown and for other events the outcome was recovered on 27May2021. Event relatedness: Covid Vaccine: a appeared to faint but she does not think he ever lost consciousness, clammy, but not really shaky, and he was hot, shaking like a seizure, lost consciousness was related. Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: The event of is assessed as possibly related to the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) based on strong temporal association. 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.,Linked Report(s) : US-PFIZER INC-2021734134 similar report from same reporter
15 2021-07-01 tingling Day after 2nd COVDI 19 vaccine patient presented with painful supracalvicular lymphadenopathy x2. Al... Read more
Day after 2nd COVDI 19 vaccine patient presented with painful supracalvicular lymphadenopathy x2. Also had mild intermittent tingling in right arm.
15 2021-07-02 numbness Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: NUMBNESS IN LEFT ... Read more
Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: NUMBNESS IN LEFT ARM
15 2021-07-02 unresponsive to stimuli patient started to feel lightheaded. His mother asked how he was, his eyes rolled back in his head a... Read more
patient started to feel lightheaded. His mother asked how he was, his eyes rolled back in his head and he was unresponsive for a few moments. we moved him to the floor and called 911. his remained very lightheaded for the next 25 minutes until which time his mother decided to transport him to the hospital for observation.
15 2021-07-05 weakness Patient received the Covid-19 vaccine and within 1 minute started to slump over with weakness and i... Read more
Patient received the Covid-19 vaccine and within 1 minute started to slump over with weakness and immobility. He had dizziness and was lightheaded. He complained of blurred vision. His mother was by his side. Pharmacist called 911 and paramedics arrived in about 5 minutes. Patient started feeling better but was pale and his vision was bad. Mom said he was dehydrated and at the lake all weekend. Paramedics took him out on stretcher to emergency room.
15 2021-07-07 burning sensation Reports sporadic burning sensation upon inspiration and left leg weakness that started morning after... Read more
Reports sporadic burning sensation upon inspiration and left leg weakness that started morning after vaccination. Had with first Pfizer dose and symptoms resolved in one week.
15 2021-07-07 seizure Patient had a seizure lasting about 1 minute. EMS was called. While waiting for the ambulance to arr... Read more
Patient had a seizure lasting about 1 minute. EMS was called. While waiting for the ambulance to arrive, we comforted the patient and gave him water to sip. By the time the EMTs arrived, he was alert and feeling better. He was evaluated by the EMT and it was suggested he go by ambulance to the emergency room; however, his father refused the ambulance. We do not know if he was taken to the hospital for evaluation.
15 2021-07-08 feeling hot We don't know when the rash actually started on his chest and back but we noticed it around 8pm that... Read more
We don't know when the rash actually started on his chest and back but we noticed it around 8pm that same day. We gave him an allergy pill but that didn't really help. We saw an Allergist (6/30) and he mentioned, it wasn't hives but that he would need to research if he could get another shot based on the reaction. After this weekend, Patient said his back would sting when he would get hot so I called back the doctor. On Wednesday, he prescribed Triamcinolone Acetonide Cream. We have used it once so far and Patient's back does look a little better but the rash is still there.
15 2021-07-08 numbness, tingling Pt had general malaise and headache that same afternoon. The next day his symptoms progressed to dul... Read more
Pt had general malaise and headache that same afternoon. The next day his symptoms progressed to dull, burning chest pain that radiated to the throat and ears along with numbness and tingling of the distal arms and hands. The chest pain was relieved by leaning forward. This continued off and on for two to three days while being monitored in the hospital. The diagnosis was myocarditis due to the vaccination.
15 2021-07-09 tremor A 15 year old child received COVID 19 Pfizer vaccine approximately 12:40PM 7/10/2021; after the vacc... Read more
A 15 year old child received COVID 19 Pfizer vaccine approximately 12:40PM 7/10/2021; after the vaccine was given and bandaid was applied, the child's body stiffened for less than 60 seconds. The child's arms and legs were stiff and stretched out and per father's observation, he claimed that his child's eyes were rolled backward. The child returned to "normal" status, he claims that he doesn't remember what happened. The child's hands were little shaky as he was attempting to drink water. We asked multiple questions - child claimed he was not nervous about the vaccine. Parents claimed that the child is doing better with vaccine anxiety compare to previous time, The child and parents informed that he did not eat anything yet. The child claimed that he is not dehydrated. 911 was called immediately at sight. EMT took the child's vital and reevaluated the child's condition. family wanted to follow up with their doctors (if correct, I believe EMT's vital check indicated 116/58 for BP) - our temperature measurement showed 97.3.
15 2021-07-10 bell's palsy Bells palsy
15 2021-07-10 feeling hot Pupils dilated and he couldn't see.; Pupils dilated and he couldn't see.; shaky; rigid; and was very... Read more
Pupils dilated and he couldn't see.; Pupils dilated and he couldn't see.; shaky; rigid; and was very hot to touch; This is a spontaneous report from a non-contactable consumer (patient). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0202), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jun2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. No medical history was reported. Patient had no known allergy. Other medical history was none. No concomitant medication was reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced pupils dilated and could not see, shaky, rigid, and was very hot to touch on 05Jun2021. This was within a few minutes of receiving the vaccine and lasted about 20-30 minutes. Seriousness criteria was reported as no. As AE treatment, Pharmacist used cold compresses and gave him juice. The outcome of the events were recovered on 2021. No follow-up attempts are possible. No further information is expected.
15 2021-07-12 feeling hot On June 2, 2021, he awoke and complained of feeling hot, tired, and not hungry. His mother had been ... Read more
On June 2, 2021, he awoke and complained of feeling hot, tired, and not hungry. His mother had been sick with acute gastroenteritis symptoms 2 days earlier. Over the course of the day, he had a fever to 101.6 F, and began to have loose stools (twice). He received Ibuprofen 400 mg by mouth every 6 hours for the fever, and drank plenty of fluids. On June 3, 2021, he continued to have fevers to 101.5 F, loose stools (twice again), and poor oral intake of food. I canceled his scheduled 2nd Pfizer-BioNTech vaccine, and got him a NP swab test for SARS-CoV-2 through the health department. On June 4, 2021, he had no fever but now complained of a rubbing left parasternal chest pain. On physical examination, his BP was elevated (130s/90s), he had a slight tachycardia (90s), and was afebrile. On auscultation, I heard a S4 gallop and took him immediately to the local ER.
15 2021-07-12 migraine I was pretty nauseous; pretty bad headache, I would say migraine level; pretty bad headache, I would... Read more
I was pretty nauseous; pretty bad headache, I would say migraine level; pretty bad headache, I would say migraine level; This is a spontaneous report from a contactable consumer reporting on himself. A 15-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Left on 19Jun2021 10:00 (Batch/Lot Number: EW0217; Expiration Date: 30Sep2021) as single dose (at age of 15-years old) for covid-19 immunization. Medical history included Allergy to penicillin (10 years ago). The patient previously received first dose of bnt162b2, solution for injection administered on 29May2021 sometime around the morning in left arm (Lot Number: EW0180 and Expiration Date: 31Aug2021) for COVID-19 immunization. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer Suspect. No relevant tests done. No prior vaccinations (within 4 weeks). It was reported that, on 19Jun2021 around 06:00, migraine which began at first on the day he received the second dose of the covid vaccine, an hour or so later. Then it came back again today. Until about 10:00 it was the same, then it got better and on the same day the patient experienced pretty bad headache. On 22Jun2021 06:45, about 45 minutes afterwards he was pretty nauseous, it got a little bit worse between 8:00 and 10:00, but currently he was better. Caller's mother was also on the line. She asked, what stage should we got the doctor and wanted to know how long the side effects might last and when they should be concerned. The patient did not visit to emergency room or physician office due to adverse events. The outcome for event headache was not recovered, for nausea and migraine it was recovering. No PQC was involved. Information on the lot/batch was available, Additional information has been requested.
15 2021-07-12 tremor, unresponsive to stimuli, weakness, flushing Site: Swelling at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadedne... Read more
Site: Swelling at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadedness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
15 2021-07-14 bell's palsy, facial paralysis Bell's Palsy. Facial paralysis on one side. Onset 7/13/2021 Outcome uncertain. Treatment just start... Read more
Bell's Palsy. Facial paralysis on one side. Onset 7/13/2021 Outcome uncertain. Treatment just started.
15 2021-07-14 feeling cold Patient passed out around 5 minutes past dose. He did not have a complete loss of consciousness. Low... Read more
Patient passed out around 5 minutes past dose. He did not have a complete loss of consciousness. Lowered him to floor, elevated legs, and slowly lowered head to ground. complained of being cold, had shivers, and complained of ringing in the ears and nausea. once resolved, sat him up and observed again. around 30 minutes past vaccine had a second fainting spell, to which called 911 for observation. Patient completely resolved and left with mom and EMS walked him to her car.
15 2021-07-14 flushing, weakness Systemic: Fainting / Unresponsive-Medium, Systemic: FAINTING BUT ABLE TO HEAR & RESPONSE IN FAINT VO... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: FAINTING BUT ABLE TO HEAR & RESPONSE IN FAINT VOICE-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: AFTER ABOUT 5 MIN OF INJECTION, PT COMPLAINT THAT HE COULDN'T SEE ANYTHING. HE HAD MORE SWEATING & WEAK. MOM TRIED TO WAKE HIM. HE DID RESPONSE IN FAINT VOICE. I HAD THE TECH CALLED 911 & I GAVE EPINEPHRINE INJECTION. FEW MINUTES LATER, HE SAID THAT HE COULD SEE. THE RESCUE MEMBERS CAME & MEASURED BP & HR WHICH WAS NORMAL SO THEY DIDN'T TAKE HIM TO ER. I CALLED MOM LATER & SHE SAID HE GOT BACK TO NORMAL. I ALSO TRIED TO FOLLOW UP FEW TIMES ON FOLLOWING DAYS BUT NO ONE ANSWERED THE PHONE.
15 2021-07-14 numbness Chest pain, left arm and jaw numbness starting 2 days after 2nd Covid vaccine. Troponin 5.64. Admitt... Read more
Chest pain, left arm and jaw numbness starting 2 days after 2nd Covid vaccine. Troponin 5.64. Admitted for observation
15 2021-07-15 weakness patient felt weak and said his vision was blurry and that he could not hear well. I called 911 immed... Read more
patient felt weak and said his vision was blurry and that he could not hear well. I called 911 immediately because of my fear of possible stroke. I lied him down and took his blood pressure because I was afraid he might faint. We gave him a granola bar and some water while he was sitting. He had not eaten at all before this so I think his blood sugar might have been low. He was feeling better already before the ambulance came and they released him to home because he seemed to be fine when they arrived.
15 2021-07-15 involuntary muscle movements, seizure, weakness Seizure. I found my son on the sofa, twisting his body, pale, sweaty, weak, confused, and staring in... Read more
Seizure. I found my son on the sofa, twisting his body, pale, sweaty, weak, confused, and staring into space. I had to call 911.
15 2021-07-15 numbness "Pt c/o of facial and tongue numbness 5 minutes after receiving his vaccine. Denies any hx of allerg... Read more
"Pt c/o of facial and tongue numbness 5 minutes after receiving his vaccine. Denies any hx of allergies or taking any medication. Negative for hives or tongue/throat swelling. Denies difficulty swallowing or breathing. Water, juice, and Graham crackers given. Vital sign stable BP 115/87, HR 71, RR16, SPO2 100%. Symptoms resolved 45 min later. ER precaution advised. Pt d/ced in stable condition. "
15 2021-07-18 pain in extremity Chest pain, Bilat Arm Pain, Fever
15 2021-07-19 pain in extremity Patient reports arm pain and difficulty moving arm since the vaccination, patient reported during se... Read more
Patient reports arm pain and difficulty moving arm since the vaccination, patient reported during second vaccine appointment and was advised that his arm would need evaluated, due to NP feeling uncomfortable administering vaccine with patient symptoms, at which time patient left clinic with father.
15 2021-07-19 seizure, cold sweat Patient passed out within a few seconds of receiving his 2nd Pfizer Covid vaccine and began what loo... Read more
Patient passed out within a few seconds of receiving his 2nd Pfizer Covid vaccine and began what looked like seizing. This lasted for 3 seconds. Vaccine given 7/20/2021 at 6:30pm. No physical injury occurred. Patient gained consciousness within seconds. Patient still felt light headed, skin clammy to touch. Patient complained of pain in neck and kept stating he wanted to lie down. 911 was called within minutes and arrived within a few minutes. Paramedics took patient BP. Patient understood the questions asked was able to answer them all. Patient left on the ambulance with the mother.
15 2021-07-20 pain in extremity, tenderness 6/26/21--;pca; 7/8/21 mild, mildly pruritic , non-painful, bilateral conjunctival injection (left m... Read more
6/26/21--;pca; 7/8/21 mild, mildly pruritic , non-painful, bilateral conjunctival injection (left more than right) without ocular discharge--attributed to seasonal allergic conjunctivitis butstill persists at present time. 7/13/21 woke up with severe (8-9/10) sub sternal and left sided chest pain/pressure sensation, whih radiated to his back with associated difficulty breathing/shortness of breath, worsening of pain with deep inspiration and sling supine, and palpitations. Bilateral calf pain and tenderness fo left foot. Symptoms persisted. To ED at Hosptial but left without being seen due to long lines then came to our ED for evaluation. Of note received 1st dose humira without apparent side effects
15 2021-07-21 grand mal seizure PATIENT RECEIVED VACCINE AND WAS ASKED TO SIT DOWN FOR OBSERVATION PERIOD, PATIENT WAS NOTICED TO B... Read more
PATIENT RECEIVED VACCINE AND WAS ASKED TO SIT DOWN FOR OBSERVATION PERIOD, PATIENT WAS NOTICED TO BE QUIET, LOST CONSCIOUSNESS, EYES ROLLED BACK AND STARTED WITH TONIC-CLONIS SEIZURES THAT LASTED ABOUT 1-1 1/2 MINUTES. PATIENT THEN REGAINED CONSCIOUSNESS, OPENED EYES, AND ASKED WHAT HAPPENED.
15 2021-07-22 seizure A 15 year old male was given a Pfizer shot and 5 minutes later had a seizure for about a minute and ... Read more
A 15 year old male was given a Pfizer shot and 5 minutes later had a seizure for about a minute and then passed out for a few seconds and then woke up. He was very pale and dizzy. A nearby customer and pharmacy tech called 911. The patient did mention that he hadn't eaten or drink anything before he got the shot. The patient refused to go to the hospital.
15 2021-07-23 seizure seizure; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored prog... Read more
seizure; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program. A 15-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191, Expiration date was not reported), via an unspecified route of administration, at the age of 15-year-old on 05Jun2021 as single dose for covid-19 immunization. The patient medical history was reported as no. The patient's concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: EW0182, Expiration date was not reported), via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization. On 09Jun2021, the patient got seizure. The patient reported that he got seizure twice already, which never happened before. 1st time was on 09Jun2021(4 days after 2nd dose), and 2nd time was on 10Jul2021. Each time it was unprovoked grand mal seizure. Patient was hospitalized by 911 on 09Jun2021. Reports revealed no mass/bleed in head, He was given Keppra IV. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of event was not recovered. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
15 2021-07-24 feeling cold Received 1st dose of Pfizer Covid Vaccine and started becoming increasingly manic within about an ho... Read more
Received 1st dose of Pfizer Covid Vaccine and started becoming increasingly manic within about an hour. Complained of stomach discomfort. Became increasingly anxious and manic and was only able to sleep for two hours (received at 4pm, slept from 12am to 2am). Awake and manic the day following. Complained of stomach pain. Eating normally with no other symptoms. Started complaining of being cold and chills. Applied rotating heated blankets until he feel asleep about 10pm. Woke up at 2am. Manic and anxious. Stomach started swelling more and becoming rigid. Gave him Miralax. No change in swelling. Increased stomach pain. Gave him a suppository. Immediate small bowel movement. After two more hours and no change in swelling, gave a second suppository. Immediate small bowel movement. Stomach becoming distended and complaining of increased pain. Took him to the ER. Pain amplified on the way. Admitted to PICU after EKG in ER. Quickly declined and went into respiratory failure. Right lung had no air exchange and left lung collapsed. Myocarditis, pleural effusion, kidney damage and new onset Type I diabetes. Unexplained pneumonia. No growth from fluid in lung.
15 2021-07-24 tremor, tingling, numbness Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt exhibited rash on both arms, that he noticed after 15 min wait, observed pt, rash itch worsened, 50 mg benadryl chewed, within minutes pt complained of facial and mouth numbness/tingling, then a couple minutes later difficulty swallowing. 911 called, 1 dose epipen administered in right thigh. mother did not wait on 911, took son to ER. mother Chambree called to say pt was fine.
15 2021-07-25 grand mal seizure, weakness I was called at bedside because pt had a grand mal sz which lasted for a few seconds. Pt woke up ale... Read more
I was called at bedside because pt had a grand mal sz which lasted for a few seconds. Pt woke up alert and oriented right away. No posttictal episode. Pt stated that he felt pain and started to feel dizzy. Pt was pale, cool to touch, diaphoretic. No injuries noted. Pt was leaning against mother. C/O weakness. Assisted to gurney by 2 person assist. Tol well. Pt felt better being placed on supine. Color slowly coming back. Per mother, pt has a history of syncopal episode. Pt had a finger fracture before, got reinjured. Pt blanked out and passed out. Pt was brought to the ED then and was cleared. 1138 92/41 (58) 51 99% RA 16; 1140 89/39 (54) 50 99% RA 16; 1143 95/46 (62) 54 100% RA 18; 1153 92/55 (65) 55 100%RA 16; Pt is now placed on semi fowlers position. Pt is tolerating positioning well. Tolerating crackers and fluids. Mother at bedside, assisting patient. Doctor on call, Dr. made aware of pt's situation and current condition. Per MD, to observe patient for 30 mins and to let him know pt's condition then. Per MD, to introduce PO intake as tolerated. @1208 Pt ate 3 packets of crackers and on the second box juice. Made mother aware that doctor on call was notified and discussed plan of care. Mother and patient verbalized understanding. Instructed mother to make appointment with pediatrician for follow up. Instructed pt and mother that pt should rest, increase PO intake today. Pt and mother verbalized understanding. @1205 98/53 (71) 56 100%RA 16 Pt sat up in a high fowlers position. Tolerating well. Denies dizziness, nausea. Pt ambulated. Tol well. No problems. Made Dr. aware. Pt is cleared to go home with PMD follow up and ED precaution instructions. Pt and mother aware. Mother is confident of taking pt home.
15 2021-07-25 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
15 2021-07-26 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe
15 2021-07-27 weakness, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt's dad noted he was well when recieving vaccine however when they were in line in the coffee shop area of the store pt leaned against dad with light headedness as if to faint. Store staff called 911 and I rushed over and took pts vitals which were normal with bp 115/72. Pt sipped some water and when I asked if he had eaten today he responded no (215 pm) his dad also reported he had just woken up and doesnt follow a sleep schedule. I was able to offer him some juice which improved his weakness
15 2021-07-27 tremor Patient complaint of dizziness, shuddered, and passed out per sister. PT passed out in car. EMS arri... Read more
Patient complaint of dizziness, shuddered, and passed out per sister. PT passed out in car. EMS arrived and assessed PT. Parent was present. VS 108/40 , HR 49 , 02 Sat 99% on RA. PT provided cold pack and water. PT's Mom declined EMS transportation to ER. VS WNL per EMS when PT left site.
15 2021-07-28 feeling hot Muscle aches and hot sweats
15 2021-07-28 tremor, weakness, cold sweat SUBJECTIVE: Pt. is a 15 year old male here vaccinated at our community vaccine event at high school ... Read more
SUBJECTIVE: Pt. is a 15 year old male here vaccinated at our community vaccine event at high school last evening and received the Pfizer vaccine Approx 10 min after receiving the vaccine the patient reported: weakness and lighheadedness At approx 10 min post vaccination he was still sitting in the chair he was vaccinated in. When I came to him he was clamy and pale and felt weak and lightheaded. He also c/o of feeling tremulous This Hx of was obtained by pt and pt's mother who was with pt at the vaccine event. Pt was feeling anxious but well prior to the vaccine. He last ate approx 5 hrs prior to vaccine and had hamburger and root beer. He had no significant activity during the day prior to the event. He did wake up approx 4 hrs earlier then his usual time on day of event because of school orientation he had that day. Pt and mom denied any prior hx of similar reactions after vaccines Pt reported it "feels like just got a shot" No nausea, itching or resp distress No PMHx -Per pt. has been on IEP for adhd No current medications NKDA SocHx: pt denied any recent drug or etoh use Sudden onset of symptoms/signs: yes Rapid progression of symptoms/signs: Rapid progression that quickly improved OBJECTIVE: General appearance: pale and clammy Skin:no rashes Resp: CTA bilat CV: RRR Vitals Vaccine given at 5:58 pm 6:05 pm BP 87/50, P 83, pox 98%- pt was given water 6:08 pm BP 134/84, - coloring in face improved and pt began to feel better- pt was alert and oriented x 3 at this point 6:13pm BP 130/66- pt was given granola bar and 2nd bottle of water BS: 118 DISPOSITION: After sitting in chair for approx 35 min, drinking two bottles of water and two granola bars pt was feeling better, appeared better with normal coloring and not clamy and had normal vitals signs. He and his mom felt comfortable going home to rest. I reviewed warning signs with mom to call or go to ED for I called the next day (7/29) and spoke with his mom and she stated pt was doing better after eating dinner and was feeling well this. She plans to call pt's pediatrician to coordinate his 2nd dose in their office or affiliated clinic.