Pfizer

Nervous system symptom reports

Female, 12 - 15 years

Age Reported Symptoms Notes
12 2021-04-19 numbness Numbness in L arm Pain in injection site
12 2021-05-14 flushing Flushed/warm skin, nausea and dizzy after 15mins of the vaccine.
12 2021-05-15 cold sweat About two minutes after she received her shot she told us she was seeing black spots. Then she told ... Read more
About two minutes after she received her shot she told us she was seeing black spots. Then she told me she couldn?t see and she passed out. She started to regain consciousness and a little bit of blurred vision and then she began dry heaving. She was clammy and sweaty at that point but continued to improve after she drank some water.
12 2021-05-15 pain in extremity Headache, stabbing pain in left leg, sleepy Took Tylenol
12 2021-05-16 cold sweat Patient received in RN triage area, post-COVID vaccination administration. Patient being observed fo... Read more
Patient received in RN triage area, post-COVID vaccination administration. Patient being observed for 15 minutes as recommended per CDC guidelines and facility policy on post-vaccination RN monitoring. Patient sitting in chair and reported feeling dizzy/lightheaded, blurred vision, ringing in the ears, patient noted pale, clammy, and diaphoretic, patient reporting feeling short of breath. Rapid response called. 14:05 Vitals: 75/34, HR: 54, 97% Patient placed on gurney, in the supine position. Patient and mother denies adverse reactions to vaccinations in past. Denies any medical history besides asthma. 14:10 Vitals: Bp: 105/53, Hr 83, 100% on 2L. Patient now denies any dizziness/lightheadeness, blurred vision, ringing in ears, and shortness of breath. 14;15 BP109/65, HR: 72, O2: 100%. COVID vaccination fact sheet and discharge information provided to patient on D/c from clinic, patient advised to review. Verbalized understanding. Appointment for 2nd COVID vaccination provided to patient. All questions and concerns addressed. Advised to follow up as needed. Patient departed with mother at 1435 symptom free.
12 2021-05-18 pain in extremity Swollen puffy eyes sore arm
12 2021-05-18 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
12 2021-05-18 seizure Patient reported history of syncope episode with another vaccine in the past. Patient has history o... Read more
Patient reported history of syncope episode with another vaccine in the past. Patient has history of seizure disorder. At 10:10am, patient was sitting with her mother when she started to convulse sitting up right in a chair. She also vomited while convulsing for about 15seconds. Full consciousness regained.
12 2021-05-18 seizure An incomplete Vaers report was previously submitted for this patient. Please reference Report. Pleas... Read more
An incomplete Vaers report was previously submitted for this patient. Please reference Report. Please disregard previous report. Adverse Event At 10:10am, patient was sitting with her mother when she started to convulse while sitting upright in a chair and vomited as well. This episode lasted for about 15seconds. Past medical Hx Patient reported one syncope episode after receiving a shot in the past, blood was drawn. No Hx of seizure disorder Treatment Patient was given crackers, juice, water EMS called at 10:31am for patient to have further evaluation. Patient was in stable condition prior to transport to ER A translator used, parent consent was provided.
12 2021-05-18 unresponsive to stimuli Patient at the clinic for their first COVID-19 Pfizer vaccine today. Patient, sister and their mo... Read more
Patient at the clinic for their first COVID-19 Pfizer vaccine today. Patient, sister and their mother were scheduling their second dose appointment when the writer heard a "thump" on the ground. The writer turned around to see the patient laying on the ground underneath a chair on her stomach with her eyes closed and not responding to voice command at approximately 1520. The writer and another nurse immediately rolled the patient to her side, a nurse moved the patient's hair from her face and the patient began to open her eyes. Patient began to become alert after less than 30 seconds of the episode. Patient remained laying down for approximately 2 minutes and stated she was embarrassed. Patient began responding to verbal commands and questions. Patient then began to go from a sitting and then to a standing position. Patient and her family escorted to the recovery room and assessed, refusing wheelchair transport. Patient's mother stated no history of this adverse event previously. Vitals taken x2 (See flow sheet). Nurses performed a head-to-toe focused assessment. Patient A & O to person, place, and time. Pupils equal and reactive to light. Patient asked "what day is it" and responded " The 18th." Patient asked "where do you go to school" and responded appropriately with school location. Patient asked "what is your mom's name" and responded. Patient asked "what is your name" and patient responded with her name. Patient asked "how old are you" and responded "12." Nurse assessed the back and both sides of the patient's head and witnessed no bumps, bleeding, or swelling. Nurse noted redness and slight swelling on the right eyebrow approximately an inch in length. No laceration or bleeding noted. The patient's mother touched the site and the patient stated that it hurt. Nurse advised the patient to place an ice pack on the site and the patient declined. Patient denies any neck pain, headache, nausea, dizziness, lightheadedness, or trouble breathing. Patient skin warm and pink. Nurse offered ice, animal crackers, and juice and patient declined. Nurse offered EMS evaluation to patient mother and the patient's mother declined. Patient's mother and the patient educated on the s/s of a head injury and allergic reaction and instructed to call 911 or go to the nearest ER. Patient and mother also instructed to follow up with a PCP and inform them of today's episode at their next visit. The patient and the patient's mother also instructed to ask to be given the vaccine in the recovery room for the second dose at the next appointment. Patient and family remained at the clinic for 30+ minutes. Patient stated that she felt ok and the patient's mother stated she felt ok to take the patient home. Patient left in the company of her mother and sister in stable condition without transport assistance out of the clinic. Patient's mother informed that a VAERS report will be filed and that they may contact her for further follow-up.
12 2021-05-19 weakness Pt c/o weakness, HA, dizziness, and Nausea. BP 121/76, HR 112, RR 22 -- > HR 98 -- > 108/62, 90. P... Read more
Pt c/o weakness, HA, dizziness, and Nausea. BP 121/76, HR 112, RR 22 -- > HR 98 -- > 108/62, 90. Patient stable and released from vaccination site.
12 2021-05-19 pain in extremity Fatigue, chills and arm pain -18-48 hours Headache and nauseous 18 hours after and still present af... Read more
Fatigue, chills and arm pain -18-48 hours Headache and nauseous 18 hours after and still present after 5 days
12 2021-05-19 unresponsive to stimuli, inability to speak child became unresponsive, clenched teeth, unable to stand alone, vomited, eyes dilated, unable to s... Read more
child became unresponsive, clenched teeth, unable to stand alone, vomited, eyes dilated, unable to speak, headache, called 911 was transported to the hospital emergency room
12 2021-05-19 unresponsive to stimuli, muscle spasms, seizure Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizur... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Vomiting-Mild, Additional Details: Patient passed out within 30 seconds of receiving the Pfizer COVID vaccine. She was out for about 15-20 seconds, during which time she had a couple spasms. After that, she woke up, was aware that she had passed out, then threw up once. She waited with her mom for 30 minutes after that, but felt fine during that period.
12 2021-05-19 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted a... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted and immediately regained consciousness. Father broke her fall but she may have hit her head on a shelf so we called paramedics to check her out. She declined to go to the hospital and paramedics cleared her to go home. She was instructed to go to hospital if any signs of severe reaction or concussion.
12 2021-05-20 cold sweat On 5/15, at 4:00pm while in the shower, patient had a pre-syncopal episode with dizziness, and heav... Read more
On 5/15, at 4:00pm while in the shower, patient had a pre-syncopal episode with dizziness, and heaviness in her arms and legs. Before she fell I was able to assist her to a sitting position. Her skin was pale and clammy, pulse thready 90bpm, bp 80/50. Symptoms improved after 15 minutes. On 5/21, at 10:00am was outside at a school sports activity. She began to feel slightly dizzy. She ran a short race and the dizziness was worse. She was pale, hr 120, bp 100/60. She drank fluids and rested but still felt unwell and a headache started so she came home. The headache evolved into a severe migraine with several episodes of vomiting. She also felt heart palpitations, which is unusual with her migraines. Hr was 100 and regular. Bp 100/60. Discussed with pediatrician, who patient had seen 5/20. Appointment scheduled with cardiology 5/26
12 2021-05-21 numbness, tingling Pt. Reported numbness, "tingling", brought to med. screening for evaluation. Felt better upon lying ... Read more
Pt. Reported numbness, "tingling", brought to med. screening for evaluation. Felt better upon lying down, drinking water . left in stable condition @10:07 Vital signs at 10:00 Pulse: 64 PO2:99% BP: 108/70 Recorded by RN Evaluated
12 2021-05-21 seizure AFTER RECIEVING VACCINE FIRST DOES PT HAD A SEIZURE AND VOMMITED. DOES HAVE HISTORY OF SEIZURES.
12 2021-05-21 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
12 2021-05-22 weakness The patient is a healthy 12 year old female with no medical history or problems, she received the CO... Read more
The patient is a healthy 12 year old female with no medical history or problems, she received the COVID Pfizer vaccine #1 on Wednesday, May 19th at 4pm and was asymptomatic at that time. Within about 5 hours, she began to experience extreme lethargy. By the following day, May 20th, she experienced profound lethargy that lasted 36hrs. During this time, she was asleep but arousable with effort, she described general myalgias, moderate left arm pain at injection site, mild headache, no other symptoms. Her profound lethargy lasted through midday on May 21st, upon which time she was able to keep her eyes open and began to regain her strength. By the evening of May 21st, she was fully recovered.
12 2021-05-22 discomfort The night after her shot, patient had a hard time sleeping. She experienced "crazy dreams". She's... Read more
The night after her shot, patient had a hard time sleeping. She experienced "crazy dreams". She's had a fever, chills, headache, tiredness, pain at injection site, and a feeling of overall discomfort. She has been resting and sleeping all day.
12 2021-05-22 pain in extremity A 12 years old female patient accompanied by mother to receive firs dose of Pfizer. When the pharm... Read more
A 12 years old female patient accompanied by mother to receive firs dose of Pfizer. When the pharmacist tried to administer the vaccine, she noticed the arm muscle was tensed and experienced a bit of difficulty to penetrate the needle in to the arm. Once the needle inside, the pharmacist tried to inject the vaccine in and noticed the plunger moved a bit and then stopped. She tried to use a bit of force to push the vaccine in further but it did not work. So the pharmacist pulled the injection out and attempt to administer again. She did inform patient's mother that she has to try again. This time the injection went well and as precaution, the pharmacist did not inject all the vaccine in since she knew the patient got a bit of the vaccine in on the first time. Mother was advised to give patient a dose of Tylenol or Ibuprofen that night (if patient is not allergic to those meds) to help out with the soreness. Mother came back to store the next day to ask more questions but there was another pharmacist on duty. That pharmacist did explain to patient's mother the mechanism of vanish point syringe and how it is supposed to work. He relayed the message with the administering pharmacist to follow up. The administering pharmacist called on Friday (May 21) but could not leave the message. She tried again on Saturday (May 22) and was able to explain in detail what happened that day. Her concern is the possibility of her daughter getting double dose and the long term effect of the vaccine. Pharmacist did ask how the patient doing and exhibits any noticeable or severe side effects beside soreness. Mother said so far she is ok besides sore arm. Pharmacist advised mother to monitor the child for a few more days to be safe and call the pharmacist or even her pediatrician if there is further concern. Pharmacist also will follow up with mother to check on how the patient is doing
12 2021-05-22 seizure, grand mal seizure First time seizure 6 days post vaccination GTC w/ post ictal state. Unknown duration of seizure. Ba... Read more
First time seizure 6 days post vaccination GTC w/ post ictal state. Unknown duration of seizure. Back to baseline in ER
12 2021-05-22 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Additional Details: upon exiting vaccination room pt fell ... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: upon exiting vaccination room pt fell forward. it is unknown if she fainted or tripped, mom was standing behind her and was unsure as well. pt bumped head and had a welt on her upper right eyebrow, also her nose began to bleed. ice pack was given/applied to head/eye, paper towel given to stop nose bleed. also water/starburst given. 911 was called. dispatchers came and quetsioned if she felt dizzy when she left room to which pt responded no, ambulance took pt.
12 2021-05-23 pain in extremity Covid toes and hands. Severe painful rash, hives on hands, palms, fingers, toes, feet
12 2021-05-23 pain in extremity I just saw a 12 year old in the office who has an odd rash that started the day after she got her fi... Read more
I just saw a 12 year old in the office who has an odd rash that started the day after she got her first COVID vaccine (Pfizer). She started with the two on her right ankle the day following the vaccine, then the two on her left ankle started the next day, followed by one more on her distal left arm over each of the next three days. She says the burn slightly when she touches them but no itching, not otherwise painful. They look to me like burns or something similar. I wonder if they are self-inflicted but she denies causing them or anything new recently aside from the vaccine. She has been using neosporin occasionally since they were noted, no other treatments. Other vaccine reaction noted: fatigue and slightly sore arm. She just completed a course of clinda for strep on 5/5. Otherwise just takes vitamin D daily. No recent open water swimming, etc.
12 2021-05-24 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
12 2021-05-25 cold sweat Approximately 15 seconds after patient received covid-19 vaccine pt had syncopal episode which laste... Read more
Approximately 15 seconds after patient received covid-19 vaccine pt had syncopal episode which lasted a few seconds, she was able to regain some consciousness for a few seconds but had syncopal episode again. Pt was unconscious for less than a minute. When pt awoke, she was pale, confused, and clammy. An ice pack was placed in the back on her back, ice water was given for patient to drink, legs were elevated, vital signs taken at 1203. Initially vital signs were 66/38, HR62, 99% O2 on room air. At 1210 second set of vitals were taken and recorded as the following, 87/40, HR88, 100% O2 on room air. Pt was placed on the gurney when patient was feeling better, pt was able to walk to gurney with no issues. Pt taken to treatment room for further observation at 1215. Report was given to RN who took patient down on gurney with Covid-19 RN, alongside pt's father. Both pt and father state pt has never had a syncopal episode in the past with vaccines or blood drawn.
12 2021-05-25 flushing Pt w/ hx of allergy to amoxicillin (unknown rxn). Pt c/o flushing/sweating, feeling tired, "head he... Read more
Pt w/ hx of allergy to amoxicillin (unknown rxn). Pt c/o flushing/sweating, feeling tired, "head heavy", and right sided tiredness. BP 120/71, HR 80, RR 16. Pt stable and released from the vaccination site.
12 2021-05-26 tingling Ringing in ears, blurry vision, difficulty breathing, tingling in left foot. Denies headache, chest ... Read more
Ringing in ears, blurry vision, difficulty breathing, tingling in left foot. Denies headache, chest pain/tightness. VSS. RR 16. O2sat 98%. HR 79. Symptoms improved with rest. Discharged with parent in stable condition.
12 2021-05-27 feeling hot Within 3-5 minutes, she was asking for water and feeling hot. Her back was sweaty. Her eyes looked ... Read more
Within 3-5 minutes, she was asking for water and feeling hot. Her back was sweaty. Her eyes looked like they were glazed- not responding; didn't look bright. She got some water and an ice pack on her back and removed her shoes and put her feet up. After drinking the water and keeping the ice pack on for the rest of those 15 minutes. Nurses were there watching her. And she was able to walk out of the clinic on her own power. It had looked like she maybe would have passed out without the intervention of water, ice pack and getting her feet up. She had muscle pain in her arm (of injection site) that day and into the next day. The muscle pain in her arm lasted for about 24 hours.
12 2021-05-27 tremor Shakes, redness, throat tightness and itch, given benedryl, and taken to hospital for observation
12 2021-05-27 unresponsive to stimuli Patient reported feeling dizzy and was not verbally responsive for 10 seconds after receiving vaccin... Read more
Patient reported feeling dizzy and was not verbally responsive for 10 seconds after receiving vaccine, and then vomited. Patient's pulse was faint, but became palpable once patient started talking again. Patient was breathing spontaneously. Patient reports last meal at 10am (7-8 hours prior vaccine administration), and anxiety to needles. Mother reports that patient faints with vaccine administration. Patient was taken to a cot to lay for 15 minutes and instructed to slowly drink sips of water in case of vomiting. Patient's symptoms resolved 15 minutes after laying supine. Instructed patient to go to ED if symptoms worsen.
12 2021-05-28 tremor, weakness developed a rash whole left arm; Feeling dizzy; dizziness was kind of severe dizziness where felt li... Read more
developed a rash whole left arm; Feeling dizzy; dizziness was kind of severe dizziness where felt like everything was moving around; weak; Shaking; Chilling; Does not feel ok; half an hour lying down; This is a spontaneous report from a contactable consumer reporting for their daughter (patient). A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at 12-years-old intramuscular, administered in arm left on 16May2021 (Batch/Lot Number: EW0177) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that within 5 minutes after taking the vaccine on 16May2021, the patient started feeling dizzy, weak and little bit of shaking, chilling. Dizziness was kind of severe dizziness where felt like everything was moving around her. They took her to urgent care center because she does not feel ok after half an hour lying down there. The doctors were there and they gave medications as an injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed (treatment). The patient got the reaction at 1145 am within five minutes feeling dizziness. After 30 minutes waiting were advised to take her to the urgent care. She was prescribed Promethazine 25mg, Ondansetron 4mg, Meclizine 3 times a day for next five days. Reports adverse event (unspecified) still maintains. Then later developed a rash, whole left arm on an unspecified date. Therapeutic measures were taken as a result which included injection of Promethazine 25 mg temporarily at first and also gave Ondansetron 4 mg and prescribed Meclizine 25 mg three times a day for 5 days as needed. The outcome of the events was unknown.
12 2021-05-29 feeling hot About 5 minutes after the shot, patient's mom said that she didn't feel good. Patient was dizzy, sw... Read more
About 5 minutes after the shot, patient's mom said that she didn't feel good. Patient was dizzy, sweaty, nauseas and really hot. The arm that got the injection was also really hot. I had the patient lay down, and gave her an ice pack for her neck/arm. After a few minutes patient said that she felt better. I had her lay down for about 5 minutes. She then sat up and said she was much better. Wasn't dizzy or nauseous anymore. Arm felt better too. I had the patient sit and wait in total 30 minutes. Mom wanted to leave sooner but I asked if she wait so that we could make sure she was ok. THey waited 30minutes and left . patient was fine.
12 2021-05-31 weakness light headed, headache, dizzy, vomiting ,sore throat, ,hard to swallow, weak, felt like someone sit... Read more
light headed, headache, dizzy, vomiting ,sore throat, ,hard to swallow, weak, felt like someone sitting on her chest lost sense of smell and taste. Taken by medics to local hospital, , Placed on IV , GI cocktail, chest x rays 2 views, EKG,
12 2021-06-01 numbness Feeling numbness in nose; numbness in forehead; This is a spontaneous report was received from a con... Read more
Feeling numbness in nose; numbness in forehead; This is a spontaneous report was received from a contactable consumer or other non hcp (patient's mother). A 12-years-old female patient of weight 40.816 kilograms and height 147 centimetres received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0175; Expiration Date: 31Aug2021), via an unspecified route of administration on 23May2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included vitamin D no's (VITAMIN D) and elderberries. The patient's mother reported that her daughter who was 12 she had COVID Vaccine on Sunday and on 24May2021, she was feeling numbness in her nose. She felt numbness in her forehead but that went away, but her nose was still numb. She knew she read through the symptoms and that was not one of them, so she was just wondering if it was like allergic reactions or was that part of the symptoms. The patient was treated with Tylenol and Ibuprofen. The patient is going to get the second dose of vaccination on 13Jun2021. On an unspecified date in 2021, the patient had recovered from numbness on the forehead and was not recovered from numbness on the nose. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are possible. Further information is expected.
12 2021-06-01 pain in extremity She started to get a sore throat and drainage the day after the first dose of the vaccine. That day ... Read more
She started to get a sore throat and drainage the day after the first dose of the vaccine. That day she had headache, sore arm with earache and joint pain. Those symptoms continued for several days with some loose stools which lasted for two to three days with abdominal pain which persisted for a little over two weeks. We visited the doctor because of ear and throat pain and nausea. All tests were negative, but the symptoms improved slowly but they are totally resolved right now.
12 2021-06-03 pain in extremity Patient awoke the morning after her 1st COVID vaccination. Reported she slept well. Her arm was sore... Read more
Patient awoke the morning after her 1st COVID vaccination. Reported she slept well. Her arm was sore from COVID shot. She was up for approximately 20 min and had brushed her teeth and did her hair. She was going to get dressed for the day and states she got a sudden pounding headache and felt nauseous. She was on her way out to the kitchen to tell us she didn't feel good when she blacked out. She face planted, hitting her forehead on the hardwood floor witnessed by both parents. She was out for approximately 30 seconds. Her blood pressure was 90/60, HR 120, O2 on rm air was 98%. She has no previous history of syncope. After spell heart rate ran in the 100-110s for about 30 min and then normalized around 88-95. Was tired and sleepy for 2 hours after. (No post ictal sx to suggest seizure) Patient also received Tdap and meningococcal vaccine in other arm at the time of 1st Covid vaccination. The night of her COVID shot patient had normal appetite and activity level.
12 2021-06-05 flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: I gave the COVID vaccine to pt in her left arm. Within 10 minutes, her mom asked me to come back there. I came and her daughter was very sweaty and feeling very dizzy. I asked one of the techs to grab her some apple juice and an ice pack. I had one of my techs call 911. As I said that, the daughter's mom started to pass out on me but I caught her. She passed out for less than a minute and then she was feeling better. I put ice packs on mom too. Paramedics took over
12 2021-06-05 flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: I gave the COVID vaccine to patient in her left arm. Within 10 minutes, her mom asked me to come back there. I came and her daughter was very sweaty and feeling very dizzy. I asked one of the techs to grab her some apple juice and an ice pack. I had one of my techs call 911. As I said that, the daughter's mom started to pass out on me but I caught her. She passed out for less than a minute and then she was feeling better. I put ice packs on mom too. Paramedics took over
12 2021-06-05 unresponsive to stimuli, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium
12 2021-06-06 weakness did well acted right, felt right up until 5 AM this morning (6/4/21), she woke up throwing up over a... Read more
did well acted right, felt right up until 5 AM this morning (6/4/21), she woke up throwing up over and over again, she couldn?t keep even a dissolvable Zofran down. > I immediately contacted her Hematologist and he told me to take her to the E.R. > blood disorder, ?Hereditary Spherocytosis? came to life, flared up. >got extremely sick, where she could not walk or stand by 8:00 am this morning, when we arrived at the E.R. she had to be placed in a wheelchair because she was so weak. > Fluids, Pain medicine, Motrin, and nausea medication were given, plus rotating cool rags on her head to get her body temperature down. > CBC, was off the charts, she has developed Anemia and was diagnosed this morning. > blood pressure dropped to 91/42. > I spoke with two hematologist on top of speaking with the 2 E.R. Doctors. >reached over 110% immunity if not more. > Both Hematologist I spoke with plus the E.R. doctors determined she was at 100% immunity with just the first dose. > Due to her reaction her Oncologist/Hematologist are communicating with other hematologist in the U.S. about a reaction of a ?12 year old pediatric patient with Hereditary Spherocytosis?, further research will begin according to the Director of Onoccologist/Hematologist in the next few weeks to help other pediatric patients with Heriditary Spherocytosis in the U.S., the main point of this research is determining that one dose of Covid vaccine reaches 100% immunity vs 2 doses which would be equivalent to ?2 doses plus 2 booster shots of Covid vaccine? to someone with hereditary spherocytosis. > > After 8 hours of going through this, she was able to walk and stand. She was back to her old self. > If you can please reach out to CDC and let them know about a 12 year olds patient with Hereditary Spherocytosis reaction to second dose of Phizer Vaccine.
12 2021-06-06 numbness 05/16/21 - vaccine administration 05/21/21 - small rash on inside right knee around 5pm; by 9pm, ras... Read more
05/16/21 - vaccine administration 05/21/21 - small rash on inside right knee around 5pm; by 9pm, rash all over body. Administered 1 Benadry tablet at 9:30pm. 05/22/21 - rash progressed; called pediatrician; administered 1 Zyrtek tablet. 05/23/21 - rash appeared to start subsiding. Child reported some numbness in fingers and toes. Administered 1 Zyrtek tablet. 05/24/21 - rash subsided significantly. Swollen fingers and toes. Administered topical itch cream. 05/25/21 - fully resolved.
12 2021-06-07 flushing Received her 2nd dose of Pfizer approximately 12:15 PM. A couple of minutes later while sitting in o... Read more
Received her 2nd dose of Pfizer approximately 12:15 PM. A couple of minutes later while sitting in observation the pt started to c/o dry cough, itchy throat, and difficulty swallowing. The pt appeared flushed. Pt was laid down and assessed by staff. 911 called and asked for lights and sirens, 911 was called at 12:19 PM. Initial VS: 107/63 HR 106, O2sat 93%, pt began to c/o worsening difficulty swallowing, pt appeared flushed, O2sat dropped to 88%. Epi Pen autoinjector administered IM in the left thigh at 12:20 PM. About a minute after the Epi pen was administered the pt?s pulse ox came back up to 96% and the pt reported a strong relief of the difficulty swallowing and the itching in her throat. BP immediately post Epi was 103/78, HR 76 O2 Sat 96% Repeat BP; 109/79 HR 89 O2Sat 99% RR 16 Repeat BP 12:27 PM 106/63 HR 114 O2Sat 98% Staff continued to monitor pt?s O2sat and HR. At one point during observation while waiting for EMS the pt reported the difficulty swallowing seemed to be returning, pulse ox remained above 90%. Pt transported to ED. Pt has no medical history or allergies per mom. Pt is not taking any medications. Mom reports when the pt received her first dose she did experience flushing, dizziness, and a cough. The pt?s pediatrician happened to be present at clinic and told the pt she was fine and was cleared to get the 2nd dose per mom. RN followed up with mom later that day, pt was home and doing well.
12 2021-06-08 cold sweat A few minutes after her vaccine the patient became dizzy, clammy, and nauseous. She said she felt sh... Read more
A few minutes after her vaccine the patient became dizzy, clammy, and nauseous. She said she felt she might pass out so we got out a yoga mat and cushion for her head so she could lie down. We took her blood pressure which was 102/71 with a pulse of 65. We elevated her legs and gave her a cold pack for her neck and wrists. After watching her for about 30 minutes she felt better and left with her mother.
12 2021-06-08 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported for a 12... Read more
Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported for a 12 year old female patient (reporter daughter). A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date (at age of 12-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unknown date, the reporter stated her 12-year-old got the vaccination and she was fine except a sore arm. Now the patient is due for second one next week. Hoping she doesn't have same reaction as her sister. All four of them in the family had sore arm. Everybody said that was to be expected. Reporter's youngest goes to have the second one next week and if she has something happen caller will calls back. The Outcome of the event was reported as unknown. The report is cross referenced to report ID: 8W2QO95A Information about batch/ lot number has been requested.
12 2021-06-08 seizure 6/8/21 -Presented with respiratory failure requiring intubation about 12 hours after 2nd dose of COV... Read more
6/8/21 -Presented with respiratory failure requiring intubation about 12 hours after 2nd dose of COVID-19 vaccine. Desaturated to the low 80's despite oxygen. Febrile to 38.8 after admission and had several breakthru seizures requiring loading doses of Keppra. 5/17/21-Had event of tachycardia into the 140s, and slight fever of 100.6, and 8 minute seizure after 1st dose.
12 2021-06-08 tremor The night of the vaccine, towards the middle of the night she had a fever 103.2; little bit of a hea... Read more
The night of the vaccine, towards the middle of the night she had a fever 103.2; little bit of a headache. Her fever went down through the night. In a.m., she was at 100 degrees. She started shaking and fainted when getting ready to go downstairs; Pulsometer - 147 for heart rate. She shook just a little. I thought she was going to have a seizure and I yelled for my husband and she regained consciousness. She hasn't had a fever since but we can't keep her heart rate down -it shoots up from 130- to low 150's. Still like that today. we took her to Dr. - he said it was reaction to vaccine. He referred her to cardiologist with an urgent designation. She's never had nay problems like this before. She will see cardiologist tomorrow. Rest and hydration is the current treatment. It hasn't gone away in the two or three days that they thought it would.
12 2021-06-09 weakness Nausea, vomiting, elevated heart rate, low grade fever, chills started next day. Weakness and mild n... Read more
Nausea, vomiting, elevated heart rate, low grade fever, chills started next day. Weakness and mild nausea day two.
12 2021-06-09 feeling hot Chest pain and pressure; fever of 101 degrees F; shallow rapid breathing; rapid heart rate (120); fa... Read more
Chest pain and pressure; fever of 101 degrees F; shallow rapid breathing; rapid heart rate (120); fatigue and tiredness; feeling of being hot and unable to catch breath.
12 2021-06-10 muscle spasms Neck pain and spasming - sharp shooting and progressing to ear and temporal pain. Initially occurri... Read more
Neck pain and spasming - sharp shooting and progressing to ear and temporal pain. Initially occurring a couple times a day and now more frequent. Also, originally started on just the left side of the neck and is now occurring on both sides.
12 2021-06-11 pain in extremity Arm soreness, really painful heart burn and acidity that lasted 24 hours
12 2021-06-13 weakness right after receiving 2nd shot of Pfizer covid vaccine pt was felling weak, nauseated. she could not... Read more
right after receiving 2nd shot of Pfizer covid vaccine pt was felling weak, nauseated. she could not stand up by her self. she was breathing and talking ok.
12 2021-06-13 cold sweat The morning after the 1st COVID vaccine, patient experienced a sudden onset of feeling clammy, pale ... Read more
The morning after the 1st COVID vaccine, patient experienced a sudden onset of feeling clammy, pale and narrowing vision. Near syncopal episode. Resolved after lying down and resting for about 10 minutes.
12 2021-06-13 grand mal seizure Generalized tonic-clonic seizure
12 2021-06-13 pain in extremity, tenderness, feeling of body temperature change Beginning Thursday night, fever onset reached 101. Patient reported extreme fatigue but aches and so... Read more
Beginning Thursday night, fever onset reached 101. Patient reported extreme fatigue but aches and sore arm made sleeping difficult. By 2 am on Friday, June 11th, vomiting and diarrhea began. Patient was given 200 mg of Tylenol and 25 mg of Benadryl. Arnaca gel was applied to the rash that formed on the vaccine site. The rash was approximately 3 cm wide and 5 cm tall oval shape. It was bright red and painful to touch (like a sunburn). Arm was also swollen from shoulder to elbow. Patient slept from 4 am - 8am on 6/11. All day on 6/11 patient had trouble keeping down fluids (tried water, juice, gatorade, and broth) and patient refused food (tried popsicles, rice, bananas, scrambled eggs, and plain noodles). Patient complained of throbbing pain in left arm. Patient refused to massage the area and would screen in pain and cry with tears if mom touched it at all. Cold packs and warm packs brought no relief. Patient continued to receive Tylenol every four hours. Fever would reach 102-102.5, break with sweats. Patient reported feeling very cold and then very hot. Fever break would last 30 min - 1 hour before climbing again. Sunday 6/12 continued the same as 6/11. Patient began alternating Advil 200 mg with Tylenol every four hours. Advil didn't seem to help any more than the Tylenol did. Parent called consulting nurse and was advised to take patient to urgent care where she received anti-nausea medication. Monday 6/13 patient continues to have difficulty with food and drink. The phenergan meds help with nausea but make patient so tired, there's little chance to get patient to eat or drink. Vomiting has stopped but diarrhea continues.
12 2021-06-13 tenderness Fever, arm swelling, arm tenderness, body aches, and rash on legs lasted 2 days. Rash on legs is wh... Read more
Fever, arm swelling, arm tenderness, body aches, and rash on legs lasted 2 days. Rash on legs is what prompted reporting of symptoms.
12 2021-06-14 discomfort Started vomiting 2hrs after vaccination. Went to ER who initially obtained CBC with stable Hgb and s... Read more
Started vomiting 2hrs after vaccination. Went to ER who initially obtained CBC with stable Hgb and sent home with Zofran. Patient continued to have bloody emesis so presented back to ER where they did CXR which was normal, gave IVF bolus, zofran, repeat CBC with Hgb 12.4 and transferred to another hospital for higher level of care. At the hospital, Initially made NPO and placed on IV fluids in preparation for possible endoscopy. Repeat labs showed stable hemoglobin compared to outside hospital. GI consulted and determined that hematemesis was most likely due to Mallory Weiss tear. Recommended carafate before meals, chloraseptic spray as needed for sore throat, continuing IV Protonix and IV zofran as needed, and gradually advancing her diet. On HD#3, she had another episode of hematemesis after eating solids. Overnight, tolerated liquids and solids without any further episodes of emesis. Tolerated transition from IV to PO meds and maintained hydration off of IV fluids. Due to symptom improvement, GI did not recommend endoscopy at this time and recommended that she be discharged on 1 week course of carafate, 2 month course of omperazole, and zofran as needed with plans for GI follow-up in 1-2 months. Had another episode of hematemesis at home after discharge. Went back to hospital and admitted again. The patient underwent upper endoscopy which showed no source of upper GI bleed. ENT was consulted and performed a nasopharyngolaryngoscopy which was negative for an ENT source of bleeding. She remained stable without an identifiable source of bleeding. Mom was comfortable with her being discharged home with close follow up by PCP. Pt seen on 6/7/21 at pediatrician's office for ER F/U. Pt reported she was still vomiting, 2x so far that day. The day before vomited 4x during the day and continued until the night. No more bright red blood in vomit. Describes vomit as blue and pink colors now. Pt does take a light green tablet that is her levothyroxine. Threw up the blue colored vomit immediately after taking this medication. Instructed to take zofran when feeling nauseous. Seen again by pediatrician on 6/10/21- Currently, per mom pt is still vomiting. Last time she vomited was last night. Pt is taking omeprazole. Pt vomited 5-6x yesterday. Decreased appetite, but has been eating some crackers and rice. Complaining of stomach pain after eating and vomiting. Pt used zofran once and it helped a little. Pt denies self induced vomiting. Pt has ben observed by family when vomiting and they do not report any self induced vomiting. Pt denies trying to lose weight. Pt never vomits up food, always liquid. Vomit is different colors, can be pink or blue. No more red color in vomit, only pink. Pt drinks water and gatorade. Pt denies feeling any burning before vomit, but feels burning sensation after vomiting. Pt has been having BMs, not regularly and hard. Taking one capful of miralax at night. Instructed for next five days, instructed to take zofran pill 1hr before dinner. F/U with GI. Seen again by pediatrician on 6/15/21- Per mom and pt she is still vomiting about 5-6 times a day. Pt went to GI yesterday, given lansoprazole 30mg qd and told to continue zofran.. Pt is now able to eat all her meals, takes zofran 1hr before dinner. Pt has vomited 1hr after dinner and has only vomited liquids. Hematemesis has resolved. Still has some blue colored vomit, most likely from levothyroxine medication she takes daily. Stopped taking Miralax 3 days ago. Pt had a soft BM earlier this morning. Pt states she has occasional stomach pains after vomiting, takes a while to calm down but then resolves. Described as lower abdominal. Pt has nausea before vomiting, after vomiting takes 15-30mins for nausea to resolve. Pt states she had a headache with a heavy sensation when vomiting. No headaches at night, but does vomit 3-4x overnight. LMP: 2wks ago. Recommended to go to ophthalmologist to r/o papilledema. WIll contact hospital to get results of any bloodwork done inpatient (reviewed - only CBC done inpt).. F/U in 1wk. Ordered MRI brain w/contrast. CMP. lipase, amylase, celiac disease panel. All results pending.
12 2021-06-14 feeling hot patient reported dizziness and was feeling hot
12 2021-06-14 pain in extremity, seizure, cold extremities, electric shock sensation, numbness, nerve pain After the second dose she had immediate pain at the injection site and over the next 24 hours she de... Read more
After the second dose she had immediate pain at the injection site and over the next 24 hours she developed: A fever of 101.4 severe abdominal pain and chest pain that made her feel like her heart was being pulled out painful electric shocks down her neck and spine that made her walk hunched over numbness and swelling in the arm she got the shot pain in her fingers and toes that turned white and were ice cold to the touch Over the next 2.5 months her abdominal, muscle and nerve pain became unbearable plus she developed new symptoms: Fatigue gastroparesis, nausea and vomiting Eventually she couldn?t even swallow food or liquids without immediately spitting it up. An itchy rash on her arms peeling skin on her feet Her menstrual cycle lasted a month with large clumps of blood She had unexplained painful cysts vision problems headaches erratic blood pressure and heart rate memory loss, mixing up words and brain fog Dizziness, fainting and then nonepileptic seizures that we suspect were from lyrica verbal and motor tics loss of feeling from the waist down, muscle weakness, abnormal gait and eventually she wasn?t able to walk at all urinary retention From the day she got her 2nd dose to today we took her to the ER nine (9) times and she was admitted to the hospital a total of 3 times totalling 2 months. The last time she was admitted to the hospital she could not walk, was unable to feel or move below her waist, threw up anything she tried to eat or drink, had tachycardia and her blood sugar was at 47. Once she got an NG tube and was stable they transferred her to Inpatient Rehabilitation and she was just discharged on June 1st. Today she is able to walk with a walker and take care of herself but she still has little to no feeling below her waist. She still has an NG tube for nutrition and continues to have GI and urinary retention problems.
12 2021-06-14 seizure My daughter had a 40-1 minute seizure 40 minutes post vaccine shot. Not prior seizures to this one.
12 2021-06-16 weakness Patient was very nervous about the receiving the 2nd dose. We had a in depth conversation about side... Read more
Patient was very nervous about the receiving the 2nd dose. We had a in depth conversation about side effects because she had a headache with the 1st dose. Mom held her hand. A few minutes post, her sister saw that she was slumped over & her eyes had rolled to the back of her head. We tried to wake her up & she was very lethargic. I gave her 2 small bottles of water, pb crackers, 3 hard candies & elevated her feet. Mom said we didn't need to get medical attention. After about 10 minutes she was still very lethargic & mom said yes to EMS when asked again. Another mom came over & helped us lay her on the floor to elevate her feet above her head. Her husband came in & assessed patient. Her pulse was 60 & when he asked her to squeeze his fingers & press against his feet it was week. She told us that she hadn't eaten a full meal since the night before, only had watermelon as a snack. The ambulance came & took her.
12 2021-06-16 weakness Fever; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; She woke up... Read more
Fever; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 07Jun2021 14:45 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received other products. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 17May2021 for COVID-19 immunization. Reporter stated, Exactly 3 weeks before second dose patient took 1st dose of vaccine. Reporter stated that, On 08Jun2021 patient woke up before 6 in the morning feeling bad and she had a fever and so they gave her Ibuprofen an hour ago and currently she still had the fever over 101 and she still feeling pretty badly like she did not like when she stand up she felt weak. Reporter was just wondering at what point they should get an alarmed the sheet said that a fever was a side effect but like at what point for a fever should be they worried; she enquired. Reporter further added, 'The sheet she received says that if experience severe reaction Call 911 but it's hard to know what is severe reaction is, you know. Reporter was informed about Pfizer Medical information department and was provided with the number. Therapeutic measures were taken as a result of fever, she woke up before 6 in the morning feeling bad; when she stand up she felt weak, she woke up before 6 in the morning feeling bad; when she stand up she felt weak as Ibuprofen was given to patient. The outcome of all events was unknown. Information on Lot/Batch number has been requested.
12 2021-06-16 pain in extremity 6 days after her first dose, she developed a rash on her knee. It was swollen and painful.we didn?t ... Read more
6 days after her first dose, she developed a rash on her knee. It was swollen and painful.we didn?t realize it was related until she developed a similar rash after her second dose. 4 days after her second dose she developed a rash on her left arm and hands. Looked the same as the one she had on her knee- raised, swollen and her arm hurt.
12 2021-06-16 tremor approx 24 hours after receiving 2nd pfizer vaccine, she developed behavioral changes including night... Read more
approx 24 hours after receiving 2nd pfizer vaccine, she developed behavioral changes including nightmares, shaking, nausea, chills, paranoia about being hurt by someone. She was up every hour and crying if mom left the room (not her typical behavior). She knew this was not how she normally was, but felt she couldn't control her fear. lasted for 36 hours and resolved. similar reaction when she received tamiflu for Influenza.
12 2021-06-17 discomfort Fever of 102.7 at peak. Treated with ibuprofen a s acetaminophen regimen. Felt fatigued and ?heavy.... Read more
Fever of 102.7 at peak. Treated with ibuprofen a s acetaminophen regimen. Felt fatigued and ?heavy.?
12 2021-06-17 feeling hot Caller stated that her 12 year old daughter received the shot on yesterday and in the middle of the ... Read more
Caller stated that her 12 year old daughter received the shot on yesterday and in the middle of the night she had slept walked out side. Daughter called her from the truck crying and hysterical. Daughter stated that she was hot in her sleep and woke up outside and ran to the house and called her mother.
12 2021-06-17 pain in extremity pain at the injection site, pain in the left arm - since after the injection - lasted for 2 days tir... Read more
pain at the injection site, pain in the left arm - since after the injection - lasted for 2 days tiredness, fatigue, low grade temp - 99.6 F orally - started on day 2, resolved on it's own by following morning.
12 2021-06-18 feeling hot, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient waited at pharmacy for 15 minutes after vaccination, then left to go get coffee with her mother. At coffee shop, patient complained of feeling hot then passed out and her head hit the floor. She immediately regained consciousness. We elevated her feet and stayed with her and monitored her until paramedics came. Paramedics assessed and stated that all vitals were good. After sitting for a bit, patient left to go home with her mother. Per patient's mother she had not eaten today.
12 2021-06-18 pain in extremity, numbness Patient experienced pain and numbness in left arm after administration. Numbness and pain were repor... Read more
Patient experienced pain and numbness in left arm after administration. Numbness and pain were reported in lower arm extremity. Patient evaluated over the course of 30 minutes. During that course patient reported pain and numbness travelling down to wrist and fingers. She also reported a pounding headache once felt on forhead. Patient did report that it was getting better than worse over the course of observation. Mother was advised to contact pediatrician for further assistance if it progresses to worst.
12 2021-06-19 cold extremities Patient loss consciousness for a few seconds, vomited, hot to the touch at first then cool to the to... Read more
Patient loss consciousness for a few seconds, vomited, hot to the touch at first then cool to the touch. 911 was called and vitals were checked by the paramedics. Patient did not go to the hospital and vitals were within range.
12 2021-06-19 seizure Multiple seizures lasting longer than 30 minutes. This happened after the second dose on 6/18/2021. ... Read more
Multiple seizures lasting longer than 30 minutes. This happened after the second dose on 6/18/2021. Happened approximately 7 hours post vaccination. Required ambulance transport to emergency room and overnight hospitalization at a hospital.
12 2021-06-20 pain in extremity, tremor The patient was in extreme pain in her legs. this spread to her whole body. She had chills, shaking,... Read more
The patient was in extreme pain in her legs. this spread to her whole body. She had chills, shaking, sweating and stomach cramps. This event lasted almost 6 hours. We called the pediatricians on-call nurse and were told to start ibuprofen. The symptoms began residing about 5 hours after on-set and then by hour 6 the majority of the symptoms were gone. Patient still had body aches and chills for 12 hours more.
12 2021-06-22 weakness As soon as getting the vaccine the Patient Fainted for a few seconds , a few minutes after regaining... Read more
As soon as getting the vaccine the Patient Fainted for a few seconds , a few minutes after regaining consciousness few was doing better but a little weak. The ambulance was called and she walked to the ambulance outside the pharmacy and the EMS professionals checked her vitals and they said they are normal. She was in pharmacy waiting area for another 30 minutes for observation and went home. In the evening we called and talked to her father and we were informed that she is doing good.
12 2021-06-22 numbness Patient reported that her arm was numb. No rash or swelling present. Patient denies pain. After talk... Read more
Patient reported that her arm was numb. No rash or swelling present. Patient denies pain. After talking to the EMTS, the patient reported that the numbness had subsided.
12 2021-06-22 seizure Patient woke up and complained of a stomach ache and went to the bathroom Patient felt dizzy and com... Read more
Patient woke up and complained of a stomach ache and went to the bathroom Patient felt dizzy and complained of a headache. Had then started having a seizure. Patient does not have seizures.
12 2021-06-24 burning sensation Pain and a hurting sensation present at site of vaccination at 1405. Pt waited 15 minutes in the EMS... Read more
Pain and a hurting sensation present at site of vaccination at 1405. Pt waited 15 minutes in the EMS room with an ice pack and then left vaccination clinic. Pt stated she was feeling better, however, pt returned with guardian and stated that burning sensation was still present. Pt was provided a second ice pack for site of vaccination. Nurse administered PO 25mg of Benadryl with guardians consent at 1430. Pt states at 1440 that she feels better. Minimal pain and burning sensation present. Pt has a history of needle phobia and anxiety.
12 2021-06-25 weakness Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headac... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: hypoglycemic event
12 2021-06-27 involuntary muscle movements Received the injection, she stood up while her other family member got their vaccine. Went to sit do... Read more
Received the injection, she stood up while her other family member got their vaccine. Went to sit down and when the immunizer came around, she was slumped over in her chair and presented with jerking motions. After about a minute, she came to and said that she was really dizzy. We asked if she was okay and asked her to stay for an additional 30 minutes for further observation. She drank some water and ate a snack afterwards. She said she was okay to leave after that and her mother was driving her home.
12 2021-06-27 pain in extremity With the first dose: Headache (came and went frequently) dizzy(2-3 days) nausea (2-3 days) sore arm ... Read more
With the first dose: Headache (came and went frequently) dizzy(2-3 days) nausea (2-3 days) sore arm (3-4 days) gave ibuprofen for about 2 days and most symptoms went away. She continued to complain about a headache every once in awhile. About a week later I noticed her eyes seemed a little yellow but it didn't seem to get worse and thought maybe she just need to drink more water and get some sleep. After second dose: Bad headache (3-4 days) dizzy and nauseous (3 days) gave ibuprofen for 2 days. Two days after the vaccine she was fully jaundice. Hadn't notice because she was feeling bad from the vaccine so I just let her sleep mostly. Next day we got into see her primary care dr who ordered stat bloodwork and stat ultrasound. That same day she got some blood work back and told us to go to the er because her platelets were really low. At the er they diagnosed her with autoimmune hemolytic anemia, which explained the jaundice. She was admitted and put on steroids. Her hemoglobin got as low as 5 and they cross matched her incase they needed to do a blood transfusion. They were concerned that there was a possibility that her immune system would attack the donor blood since it seemed to be attacking her platelets as well. Luckily the steroids started working and he levels creeped up a little. She also recieved 3 vitamin k transfusions and pain meds. When she was switched to oral steroids and her numbers were still rise they released her. She is still taking steroids and has weekly follow ups with Dr. . We are also in the process of getting a rheumatology referral to see if there is an underlying condition we didnt know about.
12 2021-06-27 unresponsive to stimuli, weakness Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
12 2021-06-27 unresponsive to stimuli Within minutes after receiving 1st dose of Pfizer-BioN Tech covid Vaccine 0.3 ml IM, patient complai... Read more
Within minutes after receiving 1st dose of Pfizer-BioN Tech covid Vaccine 0.3 ml IM, patient complained of dizziness and fell to the ground. Patient was very pale and cold to touch, not being responsive well. Patient was losing consciousness and having difficulty keeping her head up. Patient was moved to lie down on the floor with legs up. Cold water was offered and patient took a few sip. EMS was called. Patients eyes rolled back into her head and lost consciousness/possible anaphylactic shock and not being responsive. Epipen 0.3 MG IM administered. Patient regained consciousness. Nurse practitioner was called and vitals including BP and oxygen level was performed and found to be stable. EMS arrived in few minutes and vitals were checked again by EMS personnel and patient was transferred out to nearby ER. After 3 and 1/2 hours at the ER for observation, patient was discharged.
12 2021-06-28 weakness Shortly after vaccination client became pale and diaphoretic and fell from chair possible short LOC,... Read more
Shortly after vaccination client became pale and diaphoretic and fell from chair possible short LOC, weak, HR 68, BP 79/50
12 2021-06-28 unresponsive to stimuli Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: D... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium
12 2021-06-28 unresponsive to stimuli Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: D... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
12 2021-06-29 breast pain 2 weeks after the patient received the COVID vaccine in her left arm she developed an abscess in her... Read more
2 weeks after the patient received the COVID vaccine in her left arm she developed an abscess in her LEFT breast requiring ultrasound and treatment with antibiotics. She started with left breast pain then developed redness and warmth of the breast. She was seen in the office for evaluation then sent for an ultrasound. The ultrasound indicated a 10mmx10mmx8mm abscess. She was then referred to a breast surgeon that day for surgical intervention. The surgeon did not feel that surgical incision and drainage necessary at that time and agreed with the plan to treat initially with antibiotics.
12 2021-06-29 flushing, unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient reported severe dizziness and nausea about 5 minutes after receiving the Pfizer vaccine. She ended up vomiting few times. Patient was given water and crackers. She did not end up feeling better even after resting for 15 minutes. The family called 911 and Emergency services took her to the hospital
12 2021-06-29 pain in extremity Pt's mother described an injection site reaction that was swollen and hard to the touch, as well as ... Read more
Pt's mother described an injection site reaction that was swollen and hard to the touch, as well as red and raised above the skin. Did not describe any other pain outside of regular arm soreness nor any itching. Diphenhydramine oral or topical was recommended by the pharmacist on duty whom she described the reaction to.
12 2021-06-29 unresponsive to stimuli, involuntary muscle movements Approximately three minutes after administering the vaccine we heard the patient's mother speaking h... Read more
Approximately three minutes after administering the vaccine we heard the patient's mother speaking her name several times with no response. One of the technicians was in the area and observed her with her arms tucked in front of her and her feet were moving back and forth in a repetitive motion with her eyes rolled back. After a few seconds she ceased that and said "I was sleeping" We called 911 and EMS came to check her out
12 2021-06-29 unresponsive to stimuli, flushing Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweat... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: PATIENT REPORTED ARM PAIN AND PASSED OUT BRIEFLY (ABOUT 15-20 SECONDS) - GAVE WATER AND MONITORED FOR 30 MINS. TOOK BP 105/78 WHICH MOM REPORTS AS NORMAL FOR PT. FULL RECOVERY EXPECTED
12 2021-06-29 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Mom stated pt felt lightheaded, her eyes rolled back, and fainted for a few seconds. When we observed her, pt was ok but a little shaky. The paramedics came and checked on her, but mother declined going to ER
12 2021-06-30 burning sensation PATIENT EXPERIENCED REDNESS DOWN ENTIRE ARM, ITCHING AND BURNING IN FACE WITHIN 5 MINUTES OF INJECTI... Read more
PATIENT EXPERIENCED REDNESS DOWN ENTIRE ARM, ITCHING AND BURNING IN FACE WITHIN 5 MINUTES OF INJECTION.
12 2021-06-30 numbness, tingling PATIENT, WAS GIVEN THE 1ST DOSE OF PFIZER VACCINE. FEW MINUTES AFTER THE VACCINE PATIENT REPORTED FE... Read more
PATIENT, WAS GIVEN THE 1ST DOSE OF PFIZER VACCINE. FEW MINUTES AFTER THE VACCINE PATIENT REPORTED FEELING DIZZY, PATIENT STATED SHE DID NOT FEEL VERY WELL, AND PATIENT HAS REPORTED HISTORY OF FAINTING AFTER VACCINATION. PATIENT WAS ADVISED TO LAY ON THE GROUND FOR WHILE SHE FELT LITTLE BETTER. HOWEVER SHE STATED SHE FEELING DIZZY, HAS HEADACHE AND REPORTED TINGLE /NUMBNESS IN HER LEGS. AMBULANCE WAS CALLED AND TOOK THE PATIENT. I FOLLOWED UP WITH THE PATIENT,. PATIENT WAS IN OKAY CONDITION, I SPOKE TO THE PATIENTS FAMILY MEMBER THEY STATED THAT THE DOCTOR SAID PATIENT FELT DIZZY DUE TO VASOVAGAL SYNCOPE. NO OTHER SIDE EFFECT WAS REPORTED.
12 2021-06-30 pain in extremity, discomfort headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine gi... Read more
headache; threw up; shallow quick breathing; fever; Injection site sore arm 4 hours after vaccine given; very tire 10 hours after; chills; shallow quick breathing; heart racing; very uncomfortable; dry throat; arm extremely sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 12-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in Left arm on 06Jun2021 at 09:00 AM (at the age of 12-year-old), as single dose for covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EW0180), via an unspecified route of administration on 25May2021, 09:00 AM administered in left arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID 19. On 15Jun2021 at 13:00, the patient experienced injection site sore arm four hours after vaccination/ arm extremely sore; she was very tire 10 hours after chills; had fever; experienced shallow quick breathing, heart racing, dry throat; and she was very uncomfortable. On the same day, she fell asleep about 11:30pm and threw up at 3:00 AM. On 16Jun2021 (on next day), she had headache and still on day 3. Therapeutic measures were taken with Tylenol, cool compress, hydration as a result of reported events. The outcome of event was resolving. Follow-up attempts are needed. Further information is expected.
12 2021-06-30 pain in extremity Sore left arm; tiredness; This is a spontaneous report from a contactable consumer (Parent). A 12-ye... Read more
Sore left arm; tiredness; This is a spontaneous report from a contactable consumer (Parent). A 12-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in Left Arm on 12May2021 (at the age of 12-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. The Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) loratadine (CLARITINE) vaccine in two weeks. No other vaccine administered in four weeks. No Known allergies were reported. The patient did not test for covid post vaccination. The patient did not suffer from covid prior vaccination. On 12May2021, the patient experienced sore left arm and tiredness. Patient did not received ant treatment. Query included Pfizer Drug safety unit recently received the attached report submitted via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response received I first became aware of this event on 12May2021. Please let me know if you need anything else. The outcome for the events was recovering.
12 2021-06-30 pain in extremity My daughter experienced on day of her 2nd vaccine, feel nauseated in the evening time, then the seco... Read more
My daughter experienced on day of her 2nd vaccine, feel nauseated in the evening time, then the second day. Felt very lethargic, fatigue, laying in bed all day, sleeping. She still had nausea also experienced chills, highest temp 99.8F. Her arm pit on the right side where she got the vaccine was really sore. She basically like within a couple of days she started her period cycle again and it was very heavy and lasted one week and half almost two weeks. On 06-08-2021, at about 10pm, she was brushing her teeth when she saw black spots and she went to tell me. At about 11:30pm that night, she squatted to pat our dog and when she got up and she felt really dizzy, lightheaded so I got concerned. Her symptoms persisted and I scheduled an appointment with her pediatrician on 06-15-2021. The pediatrician ruled out anemia. Her pediatrician said she has Postural orthostatic tachycardia syndrome. Her pediatrician said that this is something manageable, she needs to strengthen her calf muscles and drink lots of water. They monitored her heart pressure and blood pressure. Her heart rate had increased to 40bpm. I also gave her Ibuprofen medication after the vaccine. Leading to today she has been having dizziness and light headiness every single day. My daughter is still experiencing symptoms, dizzy and light headed today. For her 1st vaccine- within few days after her 1st dose, she experienced when using the treadmill, she would feel very dizzy. I did not think anything of it at first and this happened three times then it stopped. She also had a sore arm.
12 2021-07-01 pain in extremity June 26th- started getting a painful vesicular rash on her left arm- finger- spread up arm to axilla... Read more
June 26th- started getting a painful vesicular rash on her left arm- finger- spread up arm to axilla and then to L scapular area. + axillary lymphadenopathy. + fever and headache started 6/30/2021. Had a Dr. visit 6/30/2021. Diagnosed with shingles and started on acyclovir. No other areas of rash. No other symptoms. Fever and headache resolved mid day 7/1/2021. Rash on L arm continues- painful. Also had + rapid strep test that office visit on 6/30/2021- no throat pain- but still placed on antibiotics for strep- penicillin.
12 2021-07-02 pain in extremity, sensory loss Received the 1st dose of Pfizer Covid vaccine on 6/15/21. Patient had a headache, pain in left arm a... Read more
Received the 1st dose of Pfizer Covid vaccine on 6/15/21. Patient had a headache, pain in left arm and felt tired. On 6/16/21 she woke up around 10:00am and said her legs felt numb or asleep from the ankle to mid thigh. I contacted the pediatrician office and they advised us to wait and see if she had any other additional symptoms or changes. Patient said she could feel the sensation of pressure but could not feel what was touching her. She went to her usual swim team practice and seemed to be just fine except for the strange loss of sensation in her leg.s. On 6/17/21 her symptoms were unchanged upon waking up. She attended running club practice from 9-10:30am, and when I picked her up she said that now her left arm was experiencing the same loss of feeling from shoulder to her wrist. I took her to the pediatrician office, where they advised me to take her to the emergency room for further evaluation. She was seen by two different doctors in the ER at Hospital, and no other tests were done at the time. The doctors advised us to keep monitoring her symptoms of loss of sensation and return if any other symptoms occurred. Since that time Patient has had some improvement in feeling but overall it has stayed the same. Doctors could not find any other possible causes for the symptoms either. They did recommend getting the 2nd dose but warned that the loss of sensation could get worse.
12 2021-07-03 burning sensation She got a fever, muscle aches, severe headache. Then she started getting small patches of a raised r... Read more
She got a fever, muscle aches, severe headache. Then she started getting small patches of a raised rash. It started near the injection site, then on her wrist (same arm) then on her chin, same left side. After a few more days she started getting them all over: legs, chest etc. They itch her like crazy and burn when she tries not to itch.
12 2021-07-04 weakness Loss of sight and hearing, headache, generalized weakness. No shortness of air, patient hadn?t eaten... Read more
Loss of sight and hearing, headache, generalized weakness. No shortness of air, patient hadn?t eaten breakfast before the vaccine.
12 2021-07-05 seizure Patient was vaccinated at 8:48. Her sister was vaccinated at 8:52. The patient was sitting next to... Read more
Patient was vaccinated at 8:48. Her sister was vaccinated at 8:52. The patient was sitting next to her sister when her sister started feeling faint. The sister was evaluated and provided water. It was then reported to the healthcare providers that the sister feels anxious when she gets vaccines and does pass out. While evaluating the sister and providing her water the patient became limp in her chair, dropping her personal items and laid head on her dad who was standing next to her. Upon initial evaluation the patient started having convulsive activity affecting her head, face and shoulders. The patient was lowered to the floor to a safe setting. The convulsions lasted approximately 5-10 seconds. Once convulsions were over the patient was alert and responsive. Her vital signs were HR:92, SPO2:96%; BP:113/78. Paramedics were called immediately and arrived approximately at 9:10. The patient was laying on the floor and paramedics started a complete evaluation; placing the patient onto the heart monitor, and ran another set of vital signs and a point of care blood glucose. Vital signs, monitor reading, and blood glucose were unremarkable. The patient has NKA; No past medical history and is on no current medications. Upon evaluation when the patient was helped from laying to sitting by paramedics she started to feel faint once again. The patient was taken to the hospital for further evaluation.
12 2021-07-06 weakness Meningitis pain; she woke up and said her face felt funny; pressure on her chest; pressure behind he... Read more
Meningitis pain; she woke up and said her face felt funny; pressure on her chest; pressure behind her eyes; muscle pain; she had not slept,; fever; headache; the chills; sore throat; nauseous; Caller states she was assuming hives; inflammation stayed around awhile; body aches / pain through her head and back down her neck; trying to push her eyeballs out and it is really painful; she was slumpy; swelling from the digging and scratching; her hands began to swell yesterday; she was just not feeling right; couldn't walk by herself; lip swelling and numbness; lip swelling and numbness; itching on face, hands and feet / Caller states then her daughters hands and feet began to itch; This is a spontaneous report from a contactable consumer or other non health care professional. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EW0178; Expiration Date: 31Aug2021), dose 2 via an unspecified route of administration, administered in Arm Right on 08Jun2021 16:00 (age at vaccination: 12 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, meningitis from an unknown date and unknown if ongoing at 7 years old. The patient's concomitant medications were not reported. The historical vaccine include COVID-19 Vaccine on 18May2021 for COVID-19 Immunization (1st dose Expiry Date of Covid 19 vaccine: 31Aug2021, lot EW0168 ,anatomical location: Right arm) and had she had itching on the hands. And other vaccine includes flu shots (she does the flu shot every year) for immunization. The patient experienced Meningitis pain on unspecified date, lip swelling and numbness, itching on face, hands and feet / caller states then her daughters hands and feet began to itch in Jun2021. She has pressure on her chest on 09Jun2021. She had pressure behind her eyes, muscle pain,she had not slept, fever, headache, the chills , sore throat, nauseous, caller states she was assuming hives, inflammation stayed around awhile , body aches / pain through her head and back down her neck, trying to push her eyeballs out and it is really painful , she was slumpy, swelling from the digging and scratching, her hands began to swell yesterday in Jun2021. she woke up and said her face felt funny on 09Jun202. she was just not feeling right and couldn't walk by herself on Jun2021, Caller relays her daughter will be (withheld) . HCP: Caller states she called the pediatrician office and 1 was by phone and she was seen by this provider yesterday and she encouraged her to reach out to us as well. Mom states she was aware of the possible symptoms to occur and her daughter came home Tuesday perfectly fine and went to bed and woke up with the typical symptoms, she had not slept, fever, headache, the chills, sore throat, nauseous and had all the symptoms pretty much. States she didn't have anything weird going on during the observation time the day of the vaccine. Caller relays her daughter didn't have anything weird after her 1st dose. Caller states she took a nap Wednesday about 24 hours after her 2nd dose and she woke up and her lips had begun to swell and she woke up and said her face felt funny and it was itchy. Caller states she was assuming hives. Caller states that there was nothing concerning as it wasn't in that initial 15minutes to 4 hour and that this occurs 24 hours after and that was a concern. Caller states then her daughters hands and feet began to itch and that was kind of along the same lines and said hives and she would itch itch itch and there was swelling from the digging and scratching. Caller states she has numbness in her lip with the swelling. Caller states the other symptoms that are bizarre is more yesterday and it started some on Wednesday she had a pressure in her chest and this was a child, her daughter was very strong, she got up yesterday and tried to do school and had a fever of 102 and Wednesday evening was so sick with symptoms and she still tried. Caller states the pressure in her chest is concerning and told them yesterday and she needed to be seen. States her daughter described it to the doctor that it felt like someone was sitting on her chest sort of pressure and on a scale of 1-10 she was a 7. Caller provides that not at any time did she experience trouble breathing and she never saw her lose or get weird coloring. Caller states she called her doctor Wednesday afternoon and talked to another doctor, that she called the help line after hours as they close 4:30 or 5pm. States she was told it was good news that she did not have trouble breathing but to have it at this point was weird and no one knows what to expect and everyone is different. States she was told to do Benadryl and continue with pain medication for fever and discomfort. Caller states her daughter was miserable the rest of the evening. Caller relays that the swelling subsided and the inflammation stayed around awhile and yesterday she woke up better with no nausea and the common symptoms are better and she still had the fever. Caller relays that at about 9:00 she began to have a problem where she said that behind her eyes she had significant pressure and that scared the caller what with the brain and swelling. Caller states her hands began to swell yesterday, like her lip and her fingers are itchy and swelling and it's constant itching and the pressure on her chest yesterday, that those 3 things freaked the caller out and she called the pediatrician and they said to have her checked out to make sure as nobody wanted to rush her to the ER as she was not struggling to breathe she was just not feeling right. Caller states the pediatrician did her research about heart inflammation and listened to her heart a couple of times and said her best observation for rubbing sounds was she did not hear any. Caller states when her daughter was younger she had meningitis and went through a whole lot with that and caller states she does not immediately rush to the hospital as that brings back emotions with that. Caller states the doctor said she didn't see any immediate distress and would do an EKG or they could wait and see, that she thought the pressure might be like body aches and her daughter had laid in bed all day the day before and had a time with it. Caller states she couldn't walk by herself and she was out of it. Caller states she could do the EKG or wait until today and they chose to wait. States that today she seems better and the only thing today is the continuing pressure behind her eyes that her daughter described as it felt like someone had 2 spoons and was trying to push her eyeballs out and it is really painful. Caller relays her daughter has been through meningitis pain and has pain through her head and back down her neck and the concern is swelling. Caller states it could be a weird reaction and the doctor thinks it is a weird headache she is having and is still doing ibuprofen. Caller relays that her chest is not nearly as heavy today and she has taken Benadryl again for itching and swelling. States the doctor says they don't know what did it because the risk was there and the benefit and don't want to get reactions. Caller states she had no problem with getting the shot, that weird things happen and the pediatrician is saying it can happen but doesn't know. States it is kind of scary. Caller states they checked her out and they checked her oxygen and blood pressure and that made the caller feel better. States that 9:30-10 last night after she got home she was slumpy and her head was hurting and she had chest pressure. Caller states with the hand swelling, that the caller herself went through reaction and hives and the doctor had asked if her daughter had anything new introduced and no nothing was and her daughter didn't seem concerned to share this but after her 1st dose her hands itched and she didn't pay it any mind. States she had no face swelling. Caller states she is wondering if those little hand itches after the 1st dose she didn't tell about till now was that a little bit of a sign that something else was there. States she didn't mention it after the 1st dose and was good to go. States after the 2nd dose she said mommy my hands itched after the 1st dose, her lip didn't swell and she told the doctor it's not conditions on the list of symptoms and she didn't have breathing issues. Caller states it's a non severe reaction and is assuming to dose and said yesterday if she gets a booster what does Pfizer advise. Caller states they have all intention of getting what she needs in the future. Caller states she wants to make sure she doesn't have worse and the lip swelling was freaky. Caller states she thought her daughter was out of the woods after the 20 minutes waiting and was home and then turned. Caller states it was pretty straight forward and knew what the expected symptoms were and they were fine and knew she was having the exact ones on the list and was not feeling well and had a fever. States she was thrown for a loop when others came up and the fact that they were 24 hours out, that she got the 2nd dose 4-4:15 on Tuesday and these evolved well after that time. Caller said they said to report this and her hope is that they can help if someone else has this issue. States when she said she was laying there my hands did itch after the 1st but not like this to this degree. States she never said anything and caller didn't know. States she knows as a parent there are certain questions to ask and warning signs of potential allergic reactions. Caller states she is assuming this is some sort of allergic reaction, not the worst kind but pressure in the chest and other concerns about her heart having some sort of issue she knows have been reported.Caller states that today she could have done the EKG for more information but based on her listening and what she wanted to thinking the body aches and extensive issues with that she is glad she waited. States she was laying in bed at 6:30 and asked her if she wanted to get the EKG and she said she was afraid of going to the hospital and it's not fun but would give answers if there is something else and she laid in bed until 9:30-10 and gave her more Benadryl and Ibuprofen and continued with that for the discomfort behind her eyes and the doctor is thinking it's body aches. States the fever subsided yesterday.Caller states she would like to share that her daughter is a tough kid and tough kids can be taken down too and may not pay attention. Caller states she doesn't over react but she is aware and if she had told her about her hands she would have thought allergic reaction, mild one and brought her to the doctor or at the 2nd vaccine and she didn't say anything until after the fact. Caller relays her daughter has never been through hives and the caller has and has a lot of seasonal and environmental allergies and the caller was that kid. Caller states with her daughter not having seen her lip swell and her eyes started hurting and she started thinking the worst. States the doctor pushed on her and checked her lymph nodes and did a thorough exam that lasted about 30 minutes and nobody knows. States she appreciates all that Pfizer and the other companies have done, that we need this.Caller states her daughter goes to the pediatrician in 2 weeks for her annual check up. States the doctor yesterday said her body responded and had a hard time with it. States she does the flu shot every year and this was weird and she wanted us to know and hopes this report can help. Caller states her daughter is a tough kid nobody knows and today she is better, she has a headache behind her eyes still there.Caller relays that Friday she had her annual eye check up and it's not a vision thing, that was fine until Wednesday and other other stuff and yesterday with pressure and she is sure it's residual and her body adjusting and if she can help with letting other people know.Caller relays if it comes back she is going to do the EKG, that she is not the parent to say it is nothing and will follow through with Pfizer also. Caller states she didn't have anything weird for heart beat and no rubbing sound and no signs and she thinks it was issues from body aches and hopefully she is on the up and up and nobody will have to leave and go to the doctor today. And didn't think because it was not an immediate issue with her breathing and nothing like that and didn't think it would be an issue with a booster. Caller states it could be that instead of sitting for 20 minutes they keep her longer and that when she fills out the sheet if was not an option, she knows there is severe reaction listed, she will make notes and make the person giving the dose aware that she had the delayed what they are believing to be allergic reaction and make sure, that she may never have it again and it could have been her system was so under attack. Caller states she doesn't understand vaccines and knows it's the body's job to do something and she is not reluctant helping her be immune and she understands what to do in the event and doesn't have an epi pen and her daughter has no allergies and no reactions to anything. Caller states she didn't have the worry, that there is always a chance and you worry when something foreign goes in the body that there is a chance to react. Investigations: Caller states they listened to her heart and took her vitals and tests with her fingers checking her eyes to make sure her pupils were dilating correctly and move her eyes with a moving finger. Caller states she doesn't know the medical term but the basics and let them know she was not in dire straights to rush to the hospital immediately. The patient underwent lab tests and procedures which included blood pressure measurement, body temperature: 102 fahrenheit, electrocardiogram, oxygen saturation, vital signs measurement was unknown and unspecified date. Therapeutic measures were taken as a result of lip swelling and numbness, itching on face, hands and feet / caller states then her daughters hands and feet began to itch, pressure on her chest , fever, swelling from the digging and scratching. The outcome of the events was unknown.
12 2021-07-06 seizure Patient presented to ER with mother after having 2 witnessed seizures at the family's cabin, ~12 hou... Read more
Patient presented to ER with mother after having 2 witnessed seizures at the family's cabin, ~12 hours apart. Admitted to the hospital for observation and no further seizures occurred. Neurology consulted and MRI of head completed with no significant findings (no mass, hemorrhage, or evidence of acute ischemia; no evidence of mesial temporal sclerosis; no malformations of cortical development; no suspicious areas of enhancement).
12 2021-07-07 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
12 2021-07-07 cold extremities Mom states pt fainted for the first time yesterday morning (07/07/2021). Pt stated she woke up thirs... Read more
Mom states pt fainted for the first time yesterday morning (07/07/2021). Pt stated she woke up thirsty but did not feel dizzy. Pt asked mom for water and as she was going to the kitchen she fainted. Mom states pt looked pale and her hands were cold. Pt states she does drink lots of liquids everyday. Pt states she does not have any stressors at this time and actually feels really happy. The only thing is pt did receieve the first dose of the Covid-19 vaccine on Tuesday (07/06/2021). Today pt states she feels much better. No other symptoms or concerns at this time.
12 2021-07-08 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted about 2-3 minutes post vacc... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted about 2-3 minutes post vaccination, was un-responsive for 5-7 minutes, Pulse and breathing were normal, paramedics arrived and checked her out. she ended up leaving with her mother.
12 2021-07-08 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Adverse event (fainting) occured today a... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Adverse event (fainting) occured today at time of immunization. Pt fainted near immediately, regained consciousness in about 15-20 seconds, then seemed a bit dazed for several minutes. Pt stayed at the pharmacy for about 17-18 min and seemed to recover by the end and walked out with her parents. Parents noted that this is a normal reaction to vaccines, but this time did seem to be the most severe compared to past events.
12 2021-07-09 weakness Patient got her 2nd covid19 vaccine on July 2nd. starting from July 7th, after eating methimazole, s... Read more
Patient got her 2nd covid19 vaccine on July 2nd. starting from July 7th, after eating methimazole, she feel headache, nausea, want to vomit, but can't spit it out. she is lack of energy. she take methimazole for more than 2 years, never has this symptom before. all abnormal happened 1 week after her 2nd covid19 vaccine. I am worried about her.
12 2021-07-09 discomfort Patient came in with her mom to get their first dose of Covid-19 vaccine. Mom filled out form and s... Read more
Patient came in with her mom to get their first dose of Covid-19 vaccine. Mom filled out form and selected NO for all questions. After receiving the vaccine, the mom was advised to wait in the pharmacy area for 15 minutes for observation. The patient ended up walking away a few minutes after and fainting face down in of the isles. She came to very quickly but was bleeding from her mouth. She bit her lip and was in discomfort. She was given water and her only complaint was her upper teeth "didn't feel right". She was wearing braces. Paramedics arrived and gave a thorough examination. Mom refused transport to the hospital.
12 2021-07-09 flushing, weakness Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / ... Read more
Systemic: Abdominal Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: Patient's original BP was 91/57 and second reading was 92/72. She fainted for less than a minute and regained consciousness. She suffered from severe nausea/abdominal pain and vomited. Patient was given water and felt much better after throwing up. She also complained of feeling tired.
12 2021-07-11 bell's palsy Bell's Palsey
12 2021-07-11 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: Patient had injection, appeared fine, moved to additional seating area and within 2 minutes had fainted. She regained conciousness immediately but we had her lay flat for approx 30 minutes. Her color returned, and she was talking and recovered. We told patient to report to MD her reaction and obtained pcp info to report as well. Parents advised if any additional interactions to take in to be seen.
12 2021-07-13 seizure Seizures
12 2021-07-14 weakness Polyneuropathy in bilateral legs, headache, and weakness 24 hours after first dose of Pfizer with wo... Read more
Polyneuropathy in bilateral legs, headache, and weakness 24 hours after first dose of Pfizer with worsening over subsequent 48 hours - currently being admitted to hospital for evaluation.
12 2021-07-14 pain in extremity Bilateral hand rash. Symptom onset on day 3 (June 25, 2021) with progressive worsening. Itching and ... Read more
Bilateral hand rash. Symptom onset on day 3 (June 25, 2021) with progressive worsening. Itching and soreness. Treated with Clobetas 0.05% cream - 2x daily beginning on July 2, 2021 through July 8, 2021.
12 2021-07-15 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hype... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Medium
12 2021-07-17 pain in extremity began seeing a scary image of a very distorted, grotesque person; pain in her arm; malaise; nausea; ... Read more
began seeing a scary image of a very distorted, grotesque person; pain in her arm; malaise; nausea; headache; fatigue; She is afraid to walk alone in the hallway. She has this fear that someone is gong to jump off and attack her; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 12-year-old female patient (reporter's daughter) that: A 12-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0181; Expiration Date: Aug2021), via an unspecified route of administration, administered in Arm Right on 18Jun2021 at 09:15 as single dose (at the age of 12-years-old) for covid-19 immunisation. Medical history included PFAPA syndrome, fever, and redness at the injection site. The patient's concomitant medications were not reported. Patient did not take any prior vaccinations within 4 weeks. On 18Jun2021, in the evening, patient had pain in arm, nausea, headache, fatigue and malaise. Reporter stated that, three days after receiving the vaccine, her daughter began seeing a scary image of a very distorted, grotesque person. She was afraid to walk alone in the hallway even during the day. Caller reported that it has gotten better, at least during the day. Caller reported that the patient doesn't tell her about the image, but the patient knows it's not real and not there. Caller reported that the patient says that she cannot shake this feeling of fear that something is going to jump out at her or attack her. Caller reported that the patient's feeling of fear comes and goes. Caller reported that what has gotten better it seems is during the day. Caller reported that the patient said that when she is busy or distracted, she doesn't think about it, but if the patient has more time on her hands she starts to go there. Caller reported that the patient is having kind of like this feeling, not necessarily paranoia, but a feeling like something is going to happen or jump out at her and she can't shake it. Caller reported that the patient knows that it is not real and not there. Caller reported that the patient received the Covid-19 vaccine because of school as they are not going to have a virtual option, as well as just to be safe and be able to travel. Caller reported that on night of 30Jun2021 was a little better but was a little worse at night on 01Jul2021. Caller reported that the patient was home schooled and was fully fine. Caller reported that the patient's grades were excellent and that she was happy to be home but missed her friends. Caller reported that this was very bizarre to her and that the patient's pediatrician advised the caller to call Pfizer and not to give the patient the second dose of the Covid-19 vaccine. Caller reported that although the patient's physician hadn't heard anything, she wanted to ask if Pfizer had heard anything. Caller stated that she reported the event to VAERS as well and made a submission. Caller stated that she does not know if Pfizer can give her that information or not but she just didn't know if this is something Pfizer has seen. On 19Jun2021, pain in arm, fatigue, nausea, headache and malaise was resolved. The outcome of She is afraid to walk alone in the hallway. She has this fear that someone is going to jump off and attack her and began seeing a scary image of a very distorted, grotesque person was unknown. Follow up attempts are needed. Further information has been requested.
12 2021-07-19 flushing Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: Rph gave first pfizer covid vaccine to patient and she felt nauseaus within a couple of minutes. Mother reports daughter lighter in color and needed a bag in case she needed to vomit. PT's mother declined to be brought into ER because daughter (patient) appeared to have recovered. Instructed by parametics to f/u with primary doctory.
12 2021-07-20 tremor, flushing Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, ... Read more
Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium
12 2021-07-21 seizure Approximately 3 minutes after injection, our daughter was sitting next to her mother, her head lolle... Read more
Approximately 3 minutes after injection, our daughter was sitting next to her mother, her head lolled over the back of her chair and she began to have a seizure. The event only lasted about 45 seconds before she came out of seizing. She had a bright orange ring around her mouth, trouble breathing and vision issues. the pharmacist called an ambulance. These symptoms were mostly cleared up before medical arrived, with only dizziness, disorientation and slight vision issues remaining.
12 2021-07-21 seizure Systemic: Seizure-Severe, Additional Details: patient was administed covid 19 pfizer vaccine. after ... Read more
Systemic: Seizure-Severe, Additional Details: patient was administed covid 19 pfizer vaccine. after 3 minutes, she started to convulse. she came to after about 1 minute, but was very out of it. 911 was called and she was brought to hospital.
12 2021-07-21 unresponsive to stimuli Approximately 45 seconds after vaccination, patient began drooling and became diaphoretic, pale, an... Read more
Approximately 45 seconds after vaccination, patient began drooling and became diaphoretic, pale, and non-responsive, although she remained conscious. The patient's mother thought patient looked "blue." A Health Department nurse administered one EpiPen while another staff member called 911. Patient stopped drooling, regained normal color in her face, and began smiling almost immediately after epinephrine was administered. Nurse then took and recorded patient's blood pressure as 92/62, pulse as 64bpm, and respiratory rate as 24. Paramedics arrived approximately five minutes later and evaluated patient, who seemed to have returned to normal. Patient and her mother declined to have the patient transported to the hospital via ambulance for further observation. Patient was then driven home by her mother. Deputy COVID Operations Chief spoke with patient's mother over the phone around 6:30PM that same day to follow up with the patient. Patient's mother reported that the patient had returned to her normal self, had not experienced any further adverse events, and wished to move on from the incident.
12 2021-07-22 feeling hot Parent said Pt wasn't feeling well after her first covid shot. Her pulse was low when I checked her... Read more
Parent said Pt wasn't feeling well after her first covid shot. Her pulse was low when I checked her. She looked very pale, and she said she felt hot. She said her breathing was fine so no epipen was given. Pt was able to walk after she rested, and her mom took her to the hospital.
12 2021-07-22 pain in extremity Had routine reaction immediately post vaccine (pain, redness, nausea, muscle aches, fever, etc) that... Read more
Had routine reaction immediately post vaccine (pain, redness, nausea, muscle aches, fever, etc) that recovered. Then, on 7/12/21, she started to experience pain, redness, and some swelling again but this time there was some pain on the right side as well. Pain originating from deltoid and radiating through arms and shoulders. On 7/16/21 the pain was worsening and she was no longer able to perform daily activities as well as would cry if her arms were even slightly touched. she was referred to the Urgent Care who did testing for illness and muscle conditions which came back normal. She was screaming through trying to get bloodwork due to the pain which is atypical for her and they sent us to the ER for pain with unknown origin. ER physician said all neurological processes were normal and was concerned for Complex Regional Pain Syndrome so he wanted an urgent follow-up with Primary Care. on 7/19/21 Primary Care suggested delayed response to the vaccine and referred her to Neurology. On 7/22/21 Neurology decided it was a delayed immune response to the Covid vaccine and prescribed Prednisone to start today 7/23/21.
12 2021-07-22 cold extremities Pt fainted and lips turn blue and face become pale . Hands and body felt cold. Pt fainted only fo... Read more
Pt fainted and lips turn blue and face become pale . Hands and body felt cold. Pt fainted only for few seconds. She was okay after few mins. Pt got taken to ER by EMS.
12 2021-07-23 weakness 1 day after receiving the COVID #2 vaccine, felt dizzy, body weakness, pain in stomach and head, fev... Read more
1 day after receiving the COVID #2 vaccine, felt dizzy, body weakness, pain in stomach and head, fever (tactile), 1x vomit - food contents, blood pressure low (unable to recall).
12 2021-07-23 feeling hot, flushing Warm flushing on right side of face near the ear, then eventually on the left side of face. Nausea. ... Read more
Warm flushing on right side of face near the ear, then eventually on the left side of face. Nausea. Throat felt it was swollen.
12 2021-07-24 pain in extremity Lt arm pain same day. Next morning fever 102.6 and nausea, worsening arm pain.
12 2021-07-24 tremor High fever that lasted two days (even with acetaminophen and ibuprofen), extreme chills with uncontr... Read more
High fever that lasted two days (even with acetaminophen and ibuprofen), extreme chills with uncontrollable shaking, face and neck rash.
12 2021-07-24 tremor Pt is reporting two or three instances where her leg began to shake involuntarily, with the fist ins... Read more
Pt is reporting two or three instances where her leg began to shake involuntarily, with the fist instance happening during the night after she received her vaccination.
12 2021-07-24 unresponsive to stimuli, involuntary muscle movements, tremor Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient's fath... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient's father reported that she had not eaten or drank much, if anything, prior to the vaccination appointment in the afternoon. Patient is a premenstrual, young girl, of thin build and small stature, who just turned 12 the prior month. She expressed anxiety about shots and needles. Immunizing technician and father noticed that she slouched dramatically a couple minutes after the shot. But her face became ashen, she slouched more rigidly, and jerked. ~5-10 seconds later she was back to normal
12 2021-07-25 feeling hot Patient received vaccine at 17:00. At 17:04, she complained of nausea, of feeling 'hot" and had noti... Read more
Patient received vaccine at 17:00. At 17:04, she complained of nausea, of feeling 'hot" and had noticeable diaphoresis. At 17:06, patient started having emesis X 4. We placed cold packs on her neck, directed several floor fans toward her chair, offered her cold water and reassured her. At 17:20, patient was no longer diaphoretic and she said her stomach "felt better.' At 17:28, patient denied having any more symptoms. She felt better and wanted to go home with her mother who was with her. She had no dizziness upon standing and walked out of vaccination clinic on her own.
12 2021-07-27 cold sweat, weakness Within 5 minutes of vaccine administration patient complained about feeling dizzy. Patient became pa... Read more
Within 5 minutes of vaccine administration patient complained about feeling dizzy. Patient became pale, appeared lethargic, felt clammy, dizziness, weakness, and threw up 3 times immediately. Patient was sitting in the chair, ice pack was applied to her neck and head, legs were elevated with a chair. Patient's blood pressure was taken after vomiting and was 60s/40s. Patient continued with the symptoms noted previously. Nurse assessed patient and administered Epipen 0.30mg. Blood pressure was taken again, 100/60, 911 was called and patient was taken to near by hospital, guardian left to meet at the hospital.
12 2021-07-27 seizure Patient's mother reported that the patient had a 15 second seizure 20 minutes after administration. ... Read more
Patient's mother reported that the patient had a 15 second seizure 20 minutes after administration. The patient's mother reported that the ambulance came and the patient's vitals were all normal. Patient did stay in the store for the recommended 15 minutes after the vaccine and felt ok before leaving. Recommended patient to follow up with pediatrician for full work up.
12 2021-07-28 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted as soon as the needle co... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted as soon as the needle come out of her body and the fainting lasted for less than a minute
13 2021-05-13 flushing After receiving 1st dose covid vaccine patient became lightheaded and flushed. Patient has mild auti... Read more
After receiving 1st dose covid vaccine patient became lightheaded and flushed. Patient has mild autism and communication is limited. Laid patient on cot. Vitals stable. Patient drank water and ate crackers and felt better. Patient discharged with Mother
13 2021-05-13 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted as stood up waited about... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted as stood up waited about 30 minutes, drank some water said felt fine after about 10 minutes
13 2021-05-14 cold sweat Pt presented pale, diaphoretic, with cold clammy skin @ 12:18 PM, approx. 3 minutes after receiving ... Read more
Pt presented pale, diaphoretic, with cold clammy skin @ 12:18 PM, approx. 3 minutes after receiving her first Pfizer dose. Pt positioned changed to supine with her feet elevated. Vitals @ 12:18 are: BP: 90/67 P: 85 RR: 17 O2: 100% T: 97.3. At 12:21 Pt reported feeling better and no longer presented with any previously mentioned symptoms. Pt vitals @ 12:21 are: BP: 129/67 P: 97 RR: 20 O2: 100% T: 97.1. Pt remained in supine positioned and RN continued to monitor. At 12:36 pt position changed to sitting up, water was given upon pt request. Last set of vitals before discharge at 12:45 are BP: 113/67 P: 74 RR: 20 O2: 98% T: 98. Pt was discharged with her mom.
13 2021-05-14 involuntary muscle movements Patient became unconscious after about 10 minutes after vaccine was given for about 10 seconds. Once... Read more
Patient became unconscious after about 10 minutes after vaccine was given for about 10 seconds. Once consciousness was regained, patient appeared confused and pale. Patient's eyes rolled back and arms and legs were flailing about during unconscious episode
13 2021-05-14 feeling cold After the 1st dose, my child experienced Fever 102; chills, light-head ness; body aches
13 2021-05-14 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypervent... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild
13 2021-05-14 flushing Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lighthead... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: CALLED 911. AMR MONITORED PT FOR 30 TO 40 MINS AND RELEASED HER TO GO HOME AFTER THEY DID TALK TO HER MOM.
13 2021-05-14 seizure Patient was sitting with her mother in front of the pharmacy for the 15 min waiting period after vac... Read more
Patient was sitting with her mother in front of the pharmacy for the 15 min waiting period after vaccination, and mom alerted us to "something going on here." I (pharmacist) went over to the patient and she appeared to be having a seizure, hands clenched, eyes rolled back in head, and she shook a small amount for a short period of time, though mom believes she just passed out. Mom and I protected head and held her in place, it was over within a few seconds. A Nurse Practitioner was in the clinic next door and we alerted her. Together, we laid her down, asked her questions, took pulse with pulse oximeter and blood pressure. All seemed within normal range. We called 911 due to appearance of seizure. Rescue squad came and evaluated her.
13 2021-05-14 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
13 2021-05-14 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: 13 year old female fainted when sitting during her 15 minute observation. she fainted when her mom was standing next to her. we put her on the floor and raised both of her feet. she became concious after 15 seconds. We gave her water and chocolate. we took her blood pressure and her reading was 95/71 with pulse of 78. we had her sit for an addiotional 15 minutes. After feeling ok she left with her parents.
13 2021-05-15 flushing 3:55 vaccine administered 4:05 rash on arms- clusters of pinpoint dots. notified staff- diphenhydram... Read more
3:55 vaccine administered 4:05 rash on arms- clusters of pinpoint dots. notified staff- diphenhydramine 50 mg given 4:05-4:30 rash spread to chest, neck. face flushed. throat "weird" swollen and lumpy. dizzy. No SOB. EMS called and responded- evaluated BP 130/70, O2 98. Released for private transport to Hospital ED. 4:35-5:00 private transport and seen at ED. 5:03 Epi given IM right thigh. required to observe x4 hours Symptoms resolved and discharged ~9pm
13 2021-05-15 pain in extremity pain above injection site, mild below distal extremity. no swelling or discoloration. Pt. tensed up ... Read more
pain above injection site, mild below distal extremity. no swelling or discoloration. Pt. tensed up during the time of the vaccination. Ice pack applied
13 2021-05-16 weakness HA vomiting Weakness Fatigue Injection site pain
13 2021-05-16 weakness Client after receiving her vaccine, on the way to the recovery room felt so weak and was supported b... Read more
Client after receiving her vaccine, on the way to the recovery room felt so weak and was supported by her mother before I got there to assist her. She was put on the wheelchair and taken to the rest area where she was made to relax for awhile. vital signs were 98/63, 79, SPO 99% at room air, temp, 96.7,. After resting her are SPO was 99% and respiration even and unlabored before leaving, with the mother. she took the Pfizer vaccine, lot #EW0183, FIRST DOSE.
13 2021-05-16 involuntary muscle movements, unresponsive to stimuli 10 minutes after her first dose she had been sitting in a chair & developed diaphoresis, warm skin, ... Read more
10 minutes after her first dose she had been sitting in a chair & developed diaphoresis, warm skin, loss of vision,& low blood pressure. Pt was initially not responsive, when transferred to a wheel chair to take her to a gurney, left arm & left leg jerk twice. Took her to lay down and check her blood pressure. En route, in the wheel chair within about 5 to 10 seconds, she became responsive and said she could not see. Her vision returned to normal within a minute. Her initial blood pressure was 97/64 with O2 Sat 100% on room air. Her skin temp was 95.5, and her HR was 95. She continued to be responsive with excellent oxygenation and When the EMTs arrived she had a blood sugar of 90 and improving blood pressure with a regular rate and rhythm. Her diaphoresis resolved, and she continued to improve, tolerating water. Had similar reaction last year to flu shot, no hx of seizures
13 2021-05-16 feeling hot Fainted within minutes, hot. dizzy. Lasted approximately 15 minutes. Headache appeared about 8 hour... Read more
Fainted within minutes, hot. dizzy. Lasted approximately 15 minutes. Headache appeared about 8 hours later and soreness.
13 2021-05-16 flushing, tremor Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiti... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild, Additional Details: Patient became nauseous and pale several minutes after inject. She was stated she was nervous about injections and felt a little lightheaded and did vomit one time. She returned to normal within 10 minutes and was monitored the whole time.
13 2021-05-16 pain in extremity Pain and swelling under left arm and towards left breast.
13 2021-05-17 involuntary muscle movements, feeling hot Patient came to the pharmacy to receive 1st dose of the Pfizer covid vaccine. About 5 minutes later ... Read more
Patient came to the pharmacy to receive 1st dose of the Pfizer covid vaccine. About 5 minutes later patient felt unwell. According to her mom she passed out for about 5 seconds then jerked up and passed out again for a few seconds and woke up. Mom was unsure but thought it looked like a mini seizure. Both pharmacist was informed and checked on patient. Patient was hot and sweating but breathing was fine. Patient was coherent and could talk. Patient was given water. Blood pressure check was 102/69. Patient remained sitting with head over legs as that made her feel better. EMT arrived at the scene and took patient away on a stretcher for further observation.
13 2021-05-17 feeling hot Patients is a 13 year old girl who came into facility to receive her Pfizer vaccine. She was nervous... Read more
Patients is a 13 year old girl who came into facility to receive her Pfizer vaccine. She was nervous upon receiving her vaccine and after the shot was administered she stated she feels a little warm. The vaccinating pharmacist told her to sit and wait in the sitting area for 15 minutes after receiving the vaccine. A couple minutes after her vaccine was administered the girl started not feeling well and fainted in the store and her father caught her. We immediately called 911 and checked in with the young girl. The ambulance came and did a physical exam. They offered to take her to the hospital but the patient declined. Patient left the store shortly after with her father.
13 2021-05-17 numbness Pt had been required to wait for 30 mins due to hx of allergy. Pt reported numbness in L upper arm t... Read more
Pt had been required to wait for 30 mins due to hx of allergy. Pt reported numbness in L upper arm that radiated to the neck and a headache. Vitals were normal and pt denied any other symptoms such as SOB, itching or swelling. Advised pt to wait longer till numbness resolved and to take tylenol or ibuprofen for headache. Numbness did resolve soon after and pt felt well enough to go home. Advised to go to walk in clinic if it did not fully resolve by tomorrow.
13 2021-05-18 pain in extremity pt had fever the night after taking the vax. The next day she when she woke up her entire right sid... Read more
pt had fever the night after taking the vax. The next day she when she woke up her entire right side of the body was sore and had diarhea. She had fatigue and developed a rash on her left arm. Three days later she still has a rash, sore arm, slight fever and diarhea. Pt will be going to urgent care today for treatment.
13 2021-05-18 pain in extremity Sore arm, fever, chills, headache and dizziness. All symptoms resolved within 36 hours except headac... Read more
Sore arm, fever, chills, headache and dizziness. All symptoms resolved within 36 hours except headache and dizziness. Dizziness is the biggest complaint 4 days post vaccine.
13 2021-05-18 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Visual C... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Visual Changes/Disturbances-Mild
13 2021-05-19 cold sweat, feeling cold Syncope immediately following vaccine administration. No loss of consciousness, oriented, alert, re... Read more
Syncope immediately following vaccine administration. No loss of consciousness, oriented, alert, responding appropriately to questions. Described "seeing spots in front of eyes, cold feeling". Pt denied nausea.
13 2021-05-19 feeling hot PATIENT FELT LIGHT HEADED AND DIZZY AFTER VACCINATION DURING 15 MINUTE WAIT PERIOD. MOTHER SAID HER ... Read more
PATIENT FELT LIGHT HEADED AND DIZZY AFTER VACCINATION DURING 15 MINUTE WAIT PERIOD. MOTHER SAID HER EYES ROLLED BACK AND SHE FELL AND MAY HAVE HIT HER HEAD BECAUSE HER HEAD WAS HURTING WHEN SHE CAME TO MOMENTS LATER. SHE FELT FINE EXCEPT FOR A LITTLE HOT AFTER THE EVENT. THEY WAITED FOR ANOTHER 20 MINUTES BEFORE MAKING SURE SHE WAS OKAY AND LEFT WITH NO TREATMENT
13 2021-05-19 feeling hot Felt warm, dizzy, nauseated about 5mins post vaccination Given juice, water and crackers at 10:50am ... Read more
Felt warm, dizzy, nauseated about 5mins post vaccination Given juice, water and crackers at 10:50am Discharged to home
13 2021-05-19 flushing Pt w/ amoxicillin allergy unknown reaction. Flushing/sweating, dizziness, lightheadedness. Pt had a... Read more
Pt w/ amoxicillin allergy unknown reaction. Flushing/sweating, dizziness, lightheadedness. Pt had a near syncopal episode post vaccination. Pt has a hx of "passing out" w/ shots. Pt was laid down, given juice, and stable. VSS BP 101/52, HR 74, RR 20 -- > 99/65, 82, 20. Pt stable and released from the vaccination site.
13 2021-05-19 pain in extremity Patient reports swelling at the injection site. there is a small bump noted. Reports pain in the lef... Read more
Patient reports swelling at the injection site. there is a small bump noted. Reports pain in the left arm and it is difficult to raise arm due to pain level.
13 2021-05-19 seizure like phenomena Patient wa receiving their first Pfizer COVID vaccine. Student was well hydrated and had eaten a me... Read more
Patient wa receiving their first Pfizer COVID vaccine. Student was well hydrated and had eaten a meal prior to vaccination. After administering vaccine, patient lost consciousness, slumped to her left side, and had seizure-like body jerk movements. She then regained consciousness, then lost consciousness again immediately after and proceeded to have whole body jerking movements. She then started sliding to the floor from her seat. Patient was lowered to ground with help from another RN. Vitals were taken, BP 102/82, HR 48 and RR 20. Dr. assessed patient and 911 was called for further assessment. Patient was not transported in ambulance and left clinic with parent recovered.
13 2021-05-19 tremor 5 minutes after vaccine patient started feeling dizzy and fainted, while body was shaking for 20 sec... Read more
5 minutes after vaccine patient started feeling dizzy and fainted, while body was shaking for 20 seconds. Body then regained consiousness
13 2021-05-19 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Add... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: Immunizing pharmacist checked patient's blood pressure after syncopal episode, and again before sending patient home. He then called later to follow up and was informed of a second episode, after which he accompanied patient and mother to hospital. He remained with them until she was cleared to go home.
13 2021-05-20 concussion Patient had a syncopal episode passed out hit her head and suffered bilateral nose fractures and con... Read more
Patient had a syncopal episode passed out hit her head and suffered bilateral nose fractures and concussion
13 2021-05-20 feeling hot, cold extremities, numbness Immediately began bleeding, which ran down arm from injection site. Approximately 4 minutes later, b... Read more
Immediately began bleeding, which ran down arm from injection site. Approximately 4 minutes later, back of entire arm that received injection was numb from underarm to pinky and ring finger; warm hives on front of both arms down to wrists; warm, rosy cheeks and cold hands/fingers; tickle in back of throat. Benadryl given at clinic. 2.5 hours later, numbness in arm reduced to upper arm only; hives on arms have reduced; tickle in throat gone. Continues to have pain at site of injection.
13 2021-05-20 numbness, pain in extremity, tingling Severe pain starting in left forearm extending down to the hand and tingling/numbness in hand. Pain ... Read more
Severe pain starting in left forearm extending down to the hand and tingling/numbness in hand. Pain started to travel up the arm towards the bicep.
13 2021-05-21 feeling hot, cold sweat, inability to speak Patient received her 1st dose of the Pfizer Covid vaccine around 11:20am, and started feeling bad wi... Read more
Patient received her 1st dose of the Pfizer Covid vaccine around 11:20am, and started feeling bad within about 5-7 minutes of administration. Her grandmother came to the counter to alert me that she wasn't feeling well, patient was lightheaded and just "felt bad". She did say she was nauseous, but was very agitated and had trouble verbalizing what was wrong. She was very hot and clammy, her mother reported that she looked very pale. I went to get a cuff to take her blood pressure, but by the time I got it on her arm, she was slumping significantly in the chair, so we decided to move her back to the clinic room to lay her down and elevate her feet. Her mother and I each took an arm to move her. I thought she may have briefly lost consciousness, her legs were not holding any of her weight, but her head was down, so I couldn't tell if she was alert. We moved her a few more feet into the room and her mother moved to set her down in a chair, she was talking and alert. At this time, her bladder evacuated and she vomited, her mom moved her the rest of the way to the chair. I immediately went back to the room with them and dialed 911 at 11:34am. She was more alert at this time, did not report any difficulty breathing or any swelling or itching of the mouth or throat. She was very anxious/agitated, but she did say that she felt a little better after vomiting. EMS arrived at 11:52, I believe she vomited again before they got here, she did take a few sips of water. EMS left at 12:06pm, the patient and her mother left at 12:07, she was walking on her own, with support from mom.
13 2021-05-21 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
13 2021-05-23 pain in extremity She presents complaining of tenderness over the left breast. Pain began this morning and worsened af... Read more
She presents complaining of tenderness over the left breast. Pain began this morning and worsened after a friend socked her in the left arm. Pain is rated 7 out of 10. Approximately, 15 minutes after sucking a 325 mg ASA in the Office pain is down to a "2."
13 2021-05-23 pain in extremity Patient received her first dose of the Covid vaccine without a problem. She was reading a magazine i... Read more
Patient received her first dose of the Covid vaccine without a problem. She was reading a magazine in a chair while waiting for me (her mother) to have the second dose in the same room. About 5 to 10 minutes has passed since patient had received her injection. I looked over at patient, her eyes had rolled back and she had slumped in her chair. I ran over to her - her face was very red and she did not appear to be breathing. Her eyes were open but were not focused. I sat her up as straight as I could while the technician who administered the vaccine ran for the pharmacist. This took a few minutes. By the time the pharmacist arrived patient was gaining consciousness but began throwing up (although mainly dry retching). Her face had gone pale. The pharmacist was very helpful - she gave patient some Coke to drink and took her blood pressure, which was low. After 30 minutes of observation we were allowed to leave. The event was very frightening. Patient was very pale for the rest of the day. She had a severe pain in her left arm (and leg) which gradually improved over the next three days. We are very worried about her taking the second dose of the vaccine.
13 2021-05-23 tingling, pain in extremity, numbness Friday, 5/21 around 11:55 she received her first dose. 20 minutes later she complained that it felt... Read more
Friday, 5/21 around 11:55 she received her first dose. 20 minutes later she complained that it felt like someone punched her in the face, and her left cheek was swelling. She looked woozy, with her eyes closing, and the nurses laid her down on the floor on a mat. Her tongue and throat began swelling, and she was having extreme difficulty breathing. She then could not feel anything from her neck down, like she was paralyzed. The nurse administered an Epipen and EMS showed up minutes later. In the ambulance, EMS administered another Epipen, gave her a steroid and Benadryl and rushed her to the hospital. Once at the ER, she was still having a hard time breathing, and could not feel anything from the waist down and could not move her legs. She also complained about her spine being in extreme pain around the mid to lower back. When her symptoms did not resolve, she was admitted to the hospital for observation and treatment. She had extreme pain in her joints - spine, hips, knees, ankles and toes, if someone tried to move them, she could not move on her own. She also had tingling and numbness that would travel up and down her body - weakness in her arms and legs. The medical staff continued with Bendryl - switched to Adderax, and Motrin and steroids (Prednisone?). She was discharged from the hospital Sunday, 5/23/21 in the afternoon. This morning (Monday 5/24/21) she is still experiencing back and leg pain, weakness and cannot walk with out assistance and it is extremely painful.
13 2021-05-24 hot flush Approximately 3 minutes after her injection, the patient experienced stomach pain, hot flashes, and ... Read more
Approximately 3 minutes after her injection, the patient experienced stomach pain, hot flashes, and pallor so was taken to our roof for fresh air. While being escorted by parent and staff, the patient fainted and was supported to the ground. Epinephrine was administered and 911 was called. Paramedics arrived shortly thereafter and examined patient. Patient was cleared by paramedics and walked out of the clinic unassisted.
13 2021-05-24 pain in extremity On Sunday 5/23/2021 my daughter woke up to swelling, redness & pain of the 1st metatarsal of her lef... Read more
On Sunday 5/23/2021 my daughter woke up to swelling, redness & pain of the 1st metatarsal of her left foot. One Monday 5/24/21 the swelling and symptoms in that region had resolved however throughout the day her right hand started to swell, become red and hurt. This the throughout the thumb and pointer finger region of her right hand. The swelling and redness spread further and could be seen on both palms just below the pointer finger as well as the top of her left foot. A visit to the doctor was completed on Sunday evening 5/24/21. The provider we saw believes it to be some for of reaction but it couldn't be determined if it was environmental, antibiotic or vaccine related. She was given 2 Benadryl 25 mg tablets after the medical appointment. As of this morning 5/25/21 I administered anther 25 mg Benadryl and instructed her to take a second dose around 11am at school. She is reporting there is still swelling in her hand but it doesn't hurt as bad as it did yesterday. Her PCP contacted my via phone today and is discussing her case with pediatric rheumatology as she also feels it could be a sign of allergic reaction but since much of the swelling is near joints she has reached out to them and I am waiting to hear back.
13 2021-05-24 tingling Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Patient stated s... Read more
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Patient stated she felt weird.-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Per the father, patient reported arm pain/soreness on 5/17/21, body aches on 5/18/21, and on 5/19/21 patient reported waking up with a mild headache and mild tingling of leg.
13 2021-05-24 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: i administered pfizer vaccine to patient... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: i administered pfizer vaccine to patient and after 5 minutes she experienced syncope and we had to call an ambulance for the patient. The NP within the store helped the patient as well by checking blood sugar, blood pressure and o2.
13 2021-05-25 slurring Patient felt faint and dizzy, the pharmacist and the patients mother talked to the patient but the p... Read more
Patient felt faint and dizzy, the pharmacist and the patients mother talked to the patient but the patients words were slurred. Breathing exercises were tried with the patient. EMS were offered to be called but were declined twice. Blood pressure was taken and the patients mother purchased Gatorade to hydrate her.
13 2021-05-25 tenderness Patient was vaccinated by Dr. As she was handing her dad, her sticker, she fainted. On the way to th... Read more
Patient was vaccinated by Dr. As she was handing her dad, her sticker, she fainted. On the way to the floor, she bumped the top left part of her head. No bump or swelling. She states it is tender but not painful. She recovered from the faint immediately with return to full consciousness. A& O X3. She was moved to a lounge chair and laid back for 10 minutes, then to sit position, then attempted stand. On first attempt she still felt dizzy so she returned to a sit for 5 additional minutes. Then she was able to walk on own accord to observation area. She kept ice pack to head the whole time. She had a juice, water, and a piece of candy. She denied other s/s. Dad was offered a copy of incident report but left prior to completion. PHN will mail to family. RN PHN
13 2021-05-26 weakness Pt got the COVID vaccine, felt sore right away and itchy all over -itchiness on right arm and left a... Read more
Pt got the COVID vaccine, felt sore right away and itchy all over -itchiness on right arm and left arm and then felt chest tightness and shortness of breath. Was monitored in ED and treated with benadryl, pepcid and then course of prednisone x 5 days. She seems better today but still having lower energy than normal. No vomiting or hives. She felt itchy on right arm, no rash.. Took some benadryl for this. She had COVID last November.
13 2021-05-26 feeling hot Approximately 10 minutes after vaccine she reported she felt hot and was ' having a hard time breath... Read more
Approximately 10 minutes after vaccine she reported she felt hot and was ' having a hard time breathing'. Advised her to take off mask and she vomited on floor. Had her lie down on gurney. She denied SOB or breath or difficulty breathing BP 118/84 HR 73 02 sat 94% RR 16. After resting for 5 minutes she reported improved nausea, BP 118/84, HR 73, O2 sat 97%, RR 16. Offered small sips of water. Patient rested for 30 minutes with VS monitored every 5 minutes. Patient reported feeling better and denied dizziness, SOB, or with position change. parent instructed to follow up at ER or urgent care if symptoms returned or if concerns.
13 2021-05-27 hot flush PATIENT DID EXPERIENCE A REACTION WITIN 5MINS AFTER VACCINATION WITH PFZIER 1ST SHOT. SHE EXPERIENCE... Read more
PATIENT DID EXPERIENCE A REACTION WITIN 5MINS AFTER VACCINATION WITH PFZIER 1ST SHOT. SHE EXPERIENCED BLURRY VISION, LOSS OF HEARING AND DIZZINESS FOR 15MINS WITH HOT FLASHES. GAVE HER APPLE JUICE AND HAD HER PUT HER FEET UP ON CHAIR. AFTER 20 MINS SHE WAS FEELING FINE AGAIN AND LEFT WITH DAD.
13 2021-05-27 seizure like phenomena RN reported that patient became flaccid after her vaccination, then became rigid, crossed her legs, ... Read more
RN reported that patient became flaccid after her vaccination, then became rigid, crossed her legs, and lightly slammed her head back against the wall. He reports that she fainted but had some seizure-type activity, but minimalized. She was monitored by both RN and myself. She was lowered to the floor to lay on the floor, was fanned, and her BP and pulse were monitored by RN. She was accompanied by her mother, and her mother declined having EMS contacted. Once patient regained consciousness, she was alert, laughed and talked to us, and regained a sitting position. We then gave her cold water to drink, and she was able to get up into a chair. After sitting for several minutes, she was able to walk out of the room and into one of our monitoring cubicles for an extended monitoring timeframe. We kept her here for 30 minutes for further observation, then left accompanied by her mother. Due to RN's report of the seizure-type activity, mom is going to contact patient's pediatrician to see if further treatment is needed.
13 2021-05-28 cold sweat Patient had significant anxiety prior to administration. After administration, initially patient fel... Read more
Patient had significant anxiety prior to administration. After administration, initially patient felt fine. A few minutes after patient felt faint , hands and forehead were clammy. Mom was present. Blood pressure was checked, diastolic was slightly high at 90mmHg. Patient's eyes closed for a second but patient was never unconscious. Patient did not fall. Patient did not hit head on anything. Patient was given water and sat there for about 7 minutes. Then patient was walked outside next to Mom and Pharmacy Grad Intern. Patient was not feeling well initially outside but did feel better after a while. Mom refused an ambulance. Mom and patient left at 10:50am and patient was feeling much better
13 2021-05-28 pain in extremity They made a mistake and it was an overdose; When mixing the vaccine they used less of the diluent an... Read more
They made a mistake and it was an overdose; When mixing the vaccine they used less of the diluent and more of the vaccine.; Do not recommend the vaccine for a 13 year old; Body aches; Pain at the arm; This is a spontaneous report from a contactable consumer (father) reported for a 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not provided) via unknown route of administration on 17May2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that his daughter received the first dose of the vaccine and then was called and they stated that they made a mistake and it was an overdose. The pharmacist told him that when mixing the vaccine they used less of the diluent and more of the vaccine. He stated he was scared because overdose sounded like something is wrong. He also stated he spoke with the primary care physician and they said they do not know and do not recommend the vaccine for a 13 years old and told him to call Pfizer. His daughter said she had pain and at that time he gave her some medicine, some Tylenol she feel little bit eased, she seemed okay. Every time she had pain and then the Tylenol kicks in and it helps but the second thing is he cannot understand why. She had pain at the arm and then body aches on 17May2021 and they gave her Tylenol and that medicine kind of eased her. That is what they did as far as medicine to treat. No further information provided. The outcome of the events body aches and pain in arm was resolving and the other at risk events was unknown. Information on the lot/batch number has been requested.
13 2021-05-29 pain in extremity She had troubles breathing. On the first day, she also had headaches and tummy pain. On the second d... Read more
She had troubles breathing. On the first day, she also had headaches and tummy pain. On the second day, she vomited in school. She also had a headache and troubles breathing. She had belly pain, as well. On Wednesday, around lunch break she called me to pick her up, she had troubles breathing and headache and feeling blah. Also on the first evening, Her arm was hurting and her left body side was hurting. (Wednesday this got a little bitter but she still had pain on her front left side -- especially her left leg.) I took her to primary care and he prescribed Prednisone. Prednisone started then. On Thursday, she still had troubles breathing and she stayed home from school. On Friday, it was okay for her to go to school.
13 2021-05-29 tingling Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported tha... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported that she started to have tingling numbness in both legs below the knee (predominately calf muscle) within 30 minutes of vaccine. numbness lessened after walking around, but was still noticeable 2 hours after vaccine
13 2021-05-29 tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Add... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Patient sat down in waiting room right after her first COVID shot & seemed fine. She suddenly started to shake & looked dizzy. She said she just felt nauseated. We called ambulance & they checked her vitals & everything was normal. Her mother said she reacted this way to last HPV shot last year. She went home & we called her later in the day & she was feeling fine.
13 2021-05-29 tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Add... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Additional Details: Patient sat down to wait for 15 minutes then all of a sudden started to shake & looked like she was dizzy. She said she only felt nausea. We called the ambulance & they checked on her. Her mother said she reacted this way about a year ago to her HPV shot. We called the patient a few hours later & she was feeling fine.
13 2021-05-30 pain in extremity Prolonged Fever (over 103), ringing in ears, dizziness, rash over entire body and face. Some sorenes... Read more
Prolonged Fever (over 103), ringing in ears, dizziness, rash over entire body and face. Some soreness in legs but that went away.
13 2021-05-31 unresponsive to stimuli Very pale, pupils dilated, non responsive, passed out immediately after vaccination
13 2021-06-01 tingling, seizure Passed out. Seizure without shaking muscles contracted and fists clenched. Dizziness. Tingle in arms... Read more
Passed out. Seizure without shaking muscles contracted and fists clenched. Dizziness. Tingle in arms.
13 2021-06-01 seizure Full body seizure, loss of consciousness. Stopped breathing. Was transported to the hospital by ambu... Read more
Full body seizure, loss of consciousness. Stopped breathing. Was transported to the hospital by ambulance. Outcome is pending follow up with neurologist.
13 2021-06-01 slow speech About 5 minutes after the shot, the patient was in the waiting area and started feeling lightheaded ... Read more
About 5 minutes after the shot, the patient was in the waiting area and started feeling lightheaded and dizzy. She was sweating and sounded drowsy and said she couldn't see. She did not report to be hot or itchy. We had her lie down with her feet elevated and she immediately felt better and could see again. She remained in that position for 3-5 minutes before she sat up. She felt normal again at this time.
13 2021-06-02 feeling hot Pt accompanied with mother to receive first dose. Pt tolerated well at the time of vaccination. Pt... Read more
Pt accompanied with mother to receive first dose. Pt tolerated well at the time of vaccination. Pt had dizziness and 'feeling hot' while at the observation area. Pt brought back to an exam room to be examined by Dr Dr. and MOP confirmed that this issue was because pt didn't eat anything today. Vitals taken at 1255 are B/P: 91/56, P: 92, SPO2: 100%. Pt states pain is localized to the site of injection and was minimal. Dr. required vitals every 15 minutes for the next hour. Vitals at 1310: B/P: 110/73, P: 77, SPO2: 99%, pt reported no dizziness at this time. Vitals at 1325: B/P: 117/72, P: 79, SPO2: 100%. Vitals at 1340: B/P: 108/73, P: 85, SPO2: 98%. Vitals at 1355: B/P: 111/75, P: 86, SPO2: 98%, pt denies dizziness, pain or nausea. Dr. reviewed vitals taken and assessed pt prior to discharge.
13 2021-06-02 pain in extremity a little bit of a sore arm; This is a spontaneous report from a non-contactable consumer or other no... Read more
a little bit of a sore arm; This is a spontaneous report from a non-contactable consumer or other non HCP. A 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27May2021 (13-years age at the time of vaccination) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, On 27May2021, took Pfizer COVID 19 vaccine about 30 minutes ago. She forgot to ask if she could give her medicine like Tylenol if she started having symptoms like body aches and fever. She was not having any side effects except a little bit of a sore arm. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
13 2021-06-02 pain in extremity She had her first shot vaccine yesterday June 2, 21 and today she has sintoms off.. nausea, disines... Read more
She had her first shot vaccine yesterday June 2, 21 and today she has sintoms off.. nausea, disiness , can't eat , headache, and body illness, has well a lot of pain on the arm and body muscles, and difficulty on breathing..
13 2021-06-05 feeling hot Shortly after vaccination patient started to feel warm and very dizzy. Said her throat felt funny b... Read more
Shortly after vaccination patient started to feel warm and very dizzy. Said her throat felt funny but no issues breathing. Gave her some water, an ice pack for her neck. Had her return to consultation room and administered 25 mg IM benadryl. Pt felt slightly better but did another 25 mg Benadryl liquid (10 ml of 12.5/5 solution) Patient left on her own and parent was called 3 hours later and she was tired but overall doing much better and feeling fine.
13 2021-06-06 flushing Patient was vaccinated at 1631 6/3/2021. She came to observation room with many allergies in the pa... Read more
Patient was vaccinated at 1631 6/3/2021. She came to observation room with many allergies in the past and history of serum sickness. She was to be watched in the observation room for 30 min. She developed nausea and abdominal pain (6/10) She was flushed and itching. 1645 Benadryl 50 mg given per mom's OK. 30 min later she was still the same but with dizziness too. Given gatorade to sip on and vitals taken. 125/76 Mean 95, HR 90, RA pox=97%. Continued to watch with no improvement despite interventions . RRT called ultimately. Patient taken to ER with Mom at patient's side.
13 2021-06-06 night sweats headaches, lethargy, chills, sweating through the night
13 2021-06-06 pain in extremity Patient blacked out and fell on the floor. I was alerted to what happened. When I went to investiga... Read more
Patient blacked out and fell on the floor. I was alerted to what happened. When I went to investigate what happened she was disoriented and laying on the floor. Afterwards she recovered from fainting and disorientation quickly. She had chills, a sore arm, and general feelings of tiredness and feeling unwell.
13 2021-06-06 tingling, tremor At 4:30 PM, the patient received the first dose of the COVID-19 vaccine in her right arm at facility... Read more
At 4:30 PM, the patient received the first dose of the COVID-19 vaccine in her right arm at facility. She developed a headache, along with dizziness and pain at the injection site. She also reports that her arm began tingling and felt heavy. She waited for an hour without resolution to her symptoms. Around 5:30 PM, she began having intermittent episodes of shaking her limbs. There was no seizure activity. She reports that she has had these episodes since the beginning of the school year, but hadn't told her Mom. She reports that it mostly happens when taking a test at school. The episodes are worse today since taking the vaccine. Vitals: HR 110 BP 134/75 Sat 99% on RA. An RRT was called and she was taken to the ED.
13 2021-06-06 seizure Patient fainted in the bathroom around 2:00am. When we heard the thump, we ran to her and my husban... Read more
Patient fainted in the bathroom around 2:00am. When we heard the thump, we ran to her and my husband picked her up. She wasn't talking much, she started gagging and fainted again and her body started convulsing. We believe she was having a seizure. Patient has never had a seizure, her fever was high. It only lasted probably 20-30 seconds. When she stopped, she was able to walk with assistance back to her room. We quickly gave her some medicine to bring down her fever. Wet wash cloth and a fan on her. I failed to take her temperature. I was too concerned at what was going on.
13 2021-06-06 unresponsive to stimuli, tremor, muscle spasms Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Additio... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Additional Details: 26hrs after 2nd shot, patient passed out & fell at home & brother caught her. 5 seconds later, she tried to get up but collapsed again & siblings saw her spasming for few seconds before regaining consciousness. She immediately complained of ringing in ears/fatigue/dizziness which resolved 40 minutes later. mother confirmed no history of seizures/fainting. menstruating now
13 2021-06-06 unresponsive to stimuli Daughter stated she had diarrhea for 3 weeks while we were at the hospital on 6/2 for IV fluids and ... Read more
Daughter stated she had diarrhea for 3 weeks while we were at the hospital on 6/2 for IV fluids and severe dehydration. Her poop was mushy, and not diarrhea, however for her it was much softer than normal. She collapsed at home and was unresponsive, 911 was called, ER doctor determined she was severely dehydrated and administered 2 bags of IV fluids to stabilize her blood pressure.
13 2021-06-07 weakness Temperature 101.2 General body aches, difficulty focusing, standing. Weakness.
13 2021-06-07 cold sweat Dizziness, clammy skin and dilated eyes, followed by a temporary ?black out?
13 2021-06-07 pain in extremity Sore arm, headache, fever, fatigue and later hot red blotch on arm at injection site .
13 2021-06-07 pain in extremity heart swelling or inflammation; heart swelling or inflammation; maybe she has a swollen lymph node t... Read more
heart swelling or inflammation; heart swelling or inflammation; maybe she has a swollen lymph node that is putting pressure on a nerve.; arm pain in the opposite arm of vaccination/ left arm pain that has progressively gotten worse; get worse/ left arm pain that has progressively gotten worse; swollen lymph node; excruciating pain all the way down to her hand; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 13-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8736; Expiration Date: Jul2021) via an unspecified route of administration in right arm on 13May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient did not receive any vaccination within 4 weeks prior to covid vaccine. The reporter stated that the day the vaccine was approved [for her age group] she got her initial vaccine. She received her first vaccine dose on May 13th in her right arm, several hours later she began having left arm pain that has progressively gotten worse. She reported that after running her arm was in excruciating pain all the way down to her hand. She further enquired if left arm pain a common symptom of the heart swelling or inflammation of the heart following vaccination or is left arm pain something people have when they had heart swelling or inflammation. She further stated that hadn't happened the exact same day she wouldn't connect it so much. The vaccine was given in the right arm, but it is her left arm that is hurting. she called her pediatrician, and he is thinking it is coincidental or thinking maybe she hurt herself, but caller states she doesn't know but maybe she has a swollen lymph node that is putting pressure on a nerve. The patient took Tylenol for the reported events. Outcome of the events was reported as unknown at the time of reporting. Information on Lot/Batch number was available. Additional information has been requested
13 2021-06-07 tingling At 11:05 voiced complaints of tingling in the bilateral jaw. Attendee's skin was warm and dry. Atte... Read more
At 11:05 voiced complaints of tingling in the bilateral jaw. Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. Attendee assisted to the cot to lie down. 11:08 - HR: 83 BP: 110/72 O2Sat%: 98 11:11 – Benadryl 50 mg administered. 11:15 – Tingling getting better. 11:18 – Slight jaw tingling. HR: 78 O2Sat%: 100 11:40 – injection site slight discomfort. Jaw no longer tingling. 11:45 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with their mother.
13 2021-06-08 slurring Patient received her vaccine on 6/9/2021. after Vaccine was completed the patient was asked to sit i... Read more
Patient received her vaccine on 6/9/2021. after Vaccine was completed the patient was asked to sit in the lobby for 15 minutes so she could be monitored due to 1st dose. Within 5 minutes Patient stated to parent that she was thirsty, when parent grabbed a water and returned to see Patient fainting and sliding out of her chair. Went to assist patient to make sure she was OK. Patient was saying she felt sleepy and wanted to sleep. we kept her conscious but her words began to slur. Rescue came and assessed the patient who began to turn pale. She complained of her chest hurting and she started sweating. Rescue took patient to the local ER. Patient came back from ER with parent to let us know that she was OK. Her color had returned and she was no longer pale.
13 2021-06-08 numbness, tremor, tingling, weakness, paralysis, pain in extremity Anaphylactic reaction; left cheek started swelling; looking woozy; throat and tongue started swellin... Read more
Anaphylactic reaction; left cheek started swelling; looking woozy; throat and tongue started swelling; throat and tongue started swelling; having a hard time breathing; from the neck down, she had a temporary paralysis and she could not move./she could not feel anything from the waist down.; whole body was shaking; numbness and tingling all over.; numbness and tingling all over.; extreme pain in her back; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain.; very weak; chest was tight.; cannot walk without assistance; itching all over and in her throat; itching all over and in her throat; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, 0.3 ML), at the age of 13-years-old , via an unspecified route of administration, administered in Arm Right on 21May2021 11:55 (Lot Number: EW0179; Expiration Date: Aug2021) as 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing asthma, Diagnosed as a toddler. Had RSV as a baby. ongoing seasonal allergy, To like grass and pollen. ongoing constipation, Diagnosed about a year ago. allergic to shellfish because she gets sick. She said that it happened when her daughter was 4-5 years old. Whenever she has contrast for a MRI she throws it up. The patient's concomitant medications were not reported. The patient previously took Azithromycin and Amoxicillin and were allergic. The patient experienced anaphylactic reaction on 21May2021 with outcome of recovering, left cheek started swelling on 21May2021 with outcome of unknown, looking woozy on 21May2021 with outcome of unknown, throat and tongue started swelling on 21May2021 with outcome of unknown, having a hard time breathing on 21May2021 with outcome of unknown, from the neck down, she had a temporary paralysis and she could not move./she could not feel anything from the waist down on 21May2021 with outcome of unknown, whole body was shaking on 21May2021 with outcome of unknown, numbness and tingling all over on 21May2021 with outcome of unknown, extreme pain in her back on 21May2021 with outcome of unknown , when they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain on 21May2021 with outcome of unknown, very weak on 21May2021 with outcome of unknown , chest was tight on 21May2021 with outcome of unknown , cannot walk without assistance on 21May2021 with outcome of unknown , itching all over and in her throat on 21May2021 with outcome of unknown. Patient was in hospital from 21May2021 to 23May2021. AE(s) require a visit to Emergency Room. No AE(s) following prior vaccinations. No Family Medical History Relevant to AE(s). No Relevant Tests. Clinical courses as follows: It was reported they wanted her to wait for 30 minutes after her daughter received the vaccine. She said that after about 20 minutes, her daughter said that it felt like someone punched her in the face and her left cheek started swelling. She said that her husband said that their daughter started looking woozy and her eyes were closing. The staff laid her down on a mat on the floor. Then her daughter's throat and tongue started swelling and she was having a hard time breathing. Then her daughter complained that from the neck down, she had a temporary paralysis and she could not move. Her daughter asked if she asked if she was going to die. The nurse gave her an EpiPen and called a ambulance. Her whole body was shaking, probably from the EpiPen, like almost convulsing. She said that they got her onto the ambulance and her daughter was having trouble breathing. They gave her another dose of an EpiPen in the ambulance. They also gave her daughter a steroid and some Benadryl through an IV. Her daughter was rushed to the ER, having a hard time breathing and complaining she could not feel anything from the waist down. Caller said that her daughter was also complaining of numbness and tingling all over. She also started to complain about extreme pain in her back. When they would touch her hips, toes, spine, ankles, and knees she would complain of extreme pain, like joint pain. Her daughter had numbness from waist down. If they touched her foot she could not feel it. Her daughter was admitted to the hospital and got released yesterday 23May2021. She is still experiencing pain and numbness. The numbness is from the waist down and the tingling was up and down her arms. She said that her daughter was very weak and could not feed herself. They had to give her several albuterol breathing treatments in the hospital because her chest was tight. She was not wheezing, but they could tell it was constricted and treated her with Albuterol. She said that her daughter still cannot walk without assistance this morning. She was treated with Motrin, Benadryl and Atarax, and Prednisone in the hospital. The caller said that her daughter also complained about itching all over and in her throat. The caller said that her daughter did not have a rash though.
13 2021-06-08 pain in extremity That afternoon, she was lethargic, achy and her arm was sore, so I gave her Tylenol. She had trouble... Read more
That afternoon, she was lethargic, achy and her arm was sore, so I gave her Tylenol. She had trouble sleeping that night. On Sunday morning, I gave her two Ibuprofen around 9 because her arm was still hurting. Around 9:30, she came in saying she was having chest pains and her pulse rate was over 120. I took her to the ER. Her heart rate was 128 when they triaged her. They gave her an IV and a saline drip, an EKG and chest x-ray, all of which were fine. Due to her being on birth control, they also did a d-dimer test, which was elevated at 442. They then did a lung scan to rule out a pulmonary embolism. Those results were negative as well. The chest pains resolved around 11 am. Since they ruled out the blood clot and nothing was found to be wrong with her heart, she was sent home. They figured that she maybe had an anxiety attack or heart palpations. I took her to her pediatrician the next day and she was cleared there as well.
13 2021-06-08 pain in extremity sore arm; little fatigue; This is a spontaneous report from a contactable consumer via a Pfizer spon... Read more
sore arm; little fatigue; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A contactable consumer reported for a 13-year-old female patient who received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 20May2021 (Batch/Lot Number: EW0177) as a single dose for covid-19 immunization. Medical history included athletic induced asthma (she was diagnosed maybe 3 years ago, 2018 or maybe it was 2016) and horseshoe kidney (the patient was diagnosed with a horseshoe kidney a year or two ago, meaning when the patient was in the her mother's womb, her kidneys while they were developing never separated so she has to be careful not to get kidney infections and not to get hit in the stomach when she's playing sports). On 20May2021, the patient experienced sore arm, little fatigue. Caller (reporter) stated that there was a report that came out. Caller states her daughter got her first dose, she was 13, and had no reaction other than a sore arm and a little fatigue the first day. Caller states the reports says it's causing enlarged heart in a lot of teens; she asked her doctor about it and the doctor said the benefits of getting the vaccine outweigh the risks and advised the caller to still get it for her daughter. The outcome of the events was unknown. Pfizer Covid Vaccine: Caller confirms the patient received the Pfizer Covid Vaccine. NDC: Unknown; Expiry Date: Unknown; Unknown Dosage; Indication: Caller states they are pretty good about not going anywhere, but they certainly venture out more than she does. Caller states she wants to make sure she was protected. Caller states she learned a day or two before she scheduled the shot that her daughter's school is not offering school from home next year. Caller states it's called E classroom, they are also doing hybrid but her daughter opted to stay home. Caller states she learned they weren't doing any of that next year. Caller confirms her daughter is scheduled for her second dose on 10Jun2021. PSCC Communication: Report 2 of 7. Caller does not provide any further information on patient; therefore, no further information obtained or verified. Additional information has been requested.
13 2021-06-08 pain in extremity Patient was given undiluted Pfizer vaccine straight out of the vial. When I spoke with her mother t... Read more
Patient was given undiluted Pfizer vaccine straight out of the vial. When I spoke with her mother today, she said her daughter had a sore arm yesterday and today she started feeling terrible - couldn't tell me any specific symptoms, as she was at work and her daughter was at home
13 2021-06-08 tenderness 5 days after COVID vaccine, a tender 1 cm subdermal nodule was felt inferior to the left clavicle, ... Read more
5 days after COVID vaccine, a tender 1 cm subdermal nodule was felt inferior to the left clavicle, consistent with a lymph node. Nodule remains as of 06-09-2021, although tenderness has resolved.
13 2021-06-09 discomfort, feeling hot Shot at 4 PM Monday. Woke up at 3:30 AM Tuesday feeling very hot and thirsty. Passed out in doorwa... Read more
Shot at 4 PM Monday. Woke up at 3:30 AM Tuesday feeling very hot and thirsty. Passed out in doorway of parents room when looking for assistance, Came to and began to vomit. Vomited several times. Passed out a second time. Ambulance called. Hot, sweaty. Fever and chills, massive headache and generally uncomfortable all day Tuesday. Woke up Wednesday morning feeling 100% fine.
13 2021-06-09 difficulty speaking, depressed level of consciousness She was observed for 30 minutes in the center of vaccination. At around 40 minutes, she started to s... Read more
She was observed for 30 minutes in the center of vaccination. At around 40 minutes, she started to smell a strange odor, later a strange laryngeal foreign body sensation, her voice changed tone to hoarse (dysphonia). Later she had difficulty breathing through her nose and in seconds general shortness of breath. Marked pallor of skin and lips. Strange sensation of the extremities. She does not remember what happened, she had for a few seconds cloudiness or a sensation of faintness. She spontaneously recovered from the shortness of breath around 5 minutes, time that we were able to get to the emergency room. We consulted the Clinic, emergency room. Where she was observed and monitored for two hours. She recovered well. The evening of 6/5/2021 she had fever up to 100.6, nausea, headache, mild myalgia.
13 2021-06-09 difficulty speaking At around 40 minutes he had a foreign body sensation in the pharynx and mild dysphonia. The sensatio... Read more
At around 40 minutes he had a foreign body sensation in the pharynx and mild dysphonia. The sensation of a pharyngeal foreign body did NOT prevent breathing and it decreased as the hours passed, but it persisted for 48hrs slightly. He did not require an emergency consultation. Days later we consulted in the office of an ENT and immunology.
13 2021-06-09 feeling of insects crawling on skin Tics, lethargy, "skin is crawling," headache, stomach pains
13 2021-06-09 numbness Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, ... Read more
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness of left arm(vaccination arm)
13 2021-06-09 pain in extremity Earache, Headache, Pain in arm.
13 2021-06-09 tremor Woke up exactly 12 hours after vaccine with the following symptoms: Fever 99.5-100, red cheeks, sh... Read more
Woke up exactly 12 hours after vaccine with the following symptoms: Fever 99.5-100, red cheeks, shaking, body aches, nausea, headache, couldn't lift her arms much. Symptoms lasted 24hours and as fast as they came on, they went away the same. A severe headache remained the second day.
13 2021-06-09 tremor Patient in clinic with mom and brothers to get the second dose of the Pfizer COVID 19 vaccine. Patie... Read more
Patient in clinic with mom and brothers to get the second dose of the Pfizer COVID 19 vaccine. Patient received the vaccine in right arm and a small amount of blood came out of the injection site. Patient looked at the blood and got pale. She loss consciousness for 10 seconds in the chair with her mom on her left side. We attempted to put patient on the floor to elevate her feet but she resumed consciousness right away. An ice pack was placed on the back of patient's neck. Patient did shake a bit and didn't know what happened. Patient then loss consciousness again and myself as well as another nurse helped her to the floor. Her feet were then elevated and patient regained consciousness again. Vitals were done, see vital flow sheet. No other signs of symptoms of an allergic reaction. Patient as well as parent was given signs and symptoms of allergic reaction and directed to go to ER or call 911. Patient was able to sit up after 5 minutes, then eventually stand and was able to leave clinic after 15 minutes in stable condition with parent. RN/BSN on 6/10/2021 at 1:18 PM
13 2021-06-10 burning sensation Patient originally enrolled in COVID19 vaccine trial but tested COVID19 Positive 1/7/2021 and loss s... Read more
Patient originally enrolled in COVID19 vaccine trial but tested COVID19 Positive 1/7/2021 and loss smell and taste. She has since been tested 1/21, 1/29, 2/17 & 5/19. Four of these tests were done during and with the Pfizer study for adolescents. She then came in 5/19 for her 1st Covid vaccine and came also came back positive and experienced a fever and chills after the injection, which mom associated it with her previously having Covid until that test came back positive too. Symptoms since after her vaccine include decreased appetite due to nausea, severe abdominal cramps and when she has a BM it is liquid. Patient reports when she touches cold metal her hands feel as if they are being shocked or burned. Having Headaches and very fatigued will sleep 12 hours+.
13 2021-06-10 involuntary muscle movements Mom was aware that her daughter doesn't do well with needles. Her dad is the same way, per mom. Pati... Read more
Mom was aware that her daughter doesn't do well with needles. Her dad is the same way, per mom. Patient fainted in the immunization room. We gave her a granola bar and some water before the injection, as a preventative measure. She fainted a second time. Mom checker her BP and patient felt nauseous. She started jerking and 911 was called. EMTs said it was not a seizure, but a vasovagal jerk. Paramedics said to lay the person down after the patient started jerking. When she was stable enough to be moved, EMTs wheeled her to the door of the store.
13 2021-06-10 flushing During monitoring period post initial Pfizer COVID-19 vaccine, patient experienced headache, fatigue... Read more
During monitoring period post initial Pfizer COVID-19 vaccine, patient experienced headache, fatigue, dizziness. VS 141/97, P-157, O2-99% RA. Patient states she did not eat anything today and drank very little fluids prior to administration of vaccine today. Patient began to experience chills, flushing placed in Trendelenburg position. VS: 132/80, HR 105, 02 99%. Patient remained in Observation area for an extended period of time. Nurse remained with her and Mom for duration of observation. After an hour, VS: 130/85, P- 105, O2 100% RA, stated headache lessened.
13 2021-06-10 pain in extremity The first day she had some arm pain, nothing significant. The day after, at 4pm, she had a nosebleed... Read more
The first day she had some arm pain, nothing significant. The day after, at 4pm, she had a nosebleed. The following day, she had 3 smaller nosebleeds. She never gets nosebleeds, so I took her into the Dr. to have labs done, just to make sure her platelet count was good. All tests came back normal. We are on day 3 after her 2nd Pfizer, and she has not had a nosebleed yet today, so I'm hopeful it's resolved. In addition to the nosebleed on day 2, she was exhausted, had a headache and had a low grade fever. These I expected, but not the nosebleeds.
13 2021-06-10 tingling Systemic: Dizziness / Lightheadness-Mild, Systemic: Hyperventilation-Mild, Systemic: Tingling (speci... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hyperventilation-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in fingers and toes
13 2021-06-12 tremor, pain in extremity, feeling cold Nauseous and chills (flu like symptoms for 20 hours) Still has body temperature issues. Gets very c... Read more
Nauseous and chills (flu like symptoms for 20 hours) Still has body temperature issues. Gets very cold and shakes periodically still Still has a sore arm
13 2021-06-14 muscle spasms L leg muscle (suspect sartorius muscle) intermittent spasm starting the day after vaccination and pe... Read more
L leg muscle (suspect sartorius muscle) intermittent spasm starting the day after vaccination and persisting intermittently for 2+ days. Improving with Motrin at time of this report, but not resolved.
13 2021-06-15 difficulty speaking 13 yo old girl c/o difficultly swallowing and scratchy throat approximately ten minutes after receiv... Read more
13 yo old girl c/o difficultly swallowing and scratchy throat approximately ten minutes after receiving the second dose of the Pfizer vaccine. She appears well but has a nasal tone to her voice. Auscultation of her larynx did not reveal stridor. No rash, wheezing, or other associated signs or symptoms. She was treated with 25 mg of oral diphenhydramine with a resolution of symptoms after an extended monitoring period.
13 2021-06-15 feeling hot Around 8:30am on 6/16/2021: When she went to bathroom, she felt dizzy and hot, then started to lose ... Read more
Around 8:30am on 6/16/2021: When she went to bathroom, she felt dizzy and hot, then started to lose hearing. So she was lying down in bathroom ~ 5 minutes. She was fainting (passing out???).
13 2021-06-16 weakness Patient is a 12 year old female arrived to observation area complaining of nausea, weakness, noted t... Read more
Patient is a 12 year old female arrived to observation area complaining of nausea, weakness, noted to be diaphoretic. Instructed patient to remain calm, relax. arrived to scene for further evaluation. Vital signs rendered EKG rendered. Pt. denies any pain, discomfort. Pt. refused hospitalization. Pt. recovered from adverse event and left via personal vehicle with mother at 4:10pm.
13 2021-06-16 muscle spasms, flushing Complained of SOB, "crampy, sharp" non-radiating substernal chest pain (fluctuating in severity, the... Read more
Complained of SOB, "crampy, sharp" non-radiating substernal chest pain (fluctuating in severity, the most severe becoming 8/10), fatigue, palpitations, HA, and sore throat which started on 6/14/21. Pt received her second Pfizer COVID19 immunization on 6/11/21. The first symptom to start was sore throat on 6/14/21, however Pt underwent negative strep and mono testing that same day. Pt's other sx began shortly thereafter, the most distressing symptom being the chest pain and SOB. ED Course: --febrile (39.3), tachycardic, and tachypneic which met SIRS criteria --received 20cc/kg fluid bolus --first doses of vancomycin, Zosyn started; Pt reported flushing and pruritis with vancomycin administration Currently hospitalized
13 2021-06-16 pain in extremity Fever, arm pain, passing out
13 2021-06-16 seizure like phenomena Pt passed out and appeared to seize. Pt was no aware of person place or time. 911 was called and par... Read more
Pt passed out and appeared to seize. Pt was no aware of person place or time. 911 was called and paramedics took to the ER to evaluate
13 2021-06-16 tremor, feeling cold Patient complained of not feeling well after being administered with pfizer vaccine, she said she wa... Read more
Patient complained of not feeling well after being administered with pfizer vaccine, she said she was cold, a little shaky, & nauseous. Checked her BP it was very low, elevated her feet, checked her BP several times after that and BP went up to 120/78. Called 911 because she was still not feeling well. EMS checked glucose level and it was low (patient did not have a meal all day). EMS said it was vasovagal syncope however patient did not pass out. Patient recovered while EMS was still on site.
13 2021-06-17 migraine, tremor Mom noticed she experienced tremors last night after 2nd dose and it has gone away this morning. Whe... Read more
Mom noticed she experienced tremors last night after 2nd dose and it has gone away this morning. When she woke up, she had a 102.5 F fever and a massive migraine. Mom just gave her Advil 200mg one dose after she measured the fever. Pharmacist recommended mom to give her another 200mg Advil and to seek prompt medical attention if her fever does not break or she begins to experience any other symptoms.
13 2021-06-17 nerve pain The vaccine compromised her immune system and she presented with Shingles. After examination at the ... Read more
The vaccine compromised her immune system and she presented with Shingles. After examination at the hospital's emergency room, she was prescribed an antiviral medication. Treatment also consists of alternating doses of Tylenol and Motrin for severe nerve pain.
13 2021-06-17 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: Patient most likely "passed out." Reported temporary vision loss. Vitals checked by nurse. Pulse was in 40s. Minute clinic provider also filled out non-patient safety report.
13 2021-06-17 unresponsive to stimuli Called by pharmacy staff to patient who was feverish and non responsive in a chair in the aisle. Pat... Read more
Called by pharmacy staff to patient who was feverish and non responsive in a chair in the aisle. Patient was lied on the floor, ice pack applied. She came to and wanted to sit in the chair. Was offered apple juice. After a few sips, she slumped and became unresponsive. Her breathing was shallow. Mother said she had not eaten or drunk anything today. She was lied on the floor again and remained non responsive and then said she was extremely tired. 911 was called, ice was continually applied. Patient did become responsive and drank 6 ounces of apple juice before EMS arrived. She was taken by stretcher by EMS for evaluation.
13 2021-06-18 feeling hot PATIENT FAINTED SOON AFTER VACCINE. PATIENT WAS HOT AND SWEATY AND NAUSEAOUS. PATIENT' S BLOOD PRES... Read more
PATIENT FAINTED SOON AFTER VACCINE. PATIENT WAS HOT AND SWEATY AND NAUSEAOUS. PATIENT' S BLOOD PRESSURE DROPPED
13 2021-06-18 pain in extremity, feeling hot Very sore arm, headache, hot sweats Acetaminophen, water
13 2021-06-18 pain in extremity On Day 3 evening, one hive appeared, with redness/swelling just below injection site. On Day 4 eveni... Read more
On Day 3 evening, one hive appeared, with redness/swelling just below injection site. On Day 4 evening, multiple hives (around 20) appeared, then merged into one larger mound (around 1.5" x 2"). Previously, on Day 1 evening, soreness of arm and fever started. Fever reached 103.4 degrees. Fever lasted 2 days but lower grade - 101 degrees or so. Day 2 saw bad headache and armpit pain. Day 5 seems to have recovered from hives, but will continue to watch.
13 2021-06-20 burning sensation Lipschultz Ulcer in vaginal area. Extremely painful to urniate. Extreme pain and buring. Treated ... Read more
Lipschultz Ulcer in vaginal area. Extremely painful to urniate. Extreme pain and buring. Treated with Clobetasol ointment & Lidocane jelly for pain. 10 days to heal.
13 2021-06-20 numbness, tremor Tremors on and off of both hands, numbness in legs
13 2021-06-20 pain in extremity 13-year-old otherwise healthy female presents to ED by ambulance for chest pain. Patient received he... Read more
13-year-old otherwise healthy female presents to ED by ambulance for chest pain. Patient received her second dose of the Pfizer vaccine on 6/18. The following day, patient had generalized fatigue, sore arm, and one episode of nonbloody nonbilious emesis. Yesterday, patient began to have intermittent midsternal chest pain which radiates to the back. Patient reports symptoms worsen with movement, walking, and deep inspiration. She denies any shortness of breath, or palpitations. She denies any headache, lightheadedness, fevers, chills, diarrhea, abdominal pain, or dysuria. No cardiac family history per mom. Patient did not have any symptoms after her first Pfizer vaccine. Differential Diagnosis: Chest pain, costochondritis, myocarditis secondary to vaccine.
13 2021-06-20 pain in extremity She had chest pain in her middle chest and to the left of middle. At first the pain was moving, it w... Read more
She had chest pain in her middle chest and to the left of middle. At first the pain was moving, it was up higher and down to ribs and is not upper chest, center chest and left of center of chest. hurts when breathing. She went to ER hour and half after pain started and then her leg, upper thigh, started hurting. elevating her leg helped the leg pain. The leg pain has gotten better. She also had a bad headache the first night and the night after the vaccine but the headaches have gotten better since.
13 2021-06-20 tenderness Patient received covid #2 vaccine and developed a lump above the collarbone area with swelling and p... Read more
Patient received covid #2 vaccine and developed a lump above the collarbone area with swelling and painful to touch. Diagnosed as left supraclavicular lymphadenopathy.
13 2021-06-20 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-Mild, Additional Details: patient passed out 3 times after giving the vaccine i checked her blood pressure and it was 92/62 i lift up her legs and offerd her the epipen but she refused.her parents tried to convience her to get epipen but she also refused.she spent about half hour in the store and she became good and went to home. i called her after 1 hour and she was fine
13 2021-06-21 pain in extremity Bruising to bilateral legs, chest pain that radiates to left arm, and back pain.
13 2021-06-21 seizure Pt received Pfizer vaccine and walked to observation area. RN observed pt to be fainting with convul... Read more
Pt received Pfizer vaccine and walked to observation area. RN observed pt to be fainting with convulsing movements for approx 30 seconds. Pt recovered to full cognitive alertness almost immediately, stated that she had felt dizzy, felt like she was fainting and does not remember what happened after that. Vitals and O2 sat stable, pt did not eat breakfast or hydrate today. Pt denied having symptoms but was transported to ED for further evaluation.
13 2021-06-21 unresponsive to stimuli, cold sweat fainted, grey color, cool/clammy skin, thready pulse, not responsive. EMS on site who attended her.... Read more
fainted, grey color, cool/clammy skin, thready pulse, not responsive. EMS on site who attended her. She become responsive while the assessed her. Their dx was vasal vagal and advised her mom to take daughter to urgent care. Mother's name is.
13 2021-06-22 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt.... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt. came into the pharmacy to get a 2nd dose of Covid-19 vaccine. 1st dose was on 6/1/21, with a hx of an adverse reaction of dizziness/pale Asked pt & her dad if she was fine after that incident-Pt. states she was totally fine when she got home so wanted to get 2nd dose. Shot was given ~4:15pm, and when I checked pt. if she's ok, she started to pale and told me she was dizzy. Called paramedic ~4:25pm and around 4:55pm paramedic teams walked pt. out, pt. seemed fine, and confirmed she was fine
13 2021-06-22 pain in extremity Severe leg pain in both legs. Was admitted into hospital for two days. No medication worked to treat... Read more
Severe leg pain in both legs. Was admitted into hospital for two days. No medication worked to treat this symptom.
13 2021-06-22 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Detai... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: PT FAINTED 3-5 MINUTES AFTER VACCINE WAS ADMINISTERED.
13 2021-06-23 unresponsive to stimuli 13 year old female received#2 Pfizer vaccine and within 5-10 minutes after her vaccine she was sitti... Read more
13 year old female received#2 Pfizer vaccine and within 5-10 minutes after her vaccine she was sitting in post observation with her father when one of our employees called over to me that she was fainting. I ran over to the girl and she had passed out-she was sitting in the chair and did not fall. She was breathing with a pulse of 77- her color was pasty and she was not responding verbally. She was very limp and did not awake after multiple attempts with ammonia inhalant, calling her name and rubbing her chest. 911 was called immediately and female was transported to Hospital within in 20 minutes of incident. I spoke with her stepmom and she informed me that she was sleeping now and is doing ok. They did blood work at the hospital and did not find any issues. Step mom states it took 1 1/2 hours for her color to return. She did tell me that stepdaughter has had syncope issues before and is on antidepressant med that may have caused this. We were not aware of this during time of vaccination.
13 2021-06-24 weakness After waiting the necessary 15 minutes post vaccination, patient started to feel nauseated when she ... Read more
After waiting the necessary 15 minutes post vaccination, patient started to feel nauseated when she stood up to walk away. She made it a couple aisles away from the pharmacy and felt weak and she felt like she was going to throw up. So, patient dropped to her knees to avoid passing out. Patient was brought back to the pharmacy vaccine observation area and was giving a mat to lie on with a pillow and blanket. Patient was given a box of apple juice and a few minutes after patient felt much better, was no longer dizzy, weak or nauseated. Patient left area with mother after returning back to feeling normal.
13 2021-06-24 pain in extremity Only had arm pain initially.; Bilateral knee pain; This is a spontaneous report from a contactable c... Read more
Only had arm pain initially.; Bilateral knee pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration, on an unknown date (reported as: 2 weeks ago, as of tomorrow) (at the age of 13 years old)as 1st dose, single dose for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced Pain in arm initially, Knee pain started about 2 weeks after getting vaccine, it was like bilateral knee pain mostly with exercise. She did not have it the first few days of the shot like she would expect she normally would. She did not have it until last week. It was only when running last week and now she is still having it. Reporter reported that she was concerned about getting her daughter the second dose of vaccine and would like to know if this has been reported. Reporter does not know whether this was related to the first vaccine. She does not know how to know if it was related to the vaccine. Reporter stated that she does not know, and how does somebody know if it was related or not. Reporter also stated that her daughter was not having problems before and she does not know. Reporter stated that she would like to wait at this time and see, she was not sure she should report this or not. The outcome of the events was not recovered. It was reported as the Reporter stated that she thinks that she was not sure if it was related to the Covid vaccine or not Information on Lot/Batch has been requested.
13 2021-06-24 pain in extremity Arm pain; Stomach pain; I feel like vomiting; I feel like throwing up; This is a spontaneous report ... Read more
Arm pain; Stomach pain; I feel like vomiting; I feel like throwing up; This is a spontaneous report from a contactable consumer (patient father). A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191, Expiration Date: 13Jun2021), via an unspecified route of administration, administered in left hand on 13Jun2021 as 1st dose, single dose for covid-19 immunisation. Medical history included was none and there were no concomitant medications. On 14Jun2021, Reporter stated that My daughter, she got the Pfizer COVID vaccine. She has the problem. The arm pain, which was normal because she passed all dosage stage however she keeps complaining about the stomach pain and then she says I feel like throwing up and which was, vaccination was happen on Sunday but she was keeps complaining like on 14Jun2021 Monday night, 15 Jun2021Tuesday night and also 16Jun2021 night and I thought let me update you. Is it normal or something different? She has not thrown up yet but she feel like throwing up and she was having pain in her stomach. She said, I feel like vomiting but no vomit so far but stomach pain still going on. Reporter stated that, I would like to know was that normal or she should checked by the doctor or she should wait one or two days more to get better or any other side effects which needs to be check right away. I mean she do not have any like fever or feel like emergency or anything. She was waking up in night two times. The outcome of the event arm pain and felt like vomiting was unknown and not recovered for other events. Information on lot/batch number was available. Additional information has been requested.
13 2021-06-24 seizure Systemic: Seizure-Mild, Additional Details: Patient Experienced seizure immediately after receiving ... Read more
Systemic: Seizure-Mild, Additional Details: Patient Experienced seizure immediately after receiving vaccine. Last only a few seconds. patient had no loss of memory or any other problems
13 2021-06-25 weakness Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Mild, Additional Details: patient feell... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Mild, Additional Details: patient feell week and loss counciusness. I place it on the floor on the side and she started feeling better and recovering counciusness. I adviced to continue breathing and she follow my comands and instantly started to recover.
13 2021-06-25 feeling of insects crawling on skin manic episode; scratched arms repeatedly (self harm)/scratching chest repeatedly; scratches on arms ... Read more
manic episode; scratched arms repeatedly (self harm)/scratching chest repeatedly; scratches on arms (self harm)/scratches to chest; felt like skin was crawling; This is a spontaneous report from a contactable consumer or other non-HCP. (patient's mother reported). A 13-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Left Arm on 08Jun2021 12:30 as single dose (at the age of 13-years-old) for covid-19 immunization (reported as, prevent infection of Covid 19). Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0169, Expiration date:31Aug2021) administered in Left Arm on 13May2021. Patient stated that it was a shot or needle to her left arm. Medical history included anxiety from 2015 and ongoing, depression from 2018 and ongoing. The patient's concomitant medications includes unspecified medications for Anxiety. No further details provided. History of all previous immunization with the Pfizer vaccine considered as suspect(or patient age at first and subsequent immunizations if dates of birth or immunizations are not available):None. Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) If applicable, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. On 08Jun2021 20:30 the patient experienced scratched arms repeatedly (self harm)/scratching chest repeatedly and scratches on arms (self harm)/scratches to chest. On 08Jun2021 15:30 the patient experienced felt like skin was crawling. Reporter stated that her child received the second dose of Pfizer vaccine on Tuesday and had self harm that afternoon. Does not know if it is correlated or not. Stated that she felt like her skin was crawling and had to do something about it. Stated that she had self harm where she scratched her arms and chest repeatedly. Stated that she had to go to behavioral health center. Reporter stated that the patient was anxious before the vaccine and it built up and led to harming herself. Does not know if the vaccine caused it or not. Reported stated that patient was fine now. Stated that it was all a manic episode within hours of the vaccine. On an unspecified date, the patient experienced manic episode. Patient visited Physician Office for AE self harm. Reporter did not provide the Physician details. Stated that the scratches are still there and there is a potential for scaring. Treatment were None. Relevant Tests: None. The outcome of event scratched arms repeatedly (self harm)/scratching chest repeatedly had recovered with sequelae on 08Jun2021 and the outcome of event scratches on arms (self harm)/scratches to chest had not recovered. The outcome of event manic episode was unknown while the outcome of event felt like skin was crawling had recovered on 08Jun2021. Information on Lot/Batch number is available; Further information has been requested.
13 2021-06-26 discomfort, cold sweat, speech disorder, pain in extremity, feeling hot Patient said she felt immediate, strong pain in her arm from the jab the nurse gave her. She said t... Read more
Patient said she felt immediate, strong pain in her arm from the jab the nurse gave her. She said the needle was in her arm a lot longer than when she received her first shot. I also watched patient receive her first COVID shot from a different provider, different facility, and I was surprised by the force of the jab of this second COVID shot, and length of time the needle was in her arm. After the nurse left us in the room to wait 15 minutes, patient became more and more uncomfortable, hot, sweaty and nauseous. Within 5 minutes, she was lying down on the exam table - at which time I alerted staff at the nurse's station in hallway that patient wasn't well and we needed help. She said she would get "the provider" and be right in. When I walked back into the room, patient was curled up in a ball on the table, pale, clammy and not able to speak. I yelled down the hallway for help right away, and stepped back into the room. Patient then began to vomit. At least two nurses entered the room, and began to assess her vitals. Her blood pressure was low, but she was breathing fine. 'The provider" (I don't know his name) came in and I told him about how hard she was jabbed, and that she began to feel badly immediately afterward.
13 2021-06-27 bell's palsy Left facial nerve palsy; started on prednisone
13 2021-06-27 pain in extremity Shortly after vaccination client felt intense pain in the right side of her neck radiating down he... Read more
Shortly after vaccination client felt intense pain in the right side of her neck radiating down her arm. Client was at the vaccination site in the observation lot at this time, and the Nurse called the ambulance to come assess the client. The client was transported to the ER with the consent of the mother.
13 2021-06-27 seizure like phenomena seizure-like activity x 25 seconds, loss of consciousness and fainting
13 2021-06-27 seizure Patient looked like they were having a seizure and collapsed. Patient was unconscious for about 3-4... Read more
Patient looked like they were having a seizure and collapsed. Patient was unconscious for about 3-4 minutes. Called 911, paramedics arrived in about 5-10 minutes assessed patient and transported patient to the emergency room.
13 2021-06-29 weakness, seizure UPON MY TECHNICIAN GIVING THE VACCINE, PATIENT FELT WEAK AND MY TECHNICIAN DESCRIBED HER AS HAVING A... Read more
UPON MY TECHNICIAN GIVING THE VACCINE, PATIENT FELT WEAK AND MY TECHNICIAN DESCRIBED HER AS HAVING A SEIZURE TYPE REACTION FOR A FEW SECONDS. THE PATIENT THEN FELT NAUSEOUS AND NEEDED TO LIE ON THE GROUND. UPON ARRIVAL OF THE PARAMEDICS, THEY EVALUATED PATIENT AND STATED THAT SHE WAS FINE AND DID NOT THINK THAT IT WAS A TRUE SEIZURE. PATIENT AND HER MOTHER LEFT THE PHARMACY AFTER FURTHER OBSERVATION WITH NO OTHER ISSUES THUS FAR.
13 2021-06-29 weakness Shortness of breath, weakness, headache ? Vaccine RXN Orthostatic Hypotension Nausea
13 2021-06-30 cold sweat, unresponsive to stimuli, feeling cold Patient complained of dizziness and feeling clammy. Patient was given an ice pack. Patient was not a... Read more
Patient complained of dizziness and feeling clammy. Patient was given an ice pack. Patient was not able to answer question (What day is it?) and Mom requested that paramedics be called. While waiting for the paramedics patient continued to complain of dizziness, feeling clammy/cold and changes in vison (zig zag lines).Just prior to paramedics arriving Patient was able to sit up on her own, answer questions (What day is it and Who is the President?), but still complaining of feeling cold and vision problems, Paramedics arrived and took Patient to the Ambulance to further evaluate her.
13 2021-06-30 feeling cold, seizure Mild seizure; could not see; fainting; low blood pressure; Felt cold; This is a spontaneous report f... Read more
Mild seizure; could not see; fainting; low blood pressure; Felt cold; This is a spontaneous report from a contactable consumer. A non-pregnant 13-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Jun2021 at 10:00 AM, at patient age of 13-year-old, as single dose (Lot number EwO191) for COVID-19 immunization. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 25May2021 at 15:00 PM, at patient age of 13-year-old, as single dose (Lot number Ew175) for COVID-19 immunisation. The patient experienced the adverse events from 15Jun2021 at 22:15 PM. The patient experienced mild seizure, could not see and low blood pressure, fainting. The patient felt cold and could not see is what she said before sitting in the chair at the pharmacy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with laying down with propped up legs and water. The outcome of the events was resolved. COVID was not tested post vaccination.
13 2021-06-30 tremor Patient fainted/passed out approx 10 minutes after vaccine admin, was shaky and sweating
13 2021-07-01 bell's palsy Bell's Palsy
13 2021-07-02 tremor PEDIATRIC PATIENT RECEIVED SHOT WHILST FATHER PRESENT AFTER SHOT HE STEPPED AWAY, THEN CHILD CLOSED ... Read more
PEDIATRIC PATIENT RECEIVED SHOT WHILST FATHER PRESENT AFTER SHOT HE STEPPED AWAY, THEN CHILD CLOSED HER EYE SHE LOOKED LIKE HER LIMS WERE SHAKING PER FATHERS OBSERVATION, THIS OCCURED FOR NO MORE THAN 2-5 SECONDS TECHNICIAN GAVE VACCINE. HE ALERTED ME AND I CAME OVER WITHIN 30 SECONDS. PATIENT WAS AWAKE LOOKED A BIT PALE AND HER PARENTS HAD LIFTED HER FEET UP. SHE TALKED TO ME EXPLAINING THAT SHE REMEMBERED THE BLOOD AND THE NEEDLED AND SHE DOESNT LIKE NEEDLES SHE THEN DOESNT REMEBER ANYTHING FROM WHAT SHE SAW THEN SHE DREAMED. SHE WAS ABLE TO WALK OUT THE CUBICLE AND SIT DOWN, AFTER 5 MINUTES SHE APEARED TO BE MORE SWEATY AND HOT LAYING ACROSS HER MOTHER , MOTHER GAVE HER SOME SODA-FLUID. I THEN CALLED EMERGENCY SERVICES, THEY CAME BY 5:25PM TO 5:30PM TOOK HER IN THE TRUCK TO OBSERVE, AFTER 15MINUTES OR MORE THE PARENTS CAME INTO THE DRIVE THRU AND SAID THEY WERE TAKING HER HOME SHE WAS FEELING BETTER.
13 2021-07-03 weakness, tenderness Patient is a 13-year-old who was transferred from another hospital for chest pain in the setting of ... Read more
Patient is a 13-year-old who was transferred from another hospital for chest pain in the setting of Covid vaccination. She received her second dose of Pfizer vaccine on Tuesday, June 29. On Wednesday she developed fatigue chest pain shortness of breath weakness, nausea and mild abdominal pain. She also had a fever to 102.5 Fahrenheit. mom is a nurse and took her pulse and felt that it was 30 and fast. She then took 1 with her home equipment it was in the 120s. She called her neighbor who took her pulse and it was in the 130s. She then transferred her to another Hospital for further care at hospital her vital sinus evaluation was a temperature of 37.4 pulse 119 respiratory rate is 15 blood pressure 106/62 satting 98% on room air. On exam she was well appearing with tenderness to palpation of sternum heart rate normal rate and rhythm lungs clear bilaterally and abdominal exam benign. they obtain CBC with white count of 4.8 hemoglobin 12.9 Camm that was unremarkable LFTs are within normal limits troponin that was negative BNP 223 with a normal upper limit of 125 ESR 2 D-dimer 0.697 with upper limit of normal 0.5 and a CRP of 9 with upper limit of normal of 8.1. UA bland. She was given Toradol for chest pain EKG with sinus tachycardia . She was given 1/2 L normal saline bolus ondansetron Toradol and started on maintenance IV fluids of D5 NS. She was then transferred to another hospital for further care . Upon arrival here she notes improvement in her energy level and all of her pain except for her chest pain. She describes it as a pressure on top of her chest that is right in the center and is worse with movement and deep breaths. Of note she had a appendectomy a few years ago that was complicated by surgeons making the bowel and then required her to have a bowel resection. She has no dietary restrictions and eats by mouth, no GI complications in the long-term. PMH: as above PSH: No significant past surgical history FH: Reviewed and noncontributory to current presentation SH: Lives with caregivers Meds: None Allergies: No known drug allergies Immunizations: UTD Review of Systems Constitutional: fever, no chills, no sweats, fatigue Skin: no rash, no lesions, Eye: no redness ENMT: no ear pain, no sore throat, no congestion, no hoarseness Respiratory: + shortness of breath, no cough, no wheezing Cardiovascular: + chest pain, no palpitations, Gastrointestinal: + nausea, no vomiting, no diarrhea, no GI bleeding Genitourinary: no dysuria, no hematuria, Musculoskeletal: + muscle pain, Neurologic: no headache, no dizziness, no numbness, no weakness Psychiatric: no sleeping problems, Allergy/Immunologic: no recurrent infections, Additional ROS info: All other systems of a 10 system review are negative. Briefly, patient is presenting with chest pain, myalgias, and fever in setting of recent covid vaccine (2nd dose Pfizer 2 days ago). Seen at an outside hospital where labs were notable for mildly elevated BNP and D-dimer, negative troponin, normal LFTs and chemistries. Chest x-ray reportedly negative. EKG with T wave inversions in V1 through V4 (read as nonspecific ST changes by their physician), but otherwise normal. Given the possibility of post Covid vaccine myocarditis or PE, transferred for further management. Patient states that after Toradol that she received the outside hospital all of her other symptoms have resolved but she continues to have chest pain. My exam showed: Gen: tired but nontoxic appearing, no acute distress, alert and active; HEENT: PERRL, EOMI, normal conjunctiva, neck supple without LAN; Chest: significant reproducible chest pain; Card: RRR, no murmur, good perfusion, brisk radial pulses bilaterally; Lungs: CTAB, good air entry, no increased WOB; Abd: soft, non-tender, non-distended, no masses; Ext: warm and well perfused, moving all extremities; Skin: no rashes Chest pain. Overall well appearing with normal exam with reproducible tenderness. Given recent Covid vaccine, must consider myocarditis, although only mildly elevated BNP and negative troponin at the outside hospital are reassuring, especially given reproducible pain and reassuring EKG. Symptoms then may represent musculoskeletal etiology such as costochondritis or myositis related to vaccination. Less likely pneumonia or pneumothorax, but possible. Low suspicion for PE given lack of persistent tachycardia (tachycardia improved while in ED, currently HR 80s) or hypoxia. EKG obtained which showed T wave inversions in V1-V4 (normal for age). Bedside ultrasound with normal global function and lack of pericardial effusion. Labs obtained in BCH ED notable for negative BNP and troponin, along with reassuring lipase given abdominal pain. Thus, unlikely to be true myocarditis, more likely musculoskeletal etiology such as costochondritis or chest wall pain. Cardiology will discuss with mom for reassurance. Final Diagnosis 1. Chest pain R07.9 2. Fever R50.9 3. Fatigue R53.83 4. Shortness of breath R06.00 PLEASE NOTE: Since the patient is not from here, we do not have access to her vaccination records and cannot supply lot number, etc.
13 2021-07-05 feeling hot About 2 mins after the vaccine was administered patient stated that she did not feel good. She was h... Read more
About 2 mins after the vaccine was administered patient stated that she did not feel good. She was hot, pale, sweaty, nauseas, almost passed out. We laid her on the floor and elevated her legs, then she started feeling better. The paramedics came. BP was 90/48. when they left her BP was 101/60. Her parents decided to take her home for observation. I called them at 7:58pm and mom said she was perfectly fine. Vaccine given at 4:55, paramedics left at 5:20.
13 2021-07-06 weakness, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted after giving second pfizer dose. After putting on bandaid and explaining to her she needs to wait 15 min she passed out. She leaned forward (thinking she was getting up) and fell to the ground. She hit her head on ground. Her blood pressure was checked twice, the second a half hour after the first and she was still low. She did not feel comfortable walking so we wheeled her out to parking lot and she went to urgent care. Facility filled out report as well since she hit her head.
13 2021-07-06 seizure, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seiz... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: pt fell from chair and felt dizzy and fainted .Rph got water and gatorade . she felt better and went home . Rph checkecd on pt .Mom have taled tp pedtricaid . she was much better . no too much concerned
13 2021-07-08 numbness, pain in extremity received from mother: states daughter received shot at approximately 10:00 a.m. on 7/9/21. Daughter ... Read more
received from mother: states daughter received shot at approximately 10:00 a.m. on 7/9/21. Daughter tensed up right before getting the shot. Daughter now has pain running down right arm and has numbness in fingers of right hand. No complaint of swelling or redness.
13 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.
13 2021-07-08 pain in extremity Developed rash and joint swelling the next day. Also with swelling of the lips. No fever. Rash was i... Read more
Developed rash and joint swelling the next day. Also with swelling of the lips. No fever. Rash was itchy and on arms and legs. No joint swelling resolved after 48 hours. Still with pain of feet with walking on 7/9/21
13 2021-07-10 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Sweating-Severe, Systemic: Nausea-Severe
13 2021-07-12 feeling hot, seizure The patient, 13 y/o female, presented to clinic for the second dose at approximately 9:00 AM on 7/7/... Read more
The patient, 13 y/o female, presented to clinic for the second dose at approximately 9:00 AM on 7/7/2021. The patient denied contraindications to vaccination and reported that she experienced no adverse effects with the first dose of vaccine that was administered 3-weeks prior. The vaccine was administered by the public heath nurse to the patients left deltoid and the patient tolerated the injection well. After vaccination, the patient returned to the waiting area to sit with her mother for the 15 minute observation period. Approximately 5-10 minutes later, the patient's mother called for help and reported, along with front desk staff, the the patient started convulsing for a few seconds and then lost consciousness. At this point, front desk staff contacted EMS and I arrived at the side of the patient. The patient was pale and lethargic. She had no visible swelling or difficulty breathing. She reported feeling extremely hot and appeared to struggle to stay conscious. The patient responded accurately when asked her name and date of birth. The patient was given water and placed in the supine position. EMS arrived and transported the patient to a local hospital for evaluation. The patient's father was contacted on 7/8/2021 and he reported that the patient spent a number of hours in the hospital and that medical staff did not believe that she had a seizure and that the most likely etiology of her symptoms was vasovagal syncope. He reported that the patient was starting to feel better and was resting in bed. He was instructed to contact the health department with any questions/concerns and to report any additional side effects.
13 2021-07-12 numbness pain in bilateral eyes; left hand and left leg numbness; tongue numbness with fasciculation to the l... Read more
pain in bilateral eyes; left hand and left leg numbness; tongue numbness with fasciculation to the left side; tongue numbness with fasciculation to the left side; headache; nausea; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0186, expiration date was not reported) via an unspecified route of administration at the right arm on 16Jun2021 (at the age of 13-years-old) at single dose for covid-19 immunisation. Medical history included ADD (attention deficit hyperactivity disorder) from an unknown date. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. The patient was not pregnant at time of vaccination. Concomitant medication included ibuprofen (ADVIL) and muscle relaxer taken for unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number ew0176,expiration date was not reported) via an unspecified route of administration on 27May2021 (at the age of 13-years-old) at single dose for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced pain in bilateral eyes, left leg numbness, left hand numbness, tongue numbness with fasciculation to the left side, headache, and nausea on 17Jun2021 17:30. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered in Jun2021. The report was reported as non-serious.
13 2021-07-12 seizure Within 15-20 seconds of receiving the injection, my daughter who has NO history of seizures or healt... Read more
Within 15-20 seconds of receiving the injection, my daughter who has NO history of seizures or health issues of any kind, , began having seizures. Her skin color becamee gray, her lips turned blue. The seizure last approximately 20 seconds and when she came out of it she was able to breathe but said her throat felt funny, scratchy, smaller - but she was still able to breathe. She was nauseous, head hurt and was very disoriented for approximately 20-30 minutes. The pharmacist called 911. 911 arrived and took her blood, did a multitude to tests which all came out ok. We opted not to take her to the hospital as she was breathing ok, and her color was returning.
13 2021-07-12 unresponsive to stimuli Pt. left the vaccination room and walked over 2 isles and then up past the middle of the store. Pt g... Read more
Pt. left the vaccination room and walked over 2 isles and then up past the middle of the store. Pt grabbed the mother's arm and the mom helped her slow her decent to floor. Mom stated pt. fainted and unresponsive for a couple of minutes. Pt. regained consciousness and needed no further treatment.
13 2021-07-14 electric shock sensation, tingling, pain in extremity Around 7PM on June 19th, she had chest pain and chest pressure. She also had a mild headache. She wa... Read more
Around 7PM on June 19th, she had chest pain and chest pressure. She also had a mild headache. She was taking a walk in the neighborhood and had to come home because she was experiencing shortness of breath and having difficulty breathing. She described it as an electric shock/shooting pain in her chest area, on both sides. I took her (the participant) to the ER. While at the ER, she started to feel experience pain and tingling in her left thigh. It would feel better if her leg was elevated. The leg pain subsided by the 20th. On the 21st, she was taken back to the ER because the chest pain and shortness of breath was not subsiding. They did another EKG which showed no abnormalities. Blood work came back with the same indication of virus/inflammation. They gave her a pain med (not sure of the exact name, but it is used for patients after surgery) and an IV. Also given a prescription for 27ml of ibuprofen with Tylenol in between. Two days later, on the 23rd, she had an appointment with the pediatrician. The doctor checked muscle tone and listened to her chest. My daughter gets fatigued by going up a single flight of stairs. Doctor referred her to a pediatric cardiologist. Later that night of the 23rd, she began to get a tingling sensation in her left arm that went down to her hands and lightheadedness. She was not able to move and had to lay down. Being upright made the pressure in her chest worse and she had to take shallow breaths. I took her to the ER. They did a chest x-ray that showed no abnormalities. Referred her for an echo cardiogram on the 24th. She was doing better after that until July 5th, when the pressure and pain started getting worse again. I took her to the pediatrician again and they referred her to rheumatologist on the 11th of July. The rheumatologist prescribed a steroid medication to calm her immune system. She said her immune system was activated and was inflamed, which is why she was experiencing the shortness of breath and pain. She prescribed her colchicine and Aleve. Since she has started to take the meds, she is doing better but she is still experiencing pressure at a lesser level. The pain is the same level that feels like static shock.
13 2021-07-14 tremor Immediately after the vaccination, patient felt faint, started shaking, and eyes rolled in the back ... Read more
Immediately after the vaccination, patient felt faint, started shaking, and eyes rolled in the back of her head. Patient came to and EMS came to assess her,
13 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: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient presented about 10 min after vaccination as lightheaded and nauseous. Patient vomited one time. EMS was contacted, when they arrived the patient's BP was 90/60 and HR was 88 bmp. Parent of patient refused hospital transport after EMS gave all clear, and patient was able to talk, stand, etc on her own. Mother stated that patient was very anxious before and during the vaccine.
13 2021-07-15 unresponsive to stimuli, flushing, feeling hot, tremor Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Vaccination was administered, within 10 min patient became unresponsive and appeared to lose conciousness. upon immediate assessment no signs of anaphylaxis were present, 911 was called. pt felt very warm to the touch and lost control of bladder. mother mentioned pt had passed out 7/14 at home but no prior history of any events. no reaction to any previous vaccines. paramedics arrived and took over pt was released under care of mother with suspision of dehydration
13 2021-07-17 bell's palsy Bell's palsy; Sore throat; This is a spontaneous report from a contactable Physician. A 13-year-old ... Read more
Bell's palsy; Sore throat; This is a spontaneous report from a contactable Physician. A 13-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: LSW0196) via an unspecified route of administration on 05Jul2020 (at the age of 13-year-old) as single dose for COVID-19 immunisation. The patient's medical history, concomitant medications or past drug history were not reported. On 10Jul2020 (Saturday), the patient experienced sore throat and on 11Jul2020, patient experienced numbness of face on Sunday and was diagnosed with Bell's palsy. The patient was started on unspecified steroids as treatment medication after Bell's palsy diagnosis. The parent still wants child to receive second dose of vaccine and asked if this was okay. The outcome of the events was unknown.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Bell's Palsy cannot be fully assessed/excluded. The case will be reassessed if additional 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
13 2021-07-17 burning sensation Face was on fire/ Chin burning; This is spontaneous report received from a contactable consumer (pat... Read more
Face was on fire/ Chin burning; This is spontaneous report received from a contactable consumer (patient mother reported for her daughter). A 13-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 18May2021 as dose 1, single (at the age 13-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Mother had 3 teenagers. 2 teens got the Covid vaccine last Tuesday (18May2021). The 16-year-old and 13-year-old both had substantial side effects. She did not seem to be hearing about them. She did not make the connection to the vaccine until her daughter had the same symptoms the night of her vaccine. They both had the same effects. Her daughter experienced it even worse than her son. She had 3 teenagers. One is 16, and he got the vaccine approximately 2 weeks ago. The other 2 teens got the vaccine last Tuesday (18May2021). The 16-year-old and 13-year-old both had substantial side effects. She did not seem to be hearing about them. She was concerned about whether they should get the second dose based on their reaction. She asked what Pfizer recommended. She was a social worker. Her son had severe allergies, and they knew that when he went in there. They were watching him. Upon getting it, 15 minutes later his chin was burning. It was not significant and did not get any worse. Then for the next 4 days his face was on fire to the point where he could not even use soap or moisturize because it was really painful. She did not make the connection until her daughter had the same symptoms the night of her vaccine on 18May2021. They both had the same effects. Her son had his first dose of the vaccine on 12May2021. The burning in his chin went away. She was not sure when it went away. It did not last that long. His face started the night he got the vaccine. It lasted for about 4 days. It has totally gone away. She was just wondering, she was pretty savvy in terms of reading and she has not seen this reaction publicized. Both her 16-year-old and her 13-year-old were in the later stage of puberty. That was the only other correlation between her two kids that she can imagine. They did not have the vaccine on the same day, so it was not the batch. Her daughter experienced it even worse than her son. She hoped Pfizer is figuring all of this out. The adverse event did not result emergency room or physician office visit. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
13 2021-07-17 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Additional Details: about 2 minutes after administration o... Read more
Systemic: Fainting / Unresponsive-Medium, Additional Details: about 2 minutes after administration of vaccine, patient fell out of her chair. quickly woke up, fully alert, able to speak, no pain, no anaphylaxis. fell on vaccine curtain but did not hit head, no injuries, bruises,or scratched noted or reported. mom mentioned patient was fasting prior to administration. patient reported no pain, no confusion. abulance came and escorted patient out. case number: 2021089124 sheriff's office
13 2021-07-20 weakness, flushing Site: Pain at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Addit... Read more
Site: Pain at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: patient reported signs of feeling faint and lips turning white. temp was stable at 96.7 and breathing was normal. Parents refused 911 so I instructed them to seek medical attention immediately. Parents drove to hospital themselves. Called parents later in the evening and mom said daughter was doing ok and was told px reacted to pain of getting the vaccine and not the actual vaccine and she should continue vaccines series on 8/10/21. All vitals wore normal and she's being monitored at hospital
13 2021-07-20 flushing Patient received her first Pfizer dose at 4:06pm at 4:20 mom brought patient over to me to tell me s... Read more
Patient received her first Pfizer dose at 4:06pm at 4:20 mom brought patient over to me to tell me she was feeling like her neck and leg felt swollen, we all discussed that it could be swollen lymph nodes and they choose to go and check out up front. At 4:30 Mom brought patient back to the pharmacy and said she was feeling strange. Patient said her throat felt weird, she felt dizzy and was having ear pressure, but was not having difficultly breathing. I offered Benadryl and to call 911, Mom denied her needing that at the time. While we were asking patient questions her eyes started to roll and flutter and her head would fall back, but she was alert and talking and stated that she was seeing spots. I told Mom that we were going to call 911 at that time so they could come and check her out. I also go an ice pack and we placed it on her neck, her face was flushed and I took her temperature it was 99.2 at 4:42pm. Ambulance arrived at 4:45pm and they did her vitals and she walked out to the ambulance with them to be checked out. I called Mom at 6pm to check on patient and she was doing much better and did not have to go to ER.
13 2021-07-21 weakness At first, waking up with difficulty breathing (around 4:30 AM), pain when breathing (throat), Chest... Read more
At first, waking up with difficulty breathing (around 4:30 AM), pain when breathing (throat), Chest pain. Headache. Very fast heartbeat. Took a lot of effort to walk, especially down stairs. Took Tylenol (around 5:00 AM) , went back to bed. After 7 hours of sleep, had no appetite. Headache. Symptoms faded after a couple more hours.
13 2021-07-21 tremor Patient experienced temporary fainting with shaking, dizziness, and nausea
13 2021-07-23 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received Pfizer Covid Vaccine an... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received Pfizer Covid Vaccine and went to sit in the waiting area. Immediately upon sitting down, patient said she felt dizzy and fell on the floor and bumped her forehead. Patient is responsive and pharmacist observed patient for 30 minutes. Offered to call 911 for the patient, but mother refused and they are going to see their PCP after leaving the pharmacy.
13 2021-07-25 tremor Developed a motor tick on her lower lip that was intermittent, quivering of lip
13 2021-07-26 flushing About 10 minutes after injection patient became dizzy, diaphoresis, flushed, hypotensive (100/80), d... Read more
About 10 minutes after injection patient became dizzy, diaphoresis, flushed, hypotensive (100/80), drowsy, nausea. Patient was seated and legs elevated. Cool water bottle placed behind neck, blood pressure obtained. She remained in this positi9on for about 15 minutes. No reaction noted at the injection site. When she began to stabilize we offered juice which she took and began to feel better. She was released to go home. I contacted her mother at about 7:30pm that evening and patient was feeling much better
13 2021-07-26 seizure like phenomena Seizure-like activity roughly 1 to 2 minutes after vaccination, lasted roughly 30 seconds
13 2021-07-27 muscle spasms prior to vaccine she had very regular periods for 12 months. After second dosage of vaccine, she is... Read more
prior to vaccine she had very regular periods for 12 months. After second dosage of vaccine, she is having cramping, clots, and periods about every 2 weeks
13 2021-07-27 pain in extremity Vasculitis of hands. Patient presented redness, pain and itching of hands and palms intermittently s... Read more
Vasculitis of hands. Patient presented redness, pain and itching of hands and palms intermittently starting approximately 4 weeks post-vaccination.
14 2021-01-31 pain in extremity Patient received vaccine without age verification.Patient was 14 years and 10 months. After 50 hours... Read more
Patient received vaccine without age verification.Patient was 14 years and 10 months. After 50 hours, patient has sore ULE, but no other symptoms.
14 2021-02-17 pain in extremity Day of vaccination (Monday) - arm sore, Tuesday - body aches, muscles sore, headache, Wednesday- mus... Read more
Day of vaccination (Monday) - arm sore, Tuesday - body aches, muscles sore, headache, Wednesday- muscles less sore, headache, Thursday - symptom free
14 2021-05-12 unresponsive to stimuli Pt received Pfizer vaccine, apprx 5-10mins while in the observation area pt became unresponsive with... Read more
Pt received Pfizer vaccine, apprx 5-10mins while in the observation area pt became unresponsive with full body tonic activity. Entire episode including LOC lasted ~1min. Pt regained consciousness quickly with no postictal period. During the episode pt was laid on back and turned on side, there was minimal oral secretions noted during episode. VSS after event, SpO2 96% and HR 58. EMS called and arrived on scene after ~5-10mins. VSS, parents in car and will transport pt to local hospital.
14 2021-05-13 grand mal seizure Immediate syncope lasting about 15 seconds with 5 seconds of tonic-clonic activity and brief emesis.... Read more
Immediate syncope lasting about 15 seconds with 5 seconds of tonic-clonic activity and brief emesis. Normal mental status within 30 seconds. Initial heart rate 50, and BP 90/60, recovered to normal with BP 100/60 and heart rate 70 within 30 minutes. No signs of allergic reaction or anaphylaxis. Taking fluids and felt well upon discharge.
14 2021-05-13 pain in extremity Approximately 4 minutes after administration of vaccine, patient fainted and was caught by parent an... Read more
Approximately 4 minutes after administration of vaccine, patient fainted and was caught by parent and gently laid on ground. Patient was monitored by pharmacist until paramedics arrived. Patient woke up quickly and was in good spirits and left the store on her own after being monitored by paramedics. Followed up with parent the next day and she was doing well with no adverse effects except for a mild sore arm.
14 2021-05-14 burning sensation Patient received vaccine at Health dept 5/13/2021 at 4pm. Presented to our office 5/14/21. seen by ... Read more
Patient received vaccine at Health dept 5/13/2021 at 4pm. Presented to our office 5/14/21. seen by Dr 3:09 pm, complaint that had facial burning 1-2 hours after first dose COVID vaccine. School nurse called and reported face swollen and throat itching took Benadryl and did not help. no cough or wheeze, throat itchy called and spoke allergist who stated did not expect allergic run to last that long and people will idiopathic urticaria can have reactivation of urticaria- VAERS Report filed yesterday Patient returned to Saturday walk in clinic today 5/15/21 and saw me- woke up at 2 AM c/o difficulty breathing but didn't want to bother parents on arrival 09:29 P130 sat 98%- nurses state not in distress at arrival at my arrival in room 10:20 AM noted to have frank stridor and fair to good air movement- patient seems to have worsened while here 0.3 mg Epi given IM and felt better sent to ER by ambulance - Hospital for additional monitoring? in case more epi needed
14 2021-05-14 numbness pt fainted roughly five minutes after shot. She came to shortly after and was helped back into her c... Read more
pt fainted roughly five minutes after shot. She came to shortly after and was helped back into her chair. Pt complained of dizziness and numbness in her arms. Blood pressure was taken 79/56. Paramedics came and checked pt out . Pt was released to mom after being given water and sitting for 10 more minutes.
14 2021-05-14 tremor, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
14 2021-05-14 unresponsive to stimuli 9:45am a 14 year old patient reported not feeling well, vital signs taken BP: 76/50, HR 60, then dro... Read more
9:45am a 14 year old patient reported not feeling well, vital signs taken BP: 76/50, HR 60, then dropped to 50s, 02 sat at 98% room air. Then patient became unresponsive with that 2 minutes, still with pulse of 52, Benadryl 50mg IM given to right arm, within 2 minutes patient became responsive and with color came back to her face. Ambulance came within 6 minutes, patient became responsive and vital signs stable. Report given to the ambulance. Patient and mom and sister went in the ambulance in stable condition.
14 2021-05-14 unresponsive to stimuli 14 year old female fainted. alert and oriented X 0 not verbally responsive
14 2021-05-14 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting /... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild
14 2021-05-15 feeling hot, seizure Patient received her first dose of the Pfizer Covid-19 vaccine. While waiting for observation, patie... Read more
Patient received her first dose of the Pfizer Covid-19 vaccine. While waiting for observation, patient started to faint and seized. She also reported being hot and asked to take off her sweater. Paramedic was called and patient was taking to the nearby hospital. Patient reported black out while sitting on her chair, though by the time paramedic finish with the transportation patient reported vision recovery.
14 2021-05-15 tremor, inability to speak Within 10 minutes after the vaccination, there were some body tremors and dizziness, then she lost v... Read more
Within 10 minutes after the vaccination, there were some body tremors and dizziness, then she lost vision, hearing and ability to speak for a few seconds, followed by difficulty breathing and a feeling of her heart ?jumping out of chest.? Eventually, she recovered, but her right hand (not the injection arm) still has involuntary tremors, which has not gone away.
14 2021-05-16 pain in extremity Starting at 0300 5/16/21 Pt was awoken with pain in R arm, R arm pit, and along back. Pain kept wak... Read more
Starting at 0300 5/16/21 Pt was awoken with pain in R arm, R arm pit, and along back. Pain kept waking Pt up, she slept fitfully. Pt stayed in bed until around 1300 5/16/21. She had a project for school due- had to video tape making a recipe. She was standing up videotaping the ingredients when she felt very dizzy. Pt then reported that she lost her vision- everything turned black. I had to rush to her to catch her- she had loss of consciousness for about a minute. She was very pale- lips turned blue. She had a pulse the whole time, BP was 117/60- when I checked it about 5 min later. Her temperature on a ear thermometer was 99.7. After she awoke, she was still very dizzy and stayed in bed most of the day. 5/17/21 AM- she woke up for school 0600- and was feeling better. No more dizziness, color was back in her cheeks, was able to eat and left for school.
14 2021-05-16 seizure Vasovagal Syncope @ 10:05 14 year old female. No breakfast or fluids in am before vaccination. EMT... Read more
Vasovagal Syncope @ 10:05 14 year old female. No breakfast or fluids in am before vaccination. EMT called BP 104/68 oxygen 99% HR 78 . BS 85. 10:14 seizure like behavior eyes roll back in head both arms constrict. BP 100/60 IV fluids started 100ml saline. 10:30 BP 104/70. ( Per mother history of syncope four years ago after receiving an allergy shot.) alert and oriented x4 at 10:40. released to mother .
14 2021-05-16 tremor, cold extremities Patient was given her first Pfizer Covid shot in her LUA at 3:15. After the shot one of the school n... Read more
Patient was given her first Pfizer Covid shot in her LUA at 3:15. After the shot one of the school nurses notice during observation that she stood up and looked lie she wanted to pass out. The nurse accompanied the patient to a nearby cot where she laid her down. The patient c/o lightheadedness, dry fuzzy throat. Patient's extremities were cold to touch, eyes rolling back, hand posturing (stiff and cold), shaking., 62 pulse. No problems breathing or swollen throat. Blood pressure was 119/67 at 3:25 and pulse was 80. Nurse elevated patient legs for about 10 minutes, patient felt dizzy, shaking, apparent panicking eyes still rolling back. She was able to respond to simple commands. Still fuzzy throat. Administer 50mg IM in RUE at 3:34p.m. Blood pressure 116/71 at 3:35. Patient's face cheeks started to look red and warm. Blood pressure 123/76 at 3:39p.m. We called 911 at 3:46p.m. Blood pressure 117/78 at 3:52, temperature 97.5 degrees. Paramedics arrived 3:54p.m. Blood pressure taken by paramedics:142/86, O2 saturation 70%, started oxygen via nasal canula at 3:56. Gave epinephrine 0.5ml IM in left upper thigh. Started IV line at 4:00p.m. Red tonsils, lungs diminished but clear. 4:02p.m. transported by paramedics to Hospital.
14 2021-05-17 cold sweat Patient received vaccine and within 5 minutes was not feeling well. Patient fainted and then when co... Read more
Patient received vaccine and within 5 minutes was not feeling well. Patient fainted and then when conscious began vomiting. Patient also became very pale and clammy. Patient has experienced vasovagal symptoms before when having blood work done but not during vaccination. Patient also stated afterwards that she had not eaten any food all morning prior to receiving the vaccine.
14 2021-05-17 involuntary muscle movements immediately after the injection, pt appeared to have fainted, eyes closed, still breathing, body sti... Read more
immediately after the injection, pt appeared to have fainted, eyes closed, still breathing, body stiffed and jerked for a brief moment then became slouchy on the chair. we called 911 - as we waited for ems, pt opened eyes, said very sleepy, i kept her awake by taking about greys anatomy - ems arrived - mom wanted pt to be monitored at a facility - ems took pt away on stretcher.
14 2021-05-17 cold extremities Patient states she received the COVID vaccine on 5/13/2021 at 4:00pm, on 5/14/2021 around 10:30am or... Read more
Patient states she received the COVID vaccine on 5/13/2021 at 4:00pm, on 5/14/2021 around 10:30am or 11:00am patient started to have dilated eyes, hands froze and where purple with white Raynaud's, stuttering, twitching of the left eye. Patient is still having left eye twitching but other symptoms are better.
14 2021-05-18 weakness, unresponsive to stimuli, tremor Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Light... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild
14 2021-05-19 cold sweat, tingling, feeling hot Pt appeared clammy and ashen in face 5 min after receiving 1st Pfizer vaccine . Had pt lay on floo... Read more
Pt appeared clammy and ashen in face 5 min after receiving 1st Pfizer vaccine . Had pt lay on floor in the event of passing completely out. Elevated pt's feet on the chair. Pt's hands where sweaty. Pt continued talking throughout process while laying on the floor. Pt stated she felt tired and tingly and hot. Monitored pt for next 15 minutes until she felt well enough to sit up. Pulse was normal and steady. After 15-20min pt had color returning to face. Pt felt well enough to sit up while still on floor. Had pt sit 5 min on floor and texted on phone. Pt felt well enough to sit on chair. Pt sat 5 min on chair. Pt felt well enough to stand and walk. Mom and I monitored pt walking and doing well. We sent pt home with mom.
14 2021-05-19 flushing Vaccine Administered: Pfizer COVID-19 Patient reaction: Flushing Pale Skin Nausea/Vomiting Fainting... Read more
Vaccine Administered: Pfizer COVID-19 Patient reaction: Flushing Pale Skin Nausea/Vomiting Fainting Dizziness Action taken: Antihistamine given. Outcome: Patient recovered. Late charting for 5/17/2021 - 5ml Diphenhydramine given PO 10 minute after c19 vaccine - patient dizzy, diaphoretic, and nauseous. Emergency medication entered and signed.
14 2021-05-19 pain in extremity Patient was administered the first Pfizer Covid 19 vaccine per protocol and was seated for observati... Read more
Patient was administered the first Pfizer Covid 19 vaccine per protocol and was seated for observation post administration. She became faint. Pharmacy staff broke an ammonia inhalant to help the patient recover. She responded quickly, but did require additional whiffs later. When questioned, she stated that she was having no difficulty breathing, swelling in throat, and no obvious rash. She was accompanied by her mother, who declined emergency medical care/911 assistance. The patient was not wearing constrictive clothing, so no adjustments were necessary, but she did recline further in the chair. She was also provided with cool, wet, paper towels for her forehead and neck. When she was feeling better, she had a few sips of water. Although offered a motorized cart to leave the store, she left with both parents walking with no assistance. On 5/20/21 we reached out to the family and spoke with her father. The patient did have a minor headache the evening of her vaccine administration, which has resolved. She does have a sore arm, which is a common side effect of the vaccine, Her father has reached out to her pediatrician to see whether she should get the second dose or not. He has not yet received a response.
14 2021-05-19 tingling Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Sys... Read more
Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium
14 2021-05-19 seizure Client experienced a seizure reaction shortly after vaccine injection (2 mins.) for few seconds (5).... Read more
Client experienced a seizure reaction shortly after vaccine injection (2 mins.) for few seconds (5). Mother verbalized she always has that reaction after she shot. VS BP 95/66, P 90, O2Sat 100%. VS 114/73, P 90, O2Sat 100%. After 30 mins. of observation resident stated, "I am feeling great." Mom declined the need to go to the hospital. In stable condition, resident was send home.
14 2021-05-19 unresponsive to stimuli Patient received vaccine, stood up to walk around corner, then collapsed, hitting her head on floor.... Read more
Patient received vaccine, stood up to walk around corner, then collapsed, hitting her head on floor. An EMT was in the area and stepped in. Pt was unresponsive for about a minute, pulse very weak. 911 was called. Pt was moved into a separate room once slightly responsive, she was very pale and seemed confused and was very nauseated. Her blood pressure dropped to 68/44, but over the course of a few minutes started coming back up. EMTs arrived and took patient to hospital to evaluate.
14 2021-05-19 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild
14 2021-05-20 cold sweat I administered the vaccine, got one side of the band-aid on and that is when her head fell back. He... Read more
I administered the vaccine, got one side of the band-aid on and that is when her head fell back. Her eyes rolled into the back of her head; she then leaned over the right arm of the chair. Her body stiffened next. I held her head and body with the help of a colleague. This happened for about 10 seconds, then she woke up and snatched her mask off with a confused look on her face. We asked her questions to see if she was aware. She was, then she went back out falling over to the side. I called 911. When she awakened the second time after about 7-10 seconds her face turned pale. We then moved her to the floor and propped her feet up. Patient said she was nervous and felt like she had to use the restroom. Her skin was clamy; patient said clamy skin is nothing new for her. The fire truck and ambulance arrived on scene. The workers began to assess patient. Vitals were good. She did not go in the ambulance, but stated her vision were blurry. She went home with grandparents.
14 2021-05-20 cold sweat Patient fainted two minutes after receiving vaccine. Loss of consciousness was not total. Patient wa... Read more
Patient fainted two minutes after receiving vaccine. Loss of consciousness was not total. Patient was pale, clammy, and lethargic. Patient's mother and myself held patient is place while she recovered in chair. Resolution was within 15 minutes from start of episode. Followed up with mother two and one-half hours post incident and mother said patient was completely recovered.
14 2021-05-20 flushing, weakness 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-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Weakness-Severe, Additional Details: patient started feeling hypotensive, sweating, lethargic post covid 19 vaccination. paramedics called due to low blood pressure. patients symptoms resolved gradually and didn't necessitate ER trip.
14 2021-05-20 flushing Pt began to feel faint w/ flushing/sweating in observation area. RNs were waived over by parents. ... Read more
Pt began to feel faint w/ flushing/sweating in observation area. RNs were waived over by parents. Pt transferred via w/c to observation bay. NO loss of consciousness. Dad at bedside. BP 94/55, HR 51, RR 14 -- > 98/53, 60, 16. Pt feeling much better. Pt stable and released from the vaccination site.
14 2021-05-20 numbness 14-year-old patient brought in by Ambulance to our ED last Sunday complaining of numbness and vomiti... Read more
14-year-old patient brought in by Ambulance to our ED last Sunday complaining of numbness and vomiting 3 hours after he received a Pfizer Vaccine . In ED pt given 1L NS, Zofran 4mg IVP, Pt given discharge script for Zofran ODT
14 2021-05-20 pain in extremity Pt seen ER Dr this moring 5/21, Vaccine reaction, initial encounter, dysphagia and pain with swallow... Read more
Pt seen ER Dr this moring 5/21, Vaccine reaction, initial encounter, dysphagia and pain with swallowing, received Pfizer first covid vaccine yesterday, some pain in arm after vaccination, no initial issues noted, went to bed, woke up in night complaints of painful and difficulty swallowing water, no shortness or breathe or difficulty breathing, no rash, mom gave bendayl at home this morning, able to swallow food and water now, no issues with prior vaccines, pt does have seasonal allergies, pt. discharged home with mom, continue over the counter allergy med like claritin or zyrtec for next few days, follow up with PCP for recheck prior to decision about 2nd vaccine.
14 2021-05-20 tingling Pt. c/o tingling in right arm approx. 15 minutes after receiving vaccine. Denies shortness of breat... Read more
Pt. c/o tingling in right arm approx. 15 minutes after receiving vaccine. Denies shortness of breath or lightheadedness. BP 106/66, 97%O2 P-60, repeat 98%O2, P-62. Pt. advised slow deep breaths, drink H2O2, massage hand and arm. Pt. reports normal sensation after 20 minutes. Pt advised home, rest, ice on vaccination site PRN, tylenol or ibuprofen prn, call 911 if shortness of breath, swollen lips & tongue & eyes, or tightening in throat develop. Pt & her father verbalize understanding.
14 2021-05-20 seizure like phenomena Patient stated she was not feeling well after her first dose of pfizer covid vaccine. Patient had s... Read more
Patient stated she was not feeling well after her first dose of pfizer covid vaccine. Patient had seizure like activity and was unconscious for a about 15-30 seconds. an ambulance was called vitals were taken. patient and patent family declined transport to medical facility.
14 2021-05-20 seizure Patient had syncopal episode with seizure. Diaphoretic and hives noted after regaining consciousness... Read more
Patient had syncopal episode with seizure. Diaphoretic and hives noted after regaining consciousness.
14 2021-05-21 weakness Patient had vaccine and entered waiting area for monitoring period. Started feeling dizzy and start... Read more
Patient had vaccine and entered waiting area for monitoring period. Started feeling dizzy and started to sit on ground but passed out while transferring to ground. Patient came to confused, pale, sweating and then proceeded to pass out 2-3 additional times. EMS was called as a precaution since patient reported feeling confused, weak, heart palpitations. Patient was advised to remain on the ground while waiting for EMS and was given an ice pack, water, juice and crackers.
14 2021-05-22 feeling cold Client was feeling "cold." Client was a 14-year-old female sitting upright in her observation chair,... Read more
Client was feeling "cold." Client was a 14-year-old female sitting upright in her observation chair, alert and tracking with her eyes. Client had a chief complaint of dizziness and feeling cold. Client stated that she began to feel cold and dizzy a few minutes after her observation had begun. This was the client's first dose of the Pfizer vaccine. Client denied any medical history or known allergies. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs and symptoms of anaphylaxis. Client stated that she felt "cold" and "dizzy." Client stated that her only meal was the snacks provided at the vaccination site. Airway, breathing and circulation were intact. Client's initial set of vitals at 1006 was 116/78 blood pressure, 80 heart rate, respirations 16, alert and oriented to person, place, date and event. Temperature 97.8*f. EMTs present were unable to obtain an O2 sat due to client's nail but client was negative for signs of shortness of breath. Client was asked to lie down until her complaint was resolved. Client was provided with food and was able to eat without difficulty. Client was reassessed every 15 minutes due to her stability. Vitals were as follows: 1011 - 108/78, 84, resp. 14 1021 108/78, 88, resp 14 1029 - 108/78, 80, resp 16. After approximately 10 minutes, the client denied any symptoms and was asked to sit up in an observation chair for the remainder of her observation. Client and her mother were instructed to seek emergency care if signs or symptoms of an allergic reaction occur later this evening.
14 2021-05-22 flushing, unresponsive to stimuli, feeling hot Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Nausea-Medium, Additional Details: after getting vaccine, pt felt dizzy/lightheaded. pt has had hx of fainting after getting vaccines due to anxiety. pt was very sweaty/hot. laid pt on the ground and instructed her to put legs up on the chair. provided water stated that was helping. nurse, lpn came and checked pts vitals. while we called 911. ambulance came and took her away. mom came back and said daughter was feeling better and did not go to ER
14 2021-05-22 seizure, tremor pt fainted/had seizure 50 to 10 minutes after covid vaccine. pt did not fall, dad held her.head and ... Read more
pt fainted/had seizure 50 to 10 minutes after covid vaccine. pt did not fall, dad held her.head and eyes rolled back, shaking and stiff for 2 seconds per dad. pt alert, breathing, and movement looked normal when I saw pt . pt mom called 911 and pt was taken to hospital . no history of fainting or seizures per dad
14 2021-05-23 weakness, unresponsive to stimuli, flushing Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: pt passed out after about 10 minutes while in observation area. dad was next to her and she did not fall. emt were called to check her out and after 1/2 hr pt seemed to be ok
14 2021-05-23 feeling hot Approximately 2 hours after receiving her first covid vaccine, my 14 year old fainted. She was stand... Read more
Approximately 2 hours after receiving her first covid vaccine, my 14 year old fainted. She was standing in our kitchen at home and became dizzy and started falling backwards. She said her vision was black, she was hot, her head hurt, I could see sweat on her face and chest, and she said she was having tightness in her chest/not able to get full breaths. She didn't totally lose consciousness, but she was disoriented. These symptoms lasted a few minutes, then she felt fine.
14 2021-05-23 flushing, weakness, tremor Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Di... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Pt received vaccine, spoke to her shortly after and decided to shop around the store. Shortly after walk pt started feeling light headed, and dizzy and fainted. Mom stated that this had happen to her before. Monitored patient for 30 min, gave water and a snack. Mom decided against calling 911.
14 2021-05-23 tingling angioedema (upper lip swelling, periorbital swelling, hand swelling and tingling) the next day
14 2021-05-24 feeling cold, hot flush PATIENT VISION BECAME BLURY, AND PATIENT EXPERIENCED COLD/HOT FLASHES
14 2021-05-24 tingling Patient started having paresthesia to right foot the night of the vaccine. She felt like her foot wa... Read more
Patient started having paresthesia to right foot the night of the vaccine. She felt like her foot was "asleep"...and heavy. Sunday morning she reports the symptoms were gone. SO, Thursday night, Friday, and Saturday she had the symptoms.
14 2021-05-25 weakness, seizure like phenomena, tremor, unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Sys... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: within minute of injection patient passed out, parent and witness said patient had seizure like shaking (I did not personally witness this), became extremely pale and non-responsive for few minutes. Before shot given Mom informed me patient normally faints and has extreme anxiety and aversion to needles.
14 2021-05-25 feeling cold, cold sweat, numbness Initial complaint at 1353: Lightheaded, hot, cold, headache on right side, diaphoretic to the touch... Read more
Initial complaint at 1353: Lightheaded, hot, cold, headache on right side, diaphoretic to the touch 1406 BP 110/70 HR 64 Denies SOB, tingling throat. Ate at 12 noon fruit and chips 1410 BP 122/72 HR 66 Worsening of headache on right side of head, room spinning. Hot/Cold flashes have passed. 1413 Spinning has stopped. Everything is bright. Clamminess has subsided 1417 R side of face numb. symmetrical grimace/smile 1419 Sitting up. Reports dizziness. Feeling melting down right side face. ***Documentation provided stops here.
14 2021-05-25 tremor Both arms began to shake about 45 minutes after receiving the shot and continued for approximately 3... Read more
Both arms began to shake about 45 minutes after receiving the shot and continued for approximately 30 minutes. The shaking was mild-moderate , she could continue her activities, but the right arm shook more than the left arm.
14 2021-05-26 numbness Started Tuesday evening with light headed, dizziness, headache, in the early morning hours pt said s... Read more
Started Tuesday evening with light headed, dizziness, headache, in the early morning hours pt said she felt as if her right side was going numb & asked to go to the hospital. Later in the afternoon she got worse along with bad chest pain & stomach & started vomitting
14 2021-05-26 cold extremities, feeling of body temperature change Patient developed dizziness and coldness in extremities. She tried walking and fell down, but did no... Read more
Patient developed dizziness and coldness in extremities. She tried walking and fell down, but did not lose consciousness. She then alternated between feeling hot and cold and seeing "blurry spots". I noticed her lips turning white and she said she needed to lie down. I got her water and ice packs since she was sweating. We sat on the floor for about 10 minutes, then she was able to move to a chair for another 5-10minutes and then left the facility. Mom reports that she has been lethargic and napping most of the day. Patient ate a few cheez-its for breakfast and reports that she did not get a good nights sleep last night.
14 2021-05-26 unresponsive to stimuli, flushing Patient received her first dose of the vaccine then fainted shortly after.. She appeared unresponsi... Read more
Patient received her first dose of the vaccine then fainted shortly after.. She appeared unresponsive and her cheeks were flushed. Patient only responded to verbal command with confusion. Permission was obtained from ER Dr on duty to administer EpiPen at 0.3 mg Patient was then transported to ER
14 2021-05-27 cold sweat Patient complaints of dizziness and shortness of breathing. Provider on-site assessed the condition ... Read more
Patient complaints of dizziness and shortness of breathing. Provider on-site assessed the condition of the patient and was experiencing cold clammy skin. Provider recommended to give EPIPEN 0.3 and called 911
14 2021-05-28 pain in extremity sharp pain in her neck and shoulder; sharp pain in her neck and shoulder; arm was hurting/arm pain; ... Read more
sharp pain in her neck and shoulder; sharp pain in her neck and shoulder; arm was hurting/arm pain; This is a spontaneous report from a contactable consumer (patient's mother) via medical team. A 14-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 14May2021 (at the age of 14-years-old) as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sharp pain in her neck and shoulder and her arm was hurting/ arm pain on 17May2021 night. The reporter was concerned because the pain appeared after a few days and not within 24-48 hours. She asked is this could be an indication that the vaccine was placed in the wrong place like not in the muscle. She asked if this is normal or when the patient should have this checked. The reporter stated that her and her husband did not experience any side effects. Outcome of the events was unknown. Information on the lot/batch number has been requested.
14 2021-05-28 pain in extremity arm soreness, day after vaccine fatigue, two days after vaccine
14 2021-05-28 pain in extremity Daughter was tired and went to sleep not long after shot. Woke up with sore arm around 12:30 am. And... Read more
Daughter was tired and went to sleep not long after shot. Woke up with sore arm around 12:30 am. And went back to sleep after taking Advil. She woke up and took a shower at around 9 am and fainted while showering. She?s never had a history of fainting ever.
14 2021-05-28 tremor, seizure Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, ... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Additional Details: pt passed out immediately after vaccination briefly, when she regained consciousness she convulsed for about 2 seconds, heart rate at 58, with weak pulse, called 911, pt taken to er as a precaution
14 2021-05-29 weakness 5/30/2021 11:04 AM After 4 minutes of receiving vaccine, pt became weak, diaphoretic and fainted. 91... Read more
5/30/2021 11:04 AM After 4 minutes of receiving vaccine, pt became weak, diaphoretic and fainted. 911 was called. Pt's v/s HR 46,BP80/64. Pt woke up 2 minutes later, able to pronounce name and date of birth and able to drink 3 oz of apple juice. Pt's HR 65 BP 88/58. Transfer of care to ambulance personnel at 11:12. Ambulance record.
14 2021-05-29 tenderness Patient fainted after vaccine given and fell from the exam table onto the floor landing on her left... Read more
Patient fainted after vaccine given and fell from the exam table onto the floor landing on her left side bumping the left side of her head and left shoulder. An ambulance was called. She quickly regained consciousness after approximately 10 seconds. She was alert and oriented to place, date and her birthday. She was able to move all extremities with 5/5 strength; no misalignment, asymmetry, or defects noted in head, neck, spine and major joints. She had full range of motion in all extremities and neck . Pupils equal and react to light. Left side of head above ear was slightly tender without any defects. Left shoulder was slightly tender to palpation anteriorly without difficulty with full range of motion. There were no bruises noted. She denied any difficulty breathing. BP was 88/60 and HR 125. After evaluation and assessment, patient was stable and the ambulance was cancelled per father's request. Patient remained in clinic and drank approximately 8 oz of water without difficulty. Patient's blood pressure was checked standing after 45 minutes and patient became slightly light headed again. Patient was instructed to remain in the clinic for 15 more minutes. Patient's blood pressure was re-evaluated and was 84/60 after standing for 2 minutes; she was asymptomatic and denies feeling like she would faint. HR 100. Discussed signs and symptoms of a concussion, warning signs to monitor (sleepiness, difficulty moving, headache, or vomiting), and when to go to ER. Father verbalizes understanding. Patient was able to walk out of the clinic with father and brother in a stable condition. Patient instructed to f/u with doctor in two days or ER sooner if worsening
14 2021-05-30 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: patient cant control breathing; cant walk afte... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: patient cant control breathing; cant walk after 10 min administration-Medium, Systemic: Flushed / Sweating-Medium
14 2021-05-30 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: Nausea-Mild
14 2021-05-30 tingling while in the observation area the client reported that she had a feeling of her tongue swelling, fa... Read more
while in the observation area the client reported that she had a feeling of her tongue swelling, face tingling , dizzy, lightheartedness , vision changing "felt strange". Able to speak full sentences, lung sounds clear, vital signs within normal limits. Calm and conversant. EMS summoned for evaluation . Evaluated and per the medic team father requested transport to Hospital .
14 2021-05-30 seizure Seizure
14 2021-05-30 tremor Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hype... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Medium
14 2021-05-30 tremor Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypote... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
14 2021-05-31 feeling hot -arm felt immediately warm after receiving vaccine (has felt similar after previous vaccines) -withi... Read more
-arm felt immediately warm after receiving vaccine (has felt similar after previous vaccines) -within one hour, arm was red and swollen -within two hours, left arm broke out in rash -over the next few hours, the rash spread down left arm and onto right leg -rash persisted for two+ weeks
14 2021-05-31 pain in extremity Mother return 14 year old patient for 2nd Pfizer. Pfizer was given at 14 days instead of 21 days. Fi... Read more
Mother return 14 year old patient for 2nd Pfizer. Pfizer was given at 14 days instead of 21 days. First dose was given on 05/14/2021. Second dose was given on 05/28/2021. Discussed with mother. 14 year old patient had only a sore arm from the injection only.
14 2021-06-01 burning sensation SEVERE PAIN AND BURNING. RASH APPROXIMATELY 2INCHES WIDE AND 5 INCHES LONG. STARTING ABOUT 11 AM TH... Read more
SEVERE PAIN AND BURNING. RASH APPROXIMATELY 2INCHES WIDE AND 5 INCHES LONG. STARTING ABOUT 11 AM THIS MORNING AND AFTER ICING IT CHANGED AND WAS MORE APPARENT. WENT FROM LIGHT RED TO DARK RED AND PURPLE
14 2021-06-02 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted while walking down aisle... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted while walking down aisle with dad. She immediately regained consciousness. Although she was conscious, EMTs were called to assess vitals. She was cleared by the EMTs to go home. No injuries were sustained.
14 2021-06-03 burning sensation, tingling itchy, burning, tingling rash on both feet up to the ankles
14 2021-06-03 pain in extremity vomiting several times since 8:00, it's now 11:16 headache sore arm fatigue NO DR VISIT YET
14 2021-06-05 cold sweat At 14:13 voiced complaints of Nausea, lightheadedness and dizziness. Then started vomiting. Attendee... Read more
At 14:13 voiced complaints of Nausea, lightheadedness and dizziness. Then started vomiting. Attendee was pale and clammy. Assisted to the cot after she stopped vomiting. Elevated legs, when stated that she was no longer nauseated. HR: 84 BP 120/68 RR 16 O2sat 95. 14:20 - Attendee stated she felt better, a little pale, denied any dizziness, lightheadedness or nausea. Hr 82 BP 120/68 RR 18 O2Sat 97. 14:36 -No voiced complaints- skin warm and dry. HR 69 BP 118/64 RR 20 O2Sat 98. 14:43 - Care Practitioner educated on home discharge/adverse reaction instructions and she was discharged to home with her mother.
14 2021-06-05 flushing, flushing, unresponsive to stimuli, unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patie... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient passed out for abt 5sec and cameback, Her face was flushed and immediatly after turned white. She drank some water and after that she was feeliong okay. Mother reported she has fained before from the HPV vaccine. SHe didnt not want to call the ambulace. Sat for another 15 under observaction and then she was okay to go home
14 2021-06-05 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient received vaccine. directly after administration patients pupils were dilated, she was pale, and was not answering questions. Patient was placed on floor with legs elevated, we called 911. after a couple minutes patient said she felt fine, so we sat her up in chair and gave her glass of water, which she drank. Patient again reported feeling light headed and her pupils were dilated. medics took her the hospital
14 2021-06-05 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient received vaccine. directly after administration patients pupils were dilated, she was pale, and was not answering questions. Patient was placed on floor with legs elevated, we called 911. after a couple minutes patient said she felt fine, so we sat her up in chair and gave her glass of water, which she drank. Patient again reported feeling light headed and her pupils were dilated. medics took her the native hospital
14 2021-06-05 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
14 2021-06-06 weakness Approximately 11:10 am on 6/7/2021 Adverse event occurred during the 15 minute wait period following... Read more
Approximately 11:10 am on 6/7/2021 Adverse event occurred during the 15 minute wait period following the vaccination. Pt c/o SOB, weakness , diaphoresis and pale. Pt stated that she could not see and it was hard to breath. Pt stated that she has not eaten or had anything to drink today. Hx: was taken. Pt had no known medical hx or allergies to meds
14 2021-06-06 numbness Extreme fever, 104.1 Temporel thermometer, nausea vomiting, malice fatigue, lightheaded dizziness, h... Read more
Extreme fever, 104.1 Temporel thermometer, nausea vomiting, malice fatigue, lightheaded dizziness, hallucinations with the fever, Vasoconstriction that included numbness of hands and extremities. Fever exceeds the 48 hour mark only brought down by ibuprofen and acetaminophen alternating Q3 hours then bringing the fever down to 100.1 on average between doses
14 2021-06-06 pain in extremity Patient experienced of weakness and pain in left arm. Left index finger pain upon movement. Patient'... Read more
Patient experienced of weakness and pain in left arm. Left index finger pain upon movement. Patient's vitals normal otherwise and patient declined to have transported to the hospital by ambulance and transported patient to the Hospital.
14 2021-06-06 seizure, seizure like phenomena Patient had syncope/seizure episode and fell face forward. Patient then had an episode of seizure li... Read more
Patient had syncope/seizure episode and fell face forward. Patient then had an episode of seizure like activity. She was transported to the emergency room.
14 2021-06-06 tremor After administration, the patient became dizzy, shaky and sweaty. Her eyes were slowly closing and o... Read more
After administration, the patient became dizzy, shaky and sweaty. Her eyes were slowly closing and opening. I had her parent get juice and a candy bar while I monitored her. She stayed seated for at least 30 minutes and felt better after eating and drinking. She left with her parents after she felt better.
14 2021-06-06 unresponsive to stimuli, inability to speak, seizure During the observation period after vaccine administration, patient's mom and another customer yelle... Read more
During the observation period after vaccine administration, patient's mom and another customer yelled for help and stated that patient was having a seizure. 911 was called immediately, and by the time the pharmacy staff came to help the seizure had stopped, but patient then slumped over onto her mother and was non-responsive. A minute or so later she sat up again, but still seemed very distressed and unable to answer questions. It appeared that she was going to vomit, and then gradually started to become more alert just before the paramedics arrived. She drank a little water and had some of a granola bar. The paramedics felt that she needed further evaluation, and she was transported to the hospital.
14 2021-06-07 weakness Site: Bruising at Injection Site-Mild, Systemic: Weakness-Medium, Additional Details: pt was anxious... Read more
Site: Bruising at Injection Site-Mild, Systemic: Weakness-Medium, Additional Details: pt was anxious and light headed she fainted on the floor gradualyl no bursing or hurt. pt was able to walk to car to head home and rest
14 2021-06-07 hot flush Patient began having hot flashes roughly 1 1/2 weeks after receiving her first COVID vaccine. They a... Read more
Patient began having hot flashes roughly 1 1/2 weeks after receiving her first COVID vaccine. They are frequent (almost hourly) and last approximately 15 minutes at a time. The doctor isn't 100% sure if it's vaccine related, but all of her blood work is normal.
14 2021-06-07 pain in extremity, weakness Fatigue Shooting pain in legs Joint pain Weakness Headache Loss of appetite
14 2021-06-07 tremor COVID-19 Post Vaccine #2 Vasovagal reaction. EMS notified due to patients history of anxiety and inc... Read more
COVID-19 Post Vaccine #2 Vasovagal reaction. EMS notified due to patients history of anxiety and increase in RR, patient stated she feels "shaky". Patient stated she feels better with legs elevated. Patient lowered to the ground, legs elevated and moved to the litter. VS taken and EMS notified.
14 2021-06-07 unresponsive to stimuli Immediately following first does of covid vaccine patient became unresponsive, diaphortic. Pt did ha... Read more
Immediately following first does of covid vaccine patient became unresponsive, diaphortic. Pt did have a pulse and spontaneous breathing. Pt responded to ammonia capsule by opening her eyes . She complained of sudden onset of chest and abdominal pain . Pt states she became dizzy, lightheaded immediately following the injection. Then developed chest tightness and abdominal pain and nausea . Pt rated abdominal pain 10 0n 1-10 scale. Pulse 88 resp 36 Tx at mobile clinic: Ammonia capsule, benadryl 25 mg PO Pts weight 40.1 kg Tx in ED: Prevacid , Tylenol with great relief ,symptoms resolved
14 2021-06-08 pain in extremity Projectile vomiting, double vision, confusion/ delirium No treatment just gave her time. All sympto... Read more
Projectile vomiting, double vision, confusion/ delirium No treatment just gave her time. All symptoms cleared within 6 hours of onset. Approximately 9 hours after vaccine administration. Other more expected immune response followed, sore arm, headache, body aches and lethargy. Theses all resolved 36 hours after vaccine administration.
14 2021-06-08 unresponsive to stimuli VACCINE GIVEN AT 5:30PM PATIENT HAD SYNCOPE AND FELL TO THE FLOOR BUT DAD CAUGHT HER AND LAID HER DO... Read more
VACCINE GIVEN AT 5:30PM PATIENT HAD SYNCOPE AND FELL TO THE FLOOR BUT DAD CAUGHT HER AND LAID HER DOWN ON THE GROUND SINCE SHE COULD NOT SIT UP ON HER OWN. WE TOOK HER PULSE AT 5:34PM AND WAS 68 BPM. SHE BECAME PALE AND WAS NOT RESPONDING. REGAINED CONSCIOUNESS TOOK HER BP @ 5:40 WAS 102/80. SHE WAS RESPONSIVE AND PATIENT WAS ABLE TO WALK OUT WITH DAD. RESCUE CAME AND SHE DECIDED NOT TO GO TO THE HOSPITAL **(REFUSED), LEFT AT 5:55PM.
14 2021-06-09 pain in extremity Fever, chills, nausea, sore arm, dizziness
14 2021-06-10 weakness, 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, Systemic: Weakness-Medium
14 2021-06-10 feeling hot 0918 Called to front lobby. Found patient unconscious lying on floor. Unconscious 15-30 seconds. No ... Read more
0918 Called to front lobby. Found patient unconscious lying on floor. Unconscious 15-30 seconds. No facial swelling and no difficulty breathing. Per witnesses she fell. Code called. Pale and diaphoretic. C/O hot and dizzy/ VS Resp 14 HR 78 BP 106/66 O2 Sat 100% on room air. No history of syncope with vaccines or needles. Instructed parent to remind us this happened when returns for #2 so we can administer vaccine with her lying down. Verbalizes understanding. 0920 Cleared cspine by Dr. who was fist physician on scene. 0925 Transferred to gurney via walking with two person hands on assist. Transferred to ED accompanied by ED personnel and mother.
14 2021-06-10 flushing Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
14 2021-06-10 pain in extremity Arm soreness, fever of 100.2, muscle aches in the legs all starting at 2am on 06/11/21. Administered... Read more
Arm soreness, fever of 100.2, muscle aches in the legs all starting at 2am on 06/11/21. Administered Tylenol and it didn?t help
14 2021-06-10 pain in extremity Mother received phone call that dose of vaccine was undiluted and received 3 doses at one time. Rece... Read more
Mother received phone call that dose of vaccine was undiluted and received 3 doses at one time. Received a phone call about 3-4 hours after the dose informing mother of the error. Since then about 12-18 hrs later pt is having fatigue, body aches, and chills. Arm soreness as well.
14 2021-06-10 tingling, feeling hot Patient said she felt hot and tingly, said that her throat felt "fat" and tight.
14 2021-06-11 feeling cold The female patient was feeling uneasy , after 5 minutes of second dose of Pfizer vaccine ,was consci... Read more
The female patient was feeling uneasy , after 5 minutes of second dose of Pfizer vaccine ,was conscious and talking to her mother ,she was complaining about being cold,when paramedics arrived ,paramedics took her vitals and saturation all looks good,but she was complaining about being cold
14 2021-06-11 tingling Patient was getting tingly, lightheaded, pale, and eyes rolling back after receiving her first dose ... Read more
Patient was getting tingly, lightheaded, pale, and eyes rolling back after receiving her first dose of the Pfizer Covid vaccine. We gave her some glucose tablets and she seemed to get better afterwards. I did a pulse oximeter on her her and her pulse and oxygen was normal. I offered mother if she wanted me to call 911 and she said no. I counseled mother and the girl to monitor how she is feeling and to seek 911 or urgent care if she gets worst throughout the day. The girl left the store feeling okay.
14 2021-06-12 pain in extremity Sore arm body aches flu feeling no fever
14 2021-06-13 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Me... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Systemic: Vomiting-Mild
14 2021-06-13 muscle spasms Patient experienced syncope episode : turned pale, fainted and fell off the chair, leg jerked. Had t... Read more
Patient experienced syncope episode : turned pale, fainted and fell off the chair, leg jerked. Had to call 911
14 2021-06-13 seizure Single seizure the next morning. No further events.
14 2021-06-14 feeling hot NAUSEA , FEELING HOT ICE PACK
14 2021-06-14 seizure, grand mal seizure The patient developed a severe headache. Grandmother (guardian) helped her sit in the car seat and s... Read more
The patient developed a severe headache. Grandmother (guardian) helped her sit in the car seat and she took 10 steps away from the car, when she looked back at the patient had began seizing. She was taken to the ER by rescue and diagnosed with having a grand mal seizure. Grandmother states her lips and around her mouth were blue and the seizure was severe. She was treated and released from the ER dept. The patient has been seizure free for 2 years.
14 2021-06-15 cold sweat Immediately after recieving the vaccination the patient stood up and collapsed. She was attened to b... Read more
Immediately after recieving the vaccination the patient stood up and collapsed. She was attened to be our nurses. The patient was pail and clammy and a litte dizzy. We called for paramedics who came and examined her. They offered to transport her to the hospital, but they mother declined.
14 2021-06-15 involuntary muscle movements Pt received her second dose of Pfizer COVID vaccine 0.3 ml. Pt immediately began to curl her arms an... Read more
Pt received her second dose of Pfizer COVID vaccine 0.3 ml. Pt immediately began to curl her arms and had a blank stare. Pt was pale but did not pass out. Pts mother stated she did the same thing at her 11 year old vaccines. Pt was very anxious prior to getting the vaccine.
14 2021-06-15 pain in extremity Systemic: Body Aches Generalized-Medium, Additional Details: Had pain like sensation in both legs
14 2021-06-15 tingling Patient received 1st dose COVID vaccine (Pfizer, Lot #EW0185) on 05/26/2021. At the client's 2nd dos... Read more
Patient received 1st dose COVID vaccine (Pfizer, Lot #EW0185) on 05/26/2021. At the client's 2nd dose appointment for Pfizer on 06/16/2021, she reported that that 15 minutes after receiving her first dose she experienced tingling on the right cheek lasting for about 1 minute. RN completed a medical consult and received clearance from the county medical team to vaccinate the client with 2nd dose Pfizer and observe for 30 minutes. RN educated about ER precautions and advised client to follow up with her PCP. Client received 2nd COVID vaccine (Pfizer, Lot#EW0187) at 11:15am in the Left arm by EMT Vaccinator.
14 2021-06-15 unresponsive to stimuli 9:52 Within 1 minute of being vaccinated, while seated in chair stated "I'm really lightheaded". E... Read more
9:52 Within 1 minute of being vaccinated, while seated in chair stated "I'm really lightheaded". Eyes were wide open and became unresponsive to verbal stimulation 9:53 Arms stiffened, no response, diaphoretic, pale 9:54 More responsive, groggy 9:56 Placed in supine position on floor mat with legs elevated. Stated she "could feel nurse holding me up" 9:58 BP 96/50 HR 70 laying flat 10:00 Call placed to mom 10:03 Mom arrived 10:05 Sitting up, eating snack with bottle of water 10:07 Felt "shaky" and laid down 10:09 BP 96/52 HR 80 10:15 BP 98/52 sitting up, HR 80 10:26 Seated in chair eating another snack. feels "a little lightheaded"10:25 Feels OK. DC with Mom
14 2021-06-16 feeling of body temperature change vaccine was given at the local high school (not by her doctor, the physician who is placing this rep... Read more
vaccine was given at the local high school (not by her doctor, the physician who is placing this report with mother's information) She told mother she did not feel right 10pm the night of the vaccination, felt hot and cold, sweating, could not sleep, rose up from bed at 4am to get a glass of water, mother heard a noise from kitchen, and found patient passed out on floor. She was out for 2minutes at the most Mother got her up and made her drink a lot of water. She continued to feel bad. Temp was close to 102. Around 5pm that evening she was feeling better. So this report is because of a syncopal episode about 19 1/2 hours after the Covid Pfizer vaccine #2.
14 2021-06-16 numbness On sunday night, about 36 hours after vaccination, she started to have numbness of her lower jaw and... Read more
On sunday night, about 36 hours after vaccination, she started to have numbness of her lower jaw and tongue. She started to have an incredible amount of drooling and could not swallow. She then started to have epigastric cramping and sharp abdominal pain that moved into the right lower quadrant. She had pretty severe headache that started the same time as numbness and drooling with photosensitivity. No fever. No vomiting but she was nauseous. she went to the ER late on 6/13. She was then transferred to the hospital for furthur care. She had a neurology consult that thought perhaps her headache, numbness and drooling could have been an atypical migraine-this resolved as of 6/14. Her abdominal pain resolved after appendectomy and now she just has muscular pain related to surgery.
14 2021-06-16 pain in extremity 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had... Read more
6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; This is a spontaneous report from a consumer (patient's mother). A 14-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified rout of administration on the left arm on 05Jun2021 at 09:00 (Lot number: ew0178) at 14-year-old as single dose for COVID-19 immunization. Medical history was none. Prior to the COVID vaccine, the patient didn't received any other vaccines within 4 weeks. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Known allergies was none. Concomitant medication included ascorbic acid (VIT C), ibuprofen and cetirizine hydrochloride (ZYRTEC ALLERGY) within 2 weeks of vaccination.The patient previously took the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13May2021 (Lot number: ew0169) at 14-year-old as single dose for COVID-19 immunization. On 06Jun2021 at 17:00, the patient experienced arm pain which radiate across muscles in upper back/shoulders. The reporter was aware the evening of 06Jun2021 and reported 07Jun2021 morning. The patient received ibuprofen as treatment. The outcome of events were recovering. No follow-up attempts are possible; no further information is expected.
14 2021-06-16 pain in extremity Extreme weakness in her arms and legs; Really bad cough; painful in arms and legs; not been feeling ... Read more
Extreme weakness in her arms and legs; Really bad cough; painful in arms and legs; not been feeling well; This is a spontaneous report received from a contactable consumer (Parent). A 14-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration in right shoulder on 23May2021 14:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. Family history was reported as none, they were basically a healthy family. Patient was not vaccinated within 4 weeks and no additional Vaccines administered on same Date of the Pfizer Suspect. On 23May2021, the patient experienced extreme weakness in her arms and legs, really bad cough, on an unspecified date in May2021, she had severe pain in her legs and on an unspecified date in 2021, she was not been feeling well. Patient's father called on behalf of his 14-year-old daughter who received the first dose of the Pfizer COVID-19 vaccine about two weeks ago and had extreme weakness in arms and legs, 2 weeks ago, on Sunday 23May2021. She had not been to school since then, she went for a couple hours and then they send her back. His daughter also said that it had been painful but caller states that he does not know exactly what his daughter means by that, she said that her legs hurt her, that started probably 24May2021 or 25May2021 with the bad cough also and not been feeling well. Had all leveled out the past 10 days. Had blood work and the results came back Friday. Thought there was an outside chance based on the blood work that it was strep related. Her doctor had suggested that the parents call Pfizer to see if this type of reaction had been reported in her age group after receiving the Pfizer COVID-19 vaccine. She never really had a fever. This started the day after the vaccine, and they are not sure if it was related to the vaccine or not. A couple of results were off. The Streptolysins were 468. The antinuclear antibodies were 1 to 160, which was off. Everything else was negative. The patient underwent lab tests and procedures which included antinuclear antibody: 1 to 160, streptococcus test: 468. Patient received therapeutic measure to treat adverse events, they tried Amoxicillin, which had no impact, they thought maybe it was just a virus. They also tried Tylenol and Advil, which also had no impact. Stated that the Amoxicillin was 875mg twice a day and that the Tylenol and Advil were from different packages lying around the house. Patient was scheduled for the second dose this coming Sunday but they were holding off until she was better. The outcome of events was unknown. Information on the lot/batch number has been requested.
14 2021-06-16 unresponsive to stimuli, flushing Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Sys... Read more
Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
14 2021-06-17 flushing Systemic: Flushed / Sweating-Mild, Additional Details: Patient complaint of being feeling hot after ... Read more
Systemic: Flushed / Sweating-Mild, Additional Details: Patient complaint of being feeling hot after the vaccination, gave her cold water to drink and made her lie down on the floor, fanned her, soon she was feeling better, got up and sat back on the chair, she was feeling good after wards and left.
14 2021-06-17 seizure, tremor, muscle twitching, concussion Fallen unconscious and collapsed; Fell down and she was not conscious/passed out; Had concussion lik... Read more
Fallen unconscious and collapsed; Fell down and she was not conscious/passed out; Had concussion like falling on the ground but it appears like a seizure, that was a immediate thing; Fallen unconscious and collapsed; Fell down and she was not conscious; Had concussion like falling on the ground but it appears like a seizure, that was a immediate thing; Low blood pressure; Fever; Shaking/She was shaking/still moving; She was not feeling well; She is still twitching; Eyes go back; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (mother) reported that a 14-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 (Batch/Lot number was reported as EW 'O or 0' 186) at the age of 14-years-old as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. No family medical history of seizure. The patient previously received the first dose of BNT162B2 on an unknown date at Arm Left for covid-19 immunisation. The reason for the transfer today (03Jun2021) was that her 14 year old daughter immediately after getting her second dose of the COVID vaccine started shaking, experiencing fever and fallen unconscious and collapsed and was taken to the hospital and she wanted to go ahead and report those adverse side effects for her. She (patient) was 14 year old and she got her second vaccination today and few minutes after she got it, she stood up and she said she was not feeling well and then the next thing reporter knew like her eyes go back, she do not seem conscious and she was shaking as if, looks like she was having a seizure and then she fell down and she was not conscious, so she fell down, she is still twitching. She has no history of like seizures but that is like twisting and now she was taken to the hospital. So, the hospital treated her as if she had a concussion. Reporter have reported to them that she looks like it was a seizure before she fell down, into her head. Reporter further stated "That day was her second shot and like I said she stood up, she got up from that, she said that she got funny and that I can see where she just kind of lost consciousness, eyes going back, shaking as if she was having seizures and then she fell down and she was unconscious and she is like still moving as if she is having a seizure and she was taken. Reporter stated, "it was a like a seizure but it is like over and she had concussion like falling on the ground but it appears like a seizure, that was a immediate thing." For treatment, reporter stated that "Any treatment, No. She was taken to the hospital and the hospital needs to write it down and I don't understand that, the hospital wrote down concussion but the hospital they took the vital signs and she had low blood pressure." For the date when patient went to the hospital, reporter stated "That was today, June 3rd and she is discharged. The reason she was taken was potential seizure and it was concussion and it was after she fell, she passed out and had low blood pressure. The outcome of the events was unknown. Information on the lot/batch number has been requested.
14 2021-06-17 seizure, tremor familiar to a seizure; collapsed; unconscious; fever; shaking; they told possible sign of infection;... Read more
familiar to a seizure; collapsed; unconscious; fever; shaking; they told possible sign of infection; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a 14-year-old female patient (consumer's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The relevant medical history was not reported. Concomitant medications were not reported. On an unspecified date, after getting the second dose of the Covid Vaccine immediately started experiencing fever, shaking; her eyes were back as she seemed unconscious and collapsed; it was familiar to a seizure; was taken to the hospital, they told possible sign of infection and she was advised to go ahead and just to report what had happened. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
14 2021-06-18 cold sweat, weakness 14 yo female was anxious prior to and during vaccination given at 11:59am. The patient was told to ... Read more
14 yo female was anxious prior to and during vaccination given at 11:59am. The patient was told to sit for 30 mins due to an egg allergy. After waiting 30 minutes, the mother (who was shopping) retrieved child who was sitting in the pharmacy waiting area post vaccination. After 5 more mins, another customer got the RPH attention explaining the patient was passing out. The mother assisted patient to the pharmacy waiting area, in which the patient was given chairs to sit on and put feet up. Another shopper who said she was an ER nurse told the pharmacy staff to have the patient lay down across the chairs then left. The patient was weak, cold, clammy, and pale. The patient then told the pharmacist that she had left her mother at the check out section, went upstairs, used the bathroom, was coming down the stairs when her vision started to have black spots. She reached her mother when she said she didn't feel good and started to pass out. The mother stated she caught her daughter. At this point, the RPH initiated a 911 call. She called out for the technician to call the store managers for assistance and take over the 911 call. The RPh then stayed with the patient and the mother. The tech gave the mother a bottle of water for the pt. The store managers arrived at the scene and also assisted. The patient stated she was feeling a lot better after she laid down for a little bit. The RPh notice color coming back into the patient's lips and face. The patient stated that the adverse effects didn't start until she was walking down the stairs. After 10-15 mins, the Paramedics arrived and further assisted the patient and her mother. The paramedics took the patient via stretcher to the ambulance for further treatment around 12:55pm.
14 2021-06-18 seizure My daughter lost consciousness either from passing out or seizure; My daughter lost consciousness ei... Read more
My daughter lost consciousness either from passing out or seizure; My daughter lost consciousness either from passing out or seizure; This is a spontaneous report from a non-contactable consumer (patient's mother). A 14-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right at the age of 14-year-old on 04Jun2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient previously took first dose bnt162b2 for COVID-19 Immunization. The reporter stated that 'my daughter lost consciousness either from passing out or seizure'. Event start on 05Jun2021 08:00. AE resulted in: Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included investigation: unknown results in Jun2021. Therapeutic measures were taken as a result of events (Testing and pain meds /IV fluids). The outcome of event was recovering. Information on lot/batch number has been requested.
14 2021-06-19 unresponsive to stimuli, unresponsive to stimuli Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: face was pale---consiousness was on and off-Severe, Systemic: Nausea-Severe, Additional Details: after recieving 1 st dose of pfizer vaccine--patient was in the observation area for 15 minutes,during that time frame patient started feeling nauseous and then she felt dizzy..her skin was turning pale.. her consiousness was on and off.. she would respond one time and then another second she would freeze..at one point she lost consiousness. then we called 911 (EMS) right away...before even ems arrived patient regained consiousness. when EMS arrived patient was responsive & went to hospital.
14 2021-06-20 weakness, unresponsive to stimuli Approximately 10 minutes after patient had received her 1st COVID-19 Vaccine she states she started ... Read more
Approximately 10 minutes after patient had received her 1st COVID-19 Vaccine she states she started to see spots and was feeling weak/dizzy and she proceeded to pass out. Family members and Pharmacist guided patient into a chair where she did not respond to verbal commands, patient was breathing normally and eyes remained open. Patient came to after approximately 10 seconds and was shaken up/scared, but overall feeling ok. Patient stayed in facility and saw provider, noted that BP was low at 88/40mmHg. Patient also had blood sugar checked which was 101 and BP was rechecked and was 90/50mmHg. Patient reported she had not ate all day and was nervous about receiving a shot. Provider determined that patient had returned to baseline and she was ok to go home.
14 2021-06-20 tremor Fever 101.1 Chills with shaking
14 2021-06-21 weakness, feeling hot Patient is a 14 yo girl with PMH significant for migraines who presented with one day of chest pain ... Read more
Patient is a 14 yo girl with PMH significant for migraines who presented with one day of chest pain and nausea that woke her from sleep in the setting of multiple days of malaise. She states that after receiving the COVID-19 vaccine three days prior to admission she has not been feeling well. She reports subjective fevers and chills the day after receiving the vaccine, and intermittent feelings of her heart racing. She also has been feeling hot and generally unwell. + shortness of breath. The night of admission, she awoke from sleep with burning central anterior chest pain and nausea. She tried to stand up and felt generally weak, and then had tunnel vision and felt she was going to faint. Per mom, she was pale and diaphoretic at that time. The pre-syncopal symptoms resolved within about 10 minutes and the chest pain persisted for approx one hour. Parents called EMS and she was brought to the ED for evaluation. Of note, she reports a history of pre-syncopal sx however has never lost consciousness before. Also reports a history of intermittent palpitations. No hx chest pain prior to this episode. + fevers/chills as mentioned after receiving COVID vaccine three days PTA but no infectious sx prior to that. No cough/URI sx, no abdominal pain, no nausea. + diarrhea night of admission. No sick contacts. She is active in dance and has good exercise tolerance for that; does not spend much time outdoors. No known insect or tick bites. + FHx of sister with heart murmur as a baby that spontaneously resolved; unclear diagnosis. In the ED BP 94/62, T 97.4, P 84, R 16, SpO2 100% on RA EKG: sinus rhythm, no ST or PR changes CMP: unremarkable CBC: WBC 11.8, Hgb 11.5 Trop T 0.33 Bedside echo w/ reported good function UA wnl COVID neg CXR PA and lat unremarkable On arrival to the PCICU she reported feeling at her baseline and denied chest pain and shortness of breath.
14 2021-06-21 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Patient did not have complaints during her 15 minute waiting period each time technician checked in on her. When the techinician told her her 15 minutes have elapsed, she complained of dizziness and fainted soon after. She regained consciousness after a few seconds and then complained of nausea. Paramedics were immediately called when she fainted. They arrived in about 5 minutes and transported her to ER.
14 2021-06-22 seizure she had a seizure, lasted 45 minutes
14 2021-06-22 unresponsive to stimuli Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Additiona... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: After 3-5 min from the shot she was waiving her arms and unresponsive. I then gave her a epipen. Then a few seconds later she was breathing and talking. blue lips and labored breathing was noticed. 911 was called and assessed her. father declined taking her to er.
14 2021-06-23 weakness Vomiting; Fever; Muscle aches; weakness; headache 24 hours
14 2021-06-23 bell's palsy bell's palsy left. started 6/19/21 prednisone
14 2021-06-23 slurring 16:06, patient went into syncope x3. 911 was called. Blood sugar: 116, RR-14, O2SAT-98%, heart was 4... Read more
16:06, patient went into syncope x3. 911 was called. Blood sugar: 116, RR-14, O2SAT-98%, heart was 45 bpm. When patient awoke heart rate would stay above 80 bpm but would drop back down to mid 40's, then she would become unconscious. Patient's speech was sluggish. Skin was pale and warm to the touch. Constant communication was given to try to keep patient awake. Airway remained. Patient showed no signs of inflammation. 16:10, patient was awake. Alert and oriented to person, place and time. O2SAT-98%, heart rate 82, RR-20. 16:22, patient was taken by ambulance.
14 2021-06-24 weakness, flushing, 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: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
14 2021-06-24 feeling hot, feeling cold, tremor Within 2 hours of the vaccine, patient was experiencing nausea and general feeling of unwellness. Wi... Read more
Within 2 hours of the vaccine, patient was experiencing nausea and general feeling of unwellness. Within 3 hours, patient had a fever of 99.9. At 11 pm, patient had a fever of 100. Mother administered Tylenol and patient went to bed. Patient woke up around 4:30 am with her whole body shaking uncontrollably. Mother heard her stirring and went to check on her. Her temperature was 100. Mother sat and talked with her and offered a snack, drink, and more Tylenol. Mother checked her pulse, which was normal. Patient was coherent and able to communicate. Mother left the room to get snack and drink and heard something fall over in patient's room and Mother called out and waited a few seconds for a response. Patient did not respond. Mother went back in the room, as it was unusual for patient not to respond, and found patient sitting back up and placing her head in her hands, stating in a panicked voice that she felt she was going to throw up and that she was very hot and that her head hurt really bad. Patient stated that her ears felt weird and everything went black and she somehow fell over from a sitting position on her bed to laying on her bed and had landed on the dog. Patient was unaware that she had knocked over her water bottle and had no recollection of the loud sound it made as it fell over (unusual because loud sounds are very startling for her). The shaking subsided to a tremor a few minutes after the black out. Patient then reported feeling very cold and her temperature had risen to 101. Patient complained of an extreme headache and continued nausea. Mother took patient to Urgent Care, who performed bloodwork and an EKG, and then referred patient to the Emergency Room for an EEG. ER repeated EKG and declined to do EEG and told patient to follow up with her doctor in 5 - 7 days.
14 2021-06-24 pain in extremity 6/14/2021-6/17/2021 1. Spots on body, itchy. (ER 6/15/21 am - Hives, not poison ivy) 2. Both hand... Read more
6/14/2021-6/17/2021 1. Spots on body, itchy. (ER 6/15/21 am - Hives, not poison ivy) 2. Both hands hurt, swollen, red, very painful, hard to bend fingers or hold things. Left hand worst. 3. Feet swollen, left heal hurt for a while 4. Both wrists hurt, left wrist worst. 5. Red swollen streak down spine. Swollen 1/2" or more raised off spine. 6. Left face swollen. Right jaw hurts so bad that it was hard to open mouth. *** Took benedryl 25mg every 6 hours, zrytec twice daily, continue normal pepcid pill. Everything cleared up 6/18/21 7am. Showed daily pictures to Dr. at follow up ER appt on 6/18/21.
14 2021-06-24 pain in extremity she feels like her legs are hurting; when she sits her knees has bruises on both legs/bruising on he... Read more
she feels like her legs are hurting; when she sits her knees has bruises on both legs/bruising on her left knee; This is a spontaneous report from a contactable consumer (patient's sister). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route of administration in arm left on 08Jun2021 at 18:00 as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration in arm left on 18May2021 as a 1st dose, single dose for COVID-19 immunisation, LOT# (First dose): EW0186 (When clarified as EW0176, reporter confirmed the same, contradictory information hence not captured in tab). Age at vaccination was 14 years. The patient had no prior vaccination within 4 weeks, just Pfizer. On 12Jun2021 at 14:16:17, the reporter wanted to report a Covid vaccine side effect was called on behalf of her 14-year-old sister. Stated that, she filed a report with yesterday and they gave her the Medical Information contact information to further discuss her sister's adverse reactions. The reporter stated that, her sister was 14-years-old and she got the 2nd dose of the Covid vaccine of Pfizer on Tuesday this week, on 08Jun2021 and began having bruising on her left knee, after a day on 09Jun2021, the patient felt like her legs are hurting and when she sits her knees has bruises on both legs. Stated that, the patient had got the first vaccine when she was 14 (further not clarified hence, not captured in tab). Stated that, on her research she has found that could be a rare side effect and wanted to know if they had any further data or report of this side effect. Stated that, the reporter had read all about the side effect and saw lot of scary things, it seems like rare condition to have, so the reporter concerned, was that really bad, do they had to run any test or something. Stated that, the reporter was calling and got disconnected so, she called in again. Stated that, the reporter was in the middle of filing a case about COVID vaccine side effect. Stated that, the reporter has concerns because her sister does not have a primary healthcare provider or insurance so she was unsure of what she should do. Stated that, the reporter was provided with the number of health department and she got the questions so, she wanted to call them tomorrow, it's Saturday so when they were working. Everything was good regarding this case right. Response included was advised caller, Pfizer cannot make independent patient recommendations and that she would have to seek further medical advice from a primary care provider. The dates and seriousness for the events were unspecified. The reporter stated that, the patient did not take any treatment yet. The investigation assessment was reported as no. The outcome of the events was unknown. Follow-up actions are needed. Further information is requested.
14 2021-06-24 cold extremities PATIENT CAME WITH HER PARENTS TO DO SECOND DOSE OF COVID 19 (PFIZER) . PATIENT WAS SCREENED ABOUT FI... Read more
PATIENT CAME WITH HER PARENTS TO DO SECOND DOSE OF COVID 19 (PFIZER) . PATIENT WAS SCREENED ABOUT FIRST DOSE REACTION THE PATIENT INFORMED US IT WAS ONLY ARM PAIN .A FEW MINUTES AFTER 2ND DOSE PATIENT HAD A POSSIBLE SYNCOPE EPISODE . PATEINT WAS CONSULTED TO WAIT AND SIT FOR 15 MINUTES AFTER HER VACCINATION BUT A FEW MINUTES AFTER THE SHOT SHE CLOSED HER EYES AND HER DAD WAS HOLDING HER IN BETWEEN AISLE 18 AND WE PUT HER TO SIT DOWN SHE OPENED HER EYES ALMOST RIGHT AWAY BUT HER FACE/LIPS WERE PALE AND HANDS GOT COLD SHE RECOVERED IN LESS THEN 5 MINUTES AND WAS RESPONDING BY THE TIME THE AMBULANCE CAME PATIENT REMAINED IN THE CHAIR FOR 30 MINS AND THEN LEFT WITH PARENTS. PHARMACIST CALLED SOC AND REPORTED INCIDENT
14 2021-06-25 slurring, seizure, muscle twitching Convulsions Slurred speech Hallucinations Twitching 4pm
14 2021-06-26 feeling hot Patient felt very hot, then dizzy, then fainted for a few seconds.
14 2021-06-27 involuntary muscle movements Pt eyes rolled back in head, upper arms jerked. Lowered to floor and elevated feet. Monitored for ... Read more
Pt eyes rolled back in head, upper arms jerked. Lowered to floor and elevated feet. Monitored for 30 minutes. Pt able to walk out without assistance
14 2021-06-28 flushing, tremor, weakness, 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: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
14 2021-06-28 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
14 2021-06-28 tenderness Pt had a witnessed fall post vaccination. Per mother, pt complained of being dizzy and fell. Staff w... Read more
Pt had a witnessed fall post vaccination. Per mother, pt complained of being dizzy and fell. Staff witnessed patient falling from standing to ground, and hit her head. Pt was awake and alert upon RN reaching at side. Pt was following commands. Pt stated she was dizzy and nauseated prior to syncopal episode. Maintaining C-spine precautions d/t posterior head and midline neck pain and tenderness. Team alert was called. To ED via stretcher with medics
14 2021-06-28 unresponsive to stimuli, weakness Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Mild
14 2021-06-29 weakness Generalized rash, weakness, swollen lymph nodes, general malaise, fever, chills, one episode of diar... Read more
Generalized rash, weakness, swollen lymph nodes, general malaise, fever, chills, one episode of diarrhea and vomiting and headache.
14 2021-06-29 flushing 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: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe.
14 2021-06-30 burning sensation burning and itching rash on hand and wrist (same side as injection); burning and itching rash on han... Read more
burning and itching rash on hand and wrist (same side as injection); burning and itching rash on hand and wrist (same side as injection); This is a spontaneous report from a contactable physician. A 14-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported, age at vaccination 14 years), via an unspecified route of administration on 15Jun2021 as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. The patient experienced burning and itching rash on hand and wrist (same side as injection) on 16Jun2021. The patient was treated with topical steroid for events. The outcome of the events was not recovered. Information regarding lot/batch number has been requested ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Itchy rash and the suspect drug BNT162B2. Also, as there is limited information in the case provided, the causal association between the events Burning sensation and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
14 2021-06-30 feeling hot Pt was given shot by immunizing technician. And then sat down by her parent in the waiting area. I... Read more
Pt was given shot by immunizing technician. And then sat down by her parent in the waiting area. Immunizing tech came and got me since parent was worried. Pt briefly passed out. By the time I got out into the waiting area pt had already woken up. Pt felt hot got her water and checked blood pressure and pule all within normal range. Stayed with pt who after a few minutes said was feeling better. Did not call 911 due to quick recovery. Pt was kept for observation for an additional 20 minutes. Saw further improvement and pt continued to say she feels a lot better. Told pt and mother (mother did not speak English) that they should contact primary care provider about the event and further discuss if she should receive second dose or not. Due to quick recovery, believe patient most likely was nervous and worked herself up before getting the vaccination causing her to pass out.
14 2021-06-30 pain in extremity 14 y/o female with a history of HgSS and asthma who presents 1 day post 2nd Covid vaccination with c... Read more
14 y/o female with a history of HgSS and asthma who presents 1 day post 2nd Covid vaccination with chest pain and general body aches. Some of the patients pain and aches may be associated with post-vaccination symptoms, but does have elevated retic count and right leg pain consistent with previous sickle cell pain crisis. Low concern for acute chest syndrome.
14 2021-06-30 seizure Patient received 2nd dose of covid vaccine. After vaccine was administered she appeared anxious. Aft... Read more
Patient received 2nd dose of covid vaccine. After vaccine was administered she appeared anxious. After about a minute, patient appeared to have a short seizure for 10 seconds. Patient appeared pale afterwards. Patient stated she had a history of passing out after vaccines. Ambulance came and evaluated her. She was released to go home with parent.
14 2021-07-01 seizure Pt fainted and had convulsed then became conscious.
14 2021-07-03 tingling, feeling hot Patient had her first dose of Pfizer and after she sat down she became nauseous, head pounded, very ... Read more
Patient had her first dose of Pfizer and after she sat down she became nauseous, head pounded, very hot and sweaty, coughing, her lips, face and arms got tingly. She said her heartbeat was fast and she felt like she could faint. EMT was called but they did not take her to the hospital just suggested her parent get her checked out.
14 2021-07-04 feeling hot Patient felt faint and warm
14 2021-07-04 pain in extremity I gave patient 0.3ml of an undiluted vial of vaccine. Later on, about an hour I realized what I had ... Read more
I gave patient 0.3ml of an undiluted vial of vaccine. Later on, about an hour I realized what I had done and called the Pfizer help line. They gave me a little information. I called the patients mom to let her know what had happened. I had talked to several other sources besides Pfizer about what to expect and informed mom of increased arm soreness and fever and feeling bad. I called the mom back the next day to see how she was doing and she had run fever that night and bad soreness in the arm. Mom said she was doing ok, nothing out of the ordinary. I also reported it through our compliance dept.
14 2021-07-07 weakness, seizure Within minutes of patient receiving her first dose on Pfizer Covid-19 she became limp and her head f... Read more
Within minutes of patient receiving her first dose on Pfizer Covid-19 she became limp and her head fell on her mother's shoulder. Her mother stated she was having a seizure. When the pharmacist came to her, she was conscience and alert. She stated she felt weak and she was given some water. EMS then arrived and she did not leave with EMS. She left with her mother who stated the next day that she immediately took her to ER where it was determined she had "an allergic reaction."
14 2021-07-07 migraine Been having a series of migraines.
14 2021-07-07 pain in extremity Fever, nausea, arm/shoulder pain, generally feeling unwell
14 2021-07-07 unresponsive to stimuli 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: Tinnitus-Mild, Additional Details: patient fint for 2 minutes but recovered consciousness
14 2021-07-08 seizure After vaccination, patient stood up and walked around the room. She started bouncing and acting a li... Read more
After vaccination, patient stood up and walked around the room. She started bouncing and acting a little nervous. I asked if she was feeling light headed woozy, she said a little bit. I sat her back in the chair. After about 30 seconds she fell sideways to the arm of the chair then slouched forward. I caught her before she went all the way to the floor and leaned her back into the chair, she then seized for approximately 3-5 seconds. Grandpa (legal guardian) was in the room and helped me get her to the floor where she came out for a few seconds and opened her eyes for 5-10 seconds passed out again then seized again for 3-5 seconds. She then woke up on the floor and was alert and looking around. She was very pale, I elevated her feet for a while and had her lay on the floor for 7-10 minutes. I then had her sit up on the floor and provided a bottle of water and put cold compress on the back of her neck. She stayed seated on the floor for about 5-7 minutes before I had her move to the chair to sit again with back against the back of the chair. She continued to sit there sipping water and talking for 7 minutes or so. Learned at this point that patient had not eaten breakfast and has passed out after a vaccination in the past (had not marked on the intake form). After 7 minutes or so, had the patient try to stand. She said her legs were wobbly, so I had her sit back down for several more minutes. Her coloring was much better at this point. After another several minutes we tried standing again and she felt better at that point. Had her just stand in the room for about 3 minutes before walking to the waiting room. Had her then sit in the waiting room for 5 minutes then she walked out with grandpa. They were going to get breakfast. Grandpa was going to call MD to discuss the events and follow up as necessary as well as to discuss plan going forward concerning the second dose.
14 2021-07-08 tremor, cold sweat weak pulse,changes in body temperature,clammy sweat, pale skin I called emergency services the emt f... Read more
weak pulse,changes in body temperature,clammy sweat, pale skin I called emergency services the emt firefighter came they checked her vitals her color returned and she was doing better but still shaky Mom wanted her to be checked out the emt took her to hospital
14 2021-07-09 weakness Fainting, weakness, lethargy
14 2021-07-09 involuntary muscle movements 3 days after dose 1, which was given on 05/28/21, PT reported feeling not herself. She was experienc... Read more
3 days after dose 1, which was given on 05/28/21, PT reported feeling not herself. She was experiencing brain fog and not able to focus on her school work. She was worried about not being able to finish up the school year. We figured it was just "burnout", but knew this was strange behavior for PT who is usually very focused and has no problem getting good grades. We let her get the 2nd vaccine on June 18th. About 10 days later, PT reported feeling like her mind was racing and she could not sleep for 5 nights. She was very anxious and having panic attacks. On July 4th, PT came to us and told us, "the only way to stop the thoughts is to hurt myself." We immediately took PT to the Hospital ER. We have NEVER seen PT like this and she has NEVER had thoughts like this. She was talking to herself, making strange body movements and this frightening behavior came out of nowhere. They kept her overnight and sent her home with referrals to other doctors. She is still having suicidal thoughts and cannot function. We have had to cancel all trips, summer camps and check her out of soccer for the next month. There is no way she is going to be able to go to anything.
14 2021-07-09 pain in extremity Patient developed an itchy rash on torso and upper body. They were red almost like pimples and very... Read more
Patient developed an itchy rash on torso and upper body. They were red almost like pimples and very itchy. Also developed a fever of 102, and arm was throbbing. Father alternated Ibuprofen and Tylenol for the fever , and Benadryl for the itchy rash. Today she is doing much better but still has a itchy rash on the arm. She no longer has a fever and seems to be much better.
14 2021-07-09 unresponsive to stimuli Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Un... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted within 15 minutes of receiving first dose of pfizer covid vaccine. patient immediately gained conciousness
14 2021-07-10 pain in extremity it was just mild fever; Pain in arm; sluggishness lasted for two days/sluggish for two days; she is ... Read more
it was just mild fever; Pain in arm; sluggishness lasted for two days/sluggish for two days; she is very tired; This is a spontaneous report from a contactable consumer (parent). A 14-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196, 14-years-old at the time of vaccination), intramuscular, administered in arm left on 26Jun2021 10:30 as single for covid-19 immunisation. Medical history included asthmatic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included salbutamol sulfate (ALBUTEROL SULFATE) taken for asthma. Patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186, at the age of 14-year-old), intramuscular, administered in arm left on 21May2021 12:30 as single for covid-19 immunisation and experienced four days late for her monthly menstrual cycle. On an unknown date in 2021 patient experienced mild fever, pain in her arm, sluggishness lasted for two days and she was very tired and sluggish for two days. Patient did not receive any treatment for the events. On an unknown date in 2021 events were resolved. Follow-up attempts are needed. Further information is requested.
14 2021-07-11 numbness Site: Pain at Injection Site-Severe, Additional Details: patient is to follow up with a neurologist ... Read more
Site: Pain at Injection Site-Severe, Additional Details: patient is to follow up with a neurologist due to numbness in her arm from elbow down
14 2021-07-12 feeling hot, flushing LESS THAN 5 MINUTES AFTER RECIEVING THEIR VACCINATION, THE CLIENT WAS FOUND LAYING DOWN ON A ROW OF ... Read more
LESS THAN 5 MINUTES AFTER RECIEVING THEIR VACCINATION, THE CLIENT WAS FOUND LAYING DOWN ON A ROW OF CHAIRS IN THE OBSERVATION AREA. CLIENT REPORTS HAVING FELT WARM, FLUSHED, AND LIGHT HEADED. CLIENT REMAINED LAYING DOWN FOR SEVERAL MINUTES (AROUND 30 MINUTES). CLIENT WAS GIVEN WATER AND CLIENT'S FATHER GAVE HER STARBURSTS TO HELP, AS THE CLIENT STILL FELT LIGHTHEADED. CLIENT DENIES THIS EVENT HAPPENING BEFORE AND REPORTS HAVING HAD FOOD FOR LUNCH. CLIENT WAS ABLE TO WALK OUT OF THE ROOM ON HER OWN AFTER EATING STARBURSTS. NO OTHER CONCERNS PRESENTED.
14 2021-07-12 feeling hot WITHIN A FEW SECONDS AFTER RECIEVING THEIR VACCINE, THE CLINE T TURNED WHITE AND SAID SHE FELT HOT. ... Read more
WITHIN A FEW SECONDS AFTER RECIEVING THEIR VACCINE, THE CLINE T TURNED WHITE AND SAID SHE FELT HOT. AFTER SITTING IN THE CHAIR FOR A COUPLE MINUTES, THE CLIENT WAS HELPED TO THE FLOOR AND FEET ELEVATED. WITHIN A MINUTE THE CLIENT FELT BETTER AND WAS ABLE TO SIT. SHORTLY AFTER, THE CLIENT THEN WAS ABLE TO WALK. WET COMPRESS AND A FAN HELPED CLIENT COOL. NO OTHER ISSUES OR CONCERNS.
14 2021-07-12 flushing Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic... Read more
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: passed out for 3-5 seconds-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: she passed out for 3-5 seconds, came to. Was very pale, maybe 5 minutes later threw up. Then she regained some color and was less confused. She was very anxious about getting the shot prior to getting the injection.
14 2021-07-13 pain in extremity Pt. called me crying in pain saying her stomach hurts and she's having trouble walking. She said sh... Read more
Pt. called me crying in pain saying her stomach hurts and she's having trouble walking. She said she has her menstrual cycle and it has never been this bad. She said she didn't get it last month at all. Prior to this, she said her cycles were normal. She also had pain in her thighs and trouble breathing which resulted in her needing her rescue inhaler. At this time she has been given ibuprofen and is resting with a heating pad. I as pts. mom am concerned that this may be related to vaccine.
14 2021-07-14 seizure Patient received the Pfizer Covid 19 vaccine and after waiting in the waiting room for a couple of m... Read more
Patient received the Pfizer Covid 19 vaccine and after waiting in the waiting room for a couple of minutes began having a seizure. The seizure lasted about 1 minute. 911 was called and the paramedics arrived shortly after. The patient was conscious and alert, but appeared very sluggish. The mother of the patient insisted that she be carted away to the hospital and the paramedics took her to the ambulance.
14 2021-07-15 slurring Patient presented to emergency center for evaluation of right sided headache for 12 hours with episo... Read more
Patient presented to emergency center for evaluation of right sided headache for 12 hours with episodic slurred speech day after 2nd dose of COVID vaccine. Per notes slurred speech already resolved at time of ER visit.
14 2021-07-18 seizure Patient had an syncope episode following a pfizer covid 19 shot. She had shortness of breath and app... Read more
Patient had an syncope episode following a pfizer covid 19 shot. She had shortness of breath and appear to have a seizure afterwards. Gave 1 dose of an epipen and patient vitals was stable.
14 2021-07-19 tingling Patient was very nervous about receiving the vaccine and has a fear of needles, dad confirmed and wa... Read more
Patient was very nervous about receiving the vaccine and has a fear of needles, dad confirmed and was with patient the whole time. About 15 minutes later, patient was complaining of a tingling left hand and arm, and tingling tongue. She said she could breath without any issues, but was feeling light headed. 911 was called with moms and dads consent. With moms consent, patient got one dose of benadryl 25mg tablet. Paramedics came and took the patient.
14 2021-07-19 speech disorder, grand mal seizure, tremor Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological... Read more
Tonic-Clonic seizures; Nausea; Vomiting; Severe body aches; Headache; Moderate - severe neurological events; Tics; Tremors; Confusion; Inability to speak or walk or use restroom on own; Inability to speak or walk or use restroom on own; Fine motor skills deficit; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0876, Expiration Date: not reported), via an unspecified route of administration in left arm on 15May2021 at 15:00(Age at the of 14-years old)as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at time of Vaccination. Medical history was none. Known allergies was Nka. The patient received unspecified medications within 2 weeks of vaccination. The patient did not received 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 17May2021,the patient experienced nausea, vomiting, severe body aches, headache, moderate - severe neurological events, tics, tremors, confusion, inability to speak or walk or use restroom on own, fine motor skills deficit and tonic-clonic seizures. Adverse events resulted in Emergency room/department or urgent care. The patient was hospitalized for 4 days. Hospitalization was not prolonged. The patient received treatment and stopped suspected interacting medicine. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0191, Expiration Date: not reported), via an unspecified route of administration in left arm on 06Jun202114:00 as dose 2, single for COVID-19 immunization. The outcome of the events was recovering. ~~ No follow-up attempts are possible. No further information is expected.
14 2021-07-19 tremor, discomfort Patient got vaccine her mom said that she fainted and hit her head on something and then shook like ... Read more
Patient got vaccine her mom said that she fainted and hit her head on something and then shook like she might have had a seizure. By the time that I got to her the patient was pale and she said that she felt heavy. I called 911 and the paramedics came and took over and got some vitals.
14 2021-07-20 numbness, tingling About 9pm on July 15, 2021, my daughter started to feel a tingling sensation on her face. Between 9:... Read more
About 9pm on July 15, 2021, my daughter started to feel a tingling sensation on her face. Between 9:30pm-10:30pm she gradually begin to have mild to severe numbness in her face, legs, chest and arms and her heart was beating rapidly. She told us she feels that she?s going to die. We took her to the emergency room where heart rate rose as high as 175bpm and the numbness got worse
14 2021-07-21 flushing, tremor Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injecti... Read more
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Medium, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PATIENT IS STILL FEELING CHEST PAIN AND STILL HAS RASH.
14 2021-07-21 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was still conscious just felt faint
14 2021-07-22 weakness about 1 minute after receiving covid vaccine pt had a syncopal episode falling forward out of the ch... Read more
about 1 minute after receiving covid vaccine pt had a syncopal episode falling forward out of the chair. Dry heaves following incident and felt weak after.
14 2021-07-23 tremor, flushing Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Vomiting-Medium, Additional Details: after 15mins pt vomited while walking out of store. she came back and stated she felt dizzy she was very pale. b/p was 88/86 pulse 107. had pt sit for 5 more mins. went out again and bp was 89/79 pulse 95. contacted ambulance as pt still felt faint. ambulance came 15 mins later. by that time pt had drank a whole bottle of water. pts vitals were within range. emts recommended she seek a physicians help at urgent care.
14 2021-07-25 numbness, cold sweat Patient stated she felt nauseous about 5 minutes after shot was administered. She stated that she go... Read more
Patient stated she felt nauseous about 5 minutes after shot was administered. She stated that she got tunnel vision, could not feel her hands. A few minutes later she stated that she felt vibrations in her hands, felt like she could not move her hands. She was visibly pale and clammy. Patient was given an ice pack and 25 mg dose of oral Benadryl liquid. Her symptoms resolved within 25 minutes of onset and she was able to leave the pharmacy feeling back to normal
14 2021-07-26 tingling, numbness numbness, tingling, and weakness of arm. Started immediately after vaccination. Got worse over the... Read more
numbness, tingling, and weakness of arm. Started immediately after vaccination. Got worse over the next couple of weeks and then has slowly started to get better without intervention
14 2021-07-28 weakness Patient temporarily lost consciousness twice becoming incontinent after the second episode. Patient ... Read more
Patient temporarily lost consciousness twice becoming incontinent after the second episode. Patient complained of lightheadedness, dry mouth and was pale throughout. EMT arrived and administered an IV ultimately transporting the patient to the hospital as they remained weak and unable to maintain balance.
14 2021-07-28 weakness Pt fainted on mother's arm after a few minutes of receiving vaccine. She fainted approximately 30 se... Read more
Pt fainted on mother's arm after a few minutes of receiving vaccine. She fainted approximately 30 seconds - 1 minute. When she woke up, she was pale and weak. BP was taken, and it was below normal. She drank water and ate skittles to boost her sugar and get BP back up. She was informed to sit for another 30 mins with her mother to make sure she was okay. She also had a fan blowing cool air on her to help her feel better. After waiting over 30 mins and retaking her BP, pt felt better enough to leave with her mother. Mother was advised to watch her daughter for the remainder of the day, and for the pt to eat a hearty meal before returning for her second covid imz.
14 2021-07-28 pain in extremity Myocarditis Presented to ED with 2 days of chest pain, back pain, and nausea and vomiting 1 day afte... Read more
Myocarditis Presented to ED with 2 days of chest pain, back pain, and nausea and vomiting 1 day after receiving Pfizer vaccine. Patient initially had back pain starting the night of 7/24, sudden onset. The next day she began to complain of stabbing chest pain that radiated into her left arm. Outside ED found elevated troponin of 2.93 and transferred to the hospital. Patient was COVID negative on admission and remained afebrile throughout her hospital stay. Patient was given IVIG on 7/27 which was well-tolerated, did not require steroid treatment. Cardiac markers downtrended over course of admission and was discharged 7/29 after normal Echo with Cardiology follow up.
14 2021-07-29 grand mal seizure experienced a seizure/tonic clonic seizure; she was very confused; This is a spontaneous report from... Read more
experienced a seizure/tonic clonic seizure; she was very confused; This is a spontaneous report from a contactable consumer (mother). A 14-year-old female patient (daughter) bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04Jun2021 (Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation. No medical history included. Concomitant medication included ascorbic acid (VITAMIN C) taken as vitamins from 2021 to an unspecified stop date took one time a day for three weeks). The patient previously vaccinated with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 13May2021 (Batch/Lot Number: EW0168; Expiration Date: 30Aug2021) right arm as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. It was reported that the patient experienced AE after Pfizer COVID-19 vaccine. The reporter stated that the patient received two doses, and then experienced a seizure. The patient was was seen by practitioner, who referred her to call today. The patient got her first dose 13May2021, which was given during the day, before the evening, and injected in her right arm. The second dose was given 04Jun2021, and was LOT: ER8735, with EXP: 31Jul2021 about the same time of day in the same place on the same arm. It was stated that the second dose was given 24 days after (as reported) the first dose. The patient had no side effects of getting the vaccines for a day or two afterwards, nothing. Had no seizures before, which is why they were concerned. It was added that everything was normal they tested in her blood work and everything else. The patient had her seizure on Sunday 11July2021, and they rushed her to the emergency room at 10:00AM. She says her daughter was asleep when it happened, and the seizure lasted about a minute. She says it was given to us by the emergency room that it was a tonic clonic seizure. She says for treatment they did blood work and kept her daughter for observation because she was very confused. She says that they gave her daughter no medications, and she ended following up the next day with the pediatrician, because it happened they followed up Monday with the pediatrician, and they have an appointment with a neurologist 18Aug2021 for a CT scan and EEG. She says all of her patient's blood work came back normal. The patient had no other vaccinations recently and had started no new medications, she only started taking about a month and a half ago vitamin C, just over the counter from and only took it one time a day and she took it 3 weeks, that was it. The reporter added that the has had no previous reactions to vaccinations. The reporter also stated that the patient has kind of recovered, she hasn't had any, she has been checking on her and checks on her at night when she sleeps since it happened when she was sleeping. She says she is fine, they are following up to see what triggered it. The reporter also says that they went home that day they went to the emergency room and they were at the hospital for 3 hours and didn't stay overnight. The reporter added that they got the lab results in today, the office has the blood work results already, but she doesn't have them. The reporter then asked, if after they see the neurologist in August if they need to call back with neurologist information, and results from CT scan, or if they will get back to her to follow up on this? It was added that the Seizure lasting about one minute. Time of Onset was 10:00, 11Jul2021. The Seizure require a visit to: Emergency Room and Physician Office Visit. The patient was not hospitalized. The outcome of the events was recovered.
14 2021-07-29 speech disorder experienced cognitive disruption for approximately 4 hours.; Disruption included inability to read; ... Read more
experienced cognitive disruption for approximately 4 hours.; Disruption included inability to read; difficulty with speech/context/numbers.; This is a spontaneous report from a contactable consumer (patient). A 14-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0202 and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 27Jun2021 at 13:00 (at the age of 14-years-old) as dose 2, single for covid-19 immunisation. The patient has no other medical history. The patient's concomitant medications were not reported. Patient has no known allergies. The patient previously took first dose of bnt162b2 (Lot number: EW0178) administered in left arm on 04Jun2021 at 12:00 PM (at the age of 14-years-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks. On 08Jul2021 at 10:00, 11 days after second dose, the patient experienced cognitive disruption for approximately 4 hours. Disruption included inability to read and difficulty with speech/context/numbers. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 post vaccination. No treatment was received for the events. Outcome of events was recovered on an unknown date in Jul2021.
15 2021-03-28 pain in extremity Pt was inadvertantly vaccinated at 15 yrs of age. Appt. made by mother and mother was vaccinated at... Read more
Pt was inadvertantly vaccinated at 15 yrs of age. Appt. made by mother and mother was vaccinated at the same time. No adverse reaction after the vaccination other than a sore arm. Pt. has no medical conditions, but mother is high risk.
15 2021-05-05 pain in extremity Patient is 15 years old and have received Pfizer vaccine and does not meet Pfizer age group (which i... Read more
Patient is 15 years old and have received Pfizer vaccine and does not meet Pfizer age group (which is 16 and older). Patient returned for second dose on 5/6/2021 and had no side effects on the first dose, other than a sore arm.
15 2021-05-13 feeling hot Pt. sitting with mother and sister in observation area. Mother signed for assistance. Pt reported ... Read more
Pt. sitting with mother and sister in observation area. Mother signed for assistance. Pt reported feeling hot and having blurred vision. Able to state name throughout event. Pupils dilated, skin hot. Pt instructed to remove mask and breath deeply, cool pack applied to back of neck. After several minutes patient reported vision retuning to normal. Patient incontinent during episode. Pt transferred to private room. Water, peanuts, and fruit snacks provided. Sister very tearful and anxious. Water and snacks provided. Family remained 30 minutes. Verbalized feeling okay, reported slight headache. Mother made appointment for patient to see pcp today, family left clinic.
15 2021-05-13 feeling hot Pt had waited the requisite 15 minutes and was at the front of the store with her mom. She felt "ho... Read more
Pt had waited the requisite 15 minutes and was at the front of the store with her mom. She felt "hot" and kind of slumped over . She never lost consciousness. She was pale. Sat on floor. Drank water and seemed to be doing better. Mom took her home and will follow up with her pediatrician.
15 2021-05-13 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt recovered after a few minutes of sweating and feeling nauseous.
15 2021-05-13 flushing Vaso-vagal response. Nausea, dizzines, flushing/sweating, no loss of consciousness. Pt stabilized, V... Read more
Vaso-vagal response. Nausea, dizzines, flushing/sweating, no loss of consciousness. Pt stabilized, VS stable (95/57; HR 65; RR 16; O2 sat 100%), ambulates appropriately
15 2021-05-13 flushing Pt felt faint & flushed post vaccine. Given water VS stable (BP 95/60; HR 100; RR 18; T 97.8; o2 sat... Read more
Pt felt faint & flushed post vaccine. Given water VS stable (BP 95/60; HR 100; RR 18; T 97.8; o2 sat 100%). NP assessed pt, symptoms resolved. Pt sent home in stable condition with father.
15 2021-05-13 tingling Pt started to feel lightheaded with a tingling sensation in her arms 5-10 minutes after vaccination.... Read more
Pt started to feel lightheaded with a tingling sensation in her arms 5-10 minutes after vaccination. Pt was given water and observed for 15 minutes. Pt was released in Good Health to her mother
15 2021-05-14 cold sweat In 2-3 minutes after injection patent fainted, she was conscious but dizzy, she was sweating a lot... Read more
In 2-3 minutes after injection patent fainted, she was conscious but dizzy, she was sweating a lot, her skin was pale and clamy, she felt nauseated and threw up
15 2021-05-14 tremor syncope with bilateral tonic/clonic movements. per parents, patient has history of vasovagal synco... Read more
syncope with bilateral tonic/clonic movements. per parents, patient has history of vasovagal syncope following exposure to needles or lancets (vaccines, finger prick). approx 2 minutes following injection, patient lost consciousness, followed by several clonic movements bilaterally of upper and lower extremities. patient was transfered from chair to floor, legs were elevated. She regained consciousness quickly, was given water. When she felt better, she once again sat in a chair. After another 5 minutes (approx), she had another episode of loss of consciousness with increased tone of UE and LE bilaterally and also several clonic movements. She was again transferred to the floor, regained consciousness. She was more shaky and diaphoretic following the second episode but was otherwise aware and oriented. She was observed for another 30 minutes at the pharmacy and then left.
15 2021-05-14 unresponsive to stimuli, involuntary muscle movements, tremor Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Faint... Read more
Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: 5 Minutes after the vaccine, pt lost consciousness for a few seoncds. pt showed some jerking motion. Pt was given water and benadryl. About 30 minutes after the shot, pt fully regained consciousness and back to normal
15 2021-05-15 feeling jittery BP:128/76 HR:80 02:98 headache and jittery. strong pulse, alert, does not like crowds and the vaccin... Read more
BP:128/76 HR:80 02:98 headache and jittery. strong pulse, alert, does not like crowds and the vaccine. EMS REFUSAL
15 2021-05-15 numbness, unresponsive to stimuli, tremor Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsi... Read more
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium
15 2021-05-15 migraine, numbness, tenderness, tingling Migraine, facial numbness and tingling central to nose and mouth area. Feeling like she was unable t... Read more
Migraine, facial numbness and tingling central to nose and mouth area. Feeling like she was unable to breathe when ascending steps that resulted in hyperventilating which lasted 18 minutes. Normal breathing rhythm returned after 43 minutes. Right arm extremely tender. Oxygen and heart rate at 23 min were 98 for O2 and heart rate 73 BPM.
15 2021-05-15 muscle twitching, depressed level of consciousness Patient had what appeared to be absence seizures (facial twitching, unresponsive but moving eyes, fi... Read more
Patient had what appeared to be absence seizures (facial twitching, unresponsive but moving eyes, fist clenching) for 30 seconds. This occured 10 minutes post injection. Patient did not fall out of chair as her grandmother was right next to her. 911 was called, patient recovered immediately after and had no other incidence. patient taken to hospital.
15 2021-05-15 seizure Patient received injection and sat down in the waiting area with her Mom. Less than 5 minutes after ... Read more
Patient received injection and sat down in the waiting area with her Mom. Less than 5 minutes after the injection she fainted and appeared to have a small seizure , her mother shouted at her and shook her and she became conscious and vomited. 911 was called , they evaluated the patient and she went to the hospital.
15 2021-05-15 tremor, numbness, tingling Patient received her first dose of the Pfizer COVID19 vaccine at approximately 12pm. Patient felt fi... Read more
Patient received her first dose of the Pfizer COVID19 vaccine at approximately 12pm. Patient felt fine immediately after the vaccination and was instructed to sit and wait for 15 minutes. The immunizer, watched the patient sit down in a chair. A few minutes later the mother of that patient began screaming help, help. Patient had fainted, falling on the floor and hitting her head. I ran our to assist patient, I instructed my technicians to call 911. Patient was on the floor, shaking. I assisted her in rolling over. When she came to I helped her control her breathing and take deep breaths. I used I gauze pad to stop the bleeding on her head. I made sure she was lying flat on the floor. We gave her an ice pack to help with the numbness and tingling in her hands. The paramedics arrived and took patient to the hospital.
15 2021-05-15 tremor Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Mild
15 2021-05-16 weakness AFTER COVID19 VACCINATION, PATIENT EXPRIENCED DIZZINESS, WEAKNESS WITH DIFFICULTY MAINTAINING EYE CO... Read more
AFTER COVID19 VACCINATION, PATIENT EXPRIENCED DIZZINESS, WEAKNESS WITH DIFFICULTY MAINTAINING EYE CONTACT. PATIENT STATED SHE FELT SLEEPY WITH DIFFICULTY KEEPING EYES OPEN. AFTER 25 MINUTES, PATIENT WAS AAOX4, VITALS WNL, AMBULATING WITHOUT ASSISTANCE AND LEFT CLINIC WITH FATHER, DENYING ANY DIZZINESS OR WEAKNESS. VITALS: BP HR RR SPO2 12:45 138/80 100 16 99% 12:53 150/90 85 16 99% 12:58 138/90 81 14 99% 13:02 128/80 80 14 99% 13:07 122/86 75 16 99%
15 2021-05-16 cold sweat Patient began to feel lightheaded, experienced blurred vision, clammy skin, eyes dilated, 10 minutes... Read more
Patient began to feel lightheaded, experienced blurred vision, clammy skin, eyes dilated, 10 minutes following IM dose of Pfizer vaccine, about 2pm. Dose was administered at 1:45pm Mother asked pharmacist to call 911 because her daughter was feeling dizzy. Medical first responders arrived at 2:08pm, took her blood pressure, O2, and blood sugar, temperature. All were within normal ranges. O2=100, BP 114/60mmHg . Even though all vitals were normal, first responders recommended patient should follow up with primary care provider. First responders told mother response was likely due to nervousness or anxiety about new vaccine.
15 2021-05-16 feeling hot Pt became nauseated about 5 minutes after receiving her first dose of the Pfizer vaccine. She dry-he... Read more
Pt became nauseated about 5 minutes after receiving her first dose of the Pfizer vaccine. She dry-heaved about 3 times but did not vomit. She stated that she also felt hot so was given two ice packs. She had only eaten a handful of snacks that morning. Denied dizziness or lightheadedness. BP 110/72, pulse 64 bpm. After 5 minutes she stated that she was feeling better. Pt left after 15-minute observation period with symptoms resolved
15 2021-05-16 flushing, weakness Flushing/sweating, dizziness, generalized weakness, nausea. BP 94/51; HR 60; RR 19. 17 min post vacc... Read more
Flushing/sweating, dizziness, generalized weakness, nausea. BP 94/51; HR 60; RR 19. 17 min post vaccination pt noted feeling much better. Denies pain/discomfort, no n/v. Fluid offered, seen by NP. Pt feeling better & released
15 2021-05-16 flushing Flushing/sweating, Dizziness, near syncopal event after witnessing brother have a syncopal event aft... Read more
Flushing/sweating, Dizziness, near syncopal event after witnessing brother have a syncopal event after his first dose. Pt did not have breakfast. BP 100/52, HR 59, RR 18 -- > 108/67, HR 77 -- > 110/67, 75. Improved after water, crackers, rest. Recommended patient eat and drink prior to next dose. Patient stable and released from the vaccination site.
15 2021-05-16 tingling, numbness, weakness AFTER COVID19 VACCINATION, PATIENT EXPERIENCED NUMBNESS, TINGLING, DIZZINESS, WEAKNESS, LIGHTHEADEDN... Read more
AFTER COVID19 VACCINATION, PATIENT EXPERIENCED NUMBNESS, TINGLING, DIZZINESS, WEAKNESS, LIGHTHEADEDNESS AND DIAPHORESIS AT FOREHEAD. NO LOC, NO DIB, NO SYNCOPE, NO CHEST PAIN. AFTER 15 MINUTES PATIENT WAS ASYMPTOMATIC. LEFT WITH FATHER TO HOME AT 11:16 AM. VITAL SIGNS: 1100 BP 72/36, HR 88, RR 20 1105 BP 86/46, HR 84, RR 20 1110 BP 88/62, HR 82, RR 20 1115 BP 96/68, HR 80, RR 20 1116 BP 102/70, HR 82, RR 20
15 2021-05-17 cold sweat, feeling cold 1120 pt reports dizziness after vaccine. pt cool, clammy, nauseated, bp 72/35, team called. pt trans... Read more
1120 pt reports dizziness after vaccine. pt cool, clammy, nauseated, bp 72/35, team called. pt transferred to observation area, lying down on gurney. ER staff present. Mother reports pt did not eat breakfast this am. Apple juice given. 1135 pt reports improvement in symptoms, bp 106/56, dc home in stable condition.
15 2021-05-17 cold sweat, hot flush, feeling hot Hot flashes on and off. Feeling very hot and getting clammy.
15 2021-05-17 feeling hot Patient started feeling dizzy/faint right after administration, she was sweating and felt hot to the... Read more
Patient started feeling dizzy/faint right after administration, she was sweating and felt hot to the touch, then she convulsed and shot up out of her chair for a few seconds before sitting back down. As she sat back down she vomited and then seemed to get better after. 911 was called and she was better by the time they arrived and blood pressure and vitals where all good.
15 2021-05-17 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild
15 2021-05-18 weakness Headache, body ache, nauseated, vomiting, weak
15 2021-05-18 weakness Weakness, Nausea. Seen by onsite EMS. 16:23 HR 84 regular Spo2=96% BP=79/55 16:31 Reported symp... Read more
Weakness, Nausea. Seen by onsite EMS. 16:23 HR 84 regular Spo2=96% BP=79/55 16:31 Reported symptoms resolved. left with parent. HR 83 regular Spo2=97% BP=105/84 Discharged with mother at 16:35. Recorded by RN.
15 2021-05-18 feeling cold patient reported to feel "dizzy" and cold after receiving pfizer-biontech covid vaccine after 10 min... Read more
patient reported to feel "dizzy" and cold after receiving pfizer-biontech covid vaccine after 10 minutes of administration. hard time for patient to get up. vital signs taken by EMT stable. observed in designated area for 15 minutes, patient and family reported full recovery, vital signs still stable.
15 2021-05-18 migraine Severe headache that turned into a migraine Vomiting
15 2021-05-18 muscle spasms, hot flush, tingling In her eyes, patient felt tingling and fluttering; we could not see her eyes moving at all. She als... Read more
In her eyes, patient felt tingling and fluttering; we could not see her eyes moving at all. She also felt tingling in both arms, both hands, her face, and torso; she also had a lot of pain in her back. She felt that her face was hot but to the touch it was not. After about 20 minutes of these sensations her fingers cramped in gnarled positions that she was unable to straighten. Her right hand fingers was more rigid than her left. This lasted about 30 minutes and then she was slowly able to straighten her fingers. By the time she went to bed, around 10 pm, she felt basically back to normal.
15 2021-05-18 tingling Tingling of left arm beginning shortly after vaccination. Reports 0 unusual for her.
15 2021-05-18 seizure Pt had syncope x 1 postvaccination followed by seizure x 2. Pt recovered spontaneously after 3-5 sec... Read more
Pt had syncope x 1 postvaccination followed by seizure x 2. Pt recovered spontaneously after 3-5 seconds. No labored breathing. Alert and oriented x 3. Pt brought to ER.
15 2021-05-18 unresponsive to stimuli, tremor Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakines... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
15 2021-05-19 weakness Pt received vaccine...came out of vaccination room...sat down and started talking to mother...starte... Read more
Pt received vaccine...came out of vaccination room...sat down and started talking to mother...started to feel nauseous ? sat back and started to look limp...paramedics immediately contacted...pt never loss consciousness...looked pale... not feeling well...was responsive and breathing...respirations were being monitored...EMTs arrived and took over...did take pt to hospital...
15 2021-05-19 feeling hot while sitting at the vaccination and waiting for mother, patient started to complain of feeling "ho... Read more
while sitting at the vaccination and waiting for mother, patient started to complain of feeling "hot, dizzy and lightheaded." Patient was given gatorade water and hair was pulled into ponytail off of neck to help cool down. Stable vital signs BP 110/64 P84 SpO2 98% room air. Within 5 mins, patient expressed that she was "feeling better." Alert and oriented x3. Patient expressed that she did not eat or drink anything prior to coming in to receive vaccine. Patient assisted to observation area for monitoring. Steady gait noted. Ambulated from facility with mother. No s/sx of distress noted.
15 2021-05-19 flushing, tingling Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadn... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling in fingers
15 2021-05-19 seizure Patient received vaccine and while walking around the store began to feel lightheaded/dizzy and fain... Read more
Patient received vaccine and while walking around the store began to feel lightheaded/dizzy and fainted. Her parent caught her and brought her to the ground where she began to have a seizure. Paramedics were called and took over care of the patient. She was conscious and breathing after her seizure
15 2021-05-20 inability to speak 15yo patient in observation parking lot c/o headache and laid down. honked horn because patient stat... Read more
15yo patient in observation parking lot c/o headache and laid down. honked horn because patient stated she had trouble breathing. RN's in observation area ran to the car. Patient tachypnic and couldn't talk, slightly pale with no signs of cyanosis. 911 called immediately and epi pen, 0.3mg administered at 1621. Patient layed down in the back of her car until ambulance arrived. BP stable, no pulse-ox available, respirations 66 bpm. Patient awake and alert, still unable to talk, lips pink, diaphoretic. Care turned over to Paramedics on site. No h/o allergies or anaphylactic reactions. H/O anxiety and on Prozac.
15 2021-05-20 involuntary muscle movements Patient had no reaction or side effects for 15 minutes after the shot. After 15 minutes, patient st... Read more
Patient had no reaction or side effects for 15 minutes after the shot. After 15 minutes, patient started experiencing uncontrollable movement of her upper arm and shoulder. The uncontrollable movement was mainly in the upper arm. Patient did have some uncontrollable movement in her fingers. Patient also had uncontrollable laugh as well which was not so significant. Patient's caregiver (mom) also indicated that she had trouble forming a sentence, but as per patient it was due to her being nervous. Patient stayed in the pharmacy for over an hour. Over the time, her symptoms had subside. The uncontrollable laughter was almost gone. Uncontrollable movement of her upper arm had also reduce significantly and patient was very calm after sometime. Patient was alert and able to understand and conscious. Patient was advised to see PCP or pediatrician for further evaluation.
15 2021-05-20 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt was flushed, stated she had ringing in her ears, and was seeing stars. She moved from her chair to sit on the floor and drank water and CapriSun. After a few minutes, she said she was feeling better. Mom states that she had a similar reaction to getting nose pierced not too long ago.
15 2021-05-20 pain in extremity 3 days of severe abdominal and pelvic pain that was debilitating. Patient was hardly able to walk -... Read more
3 days of severe abdominal and pelvic pain that was debilitating. Patient was hardly able to walk - she had extreme pain with urination and defecation. She also had headache, fatigue, arm pain, fever and rash - hives, with pruritus of scalp.
15 2021-05-20 unresponsive to stimuli, seizure Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium
15 2021-05-21 seizure Patient began to feel light headed and asked her mom for water. Patient then fell to the side and h... Read more
Patient began to feel light headed and asked her mom for water. Patient then fell to the side and hit her head as she fell to the floor, then had a seizure lasting 30 sec. patient was Alert and oriented x4 when we got to her. Patient stated she felt like she was falling asleep and dreaming then remembers everyone standing over her. Patient has small bump on upper left of head. Patient was taken to medical center for treatment and observation.
15 2021-05-21 seizure Pt. fell to floor from chair, dizziness, possible seizure activity 12 Lead, started IV, 0 meds. Vit... Read more
Pt. fell to floor from chair, dizziness, possible seizure activity 12 Lead, started IV, 0 meds. Vital signs: 89/40 Pulse:60 89/41 Pulse :55 89/42 Pulse:56 Recorded by RN. Pt. transported to hospital via ambulance at 11:32 A.M. with mother.
15 2021-05-22 feeling hot Patient has history of passing out. 2-3 min after Pfizer shot patient started to feel hot and was pa... Read more
Patient has history of passing out. 2-3 min after Pfizer shot patient started to feel hot and was pale. A volunteer doctor assisted to sit down on floor. Has syncope episode after seated on ground. Use ammonia capsule . Pulse was intact throughout. Airway as cleared of gum in mouth. Loss of consciousness for 15 sec. Then alert able to call mother who was in the parking lot. 911 EMS called and arrived. Cool compress applied. Ems arrived. Patient felt better. Vital by Ems Glu 80 BP 120/80. Patient was able to drink water. MD instructed mother to clear with PCP or Cardiologist to clear before getting 2nd shot. Mother declined EMS transport. MD walked patient to car.
15 2021-05-22 feeling hot Has gotten hot, nauseous and then blacked out and throws up, this has happened now 4 times.
15 2021-05-22 migraine 18h post vaccination, teen began w acute MIGRAINE
15 2021-05-23 cold sweat Dry, itchy throat with some throat swelling. Clamminess, dizziness and paleness. Local emergency ser... Read more
Dry, itchy throat with some throat swelling. Clamminess, dizziness and paleness. Local emergency services requested for assistance
15 2021-05-23 numbness, unresponsive to stimuli, tingling Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: f... Read more
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: TINGLING IN FEET
15 2021-05-23 migraine Suddenly my vision got super bright and I could hardly see, and then I couldn?t hold myself up and I... Read more
Suddenly my vision got super bright and I could hardly see, and then I couldn?t hold myself up and I slowly collapsed onto the ground. It only lasted a few minutes, and then I was perfectly fine. It came on very suddenly and didn?t last long, but it was extreme during those few minutes. It was also very hot that day. And I had a mild migraine headache in the morning, but that wasn?t very bad, and I get migraines fairly regularly.
15 2021-05-23 pain in extremity About 30 minutes following vaccine developed arm pain and a sensation that her throat was closing an... Read more
About 30 minutes following vaccine developed arm pain and a sensation that her throat was closing and wheezing. Took a Benadryl tablet. Presented to emergency department the following day at 1433 at that time no feeling of throat closing. No swelling of the uvula or any tissues examined in the pharynx. No wheezing.
15 2021-05-23 tingling Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: ... Read more
Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Stated she could not see clearly or hear well-
15 2021-05-23 speech disorder, tremor Patient is a 15 yo female with a history of anxiety, recent ankle sprain, and no other known medical... Read more
Patient is a 15 yo female with a history of anxiety, recent ankle sprain, and no other known medical history who presents to ED today after she developed persistent shaking movements after her COVID 19 vaccination today. Medical work up has been thorough and has resulted negatively, including blood work, UDS, CT Head. She has remained slightly tachycardic, though she has also been moving continuously for several hours. Her physical exam is notable for several indicators of psychogenic origin, including demonstrating variability in tremor frequency (head, legs and arms vacillating it variable rates over time), distractability from motor tasks (head or arms stop shaking when asked to focus on moving her legs, for example). Her speech has also been affected, but this is also variable and she is at times using only 1 word sentences and other times responding more completely. Certainly she may have suffered a psychological stress today as she is fearful of needles and has a history of vasovagal response and her mother notes recent overwhelm with school performance, though this is not unusual for her. If medical work up continues to be negative, it may be reasonable to conclude she is suffering a conversion disorder "FINAL DIAGNOSIS: Conversion reaction after a Covid 19 vaccine. Patient To be transferred via ground ambulance."
15 2021-05-23 tremor, flushing Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdomina... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
15 2021-05-23 tremor, seizure Pt received vaccine and was standing outside of immunization room with her parents waiting for her b... Read more
Pt received vaccine and was standing outside of immunization room with her parents waiting for her brother to receive vaccine. She felt dizzy and fainted. She hit her head and collapsed. She was seizing/ shaking on the floor. She was conscious with no visible bleeding. She was able to say her name and DOB correctly. Mother reported no history of epilepsy or seizure. Called emergency services and pt was taken to Clinic for further evaluation. A 1.5cm laceration was noted behind her left ear. Pt received 2 staples in the lacerated area.
15 2021-05-23 tremor, unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: pt immediately... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: pt immediately said she felt dizzy& eyes began to roll. Mom stated she has a fainting condition. Her Mom & I eased her to the ground. she briefly passed out, but immediately came to and asked what was happening. Her right leg was bent back but we lifted her to straighten leg. I elevated her feet & got her some water. I also got her some gatorade & a cool wet paper towel for forehead. She leaned against her Mom for a little while, then she sat. Mom said not to call 911
15 2021-05-24 weakness, pain in extremity - Typical sore arm and fatigue in Day 1 & 2 - 4 days of severe headache from Day 1 through Day 4 - D... Read more
- Typical sore arm and fatigue in Day 1 & 2 - 4 days of severe headache from Day 1 through Day 4 - Day 4 severe diarrhea - Day 4 & 5 foggy "brain" - Muscle aches and weakness Day 2 - 4 - Potential menstrual period interruption
15 2021-05-24 feeling hot Patient was hot, sweaty and turned pale 5 minutes after vaccine. She felt like she was going to pas... Read more
Patient was hot, sweaty and turned pale 5 minutes after vaccine. She felt like she was going to pass out.
15 2021-05-24 seizure, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seiz... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild
15 2021-05-24 seizure Seizure at the time of vaccination. Mother in the car and recorded. Known history of seizures and ... Read more
Seizure at the time of vaccination. Mother in the car and recorded. Known history of seizures and they will follow up with an epileptologist. They are comfortable going home as this happened after the nasal swab as well and they suspected this would happen today. No further information needed today.
15 2021-05-24 unresponsive to stimuli, flushing, tremor Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chills-Severe, ... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Turning very pale, passed out and unresponsive, sweating-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: After 5 minutes of vaccination, mom called for help in the waiting area. The patient passed out for a few minutes and responded after we both called her several times. We called 911. She was feeling nauseous. She sipped a little water and was looking very pale and was starting to become unconscious again. Mother thought it was an allergic reaction and asked for Epipen. Epinephrine was administered, and patient became alert and less pale. EMS came and took her away due to low blood pressure
15 2021-05-24 unresponsive to stimuli, flushing 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: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild, Additional Details: Patient felt dizzy and blackout/ fainted for less than 10 seconds. Vommiting and blood pressure on the low 96/64
15 2021-05-25 coordination abnormal, weakness, inability to speak Sudden onset severe excruciating upper body pain including back, abdomen, chest, throat, neck causin... Read more
Sudden onset severe excruciating upper body pain including back, abdomen, chest, throat, neck causing difficulty moving, difficulty breathing, difficulty speaking, nausea. Severe pain lasted 20-25 minutes then slowly diminishing over next hour. After severe pain diminished, ongoing symptoms included severe fatigue, lack of fine motor coordination, brain fog, weaknesses.
15 2021-05-25 facial paralysis Vaccine was given 5/23, on 5/24 she felt a heaviness in her chest, this persisted to 5/25 when she f... Read more
Vaccine was given 5/23, on 5/24 she felt a heaviness in her chest, this persisted to 5/25 when she felt like she could not eat. When she told her mother that's when mom noted the facial droop and took her to ER for evaluation. There she was given steroids and a prescription for eye drops and oral steroids. She has not taken the oral steroids at this time but nearly all of her symptoms have resolved.
15 2021-05-25 seizure Driving her to school this morning, she had a grand mal seizure for a little more than a minute...a ... Read more
Driving her to school this morning, she had a grand mal seizure for a little more than a minute...a couple hours until back to communicating. She's recovering perfectly as usual. She has them occasionally (every few months) but normallly driven by her menstrual cycle which is not coming up and made this uncommon. I just wanted to report it so you have the information. It could be in the birth defect category below, but I'm not a doctor so not sure and selected none of the above.
15 2021-05-25 unresponsive to stimuli Patient claimed she saw spots and was then unresponsive to the mother. Blood pressure was taken pri... Read more
Patient claimed she saw spots and was then unresponsive to the mother. Blood pressure was taken prior to EMT arrival with blood pressure of 105/68 and pulse of 70. Patient barely ate that day prior to coming in for the vaccine. Mother later disclosed that the patient had a event similar to this prior (date unknown) with the patient after getting an IV injection.
15 2021-05-26 concussion After the vaccine within second my child was sweating was taken out the waiting area before the 15 m... Read more
After the vaccine within second my child was sweating was taken out the waiting area before the 15 minutes and passed out on the floor .we have a broken jaw missing teeth and concussion there no protocol being followed my family is going through the worst right now this could have been avoided if guidelines were followed
15 2021-05-26 seizure Pt came in to pharmacy with her mom for her 1st dose Pfizer vaccine appointment at 2pm on 5/26/21. W... Read more
Pt came in to pharmacy with her mom for her 1st dose Pfizer vaccine appointment at 2pm on 5/26/21. We checked her in and (pharmacist ) gave her shot with her mom present at 2 10pm and she was fine with no issues. Within 2 minutes in of her observation period, she started fainting and having seizure like for about 10 seconds, and regained conscious and said she felt dizzy and then blacked out. She was pale and sweating and asked for water. Our shift lead happened to be closed by her chair where she was sitting so she prevented pt from falling down from the chair and called pharmacist for help from inside the pharmacy. Pharmacist rushed to the patient and asked shift lead to call 911. Pt was consious, but lethargic, she could breath normally, no sign of obtruction airway. Pharmacist lift her legs up to opposite chair and started to take BP. Paramedic arrived within minutes and took her vitals which was normal. Mom agreed for paramedic took her out in stretcher to hospital for check up.
15 2021-05-27 flushing Moments after the vaccine administration, pt started to experience difficulty breathing, lightheaded... Read more
Moments after the vaccine administration, pt started to experience difficulty breathing, lightheadedness, flushing of the face, swelling of lips. Epinephrine 0.3 mg IM was administered, 911 contacted. A few minutes after the epinephrine administration, pt started to breath better. EMT came in within 5-10 minutes. Checked pt's vitals, administered required care and took the pt to the ER.
15 2021-05-28 feeling hot SWEATING. BLURRY VISION. TUNNEL SOUNDS. DIZZY. HOT.
15 2021-05-31 pain in extremity Received vaccine 5/22/21 - had some local arm swelling & pain which resolved that night. 5/23 had fe... Read more
Received vaccine 5/22/21 - had some local arm swelling & pain which resolved that night. 5/23 had fever, chills, nausea, diarrhea x2 days with complete resolution. On 5/29, developed urticarial rash on legs & arms - no improvement with OTC Benadryl. No new foods/obvious exposure to other allergens other than family had tried a new scent of their brand of fabric softener. 5/31, developed nausea, vomiting, hand/feet swelling, & had a pre-syncopal episode. Presented to ER; tachycardic with symptomatic orthostatics though vitals otherwise normal. Received IV fluids, Pepcid, Decadron with improvement in HR/symptoms. Continued to be orthostatic with some extremity swelling so received IM Epinephrine - subsequent improvement in rash, nausea. Hospitalized for monitoring. Orthostatis/nausea resolved, vitals remained stable. Some intermittent itchiness/hives present that came & went still present at the time of discharge from hospital.
15 2021-06-01 cold sweat patient received first covid 19 shot on 6/1 immediately had a rxn of turning very pale, clamy, dizzy... Read more
patient received first covid 19 shot on 6/1 immediately had a rxn of turning very pale, clamy, dizzy, and was incoherent off and on. She never fully lost consciousness however we called 911 and she was checked out by emt. Mother reported she was filling better later in the day
15 2021-06-01 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypo... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium
15 2021-06-03 feeling hot, tremor Patient stated feeling hot after vaccination. Mother states patient anxious before vaccine. Transp... Read more
Patient stated feeling hot after vaccination. Mother states patient anxious before vaccine. Transported to observation with help from paramedic. 1st vitals: BP 152/109, P 121, Resp. 19, O2 95%, 15 years old BS 85. Shaking and crying. No complaint of pain or difficulty breathing. Second vitals: BP 138/86, P 107, T 98.7. Mother decided to call for transport and observation.
15 2021-06-03 flushing Vasovagal response, anxiety in Pod 7. Pt reported dizziness and was lowered to ground, supine w/ B... Read more
Vasovagal response, anxiety in Pod 7. Pt reported dizziness and was lowered to ground, supine w/ BLLE elevated on chair. Slight flushing in face. No facial edema noted. Auscultated lungs/airway, CTA, no stridor or other adventitious lung sounds noted. Transported to Med Obs 1 via litter for further assessment. VSS. Encouraged water, pt drank 1 small bottle and ate 2 pretzels. Pt reported dizziness resolved at 1025 VS prior to escorting out stable and listed below Sitting @1030 BP120/77, HR 66, RR 12, 99%RA Standing @ 1032 BP 114/73, HR 78, RR 14, 100%RA
15 2021-06-03 migraine It left her with migraines; A slight fever; Severe fatigue; This is a spontaneous report from a cont... Read more
It left her with migraines; A slight fever; Severe fatigue; This is a spontaneous report from a contactable consumer (caregiver) via a Pfizer sponsored program and medical information team. A 15-year-old female patient (reporter's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in May2021 (at the age of 15-year-old) as a single dose for COVID-19 immunization. The patient's medical history included few immunity issues which were currently being treated. Concomitant medications were not reported. It was reported that patient has a few immunity issues which we are currently treating. Patient had her first vaccine last week, it left her with migraines, a slight fever with severe fatigue on an unspecified date in 2021. Reporter was concerned that the second would be more harsh. Please advise on your research if think that we should proceed or wait. The outcome of the events was unknown. Information on the lot/batch number has been requested.
15 2021-06-03 seizure like phenomena Patient fainted immediately after vaccination, and was described as having seizure-like activity. P... Read more
Patient fainted immediately after vaccination, and was described as having seizure-like activity. Patient felt better after resting and drinking juice; refused transport to hospital and was released to home.
15 2021-06-03 seizure Immediately after the patient received the vaccine, the patient turned pale and said, "I feel a litt... Read more
Immediately after the patient received the vaccine, the patient turned pale and said, "I feel a little dizzy and my vision is blurry." The patient fainted and ended up having a seizure. Once the patient regained consciousness, the patient was nauseated and vomited. Minutes later she had another seizure but immediately came out of it. We asked the patient if this happen to her during the first dose and she said it did not. The patient does not have a history of epilepsy. The patient's mother did say she had the exact same reaction when she had braces put on. The patient sat in the waiting room for 30 minutes while drinking water. Before the patient left, we had check up on her and she said she felt completely fine. I (the pharmacist) called the mother a couple of hours later to check up on the patient. The mother said she felt fine as if nothing ever happened. I did recommend to her that her daughter gets checked up at urgent care today just to be on the safe side. The mother said she has an appointment with her primary care next week.
15 2021-06-05 flushing, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Additional Details: After getting the Pfizer vaccine, patient started to feel fainted. Patient stated that she has lightheaded and ringing in her ear. Patient was helped to lie down on the ground with both feet elevated. After 20 minutes, patient was feeling better. Blood pressure at this moment was 101/69, and pulse was 74. Patient was able to stand up and walk around.
15 2021-06-05 flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: we called 911, 3 EMT's arrived and they took her vitals and stayed with her and her father for roughly 20 minutes and she left with her father.
15 2021-06-05 pain in extremity, seizure, unresponsive to stimuli, cold sweat Immediately got a shooting pain in arm with light headness. Got pale within 30 seconds. Started to h... Read more
Immediately got a shooting pain in arm with light headness. Got pale within 30 seconds. Started to have a seizure with uncontrollable arm and leg movement. Arms went limp broke out in a clammy cold sweat. Pupil got enlarged and were unresponsive. Patient blacked out and this continued off and on for 15-20 minutes post injection. Had very labored breathing. EMS arrived and attended to patient
15 2021-06-05 pain in extremity, seizure Patient felt shooting pain up her arm, felt light headed, and then had a seizure. 911 was called, sh... Read more
Patient felt shooting pain up her arm, felt light headed, and then had a seizure. 911 was called, she was taken out in the parking lot by EMT. Spoke to the parent and she has not had any prior history of adverse reaction to other vaccinations. According to the EMT, immunizer may have hit the never. Patient is doing fine as of few hours later, upon follow up with the parent.
15 2021-06-05 pain in extremity She got the second shot of COVID-19 shot around 3 PM on 6/3. She had a sore arm, lower fever, and he... Read more
She got the second shot of COVID-19 shot around 3 PM on 6/3. She had a sore arm, lower fever, and headache on the second day (6/4), which was expected. On 6/5, she complained about chest congestion in the morning. She described that it felt like running after a mile. I asked her to drink more water and get some rest. The discomfort didn't get away, so I consulted her pediatrician over the phone. Her pulse and blood pressure were normal (86/103/75). She didn't feel short of breath. And her finger oximeter result was 99. In the afternoon, she described the discomfort as after some strenuous exercise and kept putting her hand over her heart. She felt tired and didn't have a good appetite for lunch or dinner, and only ate half meals. After dinner, around 9:30, she throws up and felt a little better. Then she took a capsule of Motrin liquid gel of 200 mg ibuprofen and went to bed. She slept well and felt OK this morning.
15 2021-06-05 seizure, unresponsive to stimuli, seizure, unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Severe
15 2021-06-05 unresponsive to stimuli, flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: we called 911 3 emt arrived they took her vitals and stayed with her and her father for roughly 20 minutes and she left with her father
15 2021-06-05 unresponsive to stimuli, tremor, flushing, unresponsive to stimuli, tremor, flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Additional Details: After vaccine administration at approximately 09:10a, per mother stood up from vaccine area to walk to post-vaccination area with complaints of feeling light headed. Pharmacist notified & went to help pt in the post vaccination area. Pt was diaphoretic, pale, and appeared as though she was going to faint. Pts mother, pharmacist, and bystander assisted patient to the ground with legs bent, water, crackers, and ice pack provided. Patient was starting to become more responsive. Paramedics called.
15 2021-06-06 burning sensation PT started to feel "dizzy and complain of body burning". PT slumped over with no LOC. Reaction tam n... Read more
PT started to feel "dizzy and complain of body burning". PT slumped over with no LOC. Reaction tam notified. PT remained slumped over for 10 minutes, then said she was starting to feel better. Talking normal, drinking water with no complaints. Sitting up on phone. PT stayed extra 30 minutes per reaction team order. Vitals as follows: 1426 Lying BP 137/89 HR 84 RR 16 SPO2 98% 1501 Lying BP 142/83 HR 60 RR 18 SPO2 96% 1520 Sitting BP 130/68 HR 84 RR 18 SPO2 98
15 2021-06-06 feeling hot, seizure Patient fainted/passed out a few minutes after receiving the vaccine. Mom stated patient had a littl... Read more
Patient fainted/passed out a few minutes after receiving the vaccine. Mom stated patient had a little seizure. Patient retain consciousness after 1-2 minutes and did not recall what happened. She felt hot/sweaty and had minor vomiting. 911 was called. They arrived and left without any major concerns.
15 2021-06-06 flushing, weakness Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mil... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild
15 2021-06-06 flushing, tremor, unresponsive to stimuli, weakness Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: after immunization patient was sat down for observation. shortly after, patient felt weak in her chair. pharmacist was called to clinic. upon arrival patient continued to feel weak. while speaking with her mother next to her, patient fainted in her chair and was promptly brought tot he floor and legs raised. patient awoke shortly after and was given water. after a few minutes patient fully recoverd. patient stated for another 15 minutes for further observation. patient had no further issues
15 2021-06-06 flushing Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: I... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Immediately after I gave her the injection I looked at her face and her eyes rolled up and her pupils were dilated and I said to her Are You OK and that was when her head fell back and and it hit the back of the wall. I looked at the top of her head and it was red and she was sweating. Patient was still sitting and we called 911. Paramedics came and checked her out. She became aware and responsive within minutes. She stayed about 30 min.
15 2021-06-06 seizure PATIENT FAINTED AND FELL TO THE GROUND COUPLE OF MINUTES AFTER RECEIVING HER VACCINATION. SHE HAD S... Read more
PATIENT FAINTED AND FELL TO THE GROUND COUPLE OF MINUTES AFTER RECEIVING HER VACCINATION. SHE HAD SEIZURES ASSOCIATED WITH SYNCOPE.
15 2021-06-06 seizure pt fainted within a couple of minutes and then appeared to have a seizure (brought arms towards body... Read more
pt fainted within a couple of minutes and then appeared to have a seizure (brought arms towards body), this was witnessed by patient's mother. Vaccinator arrived and while talking to pt the same thing happened.
15 2021-06-06 tremor, feeling cold, cold sweat Patient fainted in the waiting area within 3 minutes of receiving her 2nd dose of the Pfizer/Biontec... Read more
Patient fainted in the waiting area within 3 minutes of receiving her 2nd dose of the Pfizer/Biontech Covid vaccine. According to witness and mother, the patient fell to the ground from a seated position and was shaking. It is unknow wether the patient lost consciousness. Witnesses reported the patient may have hit her head when falling. Patient was cold and clammy to touch. 911 was called and transported to hospital.
15 2021-06-06 unresponsive to stimuli Approximately four minutes after vaccination patient became pale and unresponsive. BP 90/60, HR 93, ... Read more
Approximately four minutes after vaccination patient became pale and unresponsive. BP 90/60, HR 93, O2 Sat 93%. When she regained consciousness attempted to walk with nurses and parent short distance to stretcher. Lost consciousness again and was carried to stretcher. 911 called. Slowly regained consciousness. Sipped apple juice. Within 10 minutes, O2 Sat 97%. Evaluated by EMT-Ps, but was not transported to hospital. Walked out of clinic on own, feeling much better.
15 2021-06-07 feeling hot Patient received second COVID-19 vaccine on 06/06/2021 and on the next morning of 06/07/2021 she wo... Read more
Patient received second COVID-19 vaccine on 06/06/2021 and on the next morning of 06/07/2021 she woke up with a headache, large swollen bump on her left axillary that was red, warm and painful to touch and no fever.
15 2021-06-07 flushing Patient received 2nd dose of Pfizer vaccine today. The patient's mother asked for assistance as dau... Read more
Patient received 2nd dose of Pfizer vaccine today. The patient's mother asked for assistance as daughter was "having a reaction." Vitals/assessment at this time: 62, 16, 82/54, 99% on room air. Patient looks pale, diaphoretic, says "my vision is blurry". Questioned mother and patient, mother said "this is the first time this has happened." When asked about if she had anything to eat, she said she had not eaten breakfast. OJ given. Patient awake, alert, oriented X3. Sitting in chair. Skin warm to touch/ looks flushed. Vitals Reassessment- 72, 92/59, 95% room air. Repeat vitals taken x 2. Patient noted feeling better. Patient drank all orange juice, moving extremities, talking, walking with steady gait. Home with parent.
15 2021-06-07 tremor A 15 year old female who has completed a 15-minute observation period with the following signs and s... Read more
A 15 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness. Pfizer-BioNTech COVID-19 vaccine # 2 in series administered. Per mother, patient started shaking and passes out Action(s) taken: Transferred to higher level of care. ED. 911 called Allergy to COVID-19 vaccine documented in Allergies activity: no
15 2021-06-07 tremor Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Sys... Read more
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Shakiness-Medium
15 2021-06-08 weakness Myasthenia gravis exacerbation causing respiratory failure and intubation. Today is day 12 of sympto... Read more
Myasthenia gravis exacerbation causing respiratory failure and intubation. Today is day 12 of symptoms. She also has profound weakness from her myasthenia gravis. Treated with intubation, high dose steroids, and increased pyridostigmine.
15 2021-06-08 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Additional Details: Patient started to feel dizzy and lightheaded and sweaty within 1 minute after getting the vaccine. We informed the clinic nurse who took over care. Patient drank some cold water and after about 15 minutes, patient started to feel better. Patient is going home with her mom. Patient is feeling much better now
15 2021-06-09 inability to speak, tingling, tremor The evening of the vaccine Maddison had slightly labored breathing, pins and needles feelings in fee... Read more
The evening of the vaccine Maddison had slightly labored breathing, pins and needles feelings in feet and hands. Fever, body aches. The morning after while taking their temperature, Maddison said she couldn't see anything then fell into my arms. Her pupils quickly dilated, she made gutteral sounds while shaking slightly then lost consciousness. I couldn't see her breathing for about 15 seconds and she was confused when she came to. She couldn't hear, see or speak during the episode. We took her to the emergency room where a chest xray and ekg came back clear.
15 2021-06-09 weakness Patient presented to the observation room with her mother to schedule 2nd appointment and be observe... Read more
Patient presented to the observation room with her mother to schedule 2nd appointment and be observed after vaccination. Patient lost consciousness and was caught by the observation staff and lowered into a chair. Staff states patient lost consiousness for approximately 30 seconds. Once patient came to she knew her name, where she was, and the date. She still felt very dizzy. Patient's pulse and O2 saturation were immediately taken showing a pulse of 45 and O2 sat of 100%. Unable to get pulse up, lead of operations called for ER support. Patient was gray in color, very weak, and still complaining of dizziness when ER staff arrived. Unable to walk due to weakness, patient was transferred to cart and taken to ER
15 2021-06-09 bell's palsy Bell's palsy; tongue tingling, "weird taste" starting May 22, developed left sided Bell's palsy May ... Read more
Bell's palsy; tongue tingling, "weird taste" starting May 22, developed left sided Bell's palsy May 31
15 2021-06-09 feeling hot Aproximately 5 minutes after receipt of 2nd dose, patient began feeling hot, and dizzy. Symptoms pro... Read more
Aproximately 5 minutes after receipt of 2nd dose, patient began feeling hot, and dizzy. Symptoms progressed to gagging, loss of vision and hearing. Patient was placed in the modified tredelenburg postion, vital signs obtained and monitored for roughly 40 minutes. Vital signs were initially low, RN assessed patient had not even prior to vaccine adminsitration. Offered water and energy bar, placed bag of ice on back of neck. Patient did not experience and respiratory distress throughout event. Mother was educated on signs and symptosm to monitor for post vaccine and if any new or worsending symptoms presented to seek care at the emergency room.
15 2021-06-10 weakness Patient received her second dose of the Pfizer COVID-19 vaccine Friday, June 4th, 2021. One day afte... Read more
Patient received her second dose of the Pfizer COVID-19 vaccine Friday, June 4th, 2021. One day after the second Pfizer Covid 19 shot, (Saturday, June 5th, 2021), Patient experienced fever, fatigue, weakness and swollen lymph nodes. Two days after the second Pfizer Covid 19 shot, (Sunday, June 6th, 2021), Patient still had those symptoms in addition to the break out of several painful genital laisons. She visited her pediatrician Tuesday, June 8th, 2021, and the laisons were tested for the herpes virus. Patient was also prescribed oral antiviral medication, and topical steroid creams. The results for the herpes test came out negative. Today, June 11th 2021, the laisons are still present and painful, and continue to be treated.
15 2021-06-10 pain in extremity The patient was administered 0.3ml of pure, undiluted, Pfizer COVID-19 vaccine around 9:15 AM. When ... Read more
The patient was administered 0.3ml of pure, undiluted, Pfizer COVID-19 vaccine around 9:15 AM. When the error was discovered the patient/patient's parents were reached out to. Around 5:30 PM, we finally got in touch with the patient's mother to inform her of the error. At this time the patient's only side effect was a sore arm. We asked the patient's mother to keep us informed of any other side effects/adverse events that occur and have yet to hear anything.
15 2021-06-10 pain in extremity Patient got her 2nd Pfizer Covid-19 shot at 5:45 PM on Tues 6/8. She had some of the typical side ef... Read more
Patient got her 2nd Pfizer Covid-19 shot at 5:45 PM on Tues 6/8. She had some of the typical side effects the next day- a sore arm, flu-like body aches, a headache and fatigue. In the middle of the night Wed night/Thurs morning at 3AM she woke up with chest pain and difficulty breathing. In her words, her "heart really hurts and it is hurts to breath." I gave her 1 (500 mg ) capsule of Tylenol. This was the first pain reliever she had received post shot. She also applied Frankincense oil over her heart. Patient was unable to go back to sleep for a few hours because it hurt too much. She did finally fall back asleep in the early morning hours. Yesterday (Thursday 6/10) she reported that she was feeling a lot better. Her heart was still a little painful but by today, Friday 6/11, she says she feels fine. When I heard on the news about a number of other children between 12-15 who reported heart pain, I thought we should let you all know. I am a little worried that there might be some kind of long term complication for her heart.
15 2021-06-10 pain in extremity fever; nausea; vomiting; diarrhea; mild arm soreness; mild swelling at injection site; mild to moder... Read more
fever; nausea; vomiting; diarrhea; mild arm soreness; mild swelling at injection site; mild to moderate chills; mild to moderate muscle aches; This is a spontaneous report from a Pfizer Colleague from a contactable pharmacist (patient parent). A 15-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported via an unspecified route of administration on 04Jun2021 (at the age of 15-years-old) as single dose for COVID-19 immunization. Patient did not have known drug allergies. Patient did not have any chronic medical conditions. Patient's medical history included the first dose of bnt162b2 vaccine. The patients concomitant medications were not reported. In Jun2021, patient experienced mild arm soreness, mild swelling at injection site, mild to moderate chills, mild to moderate muscle aches, and having a slight temp the day after her vaccine. On 07Jun2021, the patient started experiencing fever, nausea, vomiting, and diarrhea. The clinical outcome of all events was unknown. Information about batch/lot number has been requested
15 2021-06-10 unresponsive to stimuli Status post vaccination , pt. experienced vasovagal syncope. Pt became dizzy, disoriented, and brief... Read more
Status post vaccination , pt. experienced vasovagal syncope. Pt became dizzy, disoriented, and briefly unresponsive. Using a pulsometer, her HR was determined to be 49BPM with an O2sat of 99%. Patient was attended to and provided water, she became oriented and responsive within a few minutes. The patient was monitored for 30 minutes.
15 2021-06-11 pain in extremity Henoch-Schonlien Purpura. Abdominal pain, rash covering legs and torso, abdominal pain, joint pain l... Read more
Henoch-Schonlien Purpura. Abdominal pain, rash covering legs and torso, abdominal pain, joint pain leg pain
15 2021-06-12 cold sweat PT LOST CONSCIOUSNESS 5 MINUTES AFTER VACCINE, SLOW HEART RATE, CLAMMY SKIN, NAUSEA, UNCONTROLLED BL... Read more
PT LOST CONSCIOUSNESS 5 MINUTES AFTER VACCINE, SLOW HEART RATE, CLAMMY SKIN, NAUSEA, UNCONTROLLED BLADDER RELEASE. PT REGAINED CONSCIOUSNESS AFTER 30 SECONDS AND AMBULANCE WAS CALLED. BP NORMAL AND PT RECOVERED AFTER ABOUT 20MINUTES AND WAS ABLE TO WALK ON HER OWN.
15 2021-06-12 pain in extremity, weakness 2nd Dose given at 830 am on June 5th. At 5pm sameday pt. Was having weak legs,dizzy, slight headache... Read more
2nd Dose given at 830 am on June 5th. At 5pm sameday pt. Was having weak legs,dizzy, slight headache trouble standing . By 9 pm pt. Was very weak, chills and she felt as if she had fever but temp was 97.3 , by 10pm she could not get out of bed because she felt so weak and achy,, her arm was so sore I couldn?t even touch it & she couldn?t lift it , had severe chills but also started to run a fever of 101.3. She could not sleep and was quite scared. I slept in her room with her to make sure she didn?t stop breathing. Gave sips of Gatorade and at 1130 gave her 1 pill tylenol rapid gel release for pain/fever sips of Gatorade through the night
15 2021-06-12 pain in extremity Sore arm and fever
15 2021-06-13 weakness Approx. 5 minutes after vaccine given Pt. felt weak and like she was going to pass out. She was sitt... Read more
Approx. 5 minutes after vaccine given Pt. felt weak and like she was going to pass out. She was sitting in chair and we gave her water and she put her head between her legs. After approx. 2-3 minutes she felt better and sat up drank water. After about 2 more minutes she felt dizzy and she went limp, she was diaphretic, pulse 50, bp 80/palp. Pt. arroused and was able to speak approx. 2 minutes later but was very weak and states "I cannot see anything". Squad was called they arrived and assumed care. Pt. was alert and oriented and was able to talk. Pt. Mom was with the patient the whole time
15 2021-06-13 concussion This patient received her 2nd Pfizer vaccine on 6/10/21 @1300. Upon waiting 15 minutes, patient was ... Read more
This patient received her 2nd Pfizer vaccine on 6/10/21 @1300. Upon waiting 15 minutes, patient was cleared of s/sx and reported feeling well to go home. The following day, mother called and reported her daughter was feeling nauseous, tired, and suffered a headache. She then proceeded to faint in the bathroom around 6am on 6/11/21. The reaction occurred approximately 12 hours after the vaccination. After the incident, patient slept until 14:30, and visited her primary care doctor, who then characterized her symptoms as a concussion.
15 2021-06-13 numbness After administration of 2nd Pfizer vaccine, patient became dizzy/light headed. After laying down for... Read more
After administration of 2nd Pfizer vaccine, patient became dizzy/light headed. After laying down for 20 mins, patient began shivering, developed a headache, had numbness in hands, and was tired. After about 30 mins with no improvement of symptoms, 911 was contacted. Paramedics arrived and gave patient EKG, BP, Temp, and Glucose. All were within normal limits.
15 2021-06-13 migraine Medication resistant migraine that lasted 4 days
15 2021-06-13 tingling, speech disorder Headache, vomiting, confusion, lost ability to speak, hypokalemia, tingling in arm all in evening of... Read more
Headache, vomiting, confusion, lost ability to speak, hypokalemia, tingling in arm all in evening of 6/12
15 2021-06-13 tremor Pt presents for Covid 19 vaccination. Pfizer vaccine given per mothers consent. Pt tolerated well. P... Read more
Pt presents for Covid 19 vaccination. Pfizer vaccine given per mothers consent. Pt tolerated well. Pt observed in recovery area for 30 min due to history of allergy to Peanuts. Pt did well in recovery and was discharged home with mom. After approx 10 min, pt mother brought pt back into recovery area stating pt had abd pain, shaking and did not feel well. Pt placed in lying position. Sat up to vomit. Vomited small amount. Mother states pt has history of significant anxiety. Pt denies any sob or tingling. Resp easy and unlabored. Pt able to answer questions. A & O x 3. VSS Pulse ox 99 sat. bp 130 /80 hr 60-70. Mother requests EMS to be called. EMS called. Attempt to reassure pt and calm down. No progressive symptoms noted. Pt VSS remain stable. EMS arrives. Pt transported to hospital per EMS per moms request. Dr medical lead called per myself. No medications given. Pt was discharged that day from ED and refered to follow up at hospital
15 2021-06-13 unresponsive to stimuli, weakness, tremor Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting... Read more
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: Patient had fainting/suncope 5 minutes after getting 2nd dose of Pfizer vaccine. Her BP dropped to 52/25/35 with shakiness. She recovered with full consciousness very quick after 2 minutes, but it took for 20 min for her BP back 97/75/96. Advised to go to Urgent Care immediately.
15 2021-06-14 feeling cold 5/18 - received Pfizer COVID Vaccine dose 1. 5/19-5/20 - very tired 5/20-5/21 - overall did okay 5/... Read more
5/18 - received Pfizer COVID Vaccine dose 1. 5/19-5/20 - very tired 5/20-5/21 - overall did okay 5/24 - woke up extremely nauseous, vomiting, fever to 100.6F -> increased to 102.5F, chills, near syncope in shower so ambulance called and went to Emergency Department 5/25 - similar symptoms as the day prior but also had headache, continued extreme fatigue. Fever continued. 5/26 - diarrhea started, vomiting resolved, continued headache and fatigue. Fever continued. 5/27 - last day of fever. Headache resolved 5/28 - diarrhea resolved.
15 2021-06-14 pain in extremity Pt received Pfizer COVID-19 vaccination at a COVID Vaccine Clinic held at Hospital on 6/12/21. She ... Read more
Pt received Pfizer COVID-19 vaccination at a COVID Vaccine Clinic held at Hospital on 6/12/21. She received the vaccine approx 9 am and had c/o of L arm pain but didn't notice bruising welts/rash until approximately noon same day. She presented to ER same day. Photos of rash were taken in ER. Swelling, tenderness, joint pain and rash noted to left upper extremity (LUE). Parent reports 5-6 "bruised welts" to LUE were noted prior to ER visit. Pt took cetirizine for rash and Tylenol for pain.
15 2021-06-14 seizure Patient exhibited symptoms of a seizure that lasted about 1-2 seconds. She came out of it right awa... Read more
Patient exhibited symptoms of a seizure that lasted about 1-2 seconds. She came out of it right away, drank some water, rested for 15 minutes then felt fine and was able to go home with her grandmother. She said she felt light-headed after her shot. She didn't seem to remember what happened though. She wasn't too talkative to tell us more about how she felt.
15 2021-06-14 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotens... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: After administration of her first COVID vaccination from Pfizer, patient was instructed to take a seat for 15 minutes for monitoring. Patient fell forward on her chair and hit her head on the shelf. Patient was immediately being cared for by the pharmacist who administered the vaccine. Patient was kept laid down on her side to prevent further complications, was given water. She was responsive, but felt nauseous and stomach ache. Blood pressure was taken 92/62 and 86/64 and was okay after 30 mins
15 2021-06-15 weakness Anaphylaxis shock became dizzy weak and throat started closing up had to be given an epi-pen rescue ... Read more
Anaphylaxis shock became dizzy weak and throat started closing up had to be given an epi-pen rescue was called decided not to take her to the hospital pediatrician decided not to let her have a second shot too risky
15 2021-06-15 concussion Developed syncope about 4 days after vaccination. Developed concussion symptoms from hitting head.
15 2021-06-15 pain in extremity administered undiluted dose. as of 24 hours-sore arm, fatigue.
15 2021-06-15 sciatica, pain in extremity sciatic, left leg pain
15 2021-06-16 discomfort Dizziness/lightheadedness; Nausea; Blurred vision; Terrible headache; a little palpitation; Clogged ... Read more
Dizziness/lightheadedness; Nausea; Blurred vision; Terrible headache; a little palpitation; Clogged throat; this heaviness (not clarified); This is a spontaneous report from a contactable consumer (parent). A 15-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 15May2021 16:00 (Batch/Lot Number: EW0182) as single dose for COVID-19 immunisation. Medical history included no other illness. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications 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. The patient previously received Amoxicillin, Azithromicin, Cefdinir, Gardasil(Pf) and had allergy. The patient had Nausea that does not go away with Gardasil. She also received HPV vaccine previously and experienced nausea and the dizziness for a month. Reporter stated, "she did not have any allergic 'condition' (not clear) but she was allergic, she had always had a rash when she had this Amoxicillin this antibiotic. She was allergic to Penicillin." The patient had the COVID Pfizer Vaccine on 15May2021 and as soon as she had her first dose she started to feel nausea and dizziness and from there 5 days later she had, she felt a terrible headache, 'this heaviness' (not clarified), headache, dizziness, palpitation. The reporter took her to the emergency room, they did all the test and they didn't really see anything in the results. From there she cannot stop to have nausea and dizziness and clogged throat so the reporter had to give allergy medication to her every day. She did have, she never had an allergic reaction to any vaccine but the HPV vaccine (captured as unspecified vaccine in tab) what was similar to what she is experiencing now. She had nausea and the dizziness for a month that she couldn't stay in school and she has this nausea and dizziness and clogged throat she has to run for this allergy medication what normally she never needed. So, she doesn't want to take this second dose and the reporter was wondering if it is Pfizer because she was just like (Height), a (Weight) pounds if because the reporter understand the vaccine is one for everybody, isn't this strong for a kid with that height that weight, that you do not needed the second dose. The patient could not she said she will not because she goes to school and she feel the nausea and dizziness and so. The reporter would like to report it because it maybe Pfizer's that she was thinking that 1 dose would be enough for kids. When asked about the start of experiencing adverse events, the reported stated that "Well the nausea and dizziness, she was a little bit not sure about like headache right after like her we stayed there like half hours because the doctor said to stay there because she has her reaction to which but then we just the reporter felt the nausea and everything was so bright you know, the reporter had the same effect but her went away and the patient after we received she was, the whole day but not too bad, 5 days after then she but she was already with this nausea, dizziness and 5 days after she got the palpitation, bad headache, nausea, dizziness and then I took her to the emergency room." Reporter stated, "No they have improved, the only thing now left is every day she has this nausea, dizziness and then she said about dizziness and then nausea and then clogged throat and then the reporter gave her the 'allergic pill I gave that, to this allergy' (not clarified further) really she gave only 1 tablet a day." Reporter stated, "On 20May2021, they did a blood test, they did urine test, they did a ECG, so the hospital did all and the doctor too, nothing new." The reporter had lab test result on chart, she stated they put on her chart but she also had the copy of the results. Okay, here they put the result is a line on the chart. Okay here they put like linear line lab test complete, she get all the line because here they didn't put results but screen for metabolic and kidney disorder they did, they did an 'urinary tract infection' (not clarified) they have marked in the ECG. Okay you going to ask for specific (incomplete sentence)." The patient had no other illness but reporter need to know what Gardasil and Covid 19 vaccine have in common because the symptoms were very similar. Nausea that does not go away. She asked if it is the preservative or what ingredients. Never had a reaction to any other vaccine. She just wanted to call the Medical Department if she should have the vaccine on Saturday or not. On 15May2021, 4:30 AM, the patient experienced dizziness, nausea, lightheadedness, blurred vision, headache, a little palpitation (as reported). The patient received treatment Children allergy medication. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events clogged throat, heaviness was unknown and other events was not recovered.
15 2021-06-16 numbness Client received her first dose of the Pfizer Covid-19 vaccine (Lot # EW0187 Exp. 08/2021) at 12:38 P... Read more
Client received her first dose of the Pfizer Covid-19 vaccine (Lot # EW0187 Exp. 08/2021) at 12:38 PM on Wednesday 6/16/21. EMTs and Lead RN responded to the incident. Lead nurse signaled over EMT at approximately 12:44 that she needed the gravity bed for a client. The client was found lethargic when EMTs arrived with a gravity bed. The client was a 15-year-old female with a chief complaint of dizziness. Client?s older brother was present during incident. Interpreter translated information between EMTs/RN and client/client?s brother. The client was alert and tracking to voice. Per the lead nurse, the client was complaining of dizziness after the administration of her first Pfizer vaccination. The client had no known allergies or medical history. The client also did not take any medication. The client's brother stated that ?she had chicken nuggets and a smoothie? to eat at approximately 10:00. The client's brother also stated that ?they had been standing at the border crossing under the sun? for an extended period of time. The client's airway, breathing, and circulation were intact. The client was negative for hives, swelling, shortness of breath, or other signs of anaphylaxis. The client was nauseous, dizzy and complained of numbness on both arms. The client was unable to bear weight and not following simple commands before she was assisted to gravity bed by EMT and RN. The client then briefly lost consciousness for less than a minute before becoming alert to person, place, date, and event. EMTs assessed vital signs every 5 minutes for a total duration of a 45-minute observation. Vital signs were taken by EMT with client lying supine immediately after losing consciousness (12:45) and were reported as follows: Blood Pressure (BP) 92/64, Pulse (P) 66, Oxygen Saturation (O2) 99%, Temperature (T) 98. Skin was intact, pale, and cool to touch immediately following patient regaining consciousness. Patient remained lying flat on gravity bed for approximately 10 minutes before she was assisted to a seated position. Patient was in a high-fowlers position when she was given a juice and granola bar. Client then stated that she was ?feeling better?. After an additional 10 minutes sitting on the gravity bed in high-fowlers position, the patient was assisted by RN and EMT from vaccination station to EMT/observation station. The client remained seated in the EMT/observation station for an additional 15 minutes. Vital signs were taken every 5 minutes during this time by EMT. They were reported as follows: 12:51- BP 112/78, P 69, O2 97%, T 98. 12:55- BP 108/78, P 77, O2 99%, T 97.9. 13:00- BP 104/78, P 66, O2 98%, T 98.1. 13:05- BP 96/62, P 83, O2 95%, T 98.1. 13:10- BP 92/68, P 76, O2 98%, T 98.1. 13:20- BP 90/70, P 92, O2 99%, T 97.6. 13:28- BP 92/72, P 93, O2 99%, T 97.9. After a 45-minute observation, client stated her condition was improving and was observed walking normally. Client?s skin color returned to a pale pink and became warm to the touch. Client denied dizziness or any other symptoms. Lead RN educated the client about what to do if symptoms returned. The client was provided with the V-Safe form and EUA form with highlighted portions pertaining to symptoms to be mindful of. The client was also instructed to call 9-1-1 if symptoms of anaphylaxis, also known as a severe allergic reaction, presented. These symptoms include difficulty breathing, shortness of breath, hives covering body, facial swelling and more. Client and client?s brother acknowledged understanding of information. The client?s brother stated that he would ?drive her straight home?. The client then left facility at approximately 13:33 with her older brother in positive disposition with steady gait.
15 2021-06-16 tremor, unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
15 2021-06-16 unresponsive to stimuli, muscle twitching Technician (licensed to vaccinate) administered vaccine to patient near pharmacist. 20 seconds or s... Read more
Technician (licensed to vaccinate) administered vaccine to patient near pharmacist. 20 seconds or so after administration, patient stated felt dizzy and immediately became unresponsive and head dropped to chest. Technician stated he then lifted the patients head because he heard a "snoring" sound indicating airway may be constricted due to positioning. Technician stated the patient's body twitched and became ridged, throwing her belongings. He called pharmacist (myself) for assistance. I immediately checked for breathing and pulse, both of which were evident. I observed pt vitals for about 20 seconds before the pt opened her eyes and was responsive and able to talk to me. Blood pressure was 120/69. Pt remained in the pharmacy waiting area for 30 minutes after. Patient said that in the past she has nearly passed out from piercings she has had, but has never fainted before and has no history of seizures.
15 2021-06-16 unresponsive to stimuli At around 9:25 am on Thursday, June 17th, 2021, a fifteen-year-old patient walked into the vaccinati... Read more
At around 9:25 am on Thursday, June 17th, 2021, a fifteen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines. Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at approx. 9:38 am. The Pfizer vaccine was administered at 9:45 am. Patient was one of the first minor patients of the group that complained of a severe headache to observation nurse. Observation nurse gave Gatorade to the patient and she took a sip of Gatorade and was calm afterward. One of the patient?s guardians instructed her to head back to the van with the rest of the group. At approximately 10:33 am observation nurse notified charge nurse that another minor patient was having a reaction to the vaccine in the parking lot area. One of our site specialists was the first to attend to patient. Site specialist stated that she saw the patient walking with one of her guardians in the parking lot and looked like she was about to faint. Charge nurse hooked up patient to the pulse oximetry and called 911 at approx. 10:34 am. The patient?s O2 level was 83 with a pulse of 107. The charge nurse observed that the patient was under a lot of stress and was hyperventilating and unable to verbalize how she was feeling. Shortly after, the patient fainted due to hyperventilation. Observation nurse advised the patient to calm down and take deep breaths but the patient did not comply and continued rapid breathing. The patient started to vomit and made some gurgling sounds in her mouth and the charge nurse with the help of site specialist laid the patient on her left side. Shortly after, the patient stopped breathing. Observation nurse administered the epi-pen on the patient?s right thigh. Immediately after administering the epi-pen, patient started to breathe again with an O2 level of 98 with a pulse of 110; but the patient was still unconscious and unresponsive. At approx. 10:36 am first responder paramedics arrived at the scene and took the patient to hospital for further evaluation.
15 2021-06-17 numbness nausea, numbness in arms, bilateral upper abdominal pain and lowered bp
15 2021-06-17 tenderness Tenderness in the arms, needle broke while being vaccinated not sure if fully went through.
15 2021-06-18 weakness Felt very weak; Body ache; Body temperature of about 100.6F; This is a spontaneous report from a con... Read more
Felt very weak; Body ache; Body temperature of about 100.6F; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 15Jun2021 at 17:15 (at the age of 15-year-old), as 1ST DOSE, SINGLE for covid-19 immunization .The patient medical history was not reported. The patient's concomitant medications were not reported. On 15Jun2021, the patient felt very weak, body ache and body temperature of about 100.6F for over 24 hours now. The reporter would like to know what they need to do about it. Also wants to know if these has been reported side effects post-vaccination; and if so, how long does this usually lasts. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 16Jun2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
15 2021-06-18 numbness 1st night numbness in right arm (not the vaccinated arm) spreading to the entire right side of the b... Read more
1st night numbness in right arm (not the vaccinated arm) spreading to the entire right side of the body with the next 2 hours. Numbness similar to the numb feeling from Novacaine. By next morning, entire body was numb from toes to scalp. Full body numbness for 3-4 days, then both arms started to feel more normal, then in the next 2-3 days remaining body parts started to come back to normal, except for the scalp. After another week, the numbness faded and felt normal again. After the numbness subsided, started having difficulty falling asleep, taking up to 3-4 hours to fall asleep. Still having difficulty now falling asleep. Not sure if the sleep issues are vaccine related.
15 2021-06-18 pain in extremity, numbness, weakness, tingling Numbness ,tingly sensation, weakness, pain on left hand palm that started at 130am and traveled to t... Read more
Numbness ,tingly sensation, weakness, pain on left hand palm that started at 130am and traveled to the forearm by mid morning and shoulder. Went to ER on 6/15/21 , several tests were done, all was normal. The pain continued the next day 6/16/21, we went to Hospital ER , more tests done, all was normal once again and we were told to follow up with primary care doctor for Neurology referral
15 2021-06-18 pain in extremity Fever; Headache; A lot of pain in throat; Couldn't swallow; arm was hurting; This is a spontaneous r... Read more
Fever; Headache; A lot of pain in throat; Couldn't swallow; arm was hurting; This is a spontaneous report received from a contactable consumer (mother). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in arm (Unknown if right or left, but thinks right) on 24May2021 (age at vaccination: 15 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unknown date in May2021 (was unsure of date, either 25May2021 or 26May2021), the patient experienced arm was hurting from the second day; on 13Jun2021 16:00, fever, headache, a lot of pain in throat and couldn't swallow. As the patient got sick and due to fever, she was sent to emergency room yesterday and they sent her home. The patient was due for second dose on an unknown date (reported as Monday, yesterday). She couldn't receive the second dose because she was sick, so she took her to the doctor yesterday because from Sunday she had a fever and Monday still having the fever so yesterday in the middle of the day, she took her to the doctor. She wasn't having symptoms from first dose, just arm was hurting, no fever or nothing else. She did not have fever after first dose until 13Jun2021 Sunday. The patient did not require a physicians' office visit. On 14Jun2021, the patient underwent test for throat infection which was negative and gave no antibiotics. The patient received the following treatment for the adverse events: Tylenol and Motrin, dose unknown, 2 pills for sore arm. For the Fever, pain in throat, headache, trouble swallowing received Tylenol every 6 hours and her daughter was getting better, no fever and headache. For swallowing: gargling with hot water, lemon, and salt, and was getting better. She no longer has the sore arm she is better now. The outcome of the event oropharyngeal pain and dysphagia was recovering, and all the other events were recovered on an unknown date in 2021. Information on Lot/Batch number was available. Additional information has been requested.
15 2021-06-20 weakness Patient was dizzy and weak after the vaccine was administered. After 10 minutes later she passed out... Read more
Patient was dizzy and weak after the vaccine was administered. After 10 minutes later she passed out. EMS came to take care of her. All the tests were normal. Her glucose level was low. She was given glucose oral gel to take before she left with her dad.
15 2021-06-20 weakness Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-M... Read more
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
15 2021-06-20 flushing, tingling At 1443 EMT observed client leaning forward in chair and approached for further assessment. Client m... Read more
At 1443 EMT observed client leaning forward in chair and approached for further assessment. Client mentioned feeling dizzy. PHN arrived at 1445 and observed client sitting upright in chair, alert and oriented x4. PHN asked EM to bring anti-gravity chair. Client able to transfer to anti-gravity on her own. First vitals by EMT at 1445: blood pressure 148/86, pulse 92, oxygen sat 100%. Grandmother present with client. Client reported feeling dizzy and nauseous. Client denied headache, blurry vision, shortness of breath. PHN observed hives on neck, bilateral arms, chest and upper left back. PHN offered Benadryl, Grandmother accepted and stated she would go get Father who was outside. Father denied client having allergies, no pertinent medical history or current medications. At 1448 PHN administered 1ml/50mg Benadryl IM on right deltoid after checking dosage table and verifying weight with client. PHN called 911 at 1449. At 1452 client reported new onset of tingling on both hands. Client appeared pale and diaphoretic. Vitals at 1452 by EMT: blood pressure 150/90, pulse 108, oxygen sat 100%. Hives on bilateral arms improving, hives on upper left back resolved. Flushing of face and ears. 1456 PHN and EMT observe edema of lower lip. PHN on phone with 911 operator asked client if she was having trouble swallowing. Client unable to fully describe, drowsy, but was speaking in full coherent sentences. At 1456 pulse 95, oxygen sat 100%. Paramedics arrived at 1458 and assumed care. Client transported to
15 2021-06-20 tingling Upon leaving the store approximately 15 minutes after receiving vaccination, patient told her father... Read more
Upon leaving the store approximately 15 minutes after receiving vaccination, patient told her father that she felt she was having an issue with her vision and was feeling faint. Her father was able to support her as she fainted and was lowered gently to the ground in front of the store. A pharmacy technician was leaving the store simultaneously and upon witnessing the event ran back to the pharmacy to tell me I was needed to assist. When I arrived, the patient was alert and breathing and able to answer questions regarding personal information, date, time and location. Patient stated she felt normal other than some tingling sensation in her hands. Patient reported that she hadn't eaten anything since waking up that morning. EMS was already en route, and I observed the patient until they arrived. Patient has since been transported to the hospital and is currently reported in stable condition.
15 2021-06-20 tremor Pt went limp immediately after vaccine administer. Seconds later head was shaking and pt returned to... Read more
Pt went limp immediately after vaccine administer. Seconds later head was shaking and pt returned to normal. Pt was observed by pharmacist and NP from clinic. Quad was called, pt was determined to be safe to go home with mother's observation.
15 2021-06-21 slurring, unresponsive to stimuli, brain damage, depressed level of consciousness, inability to speak Patient had Pfizer COVID-19 vaccines on 5/27/2021 and 6/17/2021. On the evening of 06/18/2021 she st... Read more
Patient had Pfizer COVID-19 vaccines on 5/27/2021 and 6/17/2021. On the evening of 06/18/2021 she started having headache with nausea and vomiting. Over that weekend she progressively got worse with slurred speech and then aphasia although she could still follow commands. She was then seen in the emergency department where she was then transferred to emergency department. There she was noted to have deterioration in her neurologic exam with inability to follow commands. She was then transferred to Hospital where she became more obtunded and encephalopathic and was transferred to the.
15 2021-06-21 pain in extremity IN ER VISIT: history from patient and mother: Immediate onset lightheadedness, dry throat, intermitt... Read more
IN ER VISIT: history from patient and mother: Immediate onset lightheadedness, dry throat, intermittent neck and leg pain, then blurred vision. In ER rapid twitching of eyelids and rapid eye movements, not consistent with nystagmus. Exam otherwise normal, except lying in chair with eyes closed, answers appropriate but brief. Abated with ativan and zofran. Seen at 1912 PM in ER, came by private vehicle with mother. Discharged from ER at 2300 alert ambulatory and improved.
15 2021-06-21 tremor, unresponsive to stimuli, flushing Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: brad... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: bradycardia-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
15 2021-06-22 pain in extremity On my left arm it has hurt a lot I had to put ice and now that pain has reached my shoulder.
15 2021-06-23 discomfort, throat numbness, pain in extremity, muscle spasms None stated.
15 2021-06-23 muscle spasms, weakness Severe stomach pain/cramps 7/10, Nausea, general malaise, headache, weakness
15 2021-06-23 seizure Patient began to slouch upon sitting in the waiting seat approximately 1-2 minutes after receiving t... Read more
Patient began to slouch upon sitting in the waiting seat approximately 1-2 minutes after receiving their second dose of the COVID19 (Pfizer\BioNTech) vaccination. Pharmacist immediately assisted patient and instructed for technician to call 9-1-1 immediately. We were able to catch the patient as they were falling out of the seat. Patient then began to seize for 5 seconds. Post seizure the patient was pale but cognizant and able to answer questions correctly (i.e. Name, DOB). Patient then began vomiting profusely. Patient reported no history of seizures, however reported previous an episode of fainting 3 years ago due to heat. Patient was monitored, given bag for emesis, water for rehydration, and ice pack until EMS came.
15 2021-06-24 weakness Systemic: Weakness-Mild, Additional Details: Patient felt dizziness and just fell down and recover r... Read more
Systemic: Weakness-Mild, Additional Details: Patient felt dizziness and just fell down and recover right away . I pharmacist gave some water and check vital and she was fine and made her sit down for 30 min. then send her home
15 2021-06-24 pain in extremity Patient complained of pain in left arm (injection arm) and dizziness. I monitored patient for anaph... Read more
Patient complained of pain in left arm (injection arm) and dizziness. I monitored patient for anaphylaxis. Patient showed no signs of anaphylaxis. I took her blood pressure and temperature. BP was 75/35, heart rate = 68 and temperature 98.7. I monitored patient for 30 minutes. After sipping on orange juice, she started to feel better. Her mother was present. I asked her mother who the child's doctor is and she stated that daughter has no doctor. I recommended that her doctor be seen today to monitor.
15 2021-06-24 pain in extremity Headache; lethargy; aches in large limbs; fever; injection site pain; This is a spontaneous report f... Read more
Headache; lethargy; aches in large limbs; fever; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp. A 15-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, in left arm on 16Jun2021 at 09:45 (Batch/Lot number: Not reported) (at the age of 15-years-old) as 2nd dose single for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included oxymetazoline hydrochloride (CLARITIN ALLERGIC) for seasonal allergy. Patient had no known allergies. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular in left arm in May2021 as 1st dose single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Jun2021 at 23:00, the patient experienced headache, lethargy, aches in large limbs, fever and injection site pain. Patient did not receive treatment for the events. The outcome of the events was recovering. Information on the batch/lot number has been requested.
15 2021-06-24 pain in extremity Arm was sore; This is a spontaneous report from a contactable consumer or other non-healthcare profe... Read more
Arm was sore; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's mother) received from a Pfizer sponsored program COVAX US support. A 15-years-old female patient (second daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0168, expiration date unknown) via an unspecified route of administration on 24May2021 as 1st dose, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0217, expiration date unknown) via an unspecified route of administration on 15Jun2021 as 2nd dose, single dose for covid-19 immunization. The patient medical history and concomitant medications was none. On an unspecified date, the patient experienced sore arm. The mother of the patient reported that her second daughter received the first dose of the vaccine on 24May2021 and the second dose on 15Jun2021 and stated that she had a sore arm. The outcome of the event was unknown. Information on the lot/batch was available, Additional information has been requested.
15 2021-06-24 seizure Systemic: Dizziness / Lightheadness-Medium, Systemic: Seizure-Mild
15 2021-06-24 unresponsive to stimuli Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt expressed she can pass out after vaccines and blood draws. i explained process, side effects and what to expect. I had pt look at her mom during admin. Patient did fabulous and told she did amazing as not even a speck of blood. About 5 mins later i asked pt hiow she was, which was good. About 15 mins later, she seemed lethargic and said she was dizzy. I asked questions, took Temp and got ice packs. I then called EMS as patient was not responding appropriastely. BP, O2, HR were perfect
15 2021-06-26 weakness, unresponsive to stimuli, tingling Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Un... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: tingling sensation on the arm that got the vaccine-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: as soon after giving vaccine, pt fainted. Woke up after 1-2 mins, pt was positioned flat on her back with legs elevated. Pt took apple juice and 25mg benadryl @7:30pm, watched pt for another 15 mins and took blood pressure before leaving. BP was low but mom states she always has low blood pressure. Followed up next day around 1pm, mom states pt has pain at the injection site, headache, no fever, and sleeping
15 2021-06-26 seizure Patient fainted and muscles convulsed
15 2021-06-26 tremor, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-... Read more
Systemic: Confusion-Mild, Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Medium, Systemic: Shakiness-Mild.
15 2021-06-26 unresponsive to stimuli, feeling hot AFTER vaccination and patient attempted to stand and fell backwards in seat. Patient was incoherent... Read more
AFTER vaccination and patient attempted to stand and fell backwards in seat. Patient was incoherent, hot, sweaty, loss color to face and lips and unresponsive. Blood pressure was check 100/46 65 heart rate and temp less the 85degrees. Patient was unresponsive for about 10 minutes. EMS was summoned and the patient was given water and juice to drink. Patient slowly returned to a normal state after about 30 minutes but was still slow to respond.
15 2021-06-26 unresponsive to stimuli, feeling hot Client received dose 1 of the COVID19 Pfizer vaccine (Lot# EW0187 Exp 08/31/21) at 13:32 from RN1. ... Read more
Client received dose 1 of the COVID19 Pfizer vaccine (Lot# EW0187 Exp 08/31/21) at 13:32 from RN1. RN1 reported that within 5 seconds of receiving the vaccine, the client reported she felt dizzy and experienced a syncopal episode for 2-3 seconds. As the syncopal episode was occurring, ancillary staff, requested RN2 radio for a Lead Nurse & EMT. At 13:34 Lead RN arrived at station 6, radioed for an EMT, and observed client sitting up in the vaccination chair being held by her mother and RN1. Lead RN noted client?s head was down with her eyes open, exhibiting pallor and was diaphoretic. Lead RN asked client her name and how she was feeling. Client did not respond. Co-Lead RN entered the room at 13:35. RN1, Lead RN, Co-Lead RN, and client?s mother guided client to the floor, laid her in a supine position, lifting her legs and feet on a chair. Co-Lead RN removed client?s mask, continued to ask client her name. Within 2-3 seconds of repositioning client, she became responsive and alert & oriented to person, place, time, and event. Client also immediately stated, ?I?m fine.? EMT1, EMT2, and EMT3 came to the station at 13:36 with a zero-gravity chair. The EMTs assisted client into the zero-gravity chair. Client?s mother stated client has no underlying health conditions, no allergies, and that birth control is the only medication the client takes. The client confirmed this by nodding her head in agreeance. EMT2 gave client a bottle of water and the client immediately started drinking the water. Lead RN asked client if she had eaten or drank anything today. Client?s mother stated she did not realize her daughter had not eaten or drank anything prior to coming to get vaccinated. Client stated she was given a granola bar downstairs at check-in and ate it before receiving the vaccine. At 13:45 EMT1 took vitals. Both EMT1 & EMT2 were unable to obtain client?s blood pressure (HR:61, O2Sat: 97%). Lead RN asked client and her mother what the client?s normal blood pressure is. Client and her mother did not know, and client?s mother indicated that the client is an athlete in good shape. At 13:48, EMT3 took client?s blood pressure, which was 100/60. Client?s mother stated client was anxious about being vaccinated and has fainted when anxious in the past, but the last time was around 5 years ago. Client stated she was feeling better and no longer feeling dizzy. Client stated she just ?feels hot.? Lead RN brought client an ice pack to put behind her neck and damp paper towels to wipe her face with. At 13:59 EMT3 took client?s vitals (BP: 118/70, HR: 65, O2Sat 98%). Lead RN observed that client?s color was returning to her face and client was less diaphoretic. Client finished her bottled water and was given another by EMT2, which she started drinking. Lead RN asked client if she felt she could stand up. Client stood up and stated she was ?feeling fine.? At 14:05 all 3 EMTs escorted client and her mother to the observation room where she was monitored for an additional 30 minutes. At 14:30 Lead RN went to the observation room where EMT1was taking client?s vitals (BP: 110/70, HR: 60, SPO2 Sat 98%). Lead RN observed that client?s color had fully returned, and client was no longer diaphoretic. Client stated she ?felt fine? and was hungry. Client?s mother stated she would take client to get something to eat and EMT2 gave client an additional snack that client took with her when she left. Client and her mother left at 14:30. Client was walking with a steady gait when she exited the building.
15 2021-06-27 seizure, tremor This is her 2nd medical event within the month of vaccine, previous VAERS reported Seizure activity ... Read more
This is her 2nd medical event within the month of vaccine, previous VAERS reported Seizure activity appearance on 6/27/21 witnessed by parents. Started with yawn facial expression, drooling, pale, unconscious, shaking, called 911, normal appearing once they came, brought to facility and normal eval and EEG
15 2021-06-28 pain in extremity I accidently used a syringe that I thought was loaded with vaccine(we preload them) and injected it ... Read more
I accidently used a syringe that I thought was loaded with vaccine(we preload them) and injected it into the patient's arm. It turned out that the plunger had been pulled back but no vaccine was in it. I apologized and did administer a section shot with the vaccine so the patient was injected with a needle twice. I called the patient's home this morning and her arms is a little sore as expected but no other symptoms were present.
15 2021-06-29 cold sweat, feeling hot Patient complained of nausea/vomiting, feeling hot and clammy. Vital signs were stable. Patient was ... Read more
Patient complained of nausea/vomiting, feeling hot and clammy. Vital signs were stable. Patient was observed by onsite provider for 30 minutes before discharge in stable condition.
15 2021-06-29 pain in extremity Sore left arm two hours after the vaccine was administered. on 6/21. Soreness subsided the next day.... Read more
Sore left arm two hours after the vaccine was administered. on 6/21. Soreness subsided the next day. On 6/27 hives were noticed on both arms with mild itchy symptoms. 6/28 hives appeared on both legs with mild itchy symptom. Hives are still noticeable the morning of 6/30 on both legs and arms, Benadryl was given at 9:00 am.
15 2021-06-30 bell's palsy, facial paralysis Bells Palsy - Paralysis of left facial muscles - difficulty smiling & blinking with left side. No ... Read more
Bells Palsy - Paralysis of left facial muscles - difficulty smiling & blinking with left side. No treatment. Spontaneous recovery started 12 day after onset. Muscle weakness continues.
15 2021-06-30 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 had vasovagal reaction 5 to 10 seconds after administration. Patient was seated and head was supported in chair by both administering RPh and Mom. Epi-pen was on hand but not given. Both APRN's from minute clinic came into room to assist. Patient was lied down flat on the floor. Patient was slight hypotensive with 100 OSAT and pulse of 78. Patient lied down for 5 minutes, and then was able to sit up. She sat for another 20 minutes before she felt well enough to leave.
15 2021-07-01 flushing Pt w/ hx of severe allergy to nuts. Hx of Fainting/feeling hot w/ allergy testing @ age 9. Pt c/o ... Read more
Pt w/ hx of severe allergy to nuts. Hx of Fainting/feeling hot w/ allergy testing @ age 9. Pt c/o flushing/sweating and dizziness 5mins after vaccination BP 114/70, HR 88, RR 16, O2 Sat 98% RA -- > 120/68, 86, 18, 100% RA. Pt VSS, extremities warm to touch. Pt stable and released from vaccination site ~35mins after vaccination. Pt transferred via wheelchair w/ Dad as a precaution.
15 2021-07-01 pain in extremity whiteness on both hands, specifically on the fingers.; a sore arm down to her hand; This is a report... Read more
whiteness on both hands, specifically on the fingers.; a sore arm down to her hand; This is a report from a Pfizer sponsored program received via a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 22Jun2021 (at the age of 15-year-old), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization .The patient's medical history and concomitant medications were not reported. After the vaccination, the patient experienced sore arm down to her hand and whiteness on both hands, specifically on the fingers on Jun2021. Reporter would like to know, what that is. The outcome of the events was unknown. Information on the lot/batch number has been requested
15 2021-07-01 pain in extremity Her arm is just sore this time and she is tired; Her arm is just sore this time and she is tired; Hi... Read more
Her arm is just sore this time and she is tired; Her arm is just sore this time and she is tired; His daughter received twice the dose/ They put two and a half dosage given and they didn't diluted it correctly; They put two and a half dosage given and they didn't diluted it correctly; This is a spontaneous report from a contactable consumer (patient's father/ parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (9:00 or 09:10 this morning AM) (Lot Number: EW0180; Expiration Date: 01Aug2021) as single dose (at the age of 15-years-old) for COVID-19 immunization. Medical history included allergic to peaches. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 16:00 (Lot Number: EW0167) as single dose (at the age of 15-years-old) for COVID-19 immunization. The patient received the second dose today (of the vaccine) and father was notified by the pharmacist that she received twice the dose of the vaccine today. The pharmacist called and said they put two and a half dosage given and they didn't diluted it correctly. Her arm is just sore this time and she is tired. She got her first shot and it was fine then. The patient underwent lab tests and procedures which included body temperature: fine on 07Jun2021. The patient did not receive any treatment for the events. The outcome of the events was unknown. The events were assessed as non-serious. The patient did not have any other vaccine after COVID vaccine.
15 2021-07-02 tremor patient seemed to rapidly appear to begin to faint....sweating, nervous, lethargic, eyes remained op... Read more
patient seemed to rapidly appear to begin to faint....sweating, nervous, lethargic, eyes remained open, mom held her face and had patient focus on the mother. Gave patient water which she drink, applied cool wet cloths to both forehead, neck and face, to a while for patient to fully come around to the point of saying she felt ok, was smiling and laughing at one point....before this she did exhibit her body shaking, she had the dry heaves, felt like vomiting but nothing really came up, after which she was cold and put back on her sweatshirt....improved from that point on.We offered to call 911, which the mother was in favor of, but left it up to patient, who did not want to go to the hospital, just wanted to go home....which they did approximatey 4:57pm...an rx technician helped mom walk patient to the car.
15 2021-07-03 feeling cold APPROX AROUND 6:30P MY DAUGHTER COMPLAINED OF NOT FEELING WELL. SHE COMPLAINED OF ELEVATED HEART RAT... Read more
APPROX AROUND 6:30P MY DAUGHTER COMPLAINED OF NOT FEELING WELL. SHE COMPLAINED OF ELEVATED HEART RATE (138 AND 143), HEADACHE AND FEELING COLD
15 2021-07-05 hot flush, seizure like phenomena After vaccine, went to car, she felt a hot flash and reported dizziness, she then for about 15-20 s... Read more